FDA Official Pulls Back On Estimates Of Cost To Inspect Foreign Drug Makers Properly

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 May 2008 - 7:00 PDT

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FDA Center for Drug Evaluation and Research Director Janet Woodcock on Thursday during a House hearing "backed away" from a Tuesday comment that the agency would need an estimated $225 million to improve inspections of foreign medication manufacturing plants, the Wall Street Journal reports (Mundy, Wall Street Journal, 5/2). Woodcock had said that the agency would need $225 million annually to inspect the 3,300 foreign drug making plants with the same two-year frequency as it reviews U.S. plants. 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 (Kaiser Daily Health Policy Report, 4/30).

However, Woodcock on Thursday at a House Energy and Commerce Health Subcommittee hearing declined to specify the amount that FDA would require to conduct such inspections properly (Wall Street Journal, 5/2). She said that a system to identify which drug facilities require inspection would cost $20 million annually and that FDA would require "tens of millions [of dollars] for a number of years" to develop a system compatible with U.S. Customs and Border Protection databases. Woodcock added that FDA needs $10 million to develop an electronic system to register and track drugs (Edney, CongressDaily, 5/1).

Objections to Legislation
Woodcock during the hearing also expressed concerns over the drug safety draft legislation proposed by House Energy and Commerce Committee Chair John Dingell (D-Mich.). She said several provisions "appear not to be sufficiently focused on high-risk products," adding, "Some of these requirements would divert resources, which could detract from important safety and security priorities" (CQ HealthBeat, 5/1). Woodcock said, "We believe it would be best for FDA to have the flexibility preserved to put our resources, whatever they are, against the highest risk" (CongressDaily, 5/1). She added that inspections of foreign facilities every two years would impose a financial burden on FDA (Wall Street Journal, 5/2). However, Dingell said that focusing on high-risk facilities might delay or prevent necessary inspections at other plants (CQ HealthBeat, 5/1). According to the Journal, Woodcock also was "hesitant" regarding new registration fees for drug and medical device makers that the legislation would require (Wall Street Journal, 5/2). Some members of the health subcommittee said that the new fees could make FDA too reliant on the drug industry (CQ HealthBeat, 5/1).

Point-Counterpoint
USA Today on Friday published a point-counterpoint related to contaminated batches of the blood thinner heparin that entered the supply chain through a Chinese manufacturing facility and led to the deaths of at least 81 people. Summaries appear below.

• USA Today: FDA "has borne the brunt of criticism for failing to provide necessary protection" to consumers using heparin, "but this is every bit as much the responsibility of companies that contract with low-cost Chinese suppliers," USA Today editorial states. Because FDA "mistakenly identified a different plant because of a computer mix-up," the plant making the drug was never "properly inspected," and Baxter International, one company that sold the heparin, "conducted its own inspection in a single day last September," according to USA Today. USA Today concludes, "The heparin tragedy makes it horrifically clear that ... far more needs to be done to ensure that 'made in China' meets U.S. health and safety standards" (USA Today, 5/2).
  
  
• Peter Arduini, USA Today: "Baxter's heparin was one of the targets in what appears to have been a deliberate adulteration scheme," Arduini, president of medication delivery at Baxter, writes in a USA Today opinion piece. According to Arduini, "recent events demonstrate that we live in a world in which new risks are emerging every day." Arduini continues, "This is not solely a Baxter issue," adding, "It is a global and industrywide crisis, and therefore one that calls for global and industrywide responses." Arduini concludes, "The complexity of the global drug supply chain calls not only for increased inspection, but also for new ways of thinking about and addressing vulnerabilities" (Arduini, USA Today, 5/2).
  

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