It’s Monday morning, time for what Ed Silverman calls a “ritual cup of stimulation,” and 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. At USA Today, Peter Eisler and Christopher Schnaars report that “[t]wo years after contaminated drugs linked to a compounding pharmacy in Massachusetts killed 64 and sickened more than 750 with fungal meningitis, the industry still struggles with serious safety problems affecting thousands of patients … A regulatory crackdown by the U.S. Food and Drug Administration since the outbreak in October 2012 has led to an unprecedented spate of drug recalls by compounding pharmacies — and scores of citations for bad practices.“
2. At the Food and Drug Administration’s FDAVoice blog, Jean Hu-Primmer discusses a new joint effort between FDA, the Biomedical Advanced Research and Development Authority (BARDA), and the United States Critical Illness and Injury Trials Group (USCIITG) “to gather important information about medical countermeasures used during public health emergencies.” Among other things, the project will work to “address challenges with collecting and sharing data rapidly in emergencies, including streamlining electronic case reporting for clinical trials and rapidly disseminating key findings to FDA and other stakeholders to support clinical decision-making. … USCIITG will also develop and pre-position a simple influenza treatment protocol in 10 hospitals throughout the U.S. during the 2015-2016 influenza season. The project will help doctors more easily use an investigational treatment protocol for patients with severe influenza, and test the data collection and reporting system during peak times. The goal is to help streamline the process during future influenza seasons and emergencies.”
3. At Bloomberg BNA’s Health Care blog, Alex Ruoff reports that “[n]early 60 health information technology groups and various industry associations are circulating a letter among member of Congress asking for legislation that clarifies the Food and Drug Administration’s authority to regulate health IT products. The letter was also sent to Health and Human Services Secretary Sylvia Mathews Burwell and called on lawmakers to pass legislation reflecting health IT oversight recommendations made earlier this year by three federal agencies, including the FDA and the Office of the National Coordinator for Health IT. The proposed legislation would ‘provide much needed statutory clarity and a stable foundation for continued innovation in health IT’ by establishing parameters, defined by the framework, for the FDA to oversee health IT products, the letter said.”
4. And at Bloomberg BNA’s Life Sciences Law & Industry Report, Nicole Ostrow summarizes the results of an analysis in the Annals of Internal Medicine that found that “[researchers] with financial ties to flu drug companies more often reported positive findings in their studies of the treatments… Christine Laine, editor in chief of the Annals and a senior vice president at the American College of Physicians in Philadelphia, said there’s a lot of confusion for doctors because of the conflicting findings among the studies of the flu medicines. Today’s results provide some insight into why the literature on this topic has been ‘inconsistent.’“
5. Finally, I can’t recommend it yet, because I it hasn’t climbed to the top of the pile yet, but I am looking forward to reading this month’s Health Affairs, on Specialty Pharmaceutical Spending & Policy, cover to cover. (I did sneak a peak at the Narrative Matters piece, by Leana Wen, in which “[a] doctor who stutters confronts the stigma against patients—and providers—with disabilities.” It’s off the topic of drug and device law and policy, but of general interest and very thought-provoking.)
Filed under: Drugs & Devices, Monday Morning Recap
It’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 Healthcare.gov, 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.“
Filed under: Drugs & Devices, Food and Drug Administration (FDA)
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, www.IsItLowT.com, 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 www.IsItLowT.com, 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.
Dean Hobbs writes:
It is with great sadness that I share the news of Suzan Sanal’s passing. Suzan was a well-loved member of our community. As a student she was passionate about the law and was excited to finish her degree this year. She was active in many things outside the classroom including the Health Law Forum and writing for Health Reform Watch. Suzan fought a brave battle with leukemia for over six years. She will be fondly remembered by her classmates and many professors and administrators.
The interesting and varied posts that Suzan wrote for Health Reform Watch can be found here. I regret never having met her; it is clear that she was a bright light.
Donations may be made in Suzan’s name to StupidCancer (http://stupidcancer.org/), an organization which provides support for young adults with cancer, or Be The Match (http://www.bethematch.org/), an organization that finds bone marrow donors for those with blood cancers like leukemia and lymphoma.
