In New Report FDA Admits It’s Not Meeting Its Mission? Well, Duh!
The Federal Food and Drug Administration has issued a report that outlines terrible inefficiencies at the agency, echoing what other groups have been complaining about for years. Requested by FDA Commissioner Edward von Eschenbach, the report was written by a panel of external advisers that reports to Eschenbach, who concluded that the nation’s health is at risk because the FDA does not have the funding, equipment or scientific capacity to fulfill its mission. It is the first time the agency admits it is failing. You can read about it here in the San Diego Union-Tribune.
Let me join the bandwagon of those who’ve been saying, “I told you so.” In the case of those of us in this blog community, we are still hurting from the FDA allowing silicone breast implants back on the market in November 2006, a decision made against its own scientists’ advice.
And what has that decision engendered? The Mommy Makeover, which is now so popular that both the New York Times and Newsweek have written about it over the last few days. These are mothers, folks, and plastic surgeons are blithely hawking the Makeover with little concern about how devastating the procedure could be for entire families!
So now it’s national news that the FDA does not work? Well, it’s no surprise to us. The agency has been rife with conflicts of interest. For a long time now it’s truly been about safety last.
They are asking for more money to fix the problems. But I wonder if money can fix a moral issue. They say it’s science, but if the integrity isn’t there, no amount of money will help:
When panels include doctors taking money from the manufacturers producing the very products they are on a panel to approve, something is very wrong.
When a product has so many dollars behind it that the pressure to approve is unbearable, something is wrong.
When the FDA accedes to manufacturers’ profit imperative without having all the safety data (in the case of breast implants, long-term data of women who’ve had them more than a measly three to five years), there is something very, very, very wrong!
The FDA may be painting this as a financial issue, but UNTIL the mission of the FDA is followed internally, it’s an integrity issue. Throwing money at it is not the solution.













VERY WELL SAID, Mary!!
Comment by Pam — December 17, 2007 @ 9:16 pm
[…] millions of dollars the medical device industry regularly spends on lobbying. The fact is, the FDA has admitted it is in shambles, which is why it is even now under intense Congressional scrutiny and scrambling […]
Pingback by Supreme Court Rules You Can’t Sue Medical Device Makers Because the FDA Does Such a Great Job Assessing Safety | — February 21, 2008 @ 2:59 pm