Office of the Inspector General Releases 2011 Work Plan

On October 1, the Office of the Inspector General (”OIG”) of the U.S. Dept. of Health & Human Services (”HHS”) released its Work Plan for Fiscal Year 2011 (”Work Plan”).  Each year, the OIG briefly outlines activities that OIG “plans to initiate or continue with respect to the programs and operations” of HHS.  Various offices within OIG conduct audit, evaluation, investigation, enforcement, and compliance activities.

Continuing Work Within OIG

Many of the topics outlined in the Work Plan were included in last year’s plan.  Although the repeated inclusion of these areas of focus makes compliance easier for facilities, audits should still be conducted in the following areas:

• Provider-based status
• Observation services (as part of an outpatient visit)
• Part A hospital capital payment
• Critical access hospitals
• Medicare disproportionate share payments
• Duplicate graduate medical education payments
• Hospital readmissions
• Hospital admissions with conditions coded present-on-admission
• Inpatient rehabilitation facility transmission of patient assessment instruments
• Medicare excessive payments

New Issues to be Targeted

“What we’re really looking at are four or five really brand new issues,” said Stephen Miller, JD, chief compliance and privacy officer for Trenton, NJ-based Capital Health System, Inc. for HealthLeadersMedia.com.

• Brachytherapy reimbursement
• Replacement of devices received at no cost or reduced cost
  • According to Debbie Mackaman, RHIA, CHCO, regulatory specialist for HCPro, Inc., in Marblehead, MA, “Since the medical devices replacement issue can be a difficult billing procedure to comply with, facilities should certainly do an in-depth process audit in this area.”
• Safety and quality of intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT)
  • Indicates a responsiveness on the part of OIG to headlines regarding quality concerns.  In March, the Nuclear Regulatory Commission fined Philadelphia Veterans Affairs Medical Center $227,500, its second largest fine ever against a medical institution, after “unprecedented number” of radiation errors in treating prostate cancer patients.
• Hospitals’ application of the “three-day rule” and “one-day rule” under the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010
  • Many hospitals have had difficulty in billing under the new rules, which redefined what services are related to the admission, and therefore not eligible for Medicare payment within the defined window.  According to Mackaman, “IPPS facilities should be vigilant about reviewing the current three-day rule, and the non-IPPS hospitals should review the addition of the one-day rule.”  CMS guidance on this topic can be found here.

OIG Review of FDA Administration

As HealthReformWatch previously reported, nine Food & Drug Administration (”FDA”) scientists from the Center for Devices and Radiological Health (”CDRH”) sent a letter to President Obama stating, in relevant part, that:

the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts. Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.

These scientists also wrote to Congress in 2008, accusing the top FDA officials of “serious misconduct” in ignoring scientist concerns and “approving for sale unsafe or ineffective medical devices,” according to the N.Y. Times.

According to Washington G-2 Reports, OIG also stated on September 29 that “it would re-examine the concerns of those FDA reviewers, and broaden the scope of its inquiry.”

This coming year, OIG intends to investigate CDRH “policies and procedures for resolving scientific disputes about approval of devices.”  The Work Plan states that OIG will:

review a sample of administrative files for disputed device decisions and assess the extent to which regulations, policies, and procedures were followed during the dispute resolution process. We will also assess whether CDRH managers and staff are aware of and trained on policies and procedures for resolving scientific disputes.

Additionally, OIG will continue to review FDA oversight of investigational new drug applications, the process for device approval, and oversight of postmarketing surveillance studies of medical devices.

FDA and CMS Propose Parallel Review of Medical Products

On September 17, the Centers for Medicare and Medicaid Services (CMS) and Food and Drug Administration (FDA) announced their consideration of a parallel review “process for overlapping evaluations of premarket, FDA-regulated medical products,” and their intention to create a pilot program for parallel review of medical devices.

According to the request for comments published in the Federal Register, the new process would be initiated when “the product sponsor and both agencies agree to such parallel review.”  This collaboration is among the first fruits of a June memorandum of understanding between both departments of Health and Human Services (HHS),which is intended to “promote initiatives related to the review and use of FDA-regulated drugs, biologics, medical devices, and foods, including dietary supplements.”

Among the goals set out by the agreement, the FDA and CMS sought to “[b]uild infrastructure and processes that meet the common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics and medical devices.”  The proposed parallel review process would do just that.

The proposed process is intended to reduce the time delay between “FDA marketing approval or clearance decisions and CMS national coverage determinations.”  Currently, medical products are first reviewed by the FDA for safety and effectiveness; then, CMS begins the process of making its coverage determination and payment rate, which can take up to a year.  Although CMS is only one of many third-party payors, many others follow CMS’ lead in making their own coverage decisions.  A reduction in the approval-to-payment time by CMS will positively impact the rate at which all coverage decisions are made.

The parallel process will potentially benefit patients and sponsors.  A parallel process that reduces the “approval-to-payment” time will produce savings for sponsors and lead to timely patient access to new products.   Furthermore, by reducing the time to return on investment, the parallel process may be an incentive for increased investment in innovation.

Hurdles to a Parallel Process

There are significant differences between FDA and CMS review that must be overcome.  The FDA generally reviews safety and effectiveness through various application processes (premarket approval, premarket notification, etc.).  CMS, on the other hand, must make multiple decisions regarding a medical product under the “reasonable and necessary” standard, including: “what items and services it can and should pay for; how it should accomplish the payment; and how much to pay.”

Because the FDA and CMS apply different standards in their review processes, a clinical study that demonstrates the FDA requirements of safety and effectiveness may neglect to address CMS’ “questions concerning the impact of the technology on Medicare beneficiary health outcomes.”  Ideally, the parallel process will guide sponsors to design clinical studies that simultaneously address both FDA and CMS questions.

Moving from a serial to parallel process must be carefully staged in order to preserve agency resources.  There is the potential for CMS waste if coverage decisions are begun (or even worse, completed) for products that are subsequently denied approval or clearance by the FDA.

