Monday Morning Recap: The Week (2.17.14-2.23.14)) in Drug & Device Law & Policy

February 24, 2014 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. Earlier this month, the Food and Drug Administration announced that it had approved Vimizim (elosulfase alfa), which treats Mucopolysaccharidosis Type IVA (Morquio A syndrome) and which “is also the first drug to receive the Rare Pediatric Disease Priority Review Voucher - a provision that aims to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.”  I blogged about the expansion of the PRV program to rare pediatric diseases in 2012, here.  Kurt Karst offers helpful context for the Vimizim approval here, while Ron Leuty reports here that Vimizim will cost $380,000 a year, a price its manufacturer said was “consistent with other enzyme replacement therapies.”

2. Also on the subject of the cost of specialty drugs, Avalere Health issued a report this week on the specialty drug benefit provided by health insurance plans sold through the new health insurance exchanges.  Per Dan Mendelson, Avalere Health’s CEO: “Health plans operating in the exchanges are using significant cost-sharing to meet actuarial values set forth in the law and limit premium costs. However, these formulary designs often result in high costs for patients with chronic illness who need biologics and other products on the specialty tier[.]  Tracking these patients to ensure that they are getting appropriate care is a critical quality need.”

3.  Also this week, the FDA requested comment on a proposed study that “will investigate the impact of limiting the risks presented in [direct-to-consumer (DTC)] prescription drug television ads to those that are serious and actionable, and including a disclosure to alert consumers that there are other product risks not disclosed in the ad.”

4. And the FDA announced that it will hold a public hearing “to obtain information and comments from the public on the strengths and weaknesses of the current [Over-The-Counter] Monograph Process, and to obtain and discuss ideas about modifications or alternatives to this process.”  The FDA writes: “We believe that the biggest challenges of the current system are: [(1)] the large number of products marketed under the OTC Drug Review for which there are not yet final monographs, [(2)] limitations on FDA’s ability to require, for example, new warnings or other labeling changes to address emerging safety or effectiveness issues for products marketed under the OTC Drug Review in a timely and effective manner, and [(3)] the inability of the OTC Drug Review to easily accommodate innovative changes to products regulated under the OTC Drug Review.”

5. Finally, at the Boston Globe Tracy Jan reports on the debate over whether generic painkillers should be required to be abuse-resistant.  Jan writes:  “The pharmaceutical industry has developed pills that are strongly resistant to being crushed — and are therefore difficult for addicts to abuse. But industry profit margins, battles over patents, caution over a still-emerging technology, and a ponderous federal bureaucracy have kept such abuse-resistant pills from widespread adoption in the market.”

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Monday Morning Recap: The Week (1.27.14-2.2.14) in Drug & Device Law & Policy

February 3, 2014 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. At Regulatory Reports, Alec Gaffney wrote an article, At 160 Million Patients, FDA’s Mini-Sentinel Isn’t so ‘Mini’ Anymore, in which he reports that “[a]s of July 2012, the Mini-Sentinel System’s Distributed Database (MSDD) includes information on 160 million individuals, 3.5 billion medication dispensings—more than 45 million per month—and 3.8 billion unique medical encounters.”  According to Gaffney, Mini-Sentinel can already provide the FDA “with key information on the safety of products far more quickly than the agency could do by itself in the past. … In other words, thanks to big data, the only thing ‘mini’ about the Sentinel system may wind up being the waiting time between regulators asking a question and receiving an answer.”

2. An article in JAMA Internal Medicine, Nudging Guideline-Concordant Antibiotic Prescribing: A Randomized Clinical Trial, gives the results of a clinical trial that ”found a significant decrease in unnecessary antibiotic prescribing rates for patients treated by clinicians who signed and posted a letter in their examination rooms emphasizing a commitment to avoid inappropriate antibiotic prescribing for [acute respiratory infections].”  The authors comment that interventions grounded in a rational model of clinician behavior, such as education, electronic alerts, and financial incentives, ”have not been particularly effective.” They call for investigation of novel approaches, such as theirs, that appeal to psychological factors, such as our strong motivation to follow through on our publicly-made commitments.

3. On Thursday, January 30th, Dr. Jeffrey Shuren of the Food and Drug Administration’s Center for Devices and Radiological Health said at an event sponsored by the Pew Charitable Trusts that the FDA believes that there should be an expedited pathway to approval for high-need devices, paired with agency authority to order post-approval studies of devices, authority it already has with regard to drugs.  David Pittman reports on Shuren’s speech at MedPage Today, here.

