GOVERN MENT
FDA Begins Effectiveness Review of Drugs Proteolytic enzymes will be first of drugs now on the market to get effectiveness review The Food and Drug Administration has begun the long and arduous task of reviewing most of the drugs currently on the market to see if they live up to the billing on their labels. Thirteen categories of drugs have been selected and given an order of priority for this broad-scale review of drug effectiveness. The review is required under FDA's interpretation of the 1962 Kefauver-Harris Amendments to the federal Food, Drug, and Cosmetic Act. The so-called proteolytic enzymes have been accorded the dubious distinction of being first on FDA's list for review. The categories of drugs and the order in which they will be taken up were made public for the first time by Dr. Joseph F. Sadusk, Jr., director of FDA's bureau of medicine, in an ad-
DRUG REVIEW PRIORITY LIST Proteolytic enzymes—enzymes taken either orally or by injection and which, in effect, digest proteins. They are supposed to clean up foreign matter in the body. Progestational agents—hormonetype preparations which are sold to stop habitual natural absorption and menstrual pains. "Drugs offered for anxiety and apprehensive states, most tranquilizers, monoamine oxidase inhibitors." Nonprescription iron preparations. Pediatric dosages. Topical ophthalmic antibiotic combinations—eyedrops that combine antibiotics with certain steroid drugs. "Sustained release" drugs—products which their manufacturers claim break down over a specified period. Other topical antibiotic combination products. Bioflavonoids—products generally derived from citrus peel and used for treatment of bleeding. Hormone creams. Drugs used in pregnancy. Topical antihistamines. Topical 'caines, or local anesthetics.
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C&EN
OCT. 19,
1964
dress to a meeting of the American College of Physicians in Los Angeles. He pointed out that this order of priority may change with time and that "certain specific drugs, or even categories of drugs may be deemed in the future to be of a higher priority than those listed." About 2 0 0 0 Products. The review, he predicts, will take anywhere from two to five years just to clear the approximately 2000 drugs already on the market and which fall under the new FDA requirement. In addition, FDA must review all new drugs as they appear to see if they are effective as well as safe. The 1962 drug amendments require that new drugs must be shown to be effective as well as safe for their intended use. Prior to the passage of the amendments, drug makers needed only to prove to FDA's satisfaction that new products were safe, not necessarily effective. In interpreting the 1962 amendments, FDA ruled that drug makers must go back and substantiate claims of effectiveness made for all drugs cleared for use between 1938—the time of the enactment of the Food, Drug, and Cosmetic Act—and mid1963 when the 1962 drug amendments went into effect. Challenge. But last summer the drug industry challenged in court the legality of FDA's interpretation of the new drug amendments (C&EN, Aug. 3, page 33). Drug makers say that Congress never intended to make them prove the effectiveness of products which have been widely used for many years. These drugs, they say, have come to be generally recognized as safe and effective and, therefore, are no longer "new drugs." FDA has granted drug makers a temporary stay from the new reporting requirements on the effectiveness of these old "new" drugs, due in FDA's hands by Oct. 9, pending the outcome of the industry's suit (C&EN, Sept. 21, page 29).
FDA's Dr. Joseph F. Sadusk, Jr. Review could take five years
Stressing the importance of the case, Dr. Sadusk says that the issue is "whether the drug manufacturer must offer substantial evidence that the drug he is marketing is effective for the purpose claimed in its labeling; or whether he is entitled to continue to market it unless the FDA develops adequate evidence to assume the burden of proof in court that the drug is ineffective for the purpose claimed." On the one hand, the task of reevaluating the effectiveness of drugs now on the market would be on the basis of the new provisions of the law, he says. On the other, it would be under the old law requiring case-bycase litigation in the courts. The outcome will be "of critical importance in determining whether FDA can assure the effectiveness of the nation's drug supply," he feels. In either event, he says, years of effort may be required even with the fullest cooperation of the medical community and the pharmaceutical industry. Drug makers see the issues in a considerably different light. To them it is a question of whether a federal agency is to be allowed to exceed its statutory authority and burden them with additional bookkeeping and reporting requirements—which are both costly and unnecessary. They also claim that the regulations are discriminatory in that they place the burden of proof on the originator of the drug and not on others who now make the same drug.
Hornig Sees More Research Grants of Institutional Type Dr. Donald F. Hornig, President Johnson's science adviser, sees indications that institutional-type research grants will become more widespread in the future. Speaking to a conference on research administration in Washington, D.C., Dr. Hornig noted that the project system of federal grants has prevailed in the past. Both are useful, he believes, but the best balance between the two must be found. He urges university administrators to look ahead and set definite goals for their institutions. The close ties that have evolved between the Federal Government and the nation's universities were clearly evident at the conference, which was sponsored by the American Council on Education. About one third of the panelists and speakers were from government agencies. Nearly 600 educators were drawn to the conference. Mainly university administrators and faculty, they crammed 12 hours of intense discussion into a two-day meeting. Six sessions covered a range of topics from "Conflict of Interest Situations in Sponsored Research" to "Grants vs. Contracts in Government Sponsored Research." Moon Program. While the educators and the government representatives found much to agree on, all was not smooth sailing. Dr. Raymond Ewell, vice president for research at the State University of New York at Buffalo, stated that " . . . the motivation for the man-on-the-moon program is almost entirely political." He believes there are alternatives that would provide a better investment, from both scientific and economic standpoints. He says "more people are now questioning the rationale of the space program." Philip B. Yeager, who sat on the panel with Dr. Ewell, disagrees. Mr. Yeager, who is counsel for the House Subcommittee on Science, Research, and Development, claims that while more people are questioning the value of the moon program, they still do not constitute a very large group. Nor does he agree that the motivation for the moon program is almost entirely political. Congress is still overwhelmingly in favor of the program, he says. He does not believe the money would be diverted to alternative uses if the moon program were canceled.
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OCT. 19, 1964 C & E N
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