The Call for Comments

The FDA has asked the public to comment on seventeen different issues, including:

• How parallel review should be implemented and when in the FDA review process it should start
• Whether anyone other than the product sponsor should be able to initiate a request for parallel review
• Which classes of products would benefit most from parallel review
• Whether there exist regulatory, legal or scientific barriers to review, and how they may be overcome.
• The criteria for granting a parallel review request

The FDA and CMS will publish their decisions regarding the proposed parallel review process after December 16, when the comment period closes.

The Ethics of Modern Drugs and Clinical Trials

A recent article in the New York Times raised an interesting question: are traditional, randomized, controlled trials of new genetically targeted cancer drugs unethical?

The piece recounts the story of two cousins, both diagnosed with melanoma.  After enrolling in the last phase of clinical study, the computer lottery selected one cousin to receive PLX4032, experimental “superpills.” The second cousin, now deceased, was relegated to a “notoriously ineffective” course of chemotherapy.

Randomized, controlled trials have become the gold standard in clinical research, comparing competing treatments to determine which extends life most.  The structure of the trial, with an experimental group and control group, is premised on the idea that the comparative effectiveness of the experimental treatment is unknown.  Therefore, one half of the participants in the clinical trial receive a believed to be less effective therapy for a greater good: researchers come to know definitively which treatment is more effective and future patients benefit from that knowledge.

Critics point out that these new drugs are so much more effective than prior treatments that time-consuming clinical trials are futile: the Phase III trial for PLX4032 would cost $100 million and take at least two years before possibly receiving F.D.A. approval.  That is a huge cost, in terms of lives and money, to “prove” what has already been demonstrated in early clinical testing.  Physicians are forced to forego an opportunity “to give patients symptomatic relief, even if the drug turned out not to prolong life.”

Dr. Paul B. Chapman of Sloan-Kettering, a medical oncologist at Memorial Sloan-Kettering Cancer Center and leader of the trial states in the article:

My goal is to find out as quickly as possible in as few patients as possible whether this works.  If we never know, then we’re never going to be able to build on anything.

Making patients’ tumors go away is gratifying.  But that’s not the businss I’m in.  I’m in the business of making people live longer.  That’s what I want to do.

In contrast, Dr. David E. Fisher, a leading melanoma biologist at Massachusetts General  said of the controlled trial:

My personal view is it’s nuts.  I don’t know anyone who hasn’t shuddered at the concept that we can’t let patients on the control arm cross over because we need them to die earlier to prove a point.

The trend towards more targeted and effective drugs changes the framework for evaluating the ethics of clinical trials.  Promising new treatments however, have sometimes been proven to be less effective.  Therefore, the question remains for medical researchers and the F.D.A.: when will early clinical results be so persuasive that a traditional, controlled trial is unnecessary?

A Guide to Genetically Modified Salmon

The FDA is currently reviewing safety and labeling considerations surrounding what could be the first genetically-modified animal-based food.  Aqua Bounty Technologies, Inc. (”ABT”) of Waltham, Mass. requested FDA to introduce “AquAdvantage Salmon” in U.S. food markets.

AquAdvantage Salmon are produced by introduction of an anti-freeze gene of an ocean pout fish  and the growth hormone gene of Chinook salmon into North Atlantic salmon eggs.  As a result, AquAdvantage Salmon grow produce growth hormone during the winter months, reaching maturity twice as quickly as ordinary North Atlantic salmon.  These genetically-modified eggs, which were developed at Prince Edward Island in Canada, will be grown in an inland hatchery in Panama and processed at a nearby plant before shipment to the US.

The salmon is produced by taking a portion of the gene that protects the ocean pout fish against freezing, transplanting it into the growth gene of a Chinook salmon and transferring the blended genetic material into the fertilized eggs of a North Atlantic salmon.

The resulting fish grows during the winter months as well as the summer, unlike an ordinary salmon.

The FDA initiated three days of public hearings on the genetically-engineered (GE) salmon.  On September 19-20, the FDA Veterinary Medicine Advisory Committee (VMAC) reviewed the scientific issues raised regarding the safety of AquAdvantage Salmon.  On September 21, the FDA held a public meeting regarding the “legal principles for food labeling” applicable to AquAdvantage Salmon.

Sunday & Monday: Safety

In preparation for the public meeting, FDA staff concluded that genetically altered salmon that grow at twice the speed as normal salmon were as safe to eat as traditional Atlantic salmon and posed little environmental risk.  According to the FDA staff analysis, “ABT salmon meets the standard of identity for Atlantic salmon as established by FDA’s Reference Fish Encyclopedia. All other assessments of composition have determined that there are no material differences in food from ABT salmon and other Atlantic salmon…”  In reference to the environment, “no effects on stocks of wild Atlantic salmon are expected.”  (ABT’s environmental assessment can be found here.)

Although many forecasted that the eleven-member, FDA advisory panel would vote to approve the “frankenfish,” as some critics called it, no vote was cast. Instead, the panel recommended further research.  According to the Los Angeles Times:

The panel’s chairman, David Senior of Louisiana State University, said he thought members generally believed the fish was safe to eat, but were concerned that some studies had a small sample size.

One panelist, Greg Jaffe of the nonprofit Center for Science in the Public Interest, predicted after the meeting that the FDA would eventually approve the salmon, “but I don’t think the agency’s going to go quickly on this.”
…

Several panelists raised concerns about the fast-growing fish, saying there were not enough data to answer key questions about allergens and other potential risks.

“There are questions that have not been answered by the data that has been presented,” said panelist James McKean, a veterinarian and professor at Iowa State University. But other panelists argued there was no difference between the altered salmon and its natural counterpart.

“I would not feel alarmed about eating this kind of fish,” said Gary Thorgaard, a professor and fish researcher at Washington State University.

An interesting side-note to this discussion is the regulatory pathway for genetically engineered animals for human consumption.  The rDNA introduced into the fish egg is considered a new animal drug for the purposes of the Federal Food, Drug, and Cosmetic Act (”FFDCA”) because it changes the structure or function of the GE animal.  As such, the Veterinary Medicine Advisory Committee reviews the New Animal Drug Application for safety and efficacy, requiring the VMAC to determine:

• whether the article is safe to the animal to which it is administered, which for GE animals bearing heritable rDNA constructs, means the GE animals themselves;
• whether food derived from GE animals is safe, i.e., there is a reasonable certainty of no harm from the consumption of food derived from the GE animals; and
• whether there is likely to be a significant effect on the human environment.

