News of the Week

FDA greases the way for drug approvals Drug

Alprostadil

Alprazolam Amllorlde

Amllorlde/ hydrochlo­rothiazide

Halazepam Nitroglycerine Nitroglycerine

Sucralfate Varapamil

Company

Upjohn Co.

Upjohn Co. Merck Sharp &

Dohme Merck Sharp &

Dohme

Schering Labs G. