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IPQ Inside the global regulatory dialogue

IPQ Special Report — May/June 2008

Jun 24th, 2008

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EXPANDED FDA RESOURCES AND ENFORCEMENT TOOLS ARE NEEDED to allow the agency to handle the challenges of overseeing a global marketplace, FDA and its stakeholders are telling a newly receptive U.S. Congress. In the wake of a series of serious health threats from quality breakdowns in the global supply chain, including deaths from adulterated heparin, Congress has been holding hearings to assess the implications and is developing legislation to help FDA catch up with its health protection mandates and complete its transition into an international regulatory authority. The agency, in turn, has launched a number of interrelated initiatives to strengthen its foreign inspection and import control programs. The problem before Congress is making the funding and authorities  available to actually implement them.

VOICES FROM THE DIALOGUE:
• Proposals for “FDA Globalization Act of 2008” (pp. 4-5)
•  FDA Science Board summary of its “FDA Science and Mission at Risk” report (p. 7)
•  GAO on FDA’s foreign drug inspection program (pp. 9-15)
•  Recommendations to Congress by Alliance for a Stronger FDA (p. 17)
•  Congressman  Dingell on “FDA Globalization Act” draft (p. 21)
•  Generics industry on FDA foreign drug oversight (pp. 25-28)
•  CDER’s Woodcock on heparin investigation and response (pp. 30-33)
•  FDA warning letter to Chinese heparin API manufacturer (pp. 35-37)
•  FDA’s von Eschenbach on agency response to global challenges (pp. 39-44)

CONTENTS:

3……Congressional Legislation Taking Shape
3……FDA Science Board Among Sources
8……GAO Also Advises Congress On FDA
15….Former FDAers, Commissioner Testify
16….FDAAA Helps Trigger Hiring Wave
18….Anticounterfeiting Bill Proposed
19….Congress Holds More FDA Hearings
20….Legislative Efforts Draw Comment
22….PhRMA, BIO, GPhA Add Their Voices
24….Distributors, Pharmacy Chains Weigh In
29….Congress Hears Story of Heparin
34….Lessons Differ From Heparin Case

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