More information about Atlantic salmon and FDA oversight of genetically engineered animals can be found here.

Tuesday: Labeling

During Tuesday’s Part 15 hearing, the FDA sought public comment on “the labeling (including naming) of foods made from the AquAdvantage Salmon, a genetically engineered (GE) Atlantic salmon produced by AquaBounty Technologies, Inc.”  Specifically, the FDA sought public views on:

1. Which facts about the AquAdvantage Salmon seem most pertinent for FDA’s consideration of whether there are any “material” differences between foods from this salmon and foods from other Atlantic salmon. (Keep in mind that the use of genetic engineering does not, in and of itself, constitute a “material” difference under the law.)
2. If FDA determined there are “material” differences, how would that difference be described on a food label in a way that is truthful and nonmisleading. (Keep in mind that it is the difference in composition, or in functional, organoleptic or other material properties that must be described, not the underlying production process.)

GE foods are subject to the same regulations as other foods, and must “bear an appropriate name and a label that is truthful and not misleading.”  Many consumer advocates and environmental groups insisted that GE salmon, if approved, should be labeled as such.  They argued that consumers have a right to know what they are eating.  However, in Alliance for Bio-Integrity v. Shalala, the court granted deference to the FDA’s determination that genetic engineering does not materially alter foods, and therefore, that GE plants did not need to be labeled as such.  According to the D.C. District Court, “the FDA lacks a basis upon which it can legally mandate labeling, regardless of the level of consumer demand.”

Some advocates also sought labeling as a method of monitoring safety.  As the Los Angeles Times reports:

Consumer’s Union, the nonprofit publisher of Consumer Reports, opposed the approval of the salmon, saying it has not been shown to be safe, and argued it should be labeled in the event that it eventually reaches the market. “FDA should require labeling to insure that any unexpected or unintended effects of engineering this salmon … come to FDA attention,” said CU senior scientist Michael Hansen. “Drugs approved by FDA as safe have turned out to have unexpected health effects after they were widely used by consumers.”

The implication: Without labels, how would consumers, if they experience side effects, know that they had eaten GE salmon?

The great salmon debate is not one that will affect consumers in the near future.  It is currently unclear how the FDA will decide on the safety issue and public comment on the labeling issue will remain open until November 22.  Even if passed, ABT does not expect to have AquAdvantage products on market for another two years.

Trouble Brewing for Pharmaceutical Companies

Bribery and recalls.  Federal agencies are turning up the heat on pharmaceutical companies.  Were you surprised by the eight recalls of Johnson & Johnson products this year?  Maybe you shouldn’t be.  As HealthReformWatch.com reported in We May Need More Than a Spoonful of Sugar to Help Our Medicine Go Down, drug recalls reached a record high 1,742 in 2009 — more than four times the amount in 2008.  Bowman Cox, managing editor of the Gold Sheet (which first broke the story) told CNN Money that in light of the 296 recalls issued in the first six months of 2010, there could be 600 or more recalls this year.

Why So Many Recalls?

Analysts and legislators are examining the recall statistics to find sources and solutions to the pharmaceutical safety issue.

1.   Drug repackaging

Advantage Dose, a now-defunct Shreveport, LA based drug repackager, was responsible for more than 1,000 of the 2009 recalls. Companies like Advantage Dose repackage and relabel drugs into smaller units for resale or distribution to health care facilities. After excluding Advantage Dose from the count, there still remains a 50% jump in recalls from 2008 to 2009.

2.   The generic rush

Gold Sheet’s Cox suggests that generic manufacturers cut drug design costs in their rush to be first to market after a branded-drug’s patent protection expires, decreasing quality.  “The first applicant typically gets the lion’s share of the business for the new drug… So they get the application. They make and market the drug, but they could still have problems down the road if they haven’t really understood the optimum way to make that drug.”  One example of a design failure is Caraco Pharmaceutical Laboratories’ “tablet thickness” recalls in March 2009.

3.   Manufacturing lapses

Some experts say the biggest culprits include the quality of raw materials and contamination. Approximately one month ago, HealthReformWatch.com reported in Pharmaceutical Outsourcing: Trading Quality for Lower Costs? that India’s largest pharmaceutical manufacturer had been cited several times in recent years for manufacturing violations.  Additional recalls include vaccines produced by Shantha Biotechnics for Sanofi-Aventis and injectible drugs made by Claris Lifesciences for Pfizer.  The FDA stated its intent on May 5, 2010 to “propose stronger regulation for pharmaceutical companies that outsource manufacturing, putting more responsibility on the companies to ensure the purity and safety of the products…”

4.   Increased FDA scrutiny of manufacturing facilities

Which came first, the chicken or the egg?  Increased FDA oversight may or may not have led to the increased number of recalls; however, the recalls will probably lead to increased FDA regulatory power.

As Jennifer Jascoll reported, Senator Michael F. Bennet (D-CO) proposed the Drug Safety and Accountability Act of 2010 on August 3, 2010.  According to Bennet’s press release, “[t]he bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.” Currently, the FDA is empowered to issue warnings and recommend that a manufacturer issue a recall.

Two prior bills would also increase FDA powers to mandate a recall:

• The Protect Consumers Act of 2009 (sponsored by Rep. Betty Sutton, D-OH) would require the Secretary of HHS implement a recall if it is determined to be necessary.
• H.R. 6740 (sponsored by Rep. Edolphus Towns, D-NY) would provide the Secretary of HHS with the ability to mandate a recall “if the Secretary has reason to believe that the use or consumption of, or exposure to, a drug (or an ingredient or component used in any such drug) may cause serious adverse health consequences or death to humans or animals.”

According to CNN Money, the FDA has not identified any alarming pattern.  FDA spokeswoman Elaine Gansz Bobo stated, “[s]ince every recall situation is unique, it would be difficult to assess whether there are any trends or increases in recalls this year… At this time, however, we have not identified any trends.”  Despite the FDA’s lack of concern, other federal agencies are interested in the practices of pharmaceutical companies.

