U.S. Will Speed FDA Approval of Some HIV/AIDS Drugs; Rx Companies Working Together
HHS Secretary Tommy Thompson on Sunday at a news conference in Geneva announced plans for a new FDA fast-track review program to "speed the delivery" of low-cost antiretroviral drugs, including fixed-dose combination drugs, to African and Caribbean nations covered under the President's Emergency Plan for AIDS Relief, USA Today reports (Sternberg, USA Today, 5/17). The expedited process is meant to encourage drug makers to produce FDCs to "ease delivery of drugs in remote areas in severely affected countries" and to ensure the drugs' safety, according to the New York Times. FDC antiretroviral drugs combine three different medicines into one pill that is taken as few as two times a day (Altman, New York Times, 5/17). The expedited review process will apply to new products that combine HIV/AIDS drugs that are already FDA approved into a fixed-dose pill and to new co-packaging of existing treatments. The FDA guidance for the review process will outline four scenarios for review of different FDC and co-packaged products. If the agency receives a "high-quality" application, the approval process could take between two to six weeks. For pharmaceutical companies that make generic versions of drugs whose patents are owned by another company, FDA could issue a tentative approval when it determines whether the treatment "meets the agency's normal safety and efficacy standards," according to an HHS release.
The agency also will offer a list of currently approved antiretroviral drugs that officials believe have sufficient clinical safety and efficacy data supporting use as a combination therapy (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 with information for drug companies 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 that it is unknown 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 said they are engaged in discussions to possibly package together antiretroviral drugs for use in developing countries, the Times reports (New York Times, 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.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.