Monday Morning Recap: The Week (10.13.14-10.19.14) in Drug & Device Law & Policy

October 20, 2014 by · Leave a Comment
Filed under: Drugs & Devices, Monday Morning Recap 

Picture3It’s Monday morning, time for our Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think…

1. Making the news this week was a release by WikiLeaks of “a second updated version of the Trans-Pacific Partnership (TPP) Intellectual Property Rights Chapter[,]” which will have significant implications for access to medicines. Public Citizen has released a detailed analysis of the pharmaceutical issues that remain under negotiation, here. Public Citizen notes that the negotiating countries are still wide apart on some issues and are, for example, “debating a range of possible monopoly periods for biotech drugs, ranging from zero years to twelve.”

2. Ebola drug development continued to make the news this week. This article by Peter Loftus and Betsy McKay at the Wall Street Journal provides a very helpful overview. Loftus and McKay quote Food and Drug Administration Commissioner Margaret Hamburg who “said the agency has shifted more employees to help speed the development of drugs, vaccines and diagnostics. ‘We’ve been up in the middle of the night in order to make product available’ on an emergency basis to infected patients in the U.S., she said in an interview this week.

3. Turning now to diseases for which safe and effective vaccines have been developed and are widely available, this week Karen Kaplan at the LA Times analyzes new Centers for Disease Control data on vaccine coverage among children in kindergarten. Kaplan highlights the fact that, “[a]cross the country, the median rate of MMR vaccination for kindergartners in the 2013-2014 school year was 94.7% for the MMR vaccine[,]” with “seven states and the District of Columbia [reporting] rates below 90%. At those rates, some communities are in danger of losing herd immunity – having enough people vaccinated to protect the small number of those who can’t get shots for medical reasons.”

4. At Forbes John Osborne reported that “Chairman Fred Upton (R-Michigan) and some of his colleagues on the House Energy & Commerce Committee want to talk about the off label issue.” Osborne notes that Congress could “direct the FDA to establish a new pathway under which truthful information outside the scope of the approved label would be able to be discussed with physicians. … Congress also could simply declare that the FDA may not regulate the communication of truthful information, and that may (or may not) limit the Justice Department’s determination to apply the False Claims Act to cases where off label prescribing is prevalent.” Osborne writes that “Chairman Upton plans to introduce an omnibus reform bill in the new Congress. If the off label issue is addressed, it would represent a historic change in attitude and behavior within the United States government that would clearly have significant implications for the way in which the FDA regulates drug, biotechnology and device company communications.

5. Finally, not this week but still worth noting, earlier this month the Office of Inspector General of the Department of Health and Human Services published a proposed rule which “would amend the safe harbors to the anti-kickback statute and the civil monetary penalty (CMP) rules under the authority of the Office of Inspector General (OIG).” The rule “would protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the anti-kickback statute[,]” “codify revisions to the definition of ‘remuneration,’” and “add a gainsharing CMP[.]“ This McDermott Will & Emery summary of the proposed rule provides helpful context. Comments on the rule are due December 2, 2014.


Monday Morning Recap: The Week (9.29.14-10.5.14) in Drug & Device Law & Policy

Picture3It’s October and it’s Monday, time for our  Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think. And once again, there’s been a lot going on…

1. If the questions I have been fielding from friends and family this week are any indication, the development of vaccines to prevent, and anti-viral medications to treat, Ebola virus disease is on a lot of people’s minds. In an article in The New Yorker in August, James Surowiecki gave helpful background on “Ebolanomics”, here; Lecia Bushak provided an update in last week’s Newsweek, here. Our own Carl Coleman wrote about the Food and Drug Administration’s decision to allow compassionate use of the experimental treatment ZMapp, here; in early September, the Department of Health and Human Services announced that it was partnering with ZMapp’s manufacturer to develop the drug, here. The FDA has also granted permission to Tekmira Pharmaceuticals to provide its experimental drug TKM-Ebola to patients on a compassionate use basis, here. And just today, the biopharmaceutical company Chimerix announced that the FDA has authorized compassionate use of its experimental treatment, brincidofovir, here. And this is not all, e.g., here. The pace of development in recent months is both dizzyingly fast and much too slow. As much or more focus and funding must go to stopping the current epidemic using proven public health techniques. As Atul Gawande wrote in The New Yorker last week, “The diagnosis of the first U.S. case is not the sign that we need to shut patients out. It’s the sign that we need to bring more help in. The Ebola epidemic is stoppable.

