Dow Jones Examines How AIDS ‘Revolutionized’ the FDA Drug Approval ProcessDow Jones News Service in a two-part series on Thursday examined the FDA's "fast-track" approval designation, which was developed after pressure from AIDS activists in the late 1980s and early 1990s forced the FDA to "revolutioniz[e]" its drug approval process for medications that fulfilled unmet needs. Because many people with AIDS were dying, as there was no drug treatment for HIV infection, activists wanted the FDA to take measures to reduce the amount of time necessary for the approval of any experimental drug that might help combat the disease. The agency at that time took up to five years to approve a drug because each application included at least 500 volumes of data, each two- to three-inches thick. ACT UP, an activist group founded by Larry Kramer, urged the FDA to revamp its approval process to rely more heavily on computers and asked the agency to help drug companies develop more effective clinical trial protocols. After many demonstrations by ACT UP and others, Congress in 1992 passed the Prescription Drug User Fee Act, which requires drug companies to pay a fee when they submit a drug for FDA approval. Payment of the fee guarantees that a company's application will be reviewed within 10 months for a normal drug and within six months for a drug the agency considers "a breakthrough to treat a deadly disease." The subsequent influx of additional funds helped the agency modernize its approval process and purchase more computers to speed reviews, according to Dr. Murray Lumpkin, a senior FDA official. As computers streamlined the approval process, the agency began creating different designations for new drugs. Before the emergence of AIDS, the agency had assigned drugs a designation -- A,B or C -- in descending order of priority. However, the designation did not mean a speedier review. To assist in expediting the process, the FDA created an AA priority category for drugs to treat new diseases like HIV and later "revamped" the system to create the fast-track process (Middleton, Dow Jones News Service, 9/12).
The Fast-Track Advantage
Some drug companies now use an FDA fast-track designation to "hype" their products to attract media coverage and investment. The fast-track designation does not guarantee that a drug will be approved, but it "carries cachet, a tacit endorsement that the nation's health arm considers a drug an important advance," Dow Jones reports. The FDA does not "always object when companies aggressively use the agency's designations to land financial backing for unapproved and unavailable drugs," but it has sent letters to some companies advising them against "promoting unapproved products." Consumer interest groups such as Public Citizen have urged the agency to take more aggressive action against companies that promote drugs that are pending approval, saying that the fast-track designation has placed "too much emphasis on speedy drug reviews" at the expense of consumer protection. But FDA analysts say that the agency does not have enough staff to monitor drug companies' claims, nor is it the agency's mission, according to Dow Jones (Middleton, Dow Jones News Service, 9/12).