By Christopher Wanjek, Special to CBSHealthWatch
Jan. 21 (CBS HealthWatch)-- At a time when critics are blaming the Food and Drug Administration's (FDA) accelerated drug approval process for a spate of dangerous medicines, pharmaceutical experts gathered in Washington, DC, today to discuss ways they can speed up the process even more.
"We're getting better in learning how drugs work," said Lewis Sheiner, MD, a research physician at University of California, San Francisco, and a meeting presenter. "How can we take advantage of this?"
The two-day conference, sponsored by the Drug Information Association, brought together industry representatives with speakers from the FDA and academia to discuss how drug companies can win approval for a particular medication after demonstrating its safety and effectiveness with just one study.
Sheiner said he is not advocating for a faster approval of drugs. Rather, he says that modern techniques of health monitoring and data collection are making it easier to test the usefulness of an experimental treatment with one carefully designed study. Capitalizing on such innovations, he argues, could allow drug companies to get approval for certain "non-novel" drugs that are similar to ones in use or, perhaps, are already in use but for used for another ailment.
This ease of approval could save the industry millions of dollars in research costs, Sheiner points out, which could go back into developing less-profitable drugs for rarer diseases and conditions. Indeed, the FDA Modernization Act of 1997 will sometimes allow data from "one adequate and well-controlled clinical investigation and confirmatory evidence" to establish effectiveness.
Still, the FDA says this is more the exception than the rule.
"There has to be substantial evidence that a drug is effective," said Robert Temple, MD, director of FDA's Office of Medical Policy. "Don't go into drug development with a one-study plan in mind," he advised the crowd.
The FDA has reason to be nervous, critics contend. Since 1997, the century-old administration has needed to recall seven new drugs (most only a few years old) after receiving reports of death and severe side effects. According to a recent Los Angeles Times investigation, the seven drugs were suspect in more than 1,000 deaths.
Are fewer drug studies the way to go? It depends, says Temple, who notes that the FDA views drug approval on a case-by-case basis. Some drugs might be able to get approved after passing a single study; others need substantiation. Neither route inherently places the public at risk, he says.
Temple and other FDA officials at the meeting presented several circumstances for when a drug might be approved with only a single well-controlled clinical investigation. The most notable studies would be those that are statistically very persuasive or are large multicenter studies, which minimizes possible bias from one investigator or one group of people from a similar geographical region.
Since the 1990s, Congress, prompted by the AIDS epidemic, has pressured the FDA to work with the pharmaceutical industry in ushering new medications to the marketplace more swiftly. Drugs are now reviewed, on average, in about 14 months, approximately 2.5 times faster than they were in 1993, according to the FDA.
This has lead to
232 new types of drugs hitting the pharmacy shelves since 1993, compared
to 163 in the seven years prior to that.
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