Steven Nissen Gives Obama an Rx for FDA Reform

[WillYourVoteBCounted]

A potential candidate for the FDA Commissioner's job speaks out on providing more transparency in the approval of medicines and removing conflicts of interest.

Steven Nissen Gives Obama an Rx for FDA Reform
Posted by Sarah Rubenstein Wall Street Journal Blog January 20, 2009

...Nissen, himself a potential candidate for FDA commish and often viewed as an enemy of Big Pharma, sounds off in favor of a fixed six-year term for the FDA chief to make the agency less susceptible to political pressures.

He also wants reconsideration of the system in which the drug industry funds a lot of the FDA’s budget through user fees: a system criticized by some for giving the industry too much sway over the agency.

Another Nissen call: Transparency when it comes to those letters the FDA sends when it’s decided on whether or not to approve drugs. Right now, most of the contents of the letters are secret.

“Secrecy is antithetical to both science and good government, but much of what the FDA knows about drugs, it never discloses,” he writes. “The agency must cease to regard clinical-trial data as proprietary and provide access to all available information on safety and efficacy.”

....

Nissen also recommends restricting direct to consumer advertising in new drugs first two years.

[Celebration]

1. the user fee thing is a huge deal

We need another way of funding the FDA.

As much as I disapprove of direct to consumer ads, this may be what keeps Nissen from getting the job. The advertisers are in a world of hurt economically right now. It would be best to restrict these in boom times.

By the way, my opposition to consumer ads is mostly because the end user generally is not directly paying for the drugs. So the drug companies promoting their drugs affects all of us economically, through higher insurance payments, taxes etc. If the end user paid for the drug directly, I would have no objection. I'm just not sure that the rest of us should pay for the obnoxiously high cost of presrciption drugs, just because somebody saw an ad somewhere and pressured their overworked doctor into prescribing something not needed or even harmful.

On a related note, I still remember Dorothy Hamill and those Vioxx ads.