« Return to News | Ethics/Regulatory

Pew Health urges Congress to reauthorize PDUFA

Monday, February 6, 2012 08:38 AM

Allan Coukell, director of medical programs at the Pew Health Group, issued a statement concerning a U.S. House energy and commerce subcommittee on health hearing on the reauthorization of the Prescription Drug User Fee Act (PDUFA IV), which has shortened the pharmaceutical approval process by the FDA.

"Many Americans would be surprised by the rapid and profound changes in how our prescription drugs are made and the new risks that have arisen as a result. Increased outsourcing and reliance on foreign suppliers have made pharmaceutical manufacturing more difficult to manage and have created opportunities for substandard medicines to reach patients,” said Coukell. “The FDA estimates that 80% of active ingredients used in U.S. drugs come from overseas. Despite the shift of U.S. pharmaceutical manufacturing to overseas, government oversight is overwhelmingly domestically focused.”

Coukell continued, "The reauthorization of the Prescription Drug User Fee Act and passage of other new user-fee programs offer an opportunity for Congress to tackle the risks of the global supply chain. Now it is time for this committee to act on what it has learned over the past four years since the last reauthorization of PDUFA.”

PDUFA IV, which expires Sept. 30, 2012, authorizes the FDA to collect fees from companies that produce certain human drug and biological products.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.