New Fast-Track Review Program Will Approve AIDS Drugs for PEPFAR; Drug Companies Collaborating To Produce FDCsHHS 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 ensure the drugs' safety, according to the New York Times (Altman, New York Times, 5/17). FDC antiretroviral drugs combine three different medicines into one pill that is taken as few as two times a day. Generic FDCs can cost as little as $140 per person per year (Kaiser Daily HIV/AIDS Report, 4/29). 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. 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, according to an HHS release. For pharmaceutical companies that make generic versions of drugs for which 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 the release.
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).
Some AIDS advocates said they were concerned that the new review process provides an advantage to domestic, brand-name pharmaceutical companies and that the process does not differ substantially from the World Health Organization's prequalification review system ("Morning Edition," NPR, 5/17). Certain generic FDC drugs have been approved by WHO, but U.S. officials wanted to ensure that the drugs would not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use (Kaiser Daily HIV/AIDS Report, 4/29). Global AIDS Alliance Executive Director Paul Zeitz said that the new review process sets "a dangerous precedent," adding, "While this sounds like a fast track, it's a delay" (Lueck, Wall Street Journal, 5/17). Zeitz said he objected to the establishment of additional "regulatory hurdles," which he said would slow drug delivery, according to USA Today (USA Today, 5/17). William Haddad, spokesperson for the Indian generic drug firm Cipla, said that the new review process is "unnecessary" and "unwarranted," adding, "[W]e think it's a political act" (Wall Street Journal, 5/17). "There needs to be a sense of urgency about implementing this" new review process, Elizabeth Glaser Pediatric AIDS Foundation Vice President Mark Isaac said, adding, "The one piece that's missing is that these drugs haven't been tested for kids. We need to be sure kids aren't left out" (USA Today, 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.