What follows is a weekly feature here at Health Reform Watch. Each Monday morning, we provide a recap of the drug and device (and, this week, breast milk and bone marrow) 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. FDA Commissioner Margaret Hamburg kicked off the week with a blog post heralding the passage of the Drug Quality and Security Act which will empower FDA to regulate compounded drugs and enhance the security of the drug supply chain. Commissioner Hamburg writes that ”[w]hile the law does not provide FDA with all the additional authorities sought, these provisions are a sign of progress.”
2. At FDA Law Blog, Allyson Mullen and Jeffrey Gibbs provide helpful analysis of the FDA’s final guidance on in-vitro diagnostics that are labeled for research or investigational use only. Mullen and Gibbs note that the final guidance was modified in response to manufacturers’ vociferously-voiced complaints that the draft guidance wrongly equated a manufacturer’s knowledge that a research-only diagnostic is being used for clinical purposes with the manufacturer’s intent that it be so used. Nonetheless, Mullen and Gibbs conclude that ”it is clear that FDA expects commercially available RUO and IUO products to be an area of focus for FDA enforcement.”
3. At NJ Spotlight, Andrew Kitchenman writes about legislation pending in New Jersey that would “increase public awareness of the potential dangers of informal [breast] milk sharing and require state licensure of milk banks.” As interest in donating and selling breast milk grows, so does interest in regulating its exchange. Kitchenman notes that “the health concerns are backed up by research studies, including a recent one published by the journal Pediatrics, which found that human milk purchased via the Internet exhibited high overall bacterial growth and was frequently contaminated with pathogenic bacteria due to poor collection, storage, or shipping”, but he also quotes an advocate who calls the risk of disease transmission “theoretical”.
4. At Bill of Health, Michelle Meyer offers an exhaustive set of arguments against an HHS proposal to ”criminalize compensation for providing peripheral blood stem cells (PBSCs) given through apheresis. Compensating those who allow their bone marrow to be aspirated — the other major source of hematopoietic stem cells (HSCs) — is already explicitly criminalized[.]“ Meyer also suggests a seemingly-promising alternative approach to increasing bone marrow donation, as follows: “If a major stumbling block is getting people into the registry, which is a stage at which dying patients are for many prospective registrants merely “statistical lives,” then maybe what we should be doing — all without violating [the National Organ Transplant Act], even as interpreted by the Department — is to pay people to join the registry.”
5. Finally, discussion about the FDA and 23andMe continued this week. I recommend this post by Leila Jamal at the Berman Institute’s blog, in which she argues that the fact that “most individual genetic markers have poor predictive power” is not a reason to restrict consumers’ access to tests for those markers. Jamal contends that “responsible and user-friendly DTC genomics could still be a powerful antidote to dangerous, reductionist notions about genomics….This is why we must keep the big picture in sight, and not let a tiff between the FDA and 23andMe hinder creative new ways of communicating and teaching about human genomics.”
Cross-Posted at Bill of Health
At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements. The studies include, among others, a survey study aimed at sussing out “the influence of DTC advertising in the examination room and on the relationships between healthcare professionals and patients”, a study exploring similarities and differences in the responses of adolescents and their parents to web-based prescription drug advertising, and a study that will use eye tracking technology to collect data on the effect of distracting audio and visuals on participants’ attention to risk information.
Gaffney speculates that “the proposed studies could indicate coming changes in FDA’s regulatory approach toward advertising[.]“ Another possibility is that the studies are part of an effort by FDA to build up the evidence base supporting its current regulatory approach. In a Tweet commenting on Gaffney’s article, Patricia Zettler–a Fellow at Stanford Law School’s Center for Law and the Biosciences who was formerly an Associate Chief Counsel for Drugs at FDA’s Office of Chief Counsel–asks whether the data generated by the studies could help insulate FDA from First Amendment challenges.
