Kaiser Daily HIV/AIDS Report Summarizes Editorials on FDA Fast-Track Review System for AIDS Drugs
Several newspapers this week have responded to the Bush administration's plan to establish 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. The expedited process is meant to encourage drug makers to produce FDCs to facilitate the delivery of drugs to rural areas in countries hard-hit by the HIV/AIDS epidemic and to ensure the drugs' safety and effectiveness. Summaries of the editorials appear below:
Contra Costa Times: The Bush administration has "suddenly charted a stunning -- and very welcome -- change of course" by agreeing to set up the fast-track review program, a Times editorial says. "As one of the most sophisticated and educated populations on the planet, the United States has an obligation to do what it can to stem this pandemic," the editorial says, adding that the new program as announced by HHS Secretary Tommy Thompson seems to "assure that we will do just that." Although it "should not have taken the administration this long to come around, we're glad they did so," the editorial says, concluding, "AIDS is a serious problem and it needs a serious and reasonable approach to treatment" (Contra Costa Times, 5/20).
Syracuse Post-Standard: The new expedited review process is an "overdue step" in the fight against HIV/AIDS, a Post-Standard editorial says. The change will "help millions" of HIV-positive people gain access to treatment and will "pav[e] ... the way" for "saving more lives," the editorial says. The application of the new program to antiretroviral drugs "can't happen soon enough," the Post-Standard says. About 8,000 people die of AIDS-related illnesses each day, according to Ambassador Randall Tobias, head of the State Department Office of the Global AIDS Coordinator, and only 8% of people who need antiretroviral drugs have access to them, according to the World Health Organization, the editorial says. "This recent policy shift marks a move in the right direction that could help change that," the editorial concludes (Syracuse Post-Standard, 5/20).
- Washington Post: FDA's expedited review process demonstrates a "promising shift in policy" in the Bush administration that could -- "[i]f it is implemented effectively" -- lead to a "big jump" in the number of HIV-positive people in Africa and the Caribbean who are receiving treatment, a Post editorial says. In addition to "invit[ing]" generic drug manufacturers to offer medicines to the program, the new process also is meant to "encourage" brand-name drug makers to develop combination treatments, which is a "welcome" change, according to the Post. The editorial says that the "objective is to draw in as many potential suppliers as possible, so that doctors have a choice of therapies to fight the virus in different contexts and to cope with resistance as it inevitably evolves." The Post concludes, "The challenge of treating AIDS is unfortunately so huge ... that there is room for multiple companies in this market" (Washington Post, 5/21).