In 1992, Marcia Angell, noted senior lecturer in the Department of Social Medicine at Harvard Medical School wrote this about the FDA in a Boston Globe article :
"It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay 'user fees' to the FDA for each brand-name drug considered for approval. Nearly all the money generated by these fees has been earmarked to speed up the approval process.
"In effect," Angell continued, "the user fee act put the FDA on the payroll of the industry it regulates."
She indicated the agency fast-tracks approval of brand-name drugs, resulting in a backlog of some 800 trials for generics, which she noted "is worth billions of dollars to the drug companies whose high prices depend on not having generic competition."
As a result of the pressure from fees to speed up trials, Angell wrote, FDA trials approve drugs with less evidence than in the past. Some are even approved contingent on the companies' conducting further safety studies after the drugs are on the market -- an unfulfilled contingency, Angell noted, that the agency has ignored in 70 percent of about 1,200 such studies.
In addition, the FDA refuses to release unfavorable research results it possesses without the sponsoring company's permission.
Wow.
2 comments:
i wrote about another reason for you to hate the FDA in my blog a couple days ago. they're approving high powered antibiotics for use in rare cow pneumonia. this was the same day as an announcement that extremely drug resistant TB is on the rise in 19 countries. good call, FDA.
(we'll discuss this over beer and wine on saturday, while giving the collective finger to those bastards)
what?? that's crazy!
yes. yes indeed.
Post a Comment