In what may be an attempt to indicate Congress had prior awareness of the Food and Drug Administrations challenges in inspecting foreign drugmakers, HHS has released a letter that HHS Secretary Mike Leavitt sent to Congress back in December 2007.
In the letter, Leavitt asked Congress to expand the FDAs import-safety powers to include explicit extraterritorial jurisdiction to investigate foreign drug and device manufacturers whose products are subject to the Food, Drug and Cosmetic Act, or FDCA, according to an HHS news release issued Friday.
The letter was sent to Rep. Joe Barton (R-Texas), ranking member of the House Energy and Commerce Committee, late last year, but was made public only after a series of high-profile news articles about the FDAs failure to inspect a Chinese drug plant believed responsible for tainted batches of Baxter Internationals blood thinner Heparin. The plant, co-owned by the Waunakee, Wis.-based Scientific Protein Laboratories, produced the drugs active ingredient, which has been attributed to four deaths and hundreds of reports of adverse events, according to news stories first published in mid-February.
Energy and Commerce Committee members are seeking disclosure of approval-process correspondence between Baxter and the FDA in conjunction with the Chinese facility, which, under the FDCA, should have been inspected by FDA officials before it was allowed to supply ingredients for drugs imported to the U.S.
In his letter to Barton, Leavitt thanked the Energy and Commerce Committee member for supporting the agencys request for expanded inspection powers, including the ability to investigate foreign drugmakers believed to be in violation of the FDCA.
In a written statement issued on Friday, HHS spokeswoman Christina Pearson said the expanded powers would be another arrow in our quiver for the FDAs ability to investigate overseas offenders that violate the FDCA. -- by Shawn Rhea
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