Letter to the Editor
The Washington Post, August 21, 1997, p.A18
John Schwartz’s piece on the scandal of Sen. James Jeffords’s (R-Vt.) hiring former medical device lobbyist James Hawkins to write proposed Food and Drug Administration legislation [“Hill’s Revolving Door Open For Regulators and Regulated,” Federal Page, July 29] only scratched the surface of the pathologic process riddling the F.D.A. Bill, S.830.
The bill has made it to the Senate floor despite no public hearings on its provisions, no significant consumer input on its threat to public safety and health, and despite it being written and modified behind closed doors with the administration, congressional staff, and industry with patients, consumers, and public health groups excluded.
Hawkins and Sen. Jeffords’ committee staff have jealously guarded the bill’s contents — as of today, the text that will go to the Senate floor has still not been released to the public. This secrecy is par for the course for this bill. With 25 cents of every consumer dollar spent on products regulated by the F.D.A., you would think that consumer groups would have the right to comment on legislation which shreds many significant parts of the F.D.A.’s authority to ensure those products are safe and effective.
But the original version of the bill was only released the night before it was “marked up” in committee. Since then, further negotiations on its provisions have also taken place behind locked doors, with those representing consumers kept out of the room, and those representing the drug, medical device, food and cosmetics industries invited to the table.
What has such a secret process produced? A bill that lets medical device companies buy their own reviewer to recommend that their products are safe and effective, permits companies to market experimental drugs, and poses a multitude of other threats to public safety.
This bill from the dark has had a mesmerizing effect on several senators, causing Paul Wellstone (D-Minn.) and Barbara Mikulski (D-Md.) to side with the industry, and forcing Senator Gregg (R-N.H.) to abandon his Granite State roots and press for federal preemption of state laws on over-the-counter drugs and cosmetics. This shadowy legislation and its scandals should be exposed to the glare of public scrutiny, rather than being rammed through the Senate before it can be understood.
Dr. Sidney Wolfe
Director, Public Citizen’s Health Research Group