On November 30, 2016, the House overwhelmingly passed (392-26) the 21st Century Cures Act (“Bill”). The Bill moves on to the Senate next week and it is projected to pass in the Senate as well. Notably, the Bill seeks to improve upon the federal regulatory structure regarding Federal Drug Administration (FDA) approval and expediting the development of new drugs. Under the Bill, FDA funding would increase by $500 million. The Bill also provides for the authorization of new National Institutes of Health research grant funding, in the billions, including funding for Vice President Biden’s “moonshot” to cure cancer. Importantly, a proposed provision regarding reporting under the Sunshine Act was removed from the Bill. Specifically, the proposed provision would have exempted from the reporting requirements of the Physician Payment Sunshine Act payments from drug and device manufacturers to physicians for speaking at continuing medical education events and for contributing to medical textbooks, or medical journals.
Food and Drug Law
E-Cigarettes, Food and Drug Law, HHS, Regulations / No Comments
Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in the U.S. District Court for the District of Columbia. Nicopure seeks to have the rule vacated and declared unlawful, and has requested a preliminary injunction barring enforcement of the rule and prohibiting the FDA from taking any action under the rule pending resolution of the lawsuit.
The final rule, which will take effect on August 8, 2016 absent an injunction, grants the FDA authority to regulate electronic cigarettes and other vaping products and imposes rules on the industry that many insiders fear will leave it decimated. These rules include banning sales to anyone younger than 18 years of age, requiring extensive warning labels on packing and — most significantly — subjecting all products (even those currently on the market) to the FDA approval process and the FDA’s reporting and recordkeeping requirements. The price tag associated with the FDA approval process alone likely will pose an insurmountable barrier for the small vape shops, device manufacturers and e-liquid producers that currently drive most of the industry.
Nicopure, a Florida company that distributes battery-powered vaping devices and manufactures and distributes e-liquid, seeks to have the Final Rule vacated on several grounds. First, Nicopure alleges that the deeming rule defines “tobacco product” so broadly that it constitutes an unreasonable construction of the authority granted under the Administrative Procedure Act (APA). Additionally, Nicopure contends that the rule should be vacated as arbitrary and capricious in violation of the APA. Finally, Nicopure brings a constitutional challenge, arguing that the rule violates the First Amendment by prohibiting manufacturers from “making truthful and nonmisleading statements regarding vaping devices, e-liquids and related products” and from “engaging in other forms of protected expression, including by distributing free samples of vaping devices or e-liquids.”
As of this writing, the FDA has not responded to Nicopure’s complaint, but the case (Nicopure Labs, LLC v. Food and Drug Administration, et al.,1:16-cv-00-878) will no doubt be closely watched by the rule’s proponents and detractors alike.
For more information you can contact Ryan Blaney or another member of Cozen O’Connor’s Health Law team.
The Senate Health, Education, Labor, and Pensions (HELP) committee approved a bill on May 22 that largely tracks the Draft Legislation. As outlined below, the bill would create a new category for large-scale compounders – known as “compounding manufacturers” – and give the FDA greater authority over compounding pharmacies. Continue reading…