May 17, 2004
More Program Details
The agency also will offer a list of currently approved antiretroviral drugs that officials believe have sufficient clinical safety and efficacy data supporting their use as in combination therapies (HHS release, 5/16). The new review process calls for drug makers to support the case for a drug's use in an FDC by using existing research instead of unique clinical trials. Such research could include peer-reviewed scientific literature of clinical studies and information from a company's own data, including information already submitted to FDA (HHS fact sheet, 5/16). In the past it has taken companies up to four years to develop clinical data for FDA review, according to NPR (Wilson, "Morning Edition," NPR, 5/17). Although the proposed guidelines will be open to public comment for 60 days, the program will take effect immediately, USA Today reports (USA Today, 5/17). FDA on Monday plans to publish a handbook for drug companies that will include information on how to apply for expedited review and how to "prepare their requests for authorization," according to Agence France-Presse (Agence France-Presse, 5/16).
Acting FDA Commissioner Lester Crawford said that antiretroviral drugs approved by FDA under the program must adhere to agency standards for drug safety, effectiveness and quality, according to the HHS release (HHS release, 5/16). Thompson said, "We are clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in developing countries." He added that FDCs and co-packaged products "are an important tool in improving the quality of health care in developing nations." Ambassador Randall Tobias, head of the State Department Office of the Global AIDS Coordinator, said, "The president has made it clear that his goal is to put effective treatment into the hands of those who need it in the hardest-hit developing nations and to provide these life-saving services as widely as possible. With FDA review, we will have a gold-standard assurance that a combination product will be safe and effective" (Wroughton, Reuters, 5/16).
Drug makers Merck, Bristol-Myers Squibb and Gilead Sciences on Sunday announced they have been developing a fixed-dose combination pill containing the companies' antiretrovirals Viread, Emtriva and Sustiva, according to the Times. The companies also said they are considering packaging "certain products" together, the Times reports (New York Times, 5/17). BMS spokesperson David Rosen said no one is sure how long it will take to develop any combination treatment, according to the Newark Star-Ledger. "We're hoping [it will not take] a very long time," he said. Robert LeFebvre, senior director of global HIV brands for BMS, said that the collaboration is a "great step forward," adding, "During the past year, the reality of money being put on the table allowed the rest of the world to coalesce around it. The discussions, finally, are moving toward action" (Todd, Newark Star-Ledger, 5/17). GlaxoSmithKline and Boehringer Ingelheim in a separate announcement on Sunday said they are engaged in discussions to possibly package together some of their antiretroviral drugs for use in developing countries, the Times reports (New York Times, 5/17).
"Way of the Future"
Tobias said, "We must apply real discipline to ensure that products we provide in poor nations are safe and effective. The new expedited process provides us with a solid foundation for purchasing drugs that work" (AP/Washington Post, 5/16). UNAIDS Executive Director Peter Piot said that the new review process is a "pretty radical change in U.S. policy, if applied," adding, "It will help AIDS programs everywhere" (New York Times, 5/17). Global Fund to Fight AIDS, Tuberculosis and Malaria Executive Director Richard Feachem said that FDCs and co-packaging "are the way of the future for AIDS drugs in developing countries," adding, "Simpler drug regimens can save lives and prevent spread of resistance to HIV drugs." Feachem also said that the Global Fund is "very pleased that more companies are taking up the challenge by collaborating to create new solutions" (Global Fund release, 5/17).
NPR's "Morning Edition" on Monday reported on the proposed expedited review process. The segment includes comments from Thompson ("Morning Edition," NPR, 5/17). The complete segment is available online in RealPlayer.
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2004 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.
The content on this page is free of advertiser influence and was produced by our editorial team. See our content and advertising policies.