2. Last week, the Open Payments website, which tracks payments drug and device companies make to doctors and teaching hospitals, finally went live. At Pro Publica, Charles Ornstein had this, highly critical, take: “If the federal government’s new Open Payments website were a consumer product, it would be returned to the manufacturer for a full refund. … As a health care journalist at ProPublica, I’m reasonably competent at analyzing data, plus I’m lucky to have another data reporter and a news application developer helping me. Still, it took us hours just to upload the data onto our servers so that we could dig into it.” Ornstein opines that “after the fumbled launch of, it might have been better if agency officials had pushed this off until it was in better shape.

3. At Sidley Austin’s Original Source blog, Jaime Jones and Brenna Jenny call attention to two recently-decided cases in which courts allowed the government, in one, and the relator, in the other, to establish liability using statistical inferences. Jones and Jenny write that, in U.S. ex rel. Martin v. Life Care Centers of America, “the court determined that the fraud-fighting goals of the FCA would be stymied if the court sided with the defendants and effectively required a ‘claim-by-claim review’ in every FCA suit.” These developments are no doubt being watched carefully by drug and device manufacturers, who frequently find themselves defending against FCA suits. In an article published earlier this year, I discuss (and endorse) a similar evolution towards the use of standard statistical methods to establish liability in economic injury cases brought by third-party payers against drug and device manufacturers.

4. At FiercePharma, Tracy Staton reports on a 60 Minutes segment on cancer drug pricing that aired on Sunday, October 5th. She concludes:

Over and over, experts have said that rising drug prices will eventually force a public debate. Perhaps “60 Minutes” will help touch that off. But one of the biggest obstacles to overhauling cancer costs will be Americans themselves. Everyone wants access to the latest treatments, no matter how expensive. No one wants to put a number on the value of longer life, no matter how brief.

So, while private insurers may be setting up their own barriers to expensive meds, allowing public programs to do the same is frightening. Letting payers restrict access behind closed doors is more comfortable than facing the issue in the open.

5. Finally, I enjoyed reading FierceBiotech’s brief profiles of their top fifteen women in biotech for 2014. Making the list is Amy Schulman, who joined Pfizer as General Counsel, but was running that company’s consumer healthcare business by the time she left. Schulman is now a Venture Partner at Polaris Partners where she currently serves as CEO of Polaris-funded start-up Arsia Therapeutics, which is “working on technology to make large-molecule biologics easier to administer.”  On the question of gender equity, Schulman comments: “We have to make sure we’re really being vigilant and look at, ‘Are we really gender neutral? Are we really color blind?’” she said. “… I’m hardly alone in the recognition that those of us who are here should be spending our political capital to open the doors to the next generation of women, and many of us are deeply committed to that.


What’s Next If the FDA Holds the Line on Social Media?

Kate Greenwood Portrait

Cross-Posted at Bill of Health

Earlier this week, the Food and Drug Administration announced that it was reopening the comment periods for the two draft guidances on the use of social media to promote prescription drugs and medical devices that it released in June:  Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Both guidances have drawn criticism from industry and observers, with the FDA being charged with, in the words of Pharmaguy at the Pharma Marketing Blog, “not being technically savvy enough to understand the nuances of social media and search engine advertising.”

In the draft guidance on social media platforms with character space limitations, such as Twitter and sponsored links on Google and Yahoo, the FDA states that “if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication.” The draft guidance would allow companies to limit the risks that are presented within a character-and-space-limited communication to those that are the most serious, as long as the communication also includes a direct hyperlink to a destination (for example, a landing page) that is devoted exclusively to a complete discussion of the product’s risks. The FDA emphasizes in the draft guidance that “[i]f an accurate and balanced presentation of both risks and benefits is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion).”  In the first round of comments, PhRMA commented that the amount of information that companies are required to include in a single communication “would make the use of Twitter and comparable platforms impossible in all but the rarest cases.” With regard to sponsored links, PhRMA also noted that the guidance assumes that advertisers have more control than they in fact do over “the appearance – and order of appearance – of information on such platforms.”

