The Institute Of Medicine Tells The FDA To Stop Being Big Pharma's Little Bitch Boy

Some of you in the profession may have noticed, around the time you were packing up a new wonder drug to be sent back to the manufacturer for the 6th, 7th, or 8th time, that there seems to have been a problem develop with new drug safety over the last few years. You may have noticed, but your government seems to have been a little slow. Maybe they like issuing recalls because it makes them feel all powerful and stuff. Maybe they let safety standards fall because more than half the budget the FDA spends to test new drugs comes from the pharmaceutical industry that submits the new drugs for review. I'll let you decide which is more likely. Regardless of the reason however, after Rezulin, Baycol, Bextra, Duract, Posicor, Propulsid, Tequin, Redux, Seldane, and Vioxx, the FDA had enough. It was time for action.

A study was commissioned. I wish that were a joke, but it's not.

For what it's worth, the study was released at the end of last month, and it did not have kind things to say about the FDA. According to the New York Times:

The report’s conclusions are often damning. It describes the Food and Drug Administration as rife with internal squabbles and hobbled by under financing, poor management and outdated regulations.

“Every organization has its share of dysfunctions, unhappy staff members and internal disputes,” the report said. But panel members said that they were deeply concerned about the agency’s “organizational health” and its ability to ensure the safety of the nation’s drug supply.

That's all well and good for those of us who are fascinated with the latest FDA gossip, but after 10 new drug recalls that I can think of off the top of my head while in a bit of a scotch induced haze, I'm thinking we need to have some proposed solutions. Fortunately the study has some. Back to the Times:

The report made these recommendations, most of which would require Congressional authorization:

¶Newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.

¶Drug advertisements should be restricted during this initial period.

¶The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies.

¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.

¶The F.D.A. commissioner should be appointed to a six-year term.

¶Drug makers should be required to post publicly the results of nearly all human drug trials.

The most controversial of these recommendations appears to be the advertising restrictions. The press conference called to announce the study's findings was interrupted at one point by a rabid beaver and an actor dressed as Abraham Lincoln. The beaver reportedly ran amok biting commission members in the kneecaps, while the actor playing Lincoln repeatedly fired a musket in the air in an attempt to halt the proceedings. After 20 minutes of anarchy, both the beaver and Lincoln settled into a restful sleep and the press conference continued.

Nah, I made that last paragraph up. I still can't get over those Rozerem ads.

The real reaction from the FDA was.....hmmm, searching for the right word.....wussy. Again to the Times:

In a telephone conference with reporters on Friday, top F.D.A. officials struck an awkward balance between thanking the institute for its work and defending their own leadership. They said they needed to study the report before deciding which of its recommendations to endorse.

So they have to study the study. I have an idea. Maybe they could create a commission to study the study that they commissioned.......*sigh*

When they are done studying the study, the Times story says that most of the changes would require Congressional authorization. This is where you come in. Your member of Congress is up for election next month. They all are. Can you trust your representative to put the interests of real people above those of the "artificial persons" that are corporations? If you're not sure, there's a easy way to tell. If they have a "R" after their name on the ballot the answer is no. If they have a "D" after their name the answer is "maybe, depending on which corporation is involved."

Good luck to us all.