FDA: Drug companies abuse citizen petitions to block generic competition

The Food and Drug Administration submitted an annual report to Congress regarding the use of citizen petitions that allow the general public to ask the agency to refrain from approving a generic drug or biosimilar over potential health concerns, reported STAT.

However, the FDA says most petitions they receive do not raise valid scientific concerns and believes they are filed by drug companies to delay approval of competing medicines.

Agency officials say they are forced to redirect their efforts to review these illegitimate petitions "at the expense of completing the other work of the agency," according to the FDA's report.

Michael Carrier, a professor at Rutgers University School of Law in New Brunswick, N.J., conducted an analysis of these petitions. He found that brand name drugmakers filed 92 percent of citizen petitions between 2011 and 2015. The FDA denied more than 9 out of every 10 petitions filed.

"Citizen petitions represent a hidden tool in [the brand name drugmakers'] toolkit of entry-delaying activity, all to the detriment of consumers forced to pay high drug prices," the analysis states. "And in defiance of Congress' attempt to limit abuse, citizen petitions play an increasingly important role in delaying generic competition."

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