Commercial speech is only protected under the First Amendment if it is not false or–perhaps more relevant in the context of direct-to-consumer advertising–misleading. In Christopher Robertson’s recent essay in the Boston University Law Review, he argues that when the truth about a claim is known, as it likely the case with an on-label direct-to-consumer advertisement, it is sensible to put the burden on the government to “prov[e] that the true speech is misleading…given the epistemic value of truth and our aversion to paternalism, especially as a motivation for speech regulation.”
As I discussed previously here, courts called upon to decide whether an advertisement or form of advertising is true, false, or misleading are permitted “to look to the facts to determine ‘the actual effect speech will have.’” In Florida Bar v. Went for It, for example, the Supreme Court relied on the government’s “106-page summary of its 2-year study of lawyer advertising and solicitation to the District Court,” as well as an “anecdotal record . . . noteworthy for its breadth and detail” in upholding a thirty-day moratorium on direct-mail solicitation of accident victims and their families by personal injury lawyers. In Bronco Wine Company v. Jolly, a California appeals court held that a legislative finding that the descriptor “Napa” was inherently misleading was adequately supported by “the regulatory history of brand names of geographic significance,” hearing testimony, and a survey. By contrast, in Edenfield v. Fane, the Supreme Court invalidated a ban on in-person solicitation by accountants on the grounds that the Board of Accountancy failed to ”validate [its] suppositions[.]“
Commercial speech doctrine does not precisely specify the level of deception, or the form or degree of proof, necessary to justify speech-restrictive regulations like those that limit direct-to-consumer prescription drug advertising. The government might have to show that such advertising is more often deceptive than not. Or, as in Lanham Act false advertising cases, it might have to show that a substantial percentage (typically fifteen to twenty percent) of a company’s customers is misled by it. Or, a significant risk of deception might be sufficient. Notwithstanding this uncertainty, FDA is wise to prepare to defend (and even fend off) future First Amendment challenges to the laws and regulations governing direct-to consumer prescription drug advertising by building up the evidence base underlying them.
Welcome back from what I hope was a restorative break in the routine! What 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. Last week, the warning letter that the FDA sent to 23andMe on November 22, 2013 ordering the company to stop marketing its 23andMe Saliva Collection Kit and Personal Genome Service was heavily debated. Here’s a link to a radio show on the FDA’s action featuring Nita Farahany, Hank Greely, and others.
2. At Scientific American, Dina Fine Maron reports that “[a] new process, in which the FDA approves cancer drugs on the basis of which malfunctioning growth pathways they target rather than on [the part of the body where a malignancy begins], has been quietly batted about on the sidelines of conferences or over drinks among oncologists for the past couple years. Although the FDA has not formally proposed any such change, the agency’s cancer czar, Richard Pazdur, floated the idea at a public conference on cancer care earlier this month in Washington, D.C., suggesting the idea may be gaining official traction.”
3. In an editorial in JAMA, epidemiologist Jennifer Robinson makes the case for statins for primary prevention. She writes: “Critics give several reasons to avoid statin therapy, including concerns about adverse effects, lack of a total mortality benefit, cost, and a philosophical aversion to drug therapy. However, the passage of time has allowed sufficient evidence to accumulate to refute each of these concerns.”
4. Health Affairs issued a new Health Policy Brief on specialty pharmaceuticals. The authors note that the debate over co-pay coupons, which I blogged about here, is especially heated with regard to these more expensive drugs.
5. Finally, in an editorial in the American Journal of Obstetrics and Gynecology, Anthony Vintzileos and Cande Ananth provide an alternate explanation for data demonstrating a link between oxytocin, used to induce or augment labor, and autism. The authors conclude that “the most recent evidence (birth years 1995-1998) indicates that when the appropriate diagnostic criteria for autistic disorders are applied, there was no increase in autism from baseline or any association between induced or augmented childbirth and autism.” The search for a cause continues.
What 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. Of great interest this past week were the continuing issues at Princeton University, where there has been an outbreak of a form of bacterial meningitis that is rare in this country and trustees were weighing whether to offer a vaccine that has been approved in Australia and Europe but not here in the United States.
