ACRO: Overturning Chevron increases legal risk for FDA-approved drugs

ACRO warns that US Supreme Court rulings weakening the Chevron doctrine could threaten longstanding US Food and Drug Administration (FDA) decisions and has called on lawmakers to guard existing drug approvals from potential challenges.

The clinical trials industry group raised its concerns last month, citing two Supreme Court rulings that effectively overturned the doctrine – a legal principle requiring courts to defer to a federal agency’s interpretation of statutes – as the issue.

“Recent decisions by the Supreme Court, most notably the Loper Bright Enterprises v. Raimondo decision to overturn the Chevron doctrine and the related Corner Post Inc. v. Board of Governors of the Federal Reserve System decision, threaten longstanding FDA decisions and authorities that ACRO member companies and American citizens rely upon.”

ACRO is concerned about thousands of FDA approval decisions that can now be challenged due to the rulings.

Substantial evidence

A 1962 amendment to the US Federal Food, Drug, and Cosmetic (FD&C) Act stipulated that the FDA should assess the safety and efficacy of candidate drugs based on “substantial evidence” derived from clinical trials and the assessment of qualified experts.

The amendment also empowered the FDA to use its own interpretation of this standard in its approval decisions. Since then, the agency has OKed 15,822 medicines.

Without Chevron, these decisions could now be at risk of legal challenges in the courts, according to ACRO.

To protect against this, the organization suggested “the next iteration of Cures [the 21st Century Cures Act] should include language that clarifies that the FDA has correctly interpreted congressional intent regarding its delegated responsibilities and authorities over the past 60 years, and that Congress remains confident in the agency’s science-based decision-making.”

Failing to include such assurances would “cause instability and uncertainty for biopharma and drug development companies and, more importantly, our patients,” ACRO said.

Diversity

The organization also suggested the next version of the 21st Century Cures Act should include provisions that improve diversity in clinical trials, such as removing barriers to logistical support.

“We need to be doing more to improve the representativeness of clinical trials in the United States. A large part of that is removing unnecessary barriers to participation.

“One such barrier is the persistent lack of remuneration and logistical support to patients for their participation in clinical trials. If we are serious about increasing the participation among underserved, rural, and underrepresented populations, the next piece of Cures legislation should include provisions that ensure participants are compensated for their time and that they receive support with transportation, childcare, eldercare, lodging, and meals,” the agency said.

ACRO added that “any future Cures legislation should also exempt payments received for clinical trial participation from a participant’s taxable income.”

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