FDA Counter-Terrorism Will Take Precedence Over Rx Approvals In Crisis
Executive Summary
Counter-terrorism activities will take priority over drug approvals at FDA in the event of another attack, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said
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Counter-terrorism activities will take priority over drug approvals at FDA in the event of another attack, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said. "During the crisis, we made counter-terrorism our highest priority...and put drug approval behind that," Woodcock told analysts at the Lehman Brothers Global Healthcare Conference in Orlando, Fla. Feb. 25. "If this were to happen again, we would probably do the same thing." "I don't think many things were slowed up as a result of " FDA prioritizing counter-terrorism after Sept. 11, Woodcock said. Were FDA to shift focus again, "I don't think it's going to slow down drug approvals or anything like that." FDA will issue a draft guidance on developing drugs to treat inhalational anthrax in the March 18 Federal Register. The agency has cleared Bayer's Cipro (ciprofloxacin), doxycycline and penicillin G for post-exposure treatment. Other manufacturers have also expressed interest in getting their antibiotics approved (1 (Also see "PhRMA Antibiotics Manufacturing Capability Review Requested By Thompson" - Pink Sheet, 29 Oct, 2001.), p. 3). FDA expects to issue additional guidances on development of other counter-terrorism drugs after finalizing the animal efficacy rule that would allow for the approval of products based solely on animal data. "Once this rule is in place, we can issue a much broader series of guidances, I think, on [the] drug development area," the CDER director said. "The infectious disease area, the bioterrorism, is a lot easier than some of the chemical agents...where we know a little bit less about the animal models." The agency may conduct its own animal studies in some areas. CDER also expects to approve more counter-measures such as Cipro using FDA's Subpart H regulation, the accelerated approval mechanism which requires post-marketing studies. CDC and Bayer are studying Cipro's use after the attacks (2 (Also see "Bayer Cipro Anthrax Prophylaxis Safety Data Will Be Gathered By CDC" - Pink Sheet, 5 Nov, 2001.), p. 15). "I expect we'll see a lot of approvals like that if we're successful," Woodcock said. FDA also wants to develop an electronic listing of products. The database would help assess the availability of counter-measures and other products that would be needed in an emergency. "This would help a lot in the shortage area too," Woodcock said. |