It will be interesting to see whether and how the FDA responds to these comments, as well as to any additional comments filed during the period that comments are reopened, which ends on October 29th. If the agency holds the line (as I think it should) and continues to require that companies provide at least some balance between risks and benefits in all advertising and labeling, regardless of platform, companies will no doubt (continue) to look for alternatives. At several points in the draft guidance on social media platforms with character space limitations, the FDA notes that “reminder” promotion “that calls attention to the name of a drug or device but does not, among other things, include indications, dosage recommendations, or other representations or suggestions concerning safety of effectiveness,” are exempt from the federal Food, Drug and Cosmetic Act’s risk disclosure requirements. Advertiser Simon Bein writes:

Reminder ads in paid search see some of the highest click through rates of any type of search ad and aren’t bursting at the seams with safety warnings. But when it comes to Twitter, the reality is more sobering: a reminder ad-based Twitter profile is probably about as boring as could be.

Disease awareness advertisements or labeling “that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device” are likewise exempt from the FDCA’s risk disclosure requirements. Bein writes:

If your consumers are high in the funnel—searching for disease state information—unbranded communications, which drive great engagement for many of our clients, will be key. They’re relevant to a consumer’s information-seeking activities and help develop ongoing dialogues with the consumers. And with Twitter, let’s be realistic: branded accounts numbered in the single digits. Unless the FDA has a change of heart, it’s sure to stay that way.

In a recent article in The Pink Sheet, Sarah Karlin makes a similar point, noting that “disease-awareness ads could be a powerful marketing tool in areas of confined space and regulatory uncertainty[.]” Disease awareness ads are not without their issues, though. Karlin reports that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee, both of which recently voted in support of a narrower indication for testosterone-replacement therapy, were concerned by the FDA’s lack of regulation of disease-awareness advertisements for age-related “Low-T”. The committees were shown a television advertisement run by AbbVie, the manufacturer of AndroGel, that says:

Feeling like a shadow of your former self? Don’t have the hops for hoops with your buddies? Lost your appetite for romance? And your mood is on your way down. You might not just be getting older. You might have a treatable condition called low testosterone or Low-T. Millions of men 45 or older may have Low-T. So talk to you doctor about Low-T and step out of the shadows.

Karlin explains that the advertisement “points viewers to a website,, which like the TV ad doesn’t mention any product name but does contain a page on available treatment options such as gels, patches and injections.” AbbVie does disclose its involvement with, albeit in the far right hand corner of the site, in gray text against a slightly lighter gray background. Companies are not required to make such disclosures and, in fact, doing so creates some degree of legal risk for them. Per a decade-old draft guidance, there are circumstances under which “the mere appearance of the company’s name in conjunction with a disease reference could trigger the act’s advertising or labeling requirements[.]“

Karlin goes on to report that the advisory committee members, understandably, “wanted to know how a company could discuss symptoms in a disease-awareness ad and imply treatment was available for these symptoms, when testosterone-replacement products weren’t approved to treat these symptoms.” In response, an FDA official emphasized that the agency does not have jurisdiction over such advertisements, the Federal Trade Commission does.

Particularly in character-space-limited platforms like Twitter, disease awareness advertisements merit FDA scrutiny, to ensure that they do not trigger the FDCA’s requirements, and the FTC’s scrutiny as well, to ensure that, if the FDCA does not apply, the advertisements are truthful and not misleading.


Monday Morning Recap: The Week (9.8.14-9.14.14) in Drug & Device Law & Policy

September 15, 2014 by · Leave a Comment
Filed under: Drugs & Devices, Monday Morning Recap 

Picture3Well, once again it’s been two weeks since we last did a Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think. And there’s been a lot going on…

1. The September issue of The Milbank Quarterly contains an original empirical study by Genevieve Pham-Kanter analyzing the effects of the financial ties that members of the Food and Drug Administration’s advisory committees have with drug manufacturers.  Among her very interesting findings is the fact that while a committee member with ties to one manufacturer was more likely to recommend approval of that manufacturer’s drug, committee members with ties to multiple manufacturers did not show an overall bias in favor of approval. Aaron Carroll wrote about the study at the New York Times, here, and David Schlaes wrote about it here. Per Schlaes: “The take-home lesson to me is that experts are actually experts.  Those that are in demand by multiple companies for help in analyzing or developing their products are more likely to be the kind of experts the FDA is seeking and less likely to let their financial and other relationships with sponsors get in the way of their expertise.”

