Drug safety should be included in industry fee bill, Senate told


Senate Urged to Include Prescription Drug Safety, Device Safety in User Fee Bill
Consumers Union says legislation addresses industry concerns, not consumer concerns

(Washington, D.C.) – Consumers Union today urged the Senate to address the growing public confidence crisis in prescription drug safety and medical device safety in a medical device user fee bill that is moving through Congress. The following letter was sent today to all Senators regarding S. 1420, which is expected to come up for a full vote soon.
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July 21, 2005
Dear Senator:
The Senate is about to consider S. 1420, the Medical Device User Fee Stabilization Act 2005, relating only to the Food and Drug Administration user fees on medical devices. Considering the ongoing public confidence crisis in the safety of our nation’s prescription drugs and medical devices, it is unfortunate that bipartisan legislation that is moving through the Senate does not include safety measures to protect American consumers.
We would urge you to include measures in this bill or to take up legislation soon after, that would:
1) Address the serious failures of the FDA to adequately monitor and correct the safety of drugs already on the market, or entering the market.
In recent years, there have been thousands of unnecessary and premature deaths and injuries from drugs whose dangers should have been recognized and warned against earlier. There is bipartisan legislation in the Senate, such as S. 470 and S. 930 by Senators Grassley, Dodd and others, that would address these problems and should be considered as soon as possible. These bills would require registration and public access to clinical drug trials; greater independence and authority for post-market drug safety at the FDA; clear FDA authority to require drug label changes for safety reasons, and improved safety disclosures in drug advertisements.
2) Address failures to protect children and adults in the FDA medical device safety process.
The Institute of Medicine just issued a July 18 report “Safe Medical Devices for Children” that identifies serious problems in the FDA’s postmarket approval safety evaluations of devices. These problems are similar to those in drug safety – ineffective post-market safety surveillance and funding, a lack of public information on safety problems, and weak FDA authority to require post-market safety studies.
S 1420 addresses concerns of the industry to ensure the speedy approval of devices.
We hope the Congress will soon address the safety concerns of the nation’s 300 million health care consumers for prescription drugs and medical devices.
Sincerely,
Bill Vaughan
Senior Policy Analyst,
Consumers Union