Loosened FDA Conflicts Rules May Cause Unwanted Side Effects

By Rheingold Giuffra Ruffo & Plotkin LLP

The FDA continues to allow conflictsThe Safety and Innovation Act was passed in 2012 to reauthorize user fees. This law has loosened conflict of interest restrictions on panels and has the potential to allow more drugs with harmful side effects into the marketplace.

There are waivers granted to panel members who have a financial conflict of interest that cannot exceed $50,000, which was passed in 2007. FDASIA has removed the requirement for placing caps on waivers.

These caps should in no way slow safe new drugs from being approved. These caps have also never been reached.

From October 2012 to March 2013, less than one percent of the 608 members who have participated in meetings had waivers granted to them.

Recently the FDA has been issuing more approvals. 39 new medicines, including 11 new cancer treatments were approved last year. That level of approval has not been seen in 16 years.

Related Posts