The Food and Drug Administration proposed a regulation Thursday that would require the manufacturers of all prescription drugs, including for the first time about 4,200 introduced before 1938, to report deaths or injuries associated with their products.
Health and Human Services Secretary Margaret M. Heckler described the proposal, which would broaden existing law, as "an important step in protecting the public health because it will complete the FDA's early warning system for drugs."
The present drug approval law, which requires that drugs be proved safe and effective before they can be marketed and that serious reactions to them must be reported, does not apply to drugs made before 1938, when the law was passed. The approximately 4,200 such drugs constitute about 10% of the drugs sold today.
Although pre-1938 drugs have long been marketed without known safety problems, Heckler said, new versions of the old products are of "concern," particularly if recommended for use in higher doses or in special high-risk populations, such as premature infants.
Her reference was to a series of deaths in 1983 among premature infants who were given a new, intravenous form of a pre-1938 Vitamin E product, called E-Ferol. High doses of the drug were given to about 1,000 infants to prevent an eye condition associated with prematurity, and about 30 babies died.
The new form of the drug, distributed by O'Neal, Jones & Feldman Pharmaceuticals of St. Louis, was never submitted to the FDA for approval. The FDA is still investigating the matter.
"The new rules eliminate a reporting loophole that was recognized following the E-Ferol tragedy," the FDA commissioner, Dr. Frank E. Young, said. "By broadening the reporting requirements to cover all marketed prescription drugs, today's proposed regulations should eliminate such tragic health consequences."
Subject to Public Comment
The draft regulation was published in Thursday's Federal Register and is subject to public comment for 60 days.
Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce Committee's subcommittee on health and the environment, praised the FDA's proposal.
"I'm pleased they are going to gather this data," he said. "Their responsibility is to assure the public that drugs that are sold are safe and effective. This information will help them carry out that responsibility. I worry, however, that people who suffer adverse reactions, or their physicians, may not report them--or that drug manufacturers still may not report them, even though they are required to do so."
'A Miserable Record'
Dr. Sidney Wolfe, director of the public interest Health Research Group, often a critic of the FDA, said, "Enforcing the law is just as important as having good regulations on the books--and the FDA has a miserable record in that area."
Wolfe added: "Even with the best regulations, unless drug company executives are put in jail for failing to report when people have died or have suffered adverse reactions, the industry will not take the FDA as seriously as it should."
Under the proposed rule, manufacturers would be required to report immediately, in no case taking more than 15 days, any serious or unexpected adverse drug reaction or "significant" increase in serious reactions.
Pre-1938 drugs include some commonly used products such as epinephrine, for cardiac stimulation, vitamin products used in medical treatment and the pain-killers morphine and codeine.