WSJ: Regime Change at the FDA - Bush needs to speed the drug approval process.

Wall Street Journal ^ | September 27, 2005 | Editorial

[OESY]

...Which brings us to the politically motivated attack on FDA Deputy Commissioner Scott Gottlieb -- one of the fellow forward thinkers Dr. Eschenbach will find at the agency. In its zeal to find more "cronyism" in the Bush Administration, Time fingered Dr. Gottlieb this week without offering any evidence of any special connections to the White House -- family or otherwise.

Time seems bothered that Dr. Gottlieb is young and recently worked in the private sector part-time as editor of a medical technology newsletter. Largely ignored by Time is Dr. Gottlieb's previous experience in a substantial policy-making FDA role under Dr. McClellan. Dr. Gottlieb is also one of the few senior FDA officials who still practices medicine, which has kept him attuned to the latest in best practice and to the needs of patients.

The Time piece is "irresponsible journalism," says Frank Burroughs of the Abigail Alliance for Better Access to Developmental Drugs. "Dr. Gottlieb has tried to bring much needed scientific modernization to the FDA and responsiveness to the needs of seriously ill patients." Our guess is that Time got suckered by sources who don't agree with Dr. Gottlieb on policy and used the magazine to try to damage his career.

The Bush Administration's FDA could do much better than it has. But the problem has been largely one of inattention and failure to modernize, not reckless drug approvals or cozy relationships with Big Pharma. Critics who care about more than scoring political points should recognize that the way to fix the agency is for the White House to start putting real political weight behind innovators like Drs. Eschenbach and Gottlieb.

[Grut]

It might be useful to have a law requiring the FDA to note, when they approve a drug, how many people went untreated for how long, or at least how many people died who the drug might have saved, during the approval process.

[RockyMtnMan]

I say anyone who is terminally ill should be able to wave their right to file suite in exchange for experimental medicine. Then the company should be given immunity from standard FDA procedures in those cases.

The government should not stand in the way of a dying persons desperate attempt at life and the willingness of another private party to try and help them.

[SmartCitizen]

The FDA already speeds the approval process for politically correct drugs. Take RU-486 poison pill for example. It rocketed right through even though there is direct evidence that it has resulted in the deaths of women.

The FDA is a politicized bureaucracy and most certainly does NOT have the best interests of Americans as the top priority. Put another way, the FDA is a tragic joke, just like all other federal bureaucracies are a joke.