Is the FDA Approving Drugs too Quickly?

Study warns that expedited approvals have become the rule rather than the exception.

A recent study of trends in FDA drug approvals revealed an increase in the instance of expedition in regards to investigative drugs. This raises concerns about whether most new drugs are any more effective than existing products and whether they have been adequately assessed prior to approval.

The study, carried out by The BMJ, describes how the FDA is increasingly expediting development and approval of drugs that are deemed to be important in providing extremely effective alternative to traditional medications.

Before a new drug can be marketed in the United States, it must first be approved by the FDA. However, there exists 4 possible channels for the FDA to expedite this process for promising new drugs for the treatment of serious or life threatening diseases, according to the study.

The programs, originally designed as exceptions to the rule, are now seeming to become the rule themselves with a statistically significant increase of 2.6% per year over the past 20 years in the number of drugs qualifying for the FDA’s expedited drug development and approval programs.

These early approvals and developments are controversial because they often rely on information gathered from early stage trials that are mostly small in size. The BMJ points out that “this trend is being driven by drugs that are not first in class and thus potentially less innovative.”

The study of these trends found that the majority of newly approved drugs were associated with at least one of the programs offered by the FDA, indicating that “the exceptions had become more common than the rule.”

An additional study showed wide variations in the quality of evidence preceding FDA approval of supplemental indications, which was especially true in supplements that expanded the drugs’ approved patient populations.

The study authors indicate that these findings underscore a clear need for more robust systems of post-approval drug monitoring, timely confirmatory studies, and re-examination of existing legislative incentives to promote the optimal delivery of evidence based medicine.

“Effectively, the FDA has been granting most supplemental approvals without evidence of meaningful clinical benefit,” the study authors argued.

The BMJ calls for an alternative paradigm in the face of these study results, “in which research focuses on better medicines for patients rather than for profits, where clinical trials with low risk of bias look for real benefits and faithfully report harms.”

But a paradigm shift in an established bureaucracy could take years to implement, depending on the types of changes that need to be made.