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Quality Digest

FDA Compliance

Proposal Could Strengthen Drug Safety Laws

Published: Tuesday, January 23, 2007 - 23:00

The Food and Drug Administration recently proposed recommendations to Congress that would broaden and upgrade the agency’s drug safety plan, increase resources for television advertising review and improve drug development processes.

The recommendations are part of the reauthorization process for the Prescription Drug Use Fee Act, which requires drug companies to contribute money to expedite the FDA’s human drug review programs. The PDFUA was passed by Congress in 1992 and has enabled the FDA to reduce its review times dramatically, while increasing scientific consultations, clarifying drug development issues, and increasing oversight of postmarket drug safety.

The FDA proposed an $87.4 million user-fee increase that would pay for the program enhancements; the largest portion of the money—$37.9 million—would boost postmarket drug safety efforts. In addition, the proposal calls for the creation of a separate user fee program that would collect new fees from companies that seek FDA advisory reviews of their direct-to-consumer television advertisements.

“The proposed recommendations would support significant improvements in FDA’s ability to monitor and respond to emerging drug safety issues, as well as continue FDA’s commitment to scientific improvements and streamline the drug approval process,” says Mike Leavitt, Health and Human Services secretary. “I commend FDA for the important progress it has made and look forward to working with Congress to ensure action on these proposals.”

The proposals were formed after public meetings and other consultations with health care industry stakeholders, which urged improvements to the FDA’s drug safety program. Consumer groups also widely favored the adoption of user fees to increase the FDA’s oversight of pharmaceutical drug advertising on television.

The proposals will be presented at a public meeting on Feb. 16, at which time public comments will be accepted. For more information, visit www.fda.gov/bbs/topics/news/2007/new01544.html.


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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.