Food and Drug Law
Food and Drug Law, in Developments in Administrative Law & Regulatory Practice 2016, 344-381 (Michael Tien ed., 2017)
40 Pages Posted: 3 Jan 2018 Last revised: 15 Jan 2018
Date Written: June 1, 2017
Abstract
Many will look back at 2016 as a year that led to a collective questioning of our assumptions. Most did not foresee the election of Donald Trump. The unexpected events of 2016 heralded a high degree of uncertainty over what 2017 will bring to the drug, device, food, dietary supplement, and cosmetic industries—not just in the United States, but around the world. Adding to this uncertainty, the new leader of the U.S. Food and Drug Administration (FDA) is an unknown while at least one senior leader has announced his retirement. This unpredictability comes just as 2017 is looking to be an unusually important year at the FDA. Can the FDA keep the throttle open in its progress in improving product review and approval, as well as create tools and resources to help streamline part of the research and development (R&D) process? Importantly, can this be done while ensuring that FDA-regulated products continue to be safe and effective? Keeping a sharp eye on the balance between encouraging innovation while protecting public health is of particular concern in 2017 in light of the 21st Century Cures Act passed in December 2016, which arguably reduces the FDA’s standards for drug and device approval, coupled with the Trump administration’s goals of rolling back regulations using a “1-in-2-out” executive order.
In an attempt to maintain that balance, in 2016, the FDA followed through on previous efforts to try to rein in the promotion by manufacturers of unapproved uses of drugs and devices that have not been shown to be safe and effective, referred to as the promotion of off-label uses. These FDA efforts continued to lead the development of First Amendment jurisprudence in 2016 with the high-profile settlement of the Amarin case and the jury verdict in Facteau.
In another important First Amendment case taken up by the U.S. Supreme Court in 2016, In re Tam, the Court heard arguments in early 2017 on the constitutionality of the Lanham Act’s bar on the ability to register brand names that are considered to be disparaging marks, such as “Raging Bitch” for the name of a beverage.
Antitrust continues to be an active area, with the First Circuit in 2016 joining the Third Circuit in interpreting Actavis to hold that non-cash “reverse payments” can violate antitrust law and the recognition by one federal district court that direct purchasers can claim antitrust violations for pay for delay and product hopping tactics in In re Opana ER Antitrust Litigation. And the doctrine of primary jurisdiction gained a unique twist in 2016 as it was applied differently when dealing with “natural” claims in the context of food versus cosmetics based on statements made by the FDA.
Enforcement efforts continue apace with 2016 bringing the third highest annual recovery in False Claims Act (FCA) history for the U.S. Department of Justice (DOJ). The largest recoveries in 2016—$1.2 billion—came from the drug and medical device industry. It will be interesting to watch the impact on these numbers moving forward given the 2016 Supreme Court decision in Escobar approving the use of the controversial implied certification theory, as it may be offset by the First Circuit decision in D’Agostino that sharply narrowed the ability to pursue a fraud on the FDA claim under the FCA. With regard to criminal liability, there was a similar push and pull in 2016 with the appeal of the Decosta case to the Supreme Court arguing that the Park doctrine should be limited during the same period that the First Circuit ruled in Kaplan, in a case of first impression, that the Federal Food, Drug, and Cosmetic Act’s (FDCA’s) anti-adulteration provision could support a criminal conviction for a physician’s reuse of a single use needle biopsy guide. More enforcement news comes on the heels of the FDA’s issuance of guidance, with follow-on warning letters, reflecting its interest in taking on data integrity problems that can pose risks to the safety of regulated products. While at the same time, the agency appeared to step back from taking on more off-label promotion conduct in order to focus on advertisements that fail to warn adequately of drug risks and that promote the use of investigational drugs. Additionally, the agency issued a series of adverse facility inspection observations that focused on problems with procedural issues rather than specific products or actual system deficiencies. In a long awaited major development, in 2016, the FDA finalized the Food Safety Modernization Act regulations with a focus on prevention of unintended food safety problems and the prevention of intentional food adulteration. And, for the first time in 20 years, the requirements for the Nutrition Facts panel on food were significantly updated. In another remarkable first, the FDA issued a draft environmental assessment for the release of genetically modified mosquitoes and Congress passed a long awaited genetically modified food labeling law.
Finally, the FDA changed the way that it prioritizes abbreviated new drug applications in response to companies allegedly engaging in price gauging as evidence by the uproar over the activities of the former CEO of Turing Pharmaceuticals, Martin Shkreli. The agency also dealt with other human failings, such as preventable human use errors with devices that can cause injuries.
Keywords: Food & Drug Administration, FDA, Antitrust, Actavis, False Claims Act, Escobar, Food Safety Modernization Act, 21st Century Cures Act, Trademark, Lanham Act, First Amendment, Off-label Use
JEL Classification: I1, I00, I10, I12, I13, I18, K13, K32, K41
Suggested Citation: Suggested Citation