Jennifer L. Pomeranz

Policy Points: The United States is an outlier in its permissive regulatory landscape for direct‐to‐consumer (DTC) advertising of prescription drugs. The First Amendment is a barrier to banning DTC prescription drug promotion, but it is not a barrier to addressing false, deceptive, or unfair advertising, which may include forms of influencer and social media promotion. The learned intermediary doctrine shields drug manufacturers from liability in most states, even when they engage in pervasive DTC advertising that leads to consumer misunderstanding. State courts and legislatures should reconsider this doctrine to ensure that consumers are adequately protected. The US Food and Drug Administration needs increased resources and additional authority over the promotion of compounded drugs. Context: The United States is an outlier worldwide in its permissive regulatory landscape for direct‐to‐consumer (DTC) prescription drug promotion. Recent proposals to restrict DTC prescription drug advertising raise questions about potential challenges under the First Amendment of the U.S. Constitution which protects commercial speech. Prescription drugs are unique in that they require a healthcare provider (HCP) to prescribe the product; the HCP serves as a “learned intermediary” between the pharmaceutical company and the consumer of the product. Under the learned intermediary doctrine, pharmaceutical companies satisfy their duty to warn consumers about drug risks by warning HCPs, and are thereby shielded from tort liability even if consumers rely on their advertisements and are harmed. Methods: Using government websites and Lexis+, we researched statutes, regulations and case law related to the First Amendment's protection of commercial speech, the statutory and regulatory framework for DTC prescription and compounded drug promotion, and the learned intermediary doctrine. Findings: The Food and Drug Administration (FDA) oversees DTC prescription drug promotion but lacks comparable authority over compounded drug promotion. Certain forms of DTC advertising may be particularly misleading and warrant increased FDA oversight. Although commercial speech is broadly protected under the First Amendment, false, deceptive and misleading commercial speech can be regulated or restricted. FDA issued guidance to industry for traditional media promotion, but lacks guidance on social media, online telehealth, and influencer‐generated content. The learned intermediary doctrine was created by state courts before the advent of DTC advertising and now provides perverse incentives to companies to aggressively market their drugs without consequence. Conclusions: Congress should provide FDA with equal authority over compounded drug promotion as it has for prescription drug promotion. FDA should issue regulations or guidance on modern forms of DTC advertising. The learned intermediary is based on outdated concepts and should be reconsidered by state legislatures and courts.

The Food and Drug Administration (FDA) lacks certain authorities and is persistently underresourced to fulfill its mission of protecting the public by ensuring that foods are safe, wholesome, sanitary, and properly labeled. Particularly concerning gaps exist in pre- and postmarket oversight of food ingredients that are often found in ultraprocessed foods. Numerous substances either have evidence of harm or are unknown to the FDA and the public. Additional authorities and resources are necessary. User fees have been successfully implemented to provide resources to the FDA for other programs under its purview. This legal and policy analysis evaluates the FDA's food-related authorities that would be amenable to a new user fee program. It reviews policy domains where new or enhanced user fees may be warranted. We find that a new comprehensive FDA user fee program for food may benefit industry and generate targeted new resources to strengthen the agency's oversight.

The US food supply is increasingly associated with diet-related diseases, toxicity, cancer, and other health harms. These public health concerns are partly attributable to a loophole in federal law. The Food and Drug Administration (FDA) evaluates the premarket safety of ingredients regulated as food additives but allows the food industry to self-regulate and determine which substances to classify as generally recognized as safe (GRAS) based on undisclosed data and conclusions that the FDA never sees. Furthermore, the FDA lacks a formal approach for reviewing food additives and GRAS substances already found in the food supply. Substances in the food supply thus include innocuous ingredients (e.g., black pepper), those that are harmful at high levels (e.g., salt), those that are of questionable safety (e.g., potassium bromate), and those that are unknown to the FDA and the public. A recent court decision codified these gaps in the FDA’s current approach, leaving states to try to fill the regulatory void. The FDA and Congress should consider several policy options to ensure that the FDA is meeting its mission to ensure a safe food supply. ( Am J Public Health. 2024;114(10):1061–1070. https://doi.org/10.2105/AJPH.2024.307755 )