Restoring FDA’s Premarket Review Powers

The U.S. Food and Drug Administration (FDA) is tasked with ensuring the safety of at least $3.9 trillion of food, drugs, and devices. Increasingly, however, experts have linked failures in FDA’s premarket oversight processes to public health crises. As the primary gatekeeper of these products, does FDA hold robust enough premarket review powers to fulfill its broad mandate?

In a recent article, Daniel G. Aaron, an associate professor of law at University of Utah S.J. Quinney College of Law, argues that FDA’s “premarket review is crumbling.” Aaron critiques the premarket review process and challenges traditional explanations for its downfall.

Aaron contends that corporate forces have undermined and, in certain instances, almost completely removed FDA’s premarket regulatory process. He proposes reforms to repair and revive FDA’s premarket regulatory authority.

Before 1938, FDA’s enforcement powers were “postmarket in nature”—the agency regulated products only after they were available for purchase. This status quo shifted following a medication killed over 100 people in 1937.

In response, the U.S. Congress passed the Federal Food, Drug and Cosmetic Act of 1938, granting FDA with “premarket review” powers to ensure that products were safe before they were marketed to the public. Congress expanded  these powers in 1976 to cover devices and again in 2009 to include tobacco.

FDA’s regulatory role, Aaron notes, has traditionally been viewed as promoting public health and protecting consumers by ensuring the safety, efficacy, and security of food, drugs, and devices. But increasing pressure from corporate and political interests has led to a shift in how FDA is viewed—now seen as a facilitator of innovation, with growing demands to expedite the approval of novel products.

Aaron contends that FDA has internalized these expectations, leading the agency to release products to consumers without sufficient vetting.

As early as the 1960s, Aaron explains,  the regulated industry—eager to market new drugs and inpatient with the pace of FDA’s process—waged war on FDA’s premarket review powers. By the 1970s, FDA’s budget and premarket review authority had weakened, prompting scholars to argue that the agency was in desperate need of expanded powers.

Aaron traces the decline of premarket review to external forces—corporate actors who leveraged control over FDA’s budget, lobbied for statutory changes to restrict its authority, and litigated the agency’s actions to curtail its powers.

Aaron argues that corporate influences have expanded market access for manufacturers with minimal or no oversight. He points out gaps in premarket review in several product areas.

First, Aaron points to laboratory-developed tests (LDTs)—clinical tests that are created by and for labs and are classified as medical devices. When the U.S. Congress amended the Federal Food, Drug, and Cosmetic Act to require premarket authorization for devices, device companies successfully lobbied FDA to exercise enforcement discretion and forgo premarket review of LDTs.

During the last four decades, Aaron observes, FDA has largely refrained from enforcing premarket review of LDTs. Despite emerging safety concerns that prompted the FDA to reconsider its enforcement priorities, the agency “backed off its plan” to pursue premarket review of LDTs, reflecting the influence of political and corporate actors, Aaron contends.

Had FDA continued its pursuit of LDT premarket review, Aaron predicts that it would have encountered fierce opposition from the industry and political pressures during changeovers in presidential administrations.

Aaron also offers FDA’s treatment of drugs as another example of the decline of its premarket review authority.

Twenty years ago, FDA required companies to provide more evidence of a drug’s safety and efficacy than what it does today. Industry “capture” and deregulation, Aaron argues, have undermined FDA’s ability to conduct thorough premarket reviews.

As of 2020, 68 percent of drugs were approved through what are known as “fast track” and “accelerated approval” pathways. Over time, however, the U.S. Congress has reduced evidentiary requirements for new drugs and altered the structure of FDA’s drug budget, making the agency more dependent on industry funding.

Aaron critiques expedited drug approval programs, arguing that they have shifted FDA’s role from gatekeeper to “speedy approver” that prioritizes “early access over certainty in safety and efficacy.”

Although aim to promote public health, Aaron contends that these programs “selectively fund only those FDA statutory mandates needed to bring products to market,” leading the agency to reduce its oversight of the scientific process and regulatory enforcement.

Survey data indicates that most companies using expedited drug approval pathways delay confirmatory trials until after their drugs are released to the market. Yet, Aaron observes that FDA has never used its enforcement authority to penalize these manufacturers.

To address these failures, Aaron offers two recommendations to reinforce premarket review and ensure that FDA can protect consumers from unsafe products.

First, Aaron suggests U.S. Congress pass the FDA Premarket Review Restoration Act, which would strengthen premarket review for all regulated products. His proposed statute would allow FDA the authority to litigate independently from the U.S. Department of Justice, giving FDA the authority to prosecute companies that violate premarket review requirements.

The Restoration Act would also mandate premarket review procedures for a set list of products, limiting FDA’s ability to use its discretion to deviate from statutory requirements.

To further shield FDA from external influences, Aaron argues that the agency should use public channels of communication to raise awareness of corporate attacks on its authority and form partnerships with other agencies affected by corporate lobbying. Stronger communication and alliances, Aaron explains, would promote transparency and give FDA a platform to show the public how corporate forces complicate its work.

These “bold changes,” Aaron contends, are necessary steps to prevent corporate and political actors from controlling FDA and further weakening premarket review.