Wednesday, November 22, 2006
WSJ on FDA Review of Pharmaceutical TV Ads
Article in the Wall Street Journal -- FDA Sets Deal With Drug Firms On TV-Ad Vetting, by Anna Wilde Mathews. One wonders about the possible preemption effects. Here's an excerpt:
The Food and Drug Administration has reached an agreement with the pharmaceutical industry that would require companies, for the first time, to pay fees to the agency for vetting their television advertisements, in exchange for speedier reviews.
The fees from the proposed agreement would help pay for new staff to be hired by the FDA to review the industry's TV ads, people familiar with the deal said. Many drug makers are voluntarily submitting ads to be reviewed by the FDA.
The agreement would be proposed in tandem with a separate, five-year pact setting new user fees to be paid by drug makers to the FDA when the agency reviews their applications to market new medicines. That agreement is expected to require the industry to pay substantially more money to the FDA, with a large chunk going to fund drug-safety initiatives, said people familiar with the matter.
BGS
https://lawprofessors.typepad.com/mass_tort_litigation/2006/11/wsj_on_fda_revi.html
I am 41year old female who started taking Chantix on 6/30/08. A week into it no problem. Then week two I had quit smoking and I thought this was the best smoking cessation drug. Then during week 2, I began to feel pain in my knee joints that I had never experienced like that before. In week 3, the pain was so severe I started to research it on-line. I found this web-site and began to realize it was the Chantix causing my knee joints to hurt severely. As of today, I have quit taking Chantix and will start Glucosamine capsules to help manage the knee joint pain. I hope the glucosamine helps and for those of you writing on this web-site you should also file a complaint with the Food and Drug Administration at http://www.fda.gov and I would suggest also writing a letter to Pfizer. For those of you that quit with no side effects, good for you consider yourselves very lucky. For those of us in pain, I urge you to file you complaint on-line with the FDA.
Posted by: Sam | Jul 18, 2008 6:12:47 AM