Further Federal Investigations

According to the N.Y.Times, federal prosecutors and securities regulators are investigating pharmaceutical companies for potential violations of the Foreign Corrupt Practices Act (FCPA).   The FCPA is an anti-bribery law which bars companies from offering foreign government officials items of value for profit.  For instance, Pfizer disclosed in April “that it paid $35m over six months to 4,500 doctors in private practice for education and the development and marketing of new drugs.”  Although this practice is legal in the U.S., such payments are illegal in many foreign countries where physicians are employed by the government.

On November 17, 2009, Assistant Attorney General Lanny A. Breuer stated that the Department of Justice intended to focus its attention on the pharmaceutical industry:

In some foreign countries and under certain circumstances, nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product may involve a “foreign official” within the meaning of the FCPA. The depth of government involvement in foreign health systems, combined with fierce industry competition and the closed nature of many public formularies, creates, in our view, a significant risk that corrupt payments will infect the process. Our remarkable FCPA unit and our terrific health care fraud unit will be working together to investigate FCPA violations in the pharmaceutical industry in an effort to maximize our ability to effectively enforce the law in this high-risk area.

“Corrupt practices” under the FCPA are not limited to cash in envelopes.  Inappropriate payments for lavish hospitality, consulting, licensing agreements, and even charitable donations may raise red flags for government investigators.

Could bribery be contributing to decreased quality and the sudden rise in recalls?  According to the Financial Times, the DoJ is focusing its efforts elsewhere:

[T]he DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 percent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

It appears that the DoJ’s scrutiny of clinical trials is not without merit.  The N.Y.Times reports that “[l]ast month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events.”  The clinical trials for Avandia included many foreign trial sites, which were submitted in support of the drugs’ application to enter and remain on the U.S. market.  GlaxoSmithKline, the trial’s sponsor, has not been accused of fraud.

According to recent regulatory filings, the following companies are under investigation for possible violations of the FCPA:

• Merck is cooperating with a federal investigation of company activities in multiple foreign nations.
• Medtronic is cooperating with investigations of company activities in Greece, Poland, Germany, Turkey, Italy, and Malaysia.
• Eli Lilly is cooperating with the investigations of subsidiaries in several countries, including Poland.
• Federal investigators are looking into improper payments related to the sale of Zimmer products abroad.
• Johnson & Johnson voluntary disclosed the possibility that company subsidiaries abroad had made improper payments to government officials in two countries relating to the sale of medical devices.
• Pfizer and Bristol-Myers Squibb have also disclosed that they are subject to federal investigations. AstraZeneca, GlaxoSmithKline, and Baxter SciClone have also received inquiries from federal enforcement agencies.

We May Need More Than A Spoonful Of Sugar To Help Our Medicine Go Down

Today CNNMoney reports that drug recalls quadrupled from 426 in 2008 to a record 1,742 in 2009.  The recalls have been attributed to “manufacturing lapses” in raw material quality, labeling and packaging, and contamination.  Generic and over-the-counter drugs have been affected the most.  CNNMoney notes that the race to put generic products on the market and the pressure to cut costs have caused drug companies to

sometimes fail to spend enough time learning how best to make the drug….  And since generic and over the counter drugs aren’t as lucrative for drugmakers as prescription drugs, companies may not be investing enough resources to make high-quality, safe products.

One such cost-cutting measure involves outsourcing production to foreign manufacturing sites and this measure seems to have received the most attention.  (Check out fellow blogger Jae W. Joo’s post on outsourcing.)

Earlier this month, Senator Michael Bennet (D-Colorado) introduced the Drug and Safety Accountability Act of 2010 which seeks to ensure the safety and efficacy of drugs sold in America, regardless of their manufacturing location.  The bill would require, among other things, that:

• manufacturers have quality management plans which the FDA can inspect;
• manufacturers maintain supply chain documentation;
• the Secretary of Health and Human Services track facilities manufacturing drugs or active ingredients for the American market; and
• the FDA be given more power to ensure drug safety, including the authority to enact mandatory recalls for batches of drugs that pose risks and to assess civil penalties for violations of the Federal Food, Drug, and Cosmetic Act.

Click here for more details about the bill and here for Sen. Bennet’s own promotion of it.  Sen. Bennet has lamented how:

[f]or too long, the FDA has lacked the proper authority to adequately safeguard our drug supply.  Americans need to be able to trust that the drugs in their medicine cabinets are safe, no matter where they’re made.

A father of three, Sen. Bennet has said that the recent McNeil recall of over-the-counter children’s medicine spurred him into action.

Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson has issued a statement in response to the bill, saying that:

[t]he lifeline of America’s biopharmaceutical research companies is the safety and integrity of the products they develop.  Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply.

In addition, drug manufacturing for the U.S. market — regardless of where it occurs — is regulated under Good Manufacturing Practices (GMP) by the Food and Drug Administration (FDA).  These GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the U.S. prescription drug supply.

The U.S. regulatory system for prescription drugs is the toughest and safest in the world….

Okay.  But other people here don’t think so.  (Click here to read a good opinion by Dr. Lynn Parry, Chair of the Colorado Prescription Project, on why this bill should pass.)

According to a recent Pew Prescription Project poll, less than 10% of Americans feel confident about medications manufactured in India and China.  89% of Americans support Congressional action to introduce new drug safety measures.  How many of those people realize that approximately 80% of the materials used to make or package drugs sold in America comes from foreign sources?  I didn’t, but then, is such high a percentage really that surprising?

Reading through the CNNMoney report, I was reminded a little of a scene from a seventh season episode of Friends:

Phoebe: It’s amazing! My headache is completely gone! What are those pills called?
Monica: Hexadrin.
Phoebe: Oh, I love you, Hexadrin!  Oh look!  It comes with a story!
Monica: No, Phoebe, those are, like, the side effects and stuff.
Phoebe: Say what?
Monica: You know, the possible side effects.
Phoebe: Oh my God!  Dizziness, nervousness, drowsiness, facial swelling, nausea, headache…  Headache! Vomiting, stomach bleeding, liver damage!  Now, okay, I don’t recall any of this coming up when you gave me these little death capsules! Oh, I’m sorry, extra-strength death capsules!

Admittedly, the scene concerns how potential side effects can be worse than the problem being treated (and that’s a whole other blog post).  Yet it’s also a reminder of how we can forget about the other potential hazards of these potent drugs, delivered in easy-to-swallow capsules/tablets/liquids, if there are quality control or other manufacturing issues.  It’s as easy to forget as it is to pop them, well, like candy.

