'As Congress works toward finalizing an end-of-year budget package, we urge the chambers to include bipartisan legislation to address abuse of the Food and Drug Administration's citizen petition process,' says P4ADNow.
, the Ensuring Timely Access to Generics Act,"strengthens the FDA's ability to reject citizen petitions if it believes the primary purpose of the petition is to delay approval of a generic competitor."
The bill's proponents say the proposed legislation will more effectively identify"sham" citizen petitions filed as a means of delaying FDA approval of generic drugs and biosimilars. "Passing the bipartisan citizen petition bill would be a win-win for Congress—it boosts competition by decreasing barriers for cheaper generic drugs to come to market, driving down prices for patients, and saving the government hundreds of millions of dollars," P4ADNow founder David Mitchell said in aBoth the Trump and Biden administrations have identified submission of sham citizen petitions as a threat to timely approval of generics and competition.
Carrier and Minniti concluded that"citizen petitions represent a hidden tool in [Big Pharma's] toolkit of entry-delaying activity, all to the detriment of consumers forced to pay high drug prices. And in defiance of Congress' attempt to limit abuse, citizen petitions play an increasingly important role in delaying generic competition."
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