Senator says FDA not cooperating on antibiotic

[Celebration]

http://www.abcnews.go.com/Politics/wireStory?id=2076791

WASHINGTON (Reuters) - The Food and Drug Administration may be trying to hide information about its review of a Sanofi-Aventis antibiotic linked to liver damage in some users, a top Republican lawmaker charged on Wednesday.

"I smell a cover-up," Senate Finance Committee Chairman Charles Grassley said after the FDA failed to make available one of its criminal investigators for questions about his probe of fraud in a study of the drug, Ketek.

The Iowa Republican told reporters he may hold a congressional hearing on the issue and call the investigator to testify. His committee began reviewing the FDA's approval of the antibiotic and subsequent monitoring of the drug's safety earlier this year.

The FDA said it was cooperating with Grassley's investigation and agency staff were providing more than 2 million pieces of paper with Ketek information to the committee.

Slightly more here

http://www.upi.com/NewsTrack/view.php?StoryID=20060614-125802-7252r

U.S. Sen. Chuck Grassley, R-Iowa, reportedly is not satisfied with the way regulators have handled his investigation of the antibiotic Ketek.

The chairman of the Senate Finance Committee plans to personally confront staffers at the Health and Human Services Department, parent of the Food and Drug Administration, over information he says hadn't been disclosed, reports the Wall Street Journal.

The Journal quoted Grassley saying his investigators were not allowed to interview an FDA special agent, although they had been told they could speak to other staff members.

The report said the agent was involved in the FDA's own probe of alleged problems in a study regarding the safety of the antibiotic. But despite those problems, the drug was approved by the FDA in 2004 based on other evidence, the report said.

[eowyn_of_rohan]

1. Good for Sen. Grassley

Take those SOBs to task for being in bed with the pharmaceutical companies who seem more and more like Josef Mengele all the time.

[Telly Savalas]

3. I think Grassley has also introduced legislation

which would grant the FDA a lot more power to enforce compliance with Phase IV post-marketing studies. Such studies work like this: the FDA says to a pharma company "we're 99% sure your drug is OK so we'll approve it, but you gotta follow up with a study demonstrating X so we'll be 99.9% sure it's OK." This is a pretty reasonable policy, but the problem is that the vast majority of these studies never get completed and the FDA has no leverage to force the companies to finish them. Grassley's bill would empower the FDA to shut a company's operations down if they don't comply.

Since he's got an R after his name, I'm sure the guy has some pretty crazy ideas on other things, but it's nice to see an advocate for sound policy on the sorts of bland wonky things that usually only attract industry-sponsored legislators passing laws which kiss lobbyist ass.

[undergroundpanther]

2. this is why they passed tort reform

so big pharma could test on us,and get away with poisoning us,without paying the victims they hurt or kill. The FDA is along with Big Pharma a public danger.There needs to be a shakeup and clean up in the FDA and the money flow and perks has got to be choked off from it.
The FDA is owned by big pharma anyway these days. When a failed heart drug became a sweetener I knew it was in big pharmas back pocket..but the corrupted began with that charismatic piece of shit reagan that wooed everybody with his manipulating actor shtick. Goddamn the public is so easily duped give a monster a pr.ream a good haircut and looks,and market him as wonderful a sociopath can get elected.Look at boosh.