Direct to Consumer Genetic Testing — The Need for Early Filtering of Genetic Information

[Ed. Note: We are pleased to welcome Professor Gaia Bernstein to Health Reform Watch. Articles about her recent scholarship, "Over-parenting," may be found at the ABA Journal and The New York Times Magazine.]

Genetic testing for adult onset diseases used to be mainly a medical service. In most cases a person who had a certain genetic disease that was prevalent in her family would go to test to see if she carries the genetic mutation. For example, a woman who had several cases of breast cancer in her family would test for the breast cancer genetic mutation BRCA1/BRCA2 to see if she carries the mutation and has a high probability of getting the disease. But, the proliferation of direct to consumer genetic testing changes the nature of the service to a consumer service. Companies like 23andme and Pathway Genomics (who was planning to start selling its kits in Walgreens) offer consumers the option to buy packages of tests (ranging from 25 to over a 100 conditions). Consumers often buy the tests to satisfy their curiosity or they may even receive them as a gift. People purchasing the testing packages usually do not consult a medical professional when deciding to undergo the tests and receive the results alone by accessing a website.

Yesterday I spoke before the FDA, which is considering regulating direct to consumer genetic testing. My presentation was based on a symposium piece I am working on. I argued for the need for a medical professional to guide people throughout the process and advise them not just on the interpretation of the results but also earlier in the process to determine what genetic information they actually want to have.

Interpreting the results of genetic tests is not easy. Unlike other over the counter tests, like a pregnancy test, which gives a clear positive or negative result, genetic tests are about probabilities. Even a person who tests positive for a certain mutation may still not get sick depending on other non-genetic factors. People have a hard time understanding the results of genetic tests and for that reason there have been many calls to require the guidance of a medical professional for the delivery of the results.

But I believe focusing on the interpretation of the results is only half the issue. It is important to have professional guidance also at the outset to determine what tests to undergo. A medical professional should guide individuals and tailor the panel of tests to the individual who desires to test. Why is that? Well, first of all, some people, if they get a chance to give it some thought, may not want to know all their genetic information. For example, a person may prefer not to know that he is likely to get Alzheimer’s at a young age. Secondly, not all genetic information is made equal. Some genetic tests do not convey that much useful information. For example, a positive result in some tests may only demonstrate a slightly higher likelihood of getting the disease than the probability in the general population. Eliminating such tests at the outset will facilitate the interpretation of the results. It would be possible to focus on the truly important positive results at the end of the process.

To achieve all this it is important for the law to require the guidance of a medical professional who is not a representative of the genetic testing company. A medical professional working for the genetic testing company may have good knowledge of the tests, but could have an interest in having the consumer purchase as many tests as possible. This could place him in a conflict of interest with the consumer who could be best off by purchasing a more limited panel of tests tailored specifically for him.

Cross-Posted at PrawfsBlawg

Bad Ads and Doctor Deputies

Earlier this month, the FDA launched a new initiative — the Bad Ad Program — to “help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”  In an article appearing earlier this week in Advertising Age, advertising executives and others decry the program as a “publicity stunt” with the potential to lead to physician “vigilantism” and to become “unbridled and messy.”  Also quoted in the article is PhRMA Senior Vice President Ken Johnson, who states that PhRMA views the Bad Ad Program as “another step to help educate — and receive feedback from — healthcare providers about prescription drug advertising and promotion.”  The Advertising Age article, correctly I think, characterizes this statement as offering only “tepid support.”

There appear to be two central criticisms of the Bad Ad Program: (1) that it is not as low-cost as it seems because it will take up physicians’ time and create more work for the FDA’s already overburdened Division of Drug Marketing, Advertising, and Communications (DDMAC) and (2) that it will be an ineffective compliance tool either because doctors cannot tell the difference between compliant and noncompliant advertising or because doctors will “go on personal jihads on ads they don’t like - ads that very well might be in perfect compliance.”

Both concerns seem overblown.  Doctors do not have to participate if they do not have the time or inclination — it seems likely that most will not — and pharmaceutical companies have been reporting each other’s marketing abuses to DDMAC for years, so the Division has experience sifting through more and less credible information.  Doctors may well have difficulty discerning which ads are compliant and which are not — see, e.g., this study revealing that doctors could not accurately identify the FDA-approval status of a significant percentage of the drugs they prescribe — but this is not an argument against the FDA’s effort to educate them.

The bottom line is that while pharmaceutical companies track what happens in physician offices in multiple ways, including through sales rep call notes and sales message recall studies, they do not, at least not consistently and/or voluntarily, use the information gathered in service of compliance, as opposed to sales, goals.  In the words of Arnie Friede, to the extent that the FDA’s Bad Ad Program creates “an additional incentive for a company to closely monitor and control communications by their sales people” it is “an understandable, perhaps even brilliant move.”

Allergan v. FDA: Where Does Disseminating Safety Information End and Promotion Begin?

In the Fall of 2009, the drugmaker Allergan made waves when it sued the FDA alleging that the ban on off-label promotion was chilling its “First Amendment right to share truthful medical information with physicians about how to safely use Botox off-label [to treat muscle spasticity] to achieve a benefit while minimizing risk of serious adverse events.”  Allergan was back in the news last week when the LA Times reported that trial was set to begin in a case brought against Allergan by the mother of Kristen Spears, a seven-year-old girl with cerebral palsy who died after being injected with Botox to treat muscle spasticity in her legs.

Allergan manufactures two FDA-approved botulinum toxin products, Botox Cosmetic, the well-known anti-wrinkle treatment, and Botox, which is approved to treat, among other conditions, cervical dystonia, “a movement disorder that causes [the muscles of the neck and shoulders] to contract and spasm involuntarily.”  Botox is also frequently used “off-label” for conditions it is not approved to treat, including muscle spasticity.  Per the NIH,  locally-injected Botox “has become a standard treatment for overactive muscles in children with spastic movement disorders such as cerebral palsy.”  The FDA agrees.  An agency physician describes Botox as a “commonly used” and “very effective” treatment for spasticity, which he characterizes as a “significant disability[y.]“  Per the LA Times, Botox can “sometimes help young patients walk without surgery.”

