FDA Could Face Congressional Overhaul

31 July 2008

WASHINGTON, DC: As a House of Representatives sub-committee meets today (Thursday), the US Food and Drug Administration could be facing a major Congressional assault in response to the latest in a series of scandals.

The House Sub-committee on Oversight and Investigations is holding a hearing following a salmonella outbreak originally linked by the FDA to tomatoes, but now attributed to jalapeño peppers, with tomato growers having lost millions of dollars.

Other high-profile incidents in the past year include deaths linked to “major deficiencies” in the production of Baxter International's blood thinner Heparin in China, and the association of “serious neuropsychiatric symptoms” with Pfizer's anti-smoking aid Chantix

Democrat John Dingell is a member of the committee, and has previously criticised the “total inability of the FDA to carry out its mission”. Its officials are also accused by Dingell's Republican senate ally Chuck Grassley of being “too cozy with the companies they regulate".

Dingell and Grassley have previously ordered around twenty investigations into the FDA's work, such as with regard to the approval of the antibiotic drug Ketek, the clinical trials of which were later found to be subject to “serious protocol violations”.

The pair are said to be in favour giving it the FDA the ability to fine companies that break safety regulations and recall drugs, and of limiting direct-to-consumer advertising.

Lawyers from the Pharmaceutical Research and Manufacturers of America lobby group met representatives from Dingell's committee earlier this month to talk about direct-to-consumer advertising.

The industry body's president, Billy Tauzin, says the current challenging climate is “an accumulation of things some companies did over the years. Now it's death by a thousand cuts.”

Data sourced from Wall Street Journal Online; additional content by WARC staff