Actions Speak Louder Than Words: Has The FDA Become More Cautious?
We all know that when it comes to communications, actions speak louder than words. For those who have accused the FDA for caving in to the pharmaceutical industry and approving unsafe medications, new data compiled and published today by the New York Times belies critics’ assertions.
According to the Times:
- Only 1 out of 14 drugs submitted for approval during fiscal year 2005 were cleared by the agency during initial review
- It is getting tougher to get medications similar to those already on the market through the FDA – especially if they have side effects
- Drugs for diseases like cancer are receiving fast-track review and approval by the agency.
The Times also notes that FDA drug reviewers are afraid that their decisions may come back to haunt them if they are called in front of Congress to explain why they approved a drug that was later withdrawn.
Critics of the FDA say that the numbers do not mean that the agency has become more cautious. The Times reports that “Dr. Sidney Wolfe, the head of health research at the watchdog group Public Citizen. He said that executives and Wall Street were looking for a scapegoat for the pharmaceutical industry’s failure to develop better drugs.â€
No matter what the real story is, this chart reveals a lot. It indicates that the number of drug approvals has decreased significantly.
In addition, it appears that the FDA is redoubling its efforts to review DTC advertisements. The agency has added additional staff to its marketing review office, partly because more drug firms are submitting commercials to the FDA before they are released.
While actions speak louder than words, the FDA has not talked about these developments in a big way. If the agency is indeed becoming more cautious and ramping up efforts to review pharmaceutical marketing activities, it should talk about its efforts more. At the very least, this will help the public understand what the agency is doing and why.
A big problem is that the FDA has not had steady leadership in a long time. Getting someone at the top who can communicate the agency’s mission clearly and consistently may help bolster its position and credibility with the public.
For more on the communications environment facing the FDA, please see this interview with Mark Senak of the blog Eye on FDA from the current edition of my firm’s newsletter, Envisioning.
