New Drug Law

When President Kennedy put his signature last week on a bill called "Drug Amendments of 1962"--passed unanimously by both Senate and House--the purpose was clear: to protect the American public against dangerous medicines. But the measure had gone through so many changes that few doctors or patients could figure out just what had been enacted.

Though Tennessee's limelighting Senator Estes Kefauver won little support in Congress for his proposals to put the pharmaceutical industry in a straitjacket, he was indisputably right when he said: "Few bills have had so varied a legislative history." In the end. it was not Kefauver's three-year investigation of the drug industry that put the reform legislation over, but the national shock over the thalidomide disaster (TIME. Aug. 10) and panic over the possibility that "it might happen here."

Raising Standards. After considering rival bills for months, leaders in both houses of Congress heard the wail of public anguish and feared that it would turn into a roar of indignation. They quickly got together and hammered out the reasonable compromise that Kennedy signed. Pleased spectators at the signing were the Food and Drug Administration's Commissioner George P. Larrick and Dr. Frances O. Kelsey. who kept thalidomide off the U.S. market.

To the topflight drug companies, the new law will make little difference; their standards are already high. But second-team companies will have to raise their standards of quality and rigid control. That will cost money and hurt them competitively. Some borderline drugmakers may be put out of business. The keeping of many more detailed records will be costly to all companies. The new law cannot be expected to lower the prices of any drugs, and may actually raise some by a few cents. Key provisions: > No new drug can be marketed until the manufacturer has satisfied the FDA that it is both safe and effective. Under the old law, only safety had to be proved, and approval was automatic after 60 days unless FDA took negative action. Under the new law, approval will not come automatically, and FDA must give positive approval. Even after a drug is on the market. FDA can summarily order it withdrawn if evidence appears that the medicine is unsafe or ineffective. The old law prescribed a long legal procedure to obtain withdrawal, and then only when danger had been proved.

Before any drug is even tested in human beings, the manufacturer must give FDA evidence that it has had adequate testing in animals--this will include pregnant animals--and appears safe. > Every drug container, package, leaflet and advertisement to doctors must show the general or "established" name of the drug in type at least half as big as that of the trade name. Package inserts and ads to doctors must contain a warning of undesirable effects.

>Every batch of every antibiotic for use in man must be tested by government laboratories. Under the old law, some antibiotics were so tested, but not all. > Every plant in which a drug is manufactured or processed in any way will now have to be registered with FDA, inspected at least every two years, and open to inspection at any time.

New Regulations. Ironically, there is nothing in the new law that could with certainty prevent a repetition of the thalidomide disaster. But while the bill was working its way to the White House, FDA drew up a set of new regulations (under its old-law powers) to give it tighter control of drug testing in man. Not yet formally approved and still subject to detailed amendment, these proposals require that a physician who wants to try a still unapproved drug on his patients must register with FDA, submit evidence of his qualifications, and keep full and accurate records.

On one point where doctors nnd drug makers had been at odds with FDA men and many legislators, a sensible compomise was reached. Extremists crying "Human guinea pig!" had demanded that no doctor be allowed to give an investigational drug to a patient without telling him so. This would have made it impossible to compare the effects of a drug with those of an inert dummy (a placebo), as is now done in "double-blind" studies in which neither doctors nor patients know who is getting the active substance. So the law now says that doctors must tell patients what they are getting, "except where they deem it not feasible, or contrary to the best interests" of the patients. "The drug industry can live with that," said one of its spokesmen.

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