4. Also on Thursday, CMS announced “interim financial results for select Medicare Accountable Care Organization (ACO) initiatives, an in-depth savings analysis for Pioneer ACOs, results from the Physician Group Practice demonstration, and expanded participation in the Bundled Payments for Care Improvement Initiative.  Savings from both the Medicare ACOs and Pioneer ACOs exceed $380 million.”  While less than half of the Medicare ACOs (54 of 114) that started in 2012 succeeded in cutting costs, CMS emphasized that the goal is “to achieve savings over several years, not always on an annual basis[.]“  The Pioneer ACOs also had inconsistent performance, with just 9 of 23 succeeding in cutting costs while maintaining quality.  The Pioneer ACOs nonetheless generated savings that ”far exceed findings from a previous analysis conducted by CMS, which used a different methodology.”

5. Finally, I highly recommend this article from last week by Jenny Gold at KHN News about how parents sharing information with other parents changed the standard of care for treating clubfoot.  Here’s a taste: “Surgeons are trained to operate…and usually that’s the way they make money. The Ponseti Method brings in a lot less for orthopedists. For about 50 years, technique mostly stayed in Iowa.  But then something new came along: The internet.”

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FDA’s Proposed Changes to Generic Drug Label Rules Questioned by Members of Congress

paradiseLGjpg_1Debate continues regarding the Food and Drug Administration (FDA) proposed rule that would allow generic drug manufacturers to independently make changes to a drug label on the basis of newly acquired safety information.  The proposed rule trails a trilogy of Supreme Court decisions tackling questions of federal preemption in the pharmaceutical realm: Wyeth v. Levine (2009), PLIVA v. Mensing (2011), and Bartlett v. Mutual Pharmaceutical (2013).  In Wyeth v. Levine (2009), the Supreme Court held that the federal Food, Drug, and Cosmetic Act (FDCA) does not preempt failure to warn claims for brand name, also called reference listed drugs (RLD).  Taken together, PLIVA and Bartlett establish that the FDCA does, however, impliedly preempt both state tort law failure to warn and design defect claims against generic pharmaceutical manufacturers. 

Why such seemingly opposite results regarding preemption?  It’s the result of FDA regulations and the statute.  The regulations provide that RLD manufacturers are able to update product labeling prior to FDA review of the change in a changes-being-effected (“CBE-0”) supplement.  This mechanism originated from a 1965 enforcement discretion policy in which the FDA recognized that some labeling changes ought to be implemented as soon as possible in order to adequately protect consumers.  The procedure is now contained in 21 C.F.R. 314.70, allowing RLD manufacturers to makes such labeling changes upon submission of a CBE-0 supplement in several circumstances, including the addition or strengthening of a contraindication, adverse reaction, warning, or precaution shown by newly-acquired or discovered scientific evidence. 

As for the statute, the Hatch-Waxman Act of 1984 amended the FDCA to create the abbreviated new drug application (ANDA), or generic drug approval process.  Approval of a generic drug product is based on the concept of bioequivalence, which means the generic is identical to the RLD for purposes of safety and efficacy.  The legislation explicitly requires that generic drug applicants must submit “information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug…” FDCA §505(j)(2)(A)(v); 21 U.S.C. 355(j)(2)(A)(v).  Congress included this provision to facilitate the acceptance of these products by physicians, pharmacists, and patients, as well as ensure uniformity for bioequivalent products.  Identical labels also helped bolster substitution of generic drugs for brand name drugs as a means to impart cost-savings onto both the government and consumers.  Until the publication of the recent proposed rule, the FDA has maintained the position that the statute prohibits generic manufacturers from deviating from a label identical to that of the RLD, expressed in 57 Fed. Reg. 17950, 17961 (1992).

The FDA now proposes to add a provision to the regulation to bring parity to the RLD and generic realm in terms of the availability of the CBE-0 supplement for labeling changes.  The FDA acknowledges that the proposed rule would alter the long-standing policy that the labeling of generics must be identical to the RLD.  As support for the change in position, the FDA cites changed circumstances:

[A]s the generic drug industry has matured and captured an increasing share of the market, tension has grown between the requirement that a generic drug have the same labeling as its RLD, which facilitates substitution of a generic drug for the prescribed product, and the need for an ANDA holder to be able to independently update its labeling as part of its independent responsibility to ensure that the labeling is up-to-date.

An FDA press release further emphasizes that the generic share of the market is currently over 80% of U.S. prescriptions.  The proposed rule discusses Wyeth, PLIVA, and Bartlett, noticeably understating that the rule “may” eliminate preemption for generic drugs.

Two years ago, legislators attempted such a change at the statutory level.  Companion bills, both entitled Patient Safety and Generic Labeling Improvement Act, were introduced in the House (HB 4384) and Senate (S 2295), which would have amended the FDCA to make the CBE-0 supplement available to generic manufacturers by law.  Both died.  The bill language read as follows:

(A) Notwithstanding any other provision of this Act, the holder of an approved application under this subsection may change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application under subsection (b).

