Magazine article Insight on the News

Ease FDA's Grip on Uses for New Drugs

Magazine article Insight on the News

Ease FDA's Grip on Uses for New Drugs

Article excerpt

Doctors, researchers and pharmaceutical manufacturers have developed numerous ways to tell the public about novel uses of drugs.

Unfortunately, since 1991 the Food and Drug Administration has cracked down significantly on ways drug companies can disseminate that information. Manufacturers must get formal FDA approval (through a very long and costly process) for each specific, approved use of a drug.

For example, it takes an average of nine years and $200 million for a pharmaceutical company to receive formal FDA approval for a drug to be used to treat a specific type of cancer. As often happens, doctors, hospitals and researchers later discover that the drug also is effective at treating other types of cancers. They then write up such uses in medical journals and other publications.

In the past, pharmaceutical companies routinely publicized the results of further research on their drugs after approval, thereby alerting physicians to other possible ways to save lives. But in 1991, FDA Commissioner David Kessler prohibited pharmaceutical companies from informing doctors of new uses for approved drugs. The FDA issued proposed regulations and - although the agency never made them final - warned companies they would face the agency's wrath if they violated the draft proposals.

The FDA claims that once a drug company distributes information on non-FDA approved uses of a drug, the drug becomes "misbranded."

It is still legal for doctors to prescribe drugs for off-label uses. However, it is far more difficult for them to learn of optimum dosages and treatment plans for those uses. The FDA's information ban thus is harmful to patients.

The FDA's restrictive new approach to the promotion of drugs is especially hazardous to cancer patients. More than 1 million Americans are diagnosed with cancer each year, and the FDA's restrictive policies almost certainly result in more Americans dying from cancer.

The FDA's censorial policies also have resulted in more Americans having heart attacks and in more heart-attack victims dying. A 1988 study showed that the risk of heart attack in males past age 50 is cut in half by ingesting an aspirin each day. According to an article in the British Medical Journal, wider publicity of the "aspirin-a-day" preventive medicine practice could save 10,000 American lives each year. …

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