2. The contentious debate between the drug and device industry and the Department of Justice over where to draw the line between protected  speech, on the one hand, and punishable fraud, on the other, continues. In an article at FiercePharmaMarketing this week, Tracy Staton calls attention to a brief the government filed at the end of August. Staton writes: “In essence, the brief asks the court to determine that ‘speech that serves as a conduit for violations of the law’ isn’t protected by the First Amendment. PhRMA, of course, is asking for the opposite. It wants the court to decide that the law only prohibits ‘at most, false speech,’ which would give reps the chance to talk about off-label use of meds, as long as they’re telling the truth.”

3. This week also brought news that a supervisory pharmacist at the New England Compounding Center was arraigned and pled not guilty to a single count of mail fraud. Denise Lavoie of the AP reports: “Chin, a supervisory pharmacist, is accused of participating in a scheme to fraudulently cause one lot to be labeled as injectable, meaning it was sterile and fit for human use. The drug was shipped to Michigan Pain Specialists in Brighton, Michigan, and injected into patients. As a result, 217 patients contracted fungal meningitis, and 15 died. Chin is the first person to be charged criminally in the case, but prosecutors have said the prosecution is part of a larger criminal investigation of Chin and others.

4. At the New England Journal of Medicine, Rita Redberg argues that “[b]linded, randomized, controlled trials (RCTs), in which the proposed therapy is compared with a placebo or a ‘sham’ (nontherapeutic) intervention,”which are currently “rare for medical devices” need to become more common. Dr. Redberg recommends that “the risk associated with performing unnecessary procedures … be weighed against the risk of mistaking a placebo effect for therapeutic benefit and therefore subjecting thousands or millions of patients to a procedure that actually does them no good.”

5. Finally, at the New Yorker this week, Andrew Solomon discusses the “terrifying dilemma” confronting women with depression who must weigh a dizzying array of known and unknown risks when deciding whether to pursue treatment with antidepressant medication. Solomon writes:

The debate rages, and the choice is a difficult one: to be depressed during pregnancy, with troubling consequences, or to be on medication during pregnancy, with unclear ramifications. It is not helpful when the complexity of the decision is belittled. ‘Everyone’s happier with this idea that the medications are O.K.,’ [Roni Caryn] Rabin wrote, quoting an expert. Everyone is second most happy learning, as Rabin suggests, that the medications are poison but depression is fine—because clarity and simplicity make life easy. If the meds help more than they harm, you take them; if they harm more than they help, you don’t take them. The problem is that this is a highly nuanced question to which there is no consistent answer, and about which we know too little. That makes everyone excruciatingly uncomfortable.

In this article I wrote several years ago, I review some of the reasons for the dearth of information about the risk-benefit ratio of drugs when used during pregnancy and make recommendations for policy responses.


Seton Hall Law Alum David Gibbons on Hospira v. Burwell and FDA’s Authority to Order Drug Recalls

Last week, Seton Hall Law alum David Gibbons of Hyman, Phelps & McNamara published a blog post at the firm’s FDA Law Blog on a very interesting legal question, whether a court can order the FDA to order a drug manufacturer to recall a drug. In a suit brought by Hospira challenging the FDA’s approval of generic versions of one of Hospira’s drugs, a federal district court in Maryland recently reversed itself on this point. The court vacated its earlier–unprecedented–ruling that would have required the FDA to order the generic drug manufacturers to recall the generic versions of the drug at issue. As Gibbons explains:   

Generally speaking, FDA cannot compel a mandatory recall, except in very limited circumstances as authorized by statute, none of which apply to drugs…

FDA states clearly and succinctly in its Brief: “FDA cannot order recalls.”  The Agency goes on to argue that the recall ordered in the Hospira TRO could not even be requested by FDA because the basis for the recall was a patent dispute and not a matter of product safety or efficacy.  FDA says: “consumers should believe that recalled products present a risk to health or are grossly deceptive. That is decidedly not the case here.”  The Agency admitted that “[i]f a company chooses not to comply with an FDA request to recall, FDA has no mechanism to enforce its request because it does not have statutory authority to order drug recalls.”

Read the entire post here.


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