Today, the US Food and Drug Administration (FDA) will hold a long-awaited public meeting to consider how off-label information about medicines can be shared with physicians. Washington Legal Foundation staff attorney Greg Herbers will testify at the meeting, which FDA has entitled “Communications Regarding Unapproved Uses of Approved Medical Products.”
Since WLF’s landmark victories in the Washington Legal Foundation cases, courts have consistently upheld the First Amendment right to communicate truthful and non-misleading information about the off-label uses of medical products. For instance, in US v. Caronia, WLF represented an industry employee convicted of discussing a drug’s off-label benefits and won a reversal from the US Court of Appeals for the Second Circuit on First Amendment grounds. WLF filed an amicus brief in a second case, Amarin Pharma v. FDA, in which a US federal district court followed the rationale of Caronia. Those decisions presumably played a major part in FDA’s decision to reevaluate its approach to off-label communication.
The text of WLF’s testimony is available here. WLF will also submit written comments to FDA in December.
Because “public-interest” groups cloak themselves with the feel-good mantle of protecting consumers, the environment, animals, etc., the motives of such groups rarely get questioned. But several recent developments show that all too often, activists put their own self-interest before the public’s interest.
Consider, for example, environmental groups’ opposition to a Washington state ballot measure going before voters this fall. Initiative 732 pursues a major environmentalist goal—carbon-emissions reduction—by imposing an excise tax. Revenues from the carbon tax would in turn fund sales, manufacturing, and low-income-household tax cuts. In other words, it’s revenue neutral, and that doesn’t sit well with green activists who see climate change as an effective proxy for a broader ideological goal: expanding government. Continue reading
Four members of the Senate Health, Education, Labor, and Pensions Committee (HELP), including Chairman Lamar Alexander, wrote Food & Drug Administration (FDA) Commissioner Robert Califf earlier this month to reiterate their concerns with FDA’s use of guidance as regulatory tool. Members of the committee had previously written the FDA Commissioner about the agency’s use of guidance in May 2014, to which FDA responded nearly a year later in March 2015. During his confirmation hearing before the HELP Committee last November, Commissioner Califf addressed several questions about the use of guidance and pledged to investigate the Senators’ questions. Continue reading
By Matthew A. Reed, Sedgwick LLP
“Impossibility preemption,” the US Supreme Court has warned, “is a demanding defense” to a state tort claim for failure to warn about the risks of a prescription drug. Wyeth v. Levine, 555 U.S. 555, 573 (2009). It is not, however, impossible to prove. Indeed, the Utah federal district court on March 16, 2016 acknowledged in Cerveny v. Aventis, Inc. two ways by which a prescription drug manufacturer may prove the impossibility of complying with conflicting state law and federal regulations. Continue reading
On Monday, May 2, 2016, Washington Legal Foundation hosted a program in its Media Briefing series entitled Freeing Off-Label Use Information: Three Lingering Questions for Medical-Product Innovators and Regulators. The recording of that program is available below. Also below are links to related materials, including an April 29, 2016 WLF Legal Backgrounder that draws lessons from a medical-device company’s successful defense of a criminal prosecution for alleged off-label promotion.
- Edward Berg, Sanofi US
- John Osborn, Hogan Lovells LLP
- Coleen Klasmeier, Sidley Austin LLP
- Eric Grannon, White & Case LLP (moderator)
The program can also be viewed through WLF’s website—with a higher-quality video and integrated slides—by clicking here.
John Osborn’s Yale Journal article, “Can I Tell You the Truth?”, cited by the U.S. Court of Appeals for the Second Circuit in U.S. v. Caronia, is available here.
WLF’s Legal Backgrounder, “The US v. Vascular Solutions Acquittal: Three Lessons for Targets of ‘Off-Label Promotion’ Enforcement,” is available here.
California’s federal district courts, which are already overstocked with food-labeling class-action suits, are now being asked to impose new food-product disclosure mandates. Courts have thus far dismissed lawsuits seeking on-package statements regarding alleged concerns in companies’ overseas supply chains, such as forced labor. But don’t expect those losses to dampen corporate-disclosure activists’ resolve. Such suits are just one part in a larger campaign, following in the footsteps of the mandatory “GMO labeling” crusade, to require supply-chain information on product packaging.
Manufacturers of chocolate, pet food, and seafood have been targeted for their failure to disclose on their packaging the existence of forced labor and other possible human-rights violations in foreign countries from which they source their products or product ingredients. Such an omission, the class actions claim, violates California consumer-protection laws. One remedy the plaintiffs seek is disclosure of this supply-chain data on product labels and point-of-sale advertising. Continue reading