Faster Than a Speeding Bullet

While no company has yet found the "silver bullet" that will eradicate HIV or AIDS, the FDA's approval of a retroviral therapy and a cosmetic therapy for people with HIV/AIDS show again that its fast-track program for drugs and other therapies for people with HIV or AIDS is a real showpiece. Like any of the government agencies plagued with the reputation for slowing down the progress of business and innovation (see, e.g., the PTO), the FDA at least does have some proof that when it really wants to speed up its mandated activities, it is up to the task. Even more than just boosting the potential bottom line of the drug manufacturers in this case, they've sped the distribution of desperately needed medication to millions of people.

Yesterday, the FDA announced its approval for Epzicom, by GLaxoSmithKline, and Truvada, by Gilead Sciences. The approval process for each was 10 and 4 months, respectively, which is lightning fast compared to most drug approval processes. Each are a combination of other drugs and are dosed once daily, meaning a dramatic reduction in the number of pills that those with HIV or AIDS need to take each day. Even just going from the two pills to one will likely be a tremendous boon to developing countries where trying to get patients to take both pills correctly is sometimes challenging. Just one pill to give out will be a boost to the Global AIDS program and hopefully will help in stemming the AIDS epidemic.

The cosmetic therapy was announced today, a fat filler that helps combat the facial wasting that often afflicts those with HIV/AIDS. The product by Aventis is called Sculptra and helps fill in the wrinkles and hollows that are sometimes associated with having HIV or AIDS.

The FDA has had therapies for HIV and AIDS on a super-priority since 1987 and in 1992 finalized its policies to have such therapies on a "fast-track" for review. The 10 months for Epzicom is actually about the longest an approved drug has taken (non-fast track drugs can often take a couple years to finally be approved for the market).

As a side note, there is also a fast-track program in place for vaccines and the like related to fighting bioterrorism that the FDA (among other conditions deemed important and immediate) has been trying to push to incent companies to do more research in that area. There haven't, as yet, been as many applicants as in the HIV/AIDS program, though that may be due more to relative squeamishness with dealing with such cocktail-party-conversation-stoppers as smallpox and SARS as anything else.

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