While the NIH’s website states that the undesirable side effects of Botox are “mild and short-lived,” the FDA’s informs physicians that “a Boxed Warning has been added to the prescribing information to highlight that botulinum toxin may spread from the area of injection to produce symptoms consistent with botulism,” “that swallowing and breathing difficulties can be life-threatening and there have been reports of deaths related to the effects of spread of botulinum toxin,” and “that children treated for spasticity are at greatest risk for these symptoms[.]”

In addition to requiring the addition of the black box warning to the Botox label, the FDA has ordered Allergan and other manufacturers of botulinum toxin products to adopt a Risk Evaluation and Mitigation Strategy (REMS) which includes “a Medication Guide [for patients] and Communication Plan, including a Dear Health Care Provider letter, and a timetable for submission of assessments.”

In its complaint against the FDA, Allergan alleges that while “the boxed warning and REMS materials identify the risk of potential distant spread of toxin effect, … they do not give physicians using Botox for spasticity specific guidance about how to further minimize that risk while still obtaining an acceptable therapeutic effect.”  Allergan wants to provide physicians with specific information about treating spasticity including “proper dosing, patient selection, and injection technique.”  Allergan argues, with good reason I believe, that if it were to, say, develop a slide deck about dosing, patient selection, and injection technique in treating spasticity and present it to physicians it would be exposing itself to criminal liability for promoting an off-label use.  In its brief in opposition, the FDA disagrees — sort of — arguing that disseminating safety information about unapproved uses is “not necessarily” promotion and that Allergan has “ample room” “to disseminate truthful, non-promotional information about dangers associated with unapproved uses of Botox.”  (I will have more to say about the parties’ legal arguments in a subsequent post.)

In an interesting twist, the LA Times reports that Kristen Spears’ pediatrician and his nurse practitioner wife testified in depositions that they “learned to use Botox on children with cerebral palsy at Allergan-sponsored seminars in 2000 and 2001″ and that “Allergan’s sales agents discussed the use of Botox for juvenile cerebral palsy patients … repeatedly, visiting the practice about 50 times over several years.”  They also claimed that they were told by sales representatives that other doctors were using “in range of 10 to 15 units” of Botox per kilogram to treat their pediatric patients.  Dr. Mitchell Brin, Allergan’s Chief Scientific Officer for Botox, testified that fifteen units per kilogram, which is the dose given Kristen Spears, is nearly twice the maximum dose that the company considers safe for children.  He also testified that, because of the ban on off-label promotion, Allergan did not disseminate its maximum dosage information to physicians.  If it is true that Allergan’s sales force was providing doctors with dosing information gleaned from anecdotal reports from other doctors they called on while the experts in the company’s medical department kept their dosing knowledge to themselves, it is an example of an all-too-common disconnect between the field and headquarters that in this case may have had tragic consequences.

Medical Science Liaisons: Walking the Line between Scientific Exchange and Promotion

[Ed. note: As noted in the post above, we are very pleased to welcome Kate Greenwood, J.D., to the blog today.]

As the Wall Street Journal recently reported, at a time when the ranks of pharmaceutical sales representatives are thinning, the number of medical science liaisons (MSLs) is (or was until very recently) growing.  MSLs are doctors, pharmacists, or scientists employed by drug companies to disseminate scientific information about the companies’ drugs — including information about off-label uses of those drugs — usually to physicians who are key opinion leaders.  MSLs are, at most companies, part of the medical affairs or research and development departments and, unlike sales reps, they are not typically evaluated or compensated based on increases in market share or prescription volume in their regions.  Still, as suggested by this PharmExec article on permissible metrics for measuring the value to companies of both MSLs and the thought leaders they court, it is not always clear how the work MSLs do differs from that of a sales rep.

FDA regulations ban companies from “represent[ing] in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation” but explicitly allow companies to engage in “the full exchange of scientific information.”  Sales reps cannot take advantage of the scientific exchange safe harbor to discuss off-label uses with physicians, but MSLs can, as long as they do so in response to a physician’s unsolicited request.  Jeff Patrick, who holds a doctorate in pharmacy and is Director of Medical Scientists at the biopharmaceutical company Dyax, explained to the Wall Street Journal that, unlike a sales rep, he could respond to a question like “Were there pediatrics in your trial?” even if the drug being evaluated was not approved for pediatric use.

Because MSLs are out in the field engaging doctors in free-ranging and difficult to police discussions, they present evident compliance challenges for companies attempting to follow the rules regarding off-label promotion.  On the other hand, their scientific expertise and established relationships with thought leaders may also present compliance opportunities.  For example, earlier this year, the FDA approved the use of MSLs in the Risk Evaluation and Mitigation Strategy (REMS) for UCB’s Cimzia, a drug used to treat Crohn’s disease and rheumatoid arthritis which carries with it a risk of serious infection.  The Cimzia REMS requires as part of its communication plan that the company’s MSLs make a presentation about the drug’s risks to all of the nation’s approximately 500 gastroenterology key opinion leaders.

Synthes Legal Troubles –Again

[Today's Post is by Maansi K. Raswant, a Seton Hall Law student pursuing the Health Law concentration. She is a research assistant to the Center for Health & Pharmaceutical Law & Policy and an intern at the NYC Health and Hospitals Corporation.]

Recently, the Synthes corporation has been garnering a lot of attention, but for all the wrong reasons. A June 17^th indictment comes a little over a month after the New Jersey Attorney General announced that the medical device maker had entered into a settlement agreement for failing to disclose financial conflicts of interests held by physicians conducting clinical trials for its products (see prior post, “Clinical Research: When the Compensation Begs the Answer“). Filed by the United States Attorney for the Eastern District of Pennsylvania, the recent 52-count indictment alleges that from May 2002 to Fall 2004, the Swiss company Norian, and its parent company Synthes, (both based in West Chester, Pennsylvania) conspired to conduct unauthorized clinical trials of Norian XR and Norian SRS, bone cement products used in surgery to treat vertebral compression fractures of the spine. Not only did the trials lack FDA authorization, but the FDA had specifically warned Synthes against using Norian XR for spinal surgery due to safety concerns.

