FDA On The Hotseat Because Of Safety Concerns

According to the old proverb, “He who pays the piper calls the tune.” FDA officials are now facing the music. They must answer to the American public, the people who really pay the bills.
For decades Congress has allocated billions of taxpayer dollars to the FDA to ensure that our medications are safe and effective. For the most part the agency has been left on its own to carry out this mission. But now Americans are worried about confusing headlines regarding the safety of Vioxx and a variety of other medicines.
FDA officials have been called on the carpet by Senators anxious to get to the bottom of the pain reliever puzzle. Some wonder if FDA can police drug safety on its own. Experts have proposed a separate body, independent of the agency, for this task. FDA officials do not want to give up this responsibility.
But consumers are nervous. In a recent survey, only 14 percent said they have great confidence in the FDA’s ability to safeguard the country’s drug supply. The majority of consumers in this poll favor an independent drug watchdog agency.
The FDA has maintained for months that it did nothing wrong with respect to its oversight of Vioxx and other COX-2 inhibitors like Celebrex or Bextra. But during Senate hearings, one agency official recently admitted to “lapses.”
Dr. Sandra Kweder, deputy director of the Office of New Drugs, bemoaned that it took the agency and the manufacturer more than a year to negotiate wording on heart risk for the Vioxx label. The other shortcoming she mentioned was a failure to get doctors to pay close attention to these dangers.
It’s hardly any wonder patients and physicians were so enthusiastic about Vioxx and Celebrex. The advertising on television and in magazines was compelling.
Experts have criticized this “direct to consumer” (DTC) advertising. Many physicians feel it puts them under inappropriate pressure to prescribe. And the public is getting weary of watching commercials for erectile dysfunction drugs or other prescription products.
Even the FDA is beginning to question whether DTC ads are such a good idea. Dr. Janet Woodcock, acting deputy commissioner for operations, told the Senators that such advertising leads doctors to write prescriptions many patients don’t need. She believes that some consumers don’t get an adequate understanding of risks from these commercials.
Balancing benefits against risks is difficult enough for physicians and patients. There’s often too little information when a drug is first released to evaluate long-term safety. Some critics maintain that the FDA has put too many resources into new drug approval and not enough into monitoring for hazards.
Dr. Bruce Psaty, professor of medicine and epidemiology at the University of Washington, pointed out to the Senators: “In the office of new drugs, more than 1000 employees work to review a few dozen new drugs per year. In the office of drug safety, 109 employees work to evaluate the safety of thousands of drugs currently on the market.”
If the FDA cannot respond to the American public’s concerns about drug safety, perhaps it is time for Congress to establish an independent center to do the job.