FDA reforms without industry pressures

Re “The FDA Awaits a Cure for Its Malaise,” April 30

The Food and Drug Administration needs a big fix, but not in the way that is frequently proposed. Would you believe product ratings if Consumer Reports was paid by the product producers? Would you believe automobile safety rankings if the auto companies tested the safety of their own vehicles?

The most egregious conflict of interest on the face of this planet is that drug companies test the safety and efficacy of their own drugs or directly pay someone to do it. The FDA should replace this ludicrous practice with government-funded drug testing, paid for by a blind federal trust supported by required drug company contributions.

STEVEN B. OPPENHEIMER

Cal State University System

Trustees Outstanding Professor

Northridge

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As a former congressional investigator who initiated hearings on FDA issues, I have seen FDA morale rise and fall through the years, but it has certainly been at an all-time low in recent months. Lack of safeguards and political interference are not just issues for prescription drugs, however.

As baby boomers near retirement age, their increased reliance on implanted medical devices also necessitates a permanent commissioner and a focus on science.

Whatever the FDA is reviewing, long-term safety data are essential. Unfortunately, such data are rarely required by today’s FDA.

In addition, fears about the avian flu should remind us that the FDA needs to focus its resources on safe and effective vaccines as well. The Plan B controversy is the tip of the iceberg. All FDA decisions need to be based on solid science, not ideology or industry pressure. That is true for medical devices and vaccines as much as for prescription drugs.

DIANA ZUCKERMAN

President

National Research Center

for Women & Families

Washington