The indictment explains that preliminary studies using human blood in test tubes found that the bone cement products chemically reacted with the blood to create blood clots. In further studies of the prod in a pig, the clots became wedged in the lungs. Despite this knowledge, Synthes continued to market the Norian products for use in spinal surgery, and did not stop doing so until after three patients had died on the operating table.  According to the indictment, rather than recall the products following the patient deaths, the company engaged in a cover up by lying to FDA officers during an official inspection in May and June 2004.

The two recent legal actions against Synthes break new ground, and represent significant inroads by prosecutors in the arena of clinical research. Among other remedies, the settlement with the State of New Jersey required Synthes to disclose all relevant financial interests of its investigators on a public website, and barred the company from compensating investigators with stock, a practice the Attorney General called widespread in the industry. The latest indictment contains not just the usual charges against the corporations, but also criminal charges against four corporate executives charged with shipment of unauthorized devices. If found guilty, each executive faces up to a year in prison.

Rationing or Cost Effectiveness?

In today’s Wall Street Journal, Scott Gottlieb, a former senior official with both the FDA and the Centers for Medicare and Medicaid Services (CMS), warns that “Government Health Plans Always Ration Care.” Aside from recasting the same old aspersions about “rationing,” Gottlieb warns that if reform efforts can’t tame health care costs, the “government will turn to a less appealing but more familiar tool to cut costs: the regulation of access to drugs and medical services.”

Of course, “access” can mean many things. Theoretically, Americans have “access” to the best medical technologies in the world. But practically, most Americans-including those with health insurance-don’t actually access this type of care and couldn’t even if they tried. The bottom line is that every health insurer in the world, public or private, has to “ration” for the simple fact that health care resources are not unlimited. Only wealthy citizens truly have “access” to the best medical care money can buy, regardless of the country they live in or the health system they live under. That won’t change with or without major health reform.

Gottlieb is worried that reformers might formally embrace recommendations by the Medicare Payment Advisory Committee (MedPAC), which currently has a broad statutory mandate to advise Congress on the Medicare program. He also warns that rationing is “a European import,” as if no health insurer in the United States has ever had to draw the line somewhere and decide what not to pay for. For example, Gottlieb warns about organizations like the Committee for the Evaluation of Medicines in France and the Institute for Quality and Efficiency in Health Care in Germany. He doesn’t mention the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, but it drew similar scorn after the economic stimulus package funded comparative effectiveness research here in the United States. Gottlieb cautions that European countries “aren’t shy about rationing.”

Gottlieb is correct in one aspect: these organizations are prevalent in Europe. However, he misses three important points.

First, the countries in Europe that Gottlieb warns about spend considerably less than we do on health care (and don’t suffer negative health consequences for it).

Second, wealthy residents in pretty much all of these countries can purchase services and technologies over and above what the organizations that Gottlieb warns us about approve.

And third, we’re not exactly strangers to these organizations in the United States. Gottlieb is concerned about European imports, but he’s ignoring our home grown organizations, like the Agency for Healthcare Research and Quality (AHRQ), which makes new technology assessments for Gottlieb’s old agency, CMS, and supports comparative effectiveness research. Or the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), which also performs new technology assessments. In fact, it’s no secret in Washington that Medicare has long considered some amalgam of cost effectiveness and comparative effectiveness in its coverage decisions, even if nothing in the Medicare statute explicitly allows it to do so. (CMS has long stretched the definition of “reasonable and necessary” in section 1862(a)(1)(A) of the Social Security Act to fit its fiscal realities, even if CMS or its precursor, HCFA, haven’t been successful in cementing cost effectiveness as a formal criterion, as evidenced through failed rulemaking in 1989 (54 Fed. Reg. 4,302) and 2000 (65 Fed. Reg. 31,124)).

And just as importantly, private insurers make cost and comparative effectiveness determinations too, either by following Medicare’s lead, as expressed through national and local coverage determinations (NCDs and LCDs), or by setting up their own new technology evaluation systems, like BlueCross BlueShield has with its Technology Evaluation Center. Though the offical duties and decisionmaking processes of these organizations differ, the health care community generally understands these decisions as implicitly factoring in cost effectiveness or at least clinical effectiveness-thus doing precisely what the anti-reformers like Gottlieb warn about.

Clinical Research: When the Compensation Begs the Answer

The New York Times reports that New Jersey Attorney General Anne Milgram announced a settlement agreement with medical device maker, Synthes, for failing to disclose the financial conflicts of interest of doctors researching its products. Synthes is the maker of the ProDisc, an artificial spinal disk.

The settlement agreement with Synthes was described in the AG’s press release, which quoted Ms. Milgram, as “the first of its kind because of its disclosure provisions, as well as its ban on compensating clinical researchers with company stock. She said the latter provision runs counter to widespread industry practice — a practice she called unacceptable.” Notably, the state pursued the case as a matter of consumer fraud. The premise being that the failure to fully disclose such conflicts constituted such for both human trial subjects and the purchasing public.

In a letter to the FDA, critical of the FDA and cc’d to key members of Congress, Ms. Milgram described the results of the AG’s investigation into the business and research practices of Synthes. The letter states:

The investigation revealed that a majority of the physicians who participated in these clinical trials had significant investments in the products -investments that would have been worthless had the product failed to obtain regulatory approval from the FDA. And, the investigation revealed that Synthes, which acquired ProDisc while the clinical trials were underway, failed to disclose these financial conflicts of interest to the FDA.

Yet, despite the fact that Synthes’ failure to adequately disclose these interests should have been obvious from even a cursory review of its FDA submissions, the FDA did nothing to regulate these conflicts. A number of the disclosure forms were signed and dated, but were otherwise left blank. Others indicated that the clinical investigator had a significant equity interest in the product, but did not attach the requisite details. But the FDA approved Synthes’ applications for premarket approval without any delay or further inquiry into this issue.

