FDA updates citizen petition regulations to prevent delays in drug approvals

The Food and Drug Administration cemented a final rule Tuesday updating regulations to its citizen petitions. reports the Regulatory Affairs Professionals Society.

Citizen petitions allow members of the general public to ask the agency to refrain from approving a generic drug or biosimilar over potential health concerns. However, the FDA said most petitions they receive do not raise valid scientific concerns and believes they are filed by drug companies to delay approval of competing medicines.

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

The FDA's final rule, effective Jan. 9, will limit unnecessary delays in the approval of generic and biosimilar drugs unless the delay is crucial to protect public health, according to RAPS.

The view the final rule in its entirety, click here.

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