PDUFA Nears Reauthorization

JULY 10, 2012
The US House of Representatives voted on June 20, 2012, to approve a compromise bill reauthorizing the Prescription Drug User Fee Act (PDUFA). Approval from the Senate and President Obama’s signature were expected to follow shortly thereafter, clearing the way for a 5-year extension of the program under which drug companies help fund the approval and oversight of prescription drugs.

A number of pharmacy associations, including the National Association of Chain Drug Stores and the National Community Pharmacists Association, expressed support for the bill. Among the elements singled out by the associations was a requirement that the Drug Enforcement Administration promptly address manufacturer requests for increases in quotas of Schedule II controlled substances to address shortages. They also highlighted the bill’s provisions to increase the exchange of information from prescription drug monitoring programs across state lines and requiring a report on federal efforts to ensure safe use of prescription drugs and a study on rogue online pharmacies.

In addition, the bill calls for increased oversight of domestic and foreign plants that manufacture drugs and drug ingredients, and provisions allowing the FDA to destroy counterfeit or adulterated imported drug products and impose stiffer penalties on those who counterfeit or adulterate drugs. Finally, the bill will provide for collection of $299 million per year from makers of generic drugs to fund faster approval of generic medications and more inspections of facilities that manufacture generic drugs.


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