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Gibbs note that the final guidance was modified in response to manufacturers’ vociferously-voiced complaints that the draft guidance wrongly equated a manufacturer’s knowledge that a research-only diagnostic is being used for clinical purposes with the manufacturer’s intent that it be so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.
Filed under: Drugs & Medical Devices, Liability
Cross-Posted at Bill of Health
At the end of last month, the Secretary of Health and Human Services Kathleen Sebelius made headlines when, in a letter addressed to Representative Jim McDermott (D-WA), she announced that “[qualified health plans], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act” were not “federal health care programs under section 1128B of the Social Security Act”. One implication of the Secretary’s interpretation is that the “anti-kickback act”, which is found in Section 1128B, does not apply to qualified health plans. And that, in turn, means, among other things, that individuals insured under those plans, unlike individuals on Medicare or Medicaid, will be able to use drug company coupons to defray the cost of their prescription drugs.
Prescription drug coupons have been a source of controversy, favored by branded manufacturers and patients, and opposed by generic manufacturers, health insurers, third party payers, and pharmaceutical benefit managers. Joseph Ross and Aaron Kesselheim studied a large number of coupons advertised on the website www.internetdrugcoupons.com and found that ”62% (231 of 374) were for brand-name medications for which lower-cost therapeutic alternatives were available.” Ross and Kesselheim argue that the coupons are costly at the population level, but also for individual patients. This is because the coupons are nearly always time-delimited and the short-term savings do not typically outweigh the long-term cost of taking a branded drug. On the other hand, in an article in last week’s JAMA, Leah Zullig and colleagues pointed out that reducing co-payments has been proven to improve medication adherence, a problem which there ”is an increasing business case for addressing[.]“
The coupon controversy has carried over into the courts. On March 7, 2012, seven lawsuits were filed in district courts by third party payers against a number of drugmakers, alleging that prescription drug coupons violate antitrust, commercial bribery, and racketeering laws. (This post at FDA Law Blog includes links to the seven complaints, and this one provides an update on the status of the litigation as of late June 2013.)
On June 3, 2013, Judge Paul Oetken of the Southern District of New York dismissed one of the seven suits, brought against Bristol-Myers Squibb and Otsuka, finding that the challenged coupons were not fraudulent because the program is “‘open and notorious,’ information about its terms and conditions is readily available on a number of public websites, and Plaintiffs do not allege that anyone is deceived about the effect of these programs.” The court dismissed one of the plaintiffs’ claims–that the defendants committed fraud “by reporting benchmark prices to reporting agencies while failing to account for the routine waiver of co-pays”–without prejudice to refile, which the plaintiffs did. A review of the seven dockets this morning, November 26, 2013, reveals that there are motions to dismiss pending in all that were not voluntarily dismissed by the plaintiffs.
The likely outcome of the ongoing litigation is that if an insurer wants to end the use of coupons, it will have to include a provision in its insurance contracts barring their use. Note, though, that Ross and Kesselheim found that fully 38% of the coupons offered were for prescription drugs for which there was no therapeutic alternative. The public policy arguments against using coupons are significantly weaker with regard to such drugs.
A better approach to cutting costs, I think, is to focus on doctors, not patients. Rather than take away patients’ coupons–which can be perilous, as JC Penney can tell you–insurers and third party payers should make it easier for doctors to make cost-effective prescribing decisions and harder for them to prescribe brand-name drugs that have generic substitutes or alternatives. As Judge Oetken held, “neither precedent nor logic” supports assigning to patients a duty to “pressure physicians to choose generics.” Physicians should be choosing generics, where appropriate, in the first instance. Focusing on helping them do so would be fairer and more productive than continuing the fight against coupons.
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. At Regulatory Focus, Alexander Gaffney reports on efforts by members of Congress to exempt user fees like those that support the Food and Drug Administration’s drug and device approval processes from sequestration. While appropriated funding that is subject to sequestration can be used to pay down the national debt, user fee funding may not be spent and so is sitting in an account unable to be used.
2. Gaffney also reports on a “flurry” of untitled letters alleging violations of advertising rules and regulations sent by the FDA’s Office of Prescription Drug Promotion in recent weeks, including one sent to the manufacturer of the recently-approved morning sickness drug Diclegis “the day the drug was approved, possibly marking a new speed record for the time between product approval and the first alleged marketing violation.”
3. In JAMA, Leah Zullig and colleagues survey the literature on improving medication adherence. They conclude as follows: “To date, improving medication adherence has proven elusive—yet recent advances in understanding of how to help patients sustain adherence are helping to identify the major ingredients needed for success. The challenges now involve how to create and sustain large-scale programs that ensure patient adherence on a national scale.”
4. Also this past week, Duke Law’s Center for Innovation Policy hosted a conference on “New Approaches and Incentives in Drug Development” which brought together “leading figures from the private sector, government, and academia” to ask whether “alternative economic incentives, such as targeted public funding or exclusivity terms based on research risk or disease, [should] be considered[.]“ A recorded broadcast of the conference will be posted to the conference website next month.
5. Finally, Nicole Huberfeld has just posted what looks like a fascinating essay in which she presents empirical evidence that despite the “bleak picture” painted by the media, in fact “the Medicaid expansion is progressing apace.” Huberfeld also contends that her data show “dynamic negotiations occurring within states and between the federal and state governments, which indicates that the vision of state sovereignty projected by the Court in NFIB v. Sebelius was incorrect and unnecessary.”