FDA To Approve Some Treatments for Bioterrorism-Related Diseases After Testing Only in Animals
In a "major change from past practice," the FDA yesterday said it will allow some drugs designed to treat the symptoms of biological, chemical and radiological terrorist attacks to be approved and marketed after being tested only in animals, the Washington Post reports. Previously, drugs had to undergo a series of clinical trials in humans before gaining approval. However, exposing healthy humans to the "potentially lethal or permanently disabling" agents of bioterror attacks would be unethical, making it impossible to test a drug against such threats (Kaufman, Washington Post, 5/31). The new rule would apply only to cases in which there was no ethical way to test the drugs' efficacy against a biological, chemical or radiological agent in humans, the New York Times reports. However, testing the drugs for safety and side effects would still have to be done in humans since those trials would not require exposure to a lethal agent. The drugs that fall under the new rule would have to be tested in at least two types of animals, and there would have to be enough understanding of the "mechanism of the disease and of the drug to reasonably conclude" that the animal tests were applicable to humans (Pollack/Broad, New York Times, 5/31). Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the "narrowly drawn" rule, which was first proposed in 1999, was "urgently needed" to "persuade applicants to go forward" with research on drugs that treat bioterrorist agents. Woodcock said she thought the rule would be applied less than once a year and that it would take companies about a year to design, undertake and complete the required animal testing (Washington Post, 5/31). The rule will be published in today's Federal Register and will take effect June 30 (FDA release, 5/30).
Pharmaceutical and biotechnology industry groups yesterday said that the new rule is an "important advance" that could encourage companies to devote more resources to develop treatments for bioterror agents, the Post reports. Michael Friedman, a former acting FDA administrator who now works for the Pharmaceutical Research and Manufacturers of America, said the rule is beneficial because "[t]here are medicines out there that we have every expectation would be effective against anthrax, for example, but there's been no consistent way to test them." Steve Lawton, chief attorney for the Biotechnology Industry Organization, added that the rule is "absolutely appropriate and necessary ... to combat terrorism" (Washington Post, 5/31). But Sidney Wolfe of the advocacy group Public Citizen said he was "very worried" that the rule would be abused to approve drugs without adequate testing (New York Times, 5/31). "There's been a lot of slipping and sliding in the past on this kind of speeding up the review process," he said, citing the use of the FDA's "fast-track" approval process for AIDS drugs for "many other medications" (Washington Post, 5/31).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.