FDA needs drastic changes to its policies and operations, according to Rep. John Dingell (D-MI) and Sen. Chuck Grassley (R-IA), who have developed a plan to revamp the agency. Restructuring FDA’s power and giving it the ability to recall drugs, impose fines, and regulate drug advertising are among the changes proposed by Dingell and Grassley, as outlined in a report by the Wall Street Journal (WSJ) yesterday. They also believe the agency is “too cozy” with pharmaceutical companies and are calling for the next president to appoint a commissioner with no ties to industry.

Alicia Mundy of the WSJ’s Health Blog calls Dingell (chairman of the Energy and Commerce Committee) and Grassley (a member of the Senate Finance Committee) the “drug industry’s ‘bad-dream’ team” because of the many issues each lawmaker has raised, the legislation they have proposed to regulate the drug industry, and the number of investigations their committees are involved in.

Dingell and Grassley have been quite active in questioning FDA’s role in Big Pharma’s activities, such as the safety of outsourcing, the effectiveness of FDA’s foreign inspections and the use of registration fees to fund them, investigations into “Vytorin” clinical trials data, questioning Amgen’s rebates to doctors prescribing “Aranesp,” and introducing the Physician Payments Sunshine Act, which would provide transparency of the gifts given to doctors by pharmaceutical companies.

WSJ predicts that any major FDA changes will not take effect this year because of Congress’s short session this fall before the November election, but that “2009 may bring the most significant overhaul at the FDA in a generation if Messrs. Dingell and Grassley get their way.”

Speaking of the upcoming election, the editors of PharmTech are interested to know what the two presumptive presidential candidates think of these issues facing FDA and our industry. Do you have a question you’d like to ask Senator John McCain or Senator Barack Obama about their policies regarding the administration of FDA and the pharmaceutical industry in general? Submit your questions—we’ll forward them to the candidates and print their responses in our October issue. Leave a comment below or visit pharmtech.com/election2008 to send us your question.