FDA needs additional $225 million, new authority to inspect foreign facilities to protect U.S. residents from unsafe prescription drug imports, agency officials say

Apr 30 2008

FDA officials on Tuesday said the agency would need at least $225 million in additional funding annually, along with other authoritative powers, to adequately inspect the safety of imported drug products, the Baltimore Sun reports.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told members of the House Energy and Commerce Oversight and Investigations Subcommittee that the funds and authorization would go toward implementing new standards for safety inspections of foreign companies that manufacture drugs or drug ingredients.

Woodcock said the agency would need $225 million annually to inspect the 3,300 foreign drug making plants with the same frequency as it reviews U.S. plants (Rockoff, Baltimore Sun, 4/30). U.S. plants are inspected once every two years (Armstrong, CQ Today, 4/29). A Government Accountability Office report released last week estimated FDA would need an additional $71 million annually to inspect foreign facilities every two years. FDA has budgeted $11 million for foreign facility inspections in 2008, the GAO report said (Edney, CongressDaily, 4/30).

Woodcock also called on Congress to grant the agency power to inspect foreign companies that ship drugs to the U.S., stop imports at the border if they are shipped from facilities that the U.S. does not inspect and require U.S. drug makers to police their foreign suppliers. House Democrats are drafting legislation that would expand FDA's authority and require foreign drug makers to pay user fees, which would generate an estimated $300 million annually to fund inspections.

The hearing was held in response to reports that contaminated batches of the blood thinner heparin contained an active ingredient supplied by a Chinese manufacturing facility that FDA had not inspected. At least 81 deaths in the U.S. were linked to the contaminated drug (Edney, CongressDaily, 4/30).

Broadcast Coverage

NPR's "All Things Considered" on Tuesday reported on testimony at the subcommittee hearing. The segment includes comments from subcommittee Chair Bart Stupak (D-Mich.); Leroy Hubley, whose wife and son died after receiving contaminated heparin; Colleen Hubley, Leroy Hubley's daughter in law; Rep. Jay Inslee (D-Wash.); and David Strunce, CEO of Scientific Protein Laboratories (Elliott, "All Things Considered," NPR, 4/29).

NPR's "Morning Edition" on Wednesday also reported on the hearing. The segment includes comments from Johanna Marie Staples, whose husband died after receiving contaminated heparin, and Baxter Chair and CEO Robert Parkinson (Elliott, "Morning Edition," NPR, 4/30).