FDA Clashes With Advisory Committee Panels Nearly One-Fifth of the Time

The U.S. Food and Drug Administration (FDA) disagrees with its advisory committee panels about 20% of the time, according to a new analysis of 376 panel meetings that took place between 2008 and 2015.

Of these meetings, 83 resulted in disagreements between the two bodies. In three-quarters of these disagreements, the FDA voted to impose more restrictive decisions after favorable recommendations from the committees, while a quarter resulted in more lenient decisions after unfavorable committee recommendations.

In instances when the FDA imposed more restrictive guidelines, 48 involved the approval of a new product, 13 were related to additional indications, and one involved a safety issue.

In cases where the FDA took a favorable view in contrast to the committee, 12 issues were related to safety, eight involved new product approvals, and only one was related to an additional indication for an existing product.

While the FDA is not required to follow the recommendations of advisory committees, they still play an important role in the regulatory decision-making process by providing information for physicians and the public regarding new products or new indications for existing products.

For this reason, the disagreements between the FDA and its advisory committees is raising questions about FDA approval standards and the demand for new medications.

Source: STAT, July 15, 2019.