Leaving aside for the moment the criticism of the FDA (the State of New Jersey joins a long list of increasingly vocal complainants, including the Program on Government Oversight (citing “dramatically reduced inspections of ‘good laboratory practices’ at facilities that do the earliest testing of medical devices. Such inspections declined from 33 in 2005, to seven in 2007, to just one last year”),  and FDA scientists from the Center for Devices and  Radiological Health, who have openly proclaimed that the FDA “is fundamentally broken.”), it’s worth a moment to consider that Synthes has agreed to “stop paying doctors who are conducting clinical trials of its products with stock or stock options,” and that AG Milgram described the compensation of research doctors with stock as being “apparently common” and a “widespread industry practice.”

Compensating a  doctor with stock or stock options financially tied to the results of his research may well be the antithesis of an impetus for objective clinical research.

The basic proposition is this: you, doctor, are charged with investigating whether or not this medical device is safe and fit and shows efficacy for human use. For doing so, we will give you a portion of the company (stock or stock options) which owns the medical device. If the medical device is efficacious and fit for human use, the company will stand to profit. As a holder of stock and/or stock options in the company, you will be paid a portion of that profit and/or the value of your holdings in the company will increase correspondent to your determination of safety for human use and efficacy. If you determine that the device is not safe for human use and/or not efficacious, your holdings in the company will be worth much less, if not worthless. “Is the device safe for human use and efficacious?” Does an answer of “Yes” surprise anyone?

It is also not an answer to say that the doctors may have merely been compensated in cash and then later converted that cash into stock or stock options independently. My guess is that in constructing these compensation packages, as with most securities matters, timing and knowledge is important. That the stock or stock options must be issued or at least contracted for by the researcher simultaneous with the hiring so as to avoid SEC difficulty regarding the particulars of the researchers’ “inside” and “confidential” knowledge regarding the device and the research itself. Researchers who have purchased interested stock (or who have had stock purchased by others) before news of their research has been made public have often paid a price.

And obviously, once the doctor’s research has been made public, any positive results will have been already reflected in the market price of the stock, all but foreclosing the research doctor from reaping profits tied directly to his research determinations.

As part of A.G. Milgram’s “Assurance of Voluntary Compliance agreement (the Synthes case was handled by Deputy Attorney General Megan Lewis, Chief of the Division of Law’s Affirmative Litigation Section, and Deputy Attorney General Michelle T. Weiner) Synthes must disclose any future payments made by the company to physicians conducting clinical trials on its devices, as well as any investments held by such physicians in the devices they test. A $3 billion global company, Synthes has also agreed to stop paying clinical trial physicians with company stock or stock options.”

Attorney General Milgram said that “the Synthes agreement should serve as a template for the entire industry,” and in her letter to the FDA remarked that she was “hopeful the Synthes terms will become “best practices” for disclosure among medical device makers.”

In addition to signifying her hope, Ms. Milgram announced that her office issued subpoenas “to five major medical device manufacturing companies seeking information about their business practices.”

The FDA to Evaluate 25 Medical Devices Marketed Before 1976 Without Premarket Approval

The FDA announced last week that they are requiring the makers of 25 medical devices marketed before 1976 to submit safety and effectiveness information regarding their devices.   These devices were allowed onto the market without undergoing the current FDA testing and classification because they were first manufactured before the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, and include many of the riskiest devices — defibrillators, pacemakers accessories, and heart valves.

The FDA classifies medical devices into three categories, with class III being the riskiest devices– as such, they require premarket approval.  Currently, the 25 pre-amendment devices in question are class III, but based on the 1976 law these devices were not required to undergo premarket approval at the time.

The FDA will use the submitted safety and effectiveness data to review the devices and classify them into what they deem to be the appropriate risk category.  According to the FDA, if a device is found to be a class III device, the manufacturer will need to submit a premarket approval application.  If the device is moved to class I or II, it will not require premarket approval.

The FDA’s announcement comes after the Government Accountability Office reported in January that the FDA was not doing enough to thoroughly evaluate the safety and effectiveness of many medical devices marketed before 1976.  They urged the FDA to review the devices and said that “it is imperative that FDA take immediate steps” to fix this review and approval process for devices.

Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, said regarding the FDA’s new requirement:

We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency.  New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.

This decision to evaluate these devices and further public safety comes after recent criticism of the agency, such as the opinion expressed publicly by a number of  FDA scientists that the “FDA is fundamentally broken.”  We have blogged about the much maligned agency on numerous occasions, with specific emphasis upon the Center for Devices and Radiological Health and a decline in medical device lab inspections.

U.S. District Court Says FDA Decision on Plan B Was Influenced by Political Pressure

A U.S. District Court ordered yesterday that the Food and Drug Administration (FDA) allow for the sale of the Plan B morning-after pill to females 17 years old and older without a prescription.  Since 2006, based on a FDA decision during the Bush administration, Plan B has been available over the counter only to women over the age of 18.  The FDA must comply with the order within 30 days.  Plan B is a back-up birth control pill that can reduce the chance of pregnancy when taken within 72 hours of unprotected sex or contraceptive failure.  It is manufactured by Duramed, a subsidiary of Barr Pharmaceuticals.

Judge Edward Korman of the Eastern District of New York wrote in his decision that the FDA was influenced by political pressure and their conclusion was not based on the scientific evidence available concerning the drug.  Judge Korman wrote that:

These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making.  Indeed, the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use.

Judge Korman’s statements echo similar sentiments expressed as of late that the “FDA is fundamentally broken.” We have blogged about the subject, and the alleged political influences on FDA, in a number of posts most recently.

The WSJ Health Blog wrote today that the ruling specifically blasts past and current FDA officials such as acting Surgeon General and acting Secretary for Health and Human Services, Dr. Steven Galson, and then-FDA Commissioner Lester Crawford.

The FDA is reviewing the decision and the WSJ reports that “If the Obama White House doesn’t appeal the ruling, it would mark the fourth significant departure from Bush administration positions on controversial health-care issues since President Barack Obama took office.”

Susan Woods was a top FDA official who resigned in 2005 due to the delays surrounding a FDA decision on the pill.  The Associated Press quoted her as saying:

What happened with Plan B demonstrated that the agency was off track, and was not being allowed to do its job properly.  This is telling the FDA to move forward with a focus on good science.

The President and CEO of the Reproductive Health Technologies Project, Kristen Moore, said “This ruling validates what we have known all along - politicians trumped the scientists when it came to the FDA’s handling of Plan B.”

Naturally, many conservative groups are angered over the ruling.

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