Study By Former FDA Advisors Finds Agency Is Biased Towards Approving New Drugs

Critics point to the recent FDA approval of the controversial new Alzheimer’s drug Aduhelm, which led some scientific advisors to step down in protest

A new study highlights how federal drug regulators are more likely to approve new drugs than in years past, even when scientific advisors recommended against allowing the new treatment onto the U.S. market.

The U.S. Food and Drug Administration (FDA) followed the advice of its scientific advisory committee nearly every time the advisors recommended approval of a new drug. However, the agency only followed those recommendations two thirds of the time when it recommended the agency reject a new drug approval request.

The findings were published on July 7 in the journal JAMA Health Forum.

More Drug Approvals, Less Advisory Meetings

Researchers from the Brigham and Women’s Hospital and Harvard Medical School, including former FDA advisory committee members, conducted a manual review of summaries prepared by FDA staff for 409 drug advisory committee meetings from 2010 to 2021.

The findings indicated 88% of FDA regulatory actions were aligned with advisory committee recommendations, including votes on initial drug approvals and safety actions.

However, the FDA was more likely to agree with advisory recommendations if the recommendation was in favor of approving a drug, compared to when the recommendation opposed approving a drug or withdrawing a drug from the market.

In 97% of instances where advisory committees voted in favor of approving a new drug, the FDA approved that medication. But the agency only denied a new drug approval in 67% of cases where scientific advisors recommended that drug not be approved.

The study also found that, over time, meetings involving votes on new drug approvals also declined. Over the study period, the FDA convened fewer advisory committee meetings. In 2012, there were 50 advisory meetings convened, but by 2020 that number dropped to 18, and in 2021 the FDA convened only 18 meetings.

Growing Concerns Over FDA Drug Approvals

FDA advisory committees are panels of independent experts convened to offer expert opinions on drug regulatory actions. The agency often relies heavily on the advisory committee’s drug approval recommendations and other matters, however the FDA is not required to follow advisory committee recommendations.

In recent years, the agency has suffered backlash from critics, including former scientific advisors, over its drug approval decisions.

In 2021, public scrutiny fell on the FDA after the agency approved the Alzheimer’s drug Aduhelm despite eight members of the 11-member advisory committee voting against its approval.

Two members voted that they were uncertain about the approval, and only one member voted in favor of approval. The committee warned that clinical trials did not provide strong evidence of the drug’s effectiveness.

In the wake of the decision, critics called the FDA’s decision “reckless,” and two members of the FDA advisory committee resigned in protest of the unorthodox decision. Congress also raised concerns regarding the approval of Aduhelm, and a congressional report suggested the FDA had an improperly close relationship with the drug maker, Biogen.

Research indicated that FDA-approved Alzheimer’s drugs like Aduhelm and Leqembi may lead to brain shrinkage and speed up brain atrophy, making symptoms of Alzheimer’s disease and dementia worse. But despite these concerns, the FDA approved the drugs.

Researchers call for reforms to clarify the FDA’s relationship with the advisory panel and its need to follow expert recommendations by the committee, and not defer to close relationships with drug makers.

Some critics warn that the FDA is using the advisory panel as a path to easier drug approval, not as a sounding board for expert opinion on health matters, and indicate that the relationship should be scrutinized to avoid approval bias.