The Senate Labor and Human Resources Committee on Wednesday, June 18, 1997, endorsed S. 830, the "Food and Drug Administration Modernization and Accountability Act of 1997." Four Democrats, Senators Christopher Dodd (CT), Barbara Mikulski (MD), Patty Murray (WA), and Paul Wellstone (MN) joined all ten Republicans (chairman James Jeffords (VT), Dan Coats (IN), Judd Gregg (NH), Bill Frist (TN), Mike DeWine (OH), Mike Enzi (WY), Tim Hutchinson (AR), Susan Collins
(ME), John Warner (VA), and Mitch McConnell (KY)) in voting for the bill. Ted Kennedy (D-MA), Joseph Bingaman (D-NM), Tom Harkin (D-IA), and Jack Reed (D-RI) voted against this bill.
The full Senate is scheduled to debate this bill soon after the Fourth of July holiday. There are still provisions in this bill that threaten the public's
health. This bill would:
- lower the standards for drug safety and effectiveness by allowing only one clinical study (even if one is inadequate) for drug approval;
- weaken or eliminate most regulatory protections against unsafe medical devices by allowing medical device companies to choose and independently pay reviewers outside FDA to recommend approval of their products; and
- allows a company to market a drug to health care providers, including managed care plans, solely on the basis of cost, regardless of whether their drug is comparable to other drugs in terms of safety, effectiveness, and/or patient tolerance. For example, these marketing strategies could result in managed care plans carrying only one protease inhibitor even though some percentage of patients would benefit more from another protease drug.
Negotiations are still taking place, however, and changes in this bill that will
protect patients and consumers still can happen.
ACTION: It is important that you contact your Senator on the Labor Committee
(see list above) and let them know you are either disappointed they voted for
this bill or you support their decision to vote against it.
If your Senator on the Labor Committee voted for the bill, it is important that
you call, write, or fax them expressing your disappointment in voting for a
piece of legislation that harms patients and consumers, including people with
HIV/AIDS. Tell them:
* You hope they will oppose this bill on the Senate floor or work to modify or
remove provisions that hurt patients.
If your Senator on the Labor Committee voted against the bill, call, write, or
fax them to:
* Thank them for supporting a strong FDA and helping protect the public's health
and tell them you hope they will oppose S. 830 on the Senate floor unless it is
Call the Senate Switchboard at (202) 224-3121 to be connected to your Senator's
Please contact Chad Lord at 202-986-1300 if you have any questions.
Paid for with contributions from AIDS Action Council Network Members.
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202-986-1300, extension 3053