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GENERIC DRUG INDUSTRY BLUE RIBBON PANEL WILL MEET JUNE 20

Executive Summary

GENERIC DRUG INDUSTRY BLUE RIBBON PANEL WILL MEET JUNE 20 in a public hearing. Established by the Generic Pharmaceutical Industry Association, the "Blue Ribbon Committee on Generic Medicines" plans to determine public sentiment for changing policies or operating procedures at FDA, pharmaceutical manufacturers and/or testing laboratories. The group is chaired by Lewis Engman, former president of the Pharmaceutical Manufacturers Association. Unrelated to the FDA Blue Ribbon Commission, which held its inaugural meeting May 17-18 (see related stories, p. 3 & 5), the generic panel was formed earlier this year to examine the generic drug industry and FDA's drug review and approval process ("The Pink Sheet" Feb. 12, p. 14). A press release announcing the meeting posed five specific issues for participants to consider: Whether "any new requirements" should be placed on drug firms "to improve the quality and credibility of the drug approval process" Whether changes should be made "in the internal FDA processes for generic drugs" Whether "additional requirements" should be placed on independent testing laboratories Actions drug firms, contract labs or trade associations can take "voluntarily to improve the quality and credibility of the drug approval process" Whether FDA should be given increased enforcement authority, particularly regarding recall powers and greater authority "to act promptly against improper activity in drug approval applications." The deadline for submitting requests to testify is June 8. The panel will accept written testimony until June 30.
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