FEATURE: Reading the tea leaves at the FDA

When lava flows from an island volcano--and when an extensive eruption is over with--the island will be re-shaped. Right now, that is what is happening on Capitol Hill. Members of Congress are reacting to long-standing inertia at the FDA by sending a multitude of rapid-fire letters and launching investigations into practices at the agency. Like the volcanic island, if we carefully examine the lava flow, we can get a pretty good idea as to how the regulatory landscape will change, what kind of reforms will be proposed through the election cycle, and what legislation will be sitting on the next President's desk. Here's what happened during the first quarter of 2008 in the areas that face the most change:

• Changes in Fast Track/Accelerated Approval designations - In January, Senator Sherrod Brown (D-OH) has asked the Congressional Research Service, a research arm of the Library of Congress, to conduct an investigation of Fast Track at the FDA [1] to see whether or not the practice of Fast Track is actually speeding the availability of drugs. On the other side of the aisle, Senator Chuck Grassley (R-IA) asks for an investigation by the General Accountability Office to investigate FDA's use of Accelerated Approval and the management of post-marketing commitments by companies. Pharmaceutical companies that don't know their own post-marketing commitment track record better prepare now to discuss it later at Congressional hearings.
  
• DTC and Marketing Practices - Representative John Dingell (D-MI) has questioned the FDA role in supervising the Pfizer Lipitor ad campaign over the use of Dr. Robert Jarvik [2], who, though he is a doctor, has never practiced medicine. Then there was a call for the FDA to require drug makers to include a toll-free telephone number [3] on ads so that patients can easily report adverse events experienced with drugs. Representatives Rosa DeLauro (D-CT)--who has referred to the management of the FDA as "Keystone Cops"--and Jan Schakowsky (D-IL) backed this legislation. Also on the House side, Congressmen Dingell and Stupak have written letters to Amgen and Johnson & Johnson seeking details regarding the marketing of ESAs. At the very least, look for reforms around DTC that address safety concerns and create greater transparency, or perhaps, as some have called for, a moratorium on advertising pending greater experience with a new drug.
  
• Study Publication - The timing [4] of the release of study results from the ENHANCE efficacy study on the combination drug Vytorin is the subject of another letter issued by Senator Charles Grassley sent to both Merck and to Schering Plough. Critics want to know why there was a delay between the time the results were known and the time they were released. 

In addition to all this, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations is conducting six separate investigations of the FDA--on compensation, conflicts of interest, drug safety, device safety, food safety and into the Office of Regulatory Affairs. With so much going on, the climate is ripe for reform and a new FDA is taking shape now. - Mark Senak [5]