Recent FDA Drug Bans May Signal Future Trend
The FDA, having pulled from pharmacies several "blockbuster-selling drugs" that killed or injured patients, is warning doctors and patients to prepare for "even more bans" in the future, the AP/Arizona Republic reports. Since 1997, the FDA has "yanked" 11 popular prescription drugs off the market; the latest, Lotronex, was banned for "causing deadly intestinal side effects just nine months" after hitting the market. Some critics blame the FDA's review process that "approves new drugs too quickly." Under pressure from Congress, the FDA has reduced the average review time for new drugs from 34.3 months in 1993 to 14.6 months in FY 2000 (Neergaard, AP/Arizona Republic, 12/12).
Conflict of Interest?
Some consumer groups and patient activists charge that the pharmaceutical industry has gained too much influence with the FDA. As part of the revamped approval process, drug companies pay the FDA a "users fee" to "hire more experts" and expedite new drug applications. Consumer group Public Citizen questions whether the users fee has created a conflict of interest within the FDA. Larry Sasich, a member of Public Citizen's Health Research Group, said, "Consumers will not continue to have confidence in the credibility of an agency that has even the appearance of representing the interest of the industry over its own." FDA Commissioner Jane Henney said, "We have no evidence of a [conflict of interest], but even the perception threatens consumers having confidence in our ability to conduct our job." Henney said that the agency's effort to meet new approval deadlines has been a detriment, adding, "We don't have the resources to do the things we believe are essential, such as adverse event reporting, because they were not part of the process" financed by user fees (MacDonald, Hartford Courant, 12/12). The FDA employs only 82 workers to track a drug's side effects after its approval, and Congress has "repeatedly" refused to provide the agency with additional funds to bolster the program, which depends on voluntary reporting from physicians.
The FDA, however, says that physicians are to blame for many of the drug bans because they "ignored safety warnings and prescribed [the drugs] to the wrong patients." For example, the FDA pulled heartburn drug Propulsid from the market last summer after it was linked to 80 deaths, despite two years of FDA warnings that the drug should not be prescribed to patients with kidney or heart disease. But physicians say they do not have enough time to read "the pages of fine print" and "can't remember all the warnings anyway." Moreover, physicians typically learn about new medications from sales reps "unlikely to stress risks" of the drugs.
Warning about Warnings
The FDA is debating "tougher measures," including limiting the sale of newly approved drugs or restricting which doctors can prescribe new medications. In an "unusual letter" to the Journal of the American Medical Association, Dr. Janet Woodcock, director of the FDA's drug-review center, warned that if physicians do not become more diligent about new drug safety, "additional effective drugs are likely to be withdrawn, and some drugs may never become available in the first place" (AP/Arizona Republic, 12/12). A list of the FDA-banned drugs is available at http://www.contracostatimes.com/health/stories_healthwire/733221l.htm.