Representative Edward Markey, a Democrat from Massachusetts, on Thursday became the latest lawmaker to propose legislation that would give the U.S. Food and Drug Administration greater regulatory authority over drug compounding.More info
Pew Commends Pharmaceutical User Fee Agreements, Urges Swift Action by FDA and Medical Device Industry
WASHINGTON – Allan Coukell, director of medical programs at the Pew Health Group, issued the following statement today, commenting on a package of agreements reauthorizing the U.S. Food and Drug Administration (FDA) user fee programs that fund agency oversight activities, known as the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), and Biosimilars User Fee Act (BsUFA):
"We commend the FDA and the pharmaceutical industry for working together on agreements that support the agency’s review activities. Under PDUFA, the FDA has reduced the time it takes to approve new drugs. Now thanks to the first ever agreement with the generic drug makers, industry has made an investment in greater oversight of U.S. medicines made overseas.
"Unfortunately, the Medical Device User Fee Act (MDUFA) is not final. We urge the FDA and the medical device industry not to miss this opportunity to reach an agreement so that the agency will have the resources and tools it needs to protect consumers and ensure that innovative products come to market in a timely fashion."
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Pew Health Group
The Pew Health Group is the health and consumer-product safety arm of The Pew Charitable Trusts, a nonprofit organization that applies a rigorous, analytical approach to improve public policy, inform the public and stimulate civic life. www.pewtrusts.org/health.
- Date added:
- Jan 13, 2012
On Thursday, May 23, the House Energy & Commerce Subcommittee on Health held a hearing, entitled "Examining Drug Compounding." Gabrielle Cosel, a drug safety expert, testified on the need to clarify oversight of compounding pharmacies on the state and federal level.
Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.More info