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FDA acknowledges the need for additional funding to inspect foreign
drug facilities
House subcommittee holds hearing on contaminated heparin to
identify potential steps to secure the U.S. drug supply.
FDA will require a considerable increase in funds to inspect foreign
drug facilities at the same frequency (every 2 years) it inspects
domestic plants, according to Janet Woodcock, MD, Director of the FDA
Center for Drug Evaluation and Research. During an April 29 hearing
conducted by the Oversight and Investigations Subcommittee of the House
Energy and Commerce Committee, Woodcock indicated that FDA might need
$225 million per year to perform the foreign inspections.
The hearing was the second of two on the recent FDA recall of
contaminated heparin from China that caused 83 deaths and hundreds of
adverse reactions. Committee Chairman John D. Dingell (D-Mich.) has
drafted legislation that seeks to address perceived inadequacies in
FDA’s regulatory authority and budget. Dingell asserted that there
is a lack of FDA personnel and policies to ensure safety of the U.S.
drug supply and argued that the public can no longer trust the agency.
FDA recently embarked on a hiring initiative that aims to fill more than
1,300 positions—including some requiring pharmacists—during
the next several months.
Ranking subcommittee member John Shimkus (R-Ill.) argued that
FDA’s shortcomings are institutional and have not changed from
administration to administration. He joined the democrats in asking the
agency to identify specific action needed from Congress to rectify the
situation.
Citizens whose loved ones died as a result of the heparin
contamination also spoke at the hearing, demanding congressional action
to ensure the safety of the drug supply.
Having inspectors based in China, said Woodcock, would not have
prevented the heparin contamination. She indicated that more
sophisticated systems are needed to monitor complex drug distribution
systems. FDA, according to Woodcock, is not configured to regulate a
pharmaceutical system that has become increasingly global in recent
years. She said that, since 2001, foreign manufacturing facilities have
more than doubled, while FDA inspection funding has decreased by 35%
during the same period of time.
The bill drafted by Dingell would require foreign manufacturers to
register with the FDA and pay user fees to fund foreign drug
inspections. The secretary of Health and Human Services would determine
the amount of the fee.
Web links
Related resources on www.pharmacist.com
Joe Sheffer (jsheffer@aphanet.org)
Posted May 1, 2008, 5:30 pm EDT
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