(B) In the event of a labeling change made under subparagraph (A), the Secretary may order conforming changes to the labeling of the equivalent listed drug and each drug approved under this subsection that corresponds to such listed drug.

Now, another group of legislators is taking a different stance.  On January 22, nearly 30 members of Congress signed a letter addressed to the Commissioner of the FDA, Dr. Margaret Hamburg, expressing “grave concerns” about the proposed regulation. The letter questions the authority to promulgate such a rule given the statutory language and urges that it would lead to inconsistency in drug messages to consumers and physicians alike.  The letter states that the proposed rule would “conflict directly with the statute, thwart the law’s purposes and objectives, and impose significant costs on the drug industry and healthcare consumers.”  The letter directs the Commissioner to answer 11 enumerated questions by February 5 in order to “assist the Committee(s) in better understanding the decision making process.”  Related press releases can be found here and here.

Many more are expected to chime in.  Originally scheduled to close mid-January, the FDA has extended the comment period until March 13, 2014.

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Monday Morning Recap: The Week (1.20.14-1.26.14) in Drug & Device Law & Policy

January 27, 2014 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. Last week’s JAMA includes three Original Investigation articles presenting the results of empirical research on the evidence required to get a drug or device approved by the Food and Drug Administration, an Editorial commenting on the results of the research, and two shorter Viewpoint pieces on drug approval topics.  In their Editorial “Opening the FDA Black Box,” Steven Goodman and Rita Redberg write that an “important commonality” of the three Original Investigation pieces “is that they were made possible by a degree of increased openness at the FDA.  Drugs@FDA is becoming more usable and complete, FDA staff might not have published data about unapproved drugs in an earlier era, and the FDA is currently exploring ways to share individual-patient data from clinical trials and has cosponsored a recent Institute of Medicine committee to issue guidelines for such sharing.”

2. Professor Efthimios Parasidis of Ohio State University comments on the JAMA studies here, writing: “Taken together, the articles support calls for the FDA to be more robust in the surveillance of marketed drugs and medical products. Simply stated, we need to know if the products we are using actually work. As the Downing study shows, the FDA’s pre-market review process isn’t clear on this and the public remain none the wiser.”

3. The Wall Street Journal reports that the “unfavorable economics” that have been a drag on antibiotic development have improved.  As the Journal explains: “Regulators in the U.S. and Europe recently have moved to clear roadblocks that have impeded antibiotic development, with the U.S. granting priority review for innovative new drugs.  Research funding is beginning to flow as well. The European Union funds antibiotic research projects with industry and universities. U.S. government funding is available to companies developing promising new molecules.  Alternative commercial models are being discussed that get around the problem of low sales volumes: selling new drugs in bulk to health-care providers for use when needed, or charging a fixed license fee for access to them.”

4. Also last week, IMS Health released a report, Engaging Patients through Social MediaAmong the findings are that less than half of the “top 50 global pharmaceutical manufacturers have some level of healthcare-related social media engagement”; the FDA and other “[r]egulatory agencies are active in social media even as manufacturers await final guidance on requirements”; “Wikipedia is the single leading source of medical information for patients and healthcare professionals”; and “[s]ocial media engagement lags significantly with [people age 50 and older,] the population segment that uses healthcare services the most.”

5. Finally, at RxObserver, Edward Lawrence offers a highly critical take on CMS’ effort to “[r]ewrite the Medicare Part D [p]rime [d]irective.”

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Monday Morning Recap: The Week in Drug & Device Law & Policy

December 16, 2013 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday morning, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. At The New Yorker, Ian Parker tells a gripping story about the development and approval of a next generation insomnia drug.  Parker ends the article with the following question:  “How successfully can a pharmaceutical giant—through advertising and sales visits to doctors’ offices—sell a drug at a dose that has been repeatedly described as ineffective by the scientists who developed it?”

2. An article by Ariana Eunjung Cha in The Washington Post suggests that fears of risk classification by design in the new health insurance exchanges may be coming true.  Cha writes: “The nation’s new health-care law says insurers can’t turn anyone away, even people who are sick. But some companies, patient advocates say, have found a way to discourage the chronically ill from enrolling in their plans: offer drug coverage too skimpy for those with expensive conditions.”

3. At Fierce Pharma, Tracy Staton reports on a fine issued by the Swedish stock exchange against a drug company, Medivir, that failed to respond for three hours to a conversation on Twitter that sent the company’s shares soaring.

4. Also in the news last week was the FDA’s decision to “implement[] a voluntary plan with industry to phase out the use of certain antibiotics for enhanced food production. … Because all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary.”

5. Finally, at The Incidental Economist Aaron Carroll highlights a study in JAMA Pediatrics that found that the “vast, vast majority of drugs used in the care of neonates have not been studied in neonates.”  Carroll writes: “We need to work on fixing this. Legislation hasn’t done enough.”

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