L.A. Times Looks at FDA’s Fast Track Process

While the FDA has long been regarded as a watchdog for prescription drug safety, a Los Angeles Times special report finds that under mounting pressure to speed up the drug approval process, the agency in recent years has approved some drugs that have had "deadly" consequences. Pushed by AIDS advocates in the early 1990s to accelerate approval of potentially life-saving medications, the FDA was asked by Congress to "work closely" with pharmaceutical companies to get new drugs to market "more swiftly." Over the last two years, the Times examined "thousands of pages" of government documents and conducted interviews with more than 60 former and present agency officials about the safety and efficiency of the new approval process. The Times reports that since 1993, the year after Congress and then president George Bush approved the Prescription Drug User Free Act that helped accelerate the drug approval process, the FDA has withdrawn "seven deadly drugs" that have been linked to 1,002 patient deaths. Those seven drugs, which the Times reports were not necessary to "save lives," include:

• Lotronex, a drug for irritable bowel syndrome that was pulled off the market Nov. 28 after it was linked to five deaths;
  
• Redux, a diet pill that was pulled in September 1999 after some patients taking the medication developed heart-valve damage;
  
• Raxar, an antibiotic that was removed from the market in October 1999 after evidence that the drug was associated with fatal heart rhythm disruptions in some clinical trial patients;
  
• Posicor, a blood pressure medication that was pulled from the market in 1998 after it was linked to heart rhythm dysfunction;
  
• Duract, a painkiller that was withdrawn in 1998 after it was linked to liver failure;
  
• Rezulin, a diabetes medication that was pulled in March 2000 because of its link with liver failure; and
  
• Propulsid, a heartburn medication that was pulled in July after it was linked to heart-rhythm disorders.

While the new process provided consumers with access to more treatments, former and current FDA specialists say that some agency officials have lost sight of the FDA primary goal, to "protect the public health by ensuring ... that drugs are safe and effective." Dr. Lemuel Moye, a physician who served on the FDA advisory committee from 1995-1999, said, "They've lost their compass and they forget who it is that they are ultimately serving. Unfortunately, the public pays for this because the public believes that the FDA is watching the door, that they are the sentry." Further complicating the issue, is the "perception of coziness" with pharmaceutical companies. The FDA allows some advisory committee members to remain as consultants or researchers for "the same companies whose products they are evaluating." Adding to the pressure to approve drugs, pharmaceutical companies provide the FDA with "user fees," which provide funding for more reviewers to help speed the approval process. The Times reports that both reviewers and their bosses fear that if new drugs are not approved, drug companies can pull the fees and jobs will be lost.

But FDA officials maintain that they are "conscientiously" working to weigh the benefits and risks of all new medications. Dr. Janet Woodcock, director of the FDA's drug review center, said that the agency relies on physicians "to take into account the risks, read the label." She added, "We rely on the practitioner community to be the learned intermediary. That's why drugs are prescription drugs." However, Woodcock said that the agency cannot rely on drug warning labels alone. She said, "As medical practice has changed ... it's just much more difficult for (doctors) to manage" the number of drugs available. She added, "They rely upon us much more to make sure the drugs are safe."

Still, the Times reports that any number of factors, including a company's failure to report adverse effect in clinical trials, FDA regulatory actions, a physician's failure to read warning labels or a patient's inability to adhere to dosing schedules, can contribute to serious complications. Summing up the FDA position, Woodcock said, "Consumer protection advocates want to have drugs worked up well and thoroughly evaluated for safety and efficacy before getting to the market. On the other hand, there are economic pressures to get the drugs on the market as soon as possible, and these are highly valid" (Willman, Los Angeles Times, 12/20).