2. In the New England Journal of Medicine, Janet Woodcock and colleagues from the FDA’s Center for Drug Evaluation and Research discuss the new “breakthrough therapy” designation and provide a helpful chart comparing it to the FDA’s other accelerated approval programs. Woodcock and colleagues conclude that “[a]s the pace of scientific discovery continues to increase, drug development pathways will need to evolve in parallel.”
3. At the FDA Law Blog, Dara Katcher Levy comments on a November 8, 2013 Warning Letter, in which the FDA’s Office of Prescription Drug Promotion “alleges that statements made by Aegerion Pharmacueticals’ CEO during broadcast interviews on a CNBC talk show, ‘Fast Money,’ constitute evidence of a new, unapproved, intended use for its drug, Juxtapid (lomitapide) capsules.” Ms. Levy explains that “[t]his is the first OPDP Warning Letter that takes issue with an initial broadcast of statements aimed at the financial community, rather than the re-distribution of these materials for purposes of product promotion or as part of a ‘media pitch’” and writes that she is “interested to see whether OPDP will be increasing its enforcement focus on investor-related materials and other materials intended for the financial community.”
3. At JAMA, Bridget Kuehn addresses the American Psychiatric Association’s contribution to the Choosing Wisely initiative, five recommendations for when physicians should avoid–and patients should question–prescribing an anti-psychotic medication. Kuehn quotes Robert Rosenheck: “The unanswered question is how to discourage inappropriate use of the drugs without impinging on physicians’ rights to prescribe them off label when they feel their use is warranted[.]“
5. Finally, Ed Silverman at Pharmalot reports on the European Medicines Agency’s decision to delay finalizing its new policy on disclosing patient-level clinical trial data. Silverman writes: “There was no indication that the draft policy will be changed, but the potential delay does suggest the possibility that the agency may consider modifying its language. If nothing else, the move underscores the volatility surrounding its plan and vehemence with which the larger issue of disclosing clinical trial data is regarded.”
What follows is a weekly feature here at Health Reform Watch. Usually on Monday–but this week on Tuesday to make room for Jordan Paradise’s commentary on the FDA’s new approach to regulating trans fats–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. Ed Silverman at Pharmalot reports on the FDA’s proposed rule allowing generic drug manufacturers to make safety-related changes to their products’ labels, a rule that would “mean that generic drugmakers could face the same sort of liability over product labeling as brand-name drugmakers.”
2. At Drug and Device Law, Steven Boranian comments on a recent decision in a line of cases in which a plaintiff who seeks to hold the manufacturer of an innovator drug liable for injuries caused by a different manufacturer’s generic copy: “Add another opinion to the “innovator liability” scorecard, and join us in foretelling that Conte will eventually collapse under the mountain of well-reasoned authority that is piling up against it.”
3. Writing at The Hill’s RegWatch blog, Julian Hattem quotes FDA Commissioner Margaret Hamburg on the pending pharmaceutical compounding legislation: “Believe me, it’s not that FDA is looking for a whole lot of new responsibilities, but when there is a health and safety problem like this where we think that we have the expertise and where clearly there should be national standards, we do believe that we should be given the authority that we need.”
4. In an essay in the New York Times entitled “Slow Dancing with Part D”, Jane Gross explains how a report from the Kaiser Family Foundation made her realize that her Medicare Part D plan “was an outlier … one of only two with premium increases in the 50 percent range.” Gross writes: “Does this mean I have to reconsider reconsidering? Be a responsible consumer? Just the prospect of vetting these plans year after year exhausts me. Open enrollment ends Dec. 7, which gives me a few days to kick the can down the road.”
5. Finally, Arthur Caplan and Nirav Shah argue in an opinion piece in JAMA that New York’s new requirement that “unvaccinated health care personnel in regulated settings to wear a surgical mask in areas where patients or residents may be present … is absolutely consistent with sound and ethical public policy.”