Guest guest Posted August 20, 2004 Report Share Posted August 20, 2004 http://www.nti.org/d_newswire/issues/2004_8_19.html#1443DBD3 > FDA Plans Use of Unapproved Drugs in WMD Events > > By Joe Fiorill > Global Security Newswire > > WASHINGTON - The U.S. Food and Drug Administration > has begun preparing for the use of otherwise > unapproved vaccines and treatments in the event of a > WMD emergency. > > The agency is drafting guidelines on an > emergency-use capability authorized in the Project > Bioshield law signed a month ago by President George > W. Bush, FDA Assistant Commissioner for > Counterterrorism Margaret Glavin said last week (see > GSN, July 21). > > " You can't anticipate every possible situation, so > what we're trying to do is to lay out a thought > process, rather than specific procedures and > specific decision rules, " Glavin said in an > interview. > > The agency, which takes an average of 12 years to > approve drugs for use in the United States, is > developing the emergency-use guidelines in > consultation with other bodies that would be > involved in administering the unapproved drugs. The > goal, Glavin said, is for the agencies to reach a > " common understanding of what the boundaries are. " > > The best-publicized component of Bioshield is the > creation of a government-guaranteed market for > otherwise unprofitable WMD countermeasures, which > drug makers do not currently produce in quantities > sufficient for a large attack. > > A separate provision of the new law allows the > health and human services secretary to declare a > one-year emergency, in the event of a WMD attack on > the United States, during which drugs that lack FDA > approval or are approved for other purposes may be > used to combat biological or chemical agents or > radiation. > > Although the health secretary is responsible for > formally declaring any emergency under the > provision, the determination that the declaration is > needed can also originate with the defense or > homeland security secretary. The health secretary > must also consult with the heads of the National > Institutes of Health and Centers for Disease Control > and Prevention before authorizing any specific > unapproved product for use in a given emergency. > > Glavin said her agency would be central in any > emergency-use decisions. " We see the authorizations > as coming from the [FDA] commissioner under existing > . authority. . We would be the operating entity > within HHS to do the work on it, " she said. > > Liability Questions Remain Unresolved > > Even though Bioshield is now law, the legal status > of emergency-approved drugs under the legislation > remains unclear, potentially limiting the law's > effectiveness in sparking drug development (see GSN, > July 26). " Bioshield II " legislation planned for > later this year by Senators Joe Lieberman (D-Conn.) > and Orrin Hatch (R-Utah) would address matters > including manufacturers' concerns about legal > liability for damages from Bioshield-related drugs. > > Meanwhile, the FDA is considering the creation of a > new regulatory category for otherwise unapproved > drugs that are potentially useful in a WMD > emergency, according to Bioshield expert Stephen > Prior, who directs the National Security Health > Policy Center at the Potomac Institute for Policy > Studies. Providing such a status to certain drugs > could ease liability concerns and smooth the > emergency-authorization process in time of need. > > The usefulness of a new drug category is clear, > Prior said yesterday in an interview. If an attack > warranting an emergency-use authorization occurred > tomorrow, he said, the current legal uncertainty > could necessitate a presidential order accepting > total government liability for damages. > > " That's not a good way to go for the government, to > just take on unwarranted levels of indemnification, > but they will do that in an emergency if there's no > other recourse, " Prior said. > > Bioshield stipulates that the health secretary " may " > impose conditions on emergency use that include > informing patients of the option and possible > consequences of refusing emergency-authorized drugs. > > Such measures would probably be less cumbersome than > those commonly taken for medicines granted an > existing investigational new drug status, which > allows activities such as transporting unapproved > drugs across state lines and testing them on > consenting subjects. Bioshield stipulates that > authorizing drugs for emergency use does not grant > them investigational new drug status. > > National Institute of Allergy and Infectious > Diseases Director Anthony Fauci last year told a > House of Representatives subcommittee that, although > investigational new drugs could sometimes be used in > emergencies under existing laws, the amount of > paperwork they required would prevent large-scale > use. > > " If you have to vaccinate 10 million people, " Fauci > said, " there isn't a chance that you're going to be > able to do that under an investigational new drug, > so what the [bioshield emergency-use] proposal says > is that [there can be] something between a full > licensure and something that is an investigational > drug. " > > According to Prior, the Bioshield emergency-use > authorization could lead to storage of unapproved > drugs in the Strategic National Stockpile of > emergency countermeasures, potentially resolving a > long-standing debate over the legality of including > investigational new drugs in the stockpile. FDA > rules that govern distribution of drugs should not > apply to the stockpile, Prior said, since the > stockpile " is only used under specific > authorization " and " is not a general distribution > system. " > > " The purpose of the Bioshield legislation is to > create an environment in which those products which > could become part of the Strategic National > Stockpile could be developed and, if necessary, > purchased, " Prior said. > > Glavin said Bioshield's usefulness is in providing > options for " circumstances where doing something is > better than doing nothing. " Existing FDA powers such > as the conferral of investigational new drug status, > she said, would be of limited use in a large-scale > emergency. > > " They really don't contemplate a mass-casualty > situation, " she said, " and they don't contemplate > what Bioshield contemplates, which is an act of > terror in which some larger number of individuals > could be affected and in which time is of the > essence. " > > A drug authorized in an emergency could carry risks, > Glavin said, but the scenario implies that a greater > and more immediate danger is already present. An > unproven drug could be the only hope in such a > situation, she said, " and it might be better to use > it than not. " Quote Link to comment Share on other sites More sharing options...
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