It’s that time again. Here’s 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. On Friday, September 19th, the news broke that a Chinese court imposed a $500 million criminal fine on GlaxoSmithKline, which was accused of using third parties to pay bribes to doctors and hospitals in China. At the New York Times, Keith Bradsher and Chris Buckley highlighted the fact that “[i]n a rare move, authorities also prosecuted the foreign-born executive who ran Glaxo’s Chinese unit. After a one-day trial held in secrecy, the court sentenced Glaxo’s British former country manager, Mark Reilly, and four other company managers to potential prison terms of up to four years.” In a client alert, the law firm Davis Polk points out that “the Changsha Intermediate Court ruled that GSK violated Chinese laws prohibiting commercial bribery, rather than bribery of government officials. This suggests that Chinese authorities do not view the relevant healthcare professional to be government officials. However, this position does not preclude U.S. regulators from potentially penalizing GSK for bribery of foreign government officials, under the same facts, in violation of the Foreign Corrupt Practices Act; the U.S. regulators consider local law designations of ‘government official’ status as one of a number of factors when determining FCPA liability.“
2. Also this week, as Roni Caryn Rabin reported at the New York Times, “the National Institutes of Health announced Tuesday that it will distribute $10.1 million in grants to more than 80 scientists studying a diverse array of subjects, including drug addiction, fetal development, migraines and stroke. The researchers will use the additional funds to include more human participants — generally women — in clinical trials and to ensure that their laboratory animals, even cell lines, are representative of both genders. The money also will be used to analyze gender differences in the resulting data[.]” Rabin quotes the NIH’s Dr. Janine Austin Clayton who said: “We literally know less about every aspect of female biology compared to male biology.”
3. On the device side, there were two interesting posts this week at Covington & Burling’s Inside Medical Devices blog. The first, by Tyler Evans, discussed a recently-settled False Claims Act case in which a device company was alleged to have failed to comply with the Trade Agreements Act when it “sold orthopedic devices on a federal supply schedule administered by the U.S. Department of Veterans Affairs (VA) after purchasing the devices from a third-party manufacturer in Malaysia.” Evans writes: “The settlement serves as a reminder to medical device manufacturers and suppliers that conducting due diligence regarding the country of origin of their products is typically necessary when doing business with the U.S. Government. Medical device companies should be aware of the potential risk of comingling end products when sourcing items from countries that are not compliant with the TAA.”
4. The second post, by Brianne Bharkhda, highlights the importance of internal email to a jury in a products liability case. As Bharkhda explains, earlier this month, “a state court jury in Dallas awarded the plaintiffs in a pelvic mesh device litigation against Boston Scientific approximately $23.5 million in compensatory damages and $50 million in punitive damages.” At the trial, the plaintiffs introduced an August 2010 email in which “a Boston Scientific executive discussed a study published in December 2009 in the American Journal of Obstetrics and Gynecology comparing Boston Scientific’s Obtryx device with its Advantage sling system. In the email, the executive stated, ‘I don’t feel this paper would be useful to the sales force in terms of helping defend business or selling more slings.’ ‘It actually is a fairly negative outcome in terms of our Obtryx sling. I certainly wouldn’t hand this out to any physicians.’” As Bharkhda writes: “The . . . case is a prime example of how internal company communications can play a major, even decisive, role in medical device product liability trials.“
5. Finally, in an update circulated this past week, Sidley Austin writes that “[d]espite OIG guidance, Congressional reports, and press attention that has been critical of [physician-owned distributors ("PODs")], there was a noticeable lack of healthcare fraud and abuse enforcement activity involving PODs. That changed on September 8, 2014, when the Department of Justice (“DOJ”) filed a False Claims Act (“FCA”) suit against Reliance Medical Systems, LLC. . . . The medical device industry will want to follow Reliance closely as this case might signal either the start of an enforcement trend against PODs or simply reflect an action targeting a network of PODs that allegedly paid particularly lucrative profits to physicians, while placing intense pressure on them to increase utilization of Reliance devices.“