Recent FDA Bans May Signal Future Trend
After pulling several "blockbuster-selling drugs" that killed or injured patients off the market, the FDA is now 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 new 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).
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.
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.
In other FDA banishment news, the agency has initiated proceedings that could result in a permanent research ban on University of Pennsylvania gene therapy researcher James Wilson. Wilson directed a gene therapy experiment that resulted in the death of teenager Jesse Gelsinger last year. In a Nov. 30 letter to Wilson, the FDA charges that the researcher "repeatedly or deliberately violated regulations governing the proper conduct of clinical studies." The FDA alleges that Wilson allowed medically "ineligible" volunteers to take part; that he "misled" participants to believe the FDA "was comfortable with the study"; and accepted "less healthy" volunteers into the study. In proposing that Wilson be "disqualified" as a clinical investigator, the FDA action is the research equivalent of a lawyer being disbarred. Wilson has until Dec. 30 to respond in writing to the charges (Weiss, Washington Post, 12/12).
The agency has issued a warning to arthritis drug Celebrex co-marketers Pfizer Inc. and Pharmacia Corp. for a "misleading" advertisement. The two companies have been warned that the drug's marketing is "false or misleading." The ad shows "arthritis sufferers" playing in a park while a vocalist sings "Celebrate, celebrate -- do what you like to do." The FDA says the images, music and audio statements "overstate the efficacy for Celebrex." In a Nov. 14 letter to the drug companies, the FDA wrote the ad "collectively suggest[s] that Celebrex is more effective than has been demonstrated by substantial evidence." The ad was pulled, "retailored" and returned to the airwaves on Nov. 23. Sales of Celebrex this year topped $1.8 billion through the third quarter (Adams, Wall Street Journal, 12/12).
To help consumers avoid Salmonella enteritidis, the FDA is mandating that producers label egg cartons with a warning on the bacteria and how to safely handle eggs. The warning will read: "To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook food containing eggs thoroughly." The FDA estimates that one out of every 20,000 eggs is contaminated with salmonella, and the agency says these eggs are responsible for more than 115,000 salmonella-related illnesses and 66 deaths each year. The labeling requirement is expected to cost $56 million the first year and $10 million for each subsequent year (Skrzycki, Washington Post, 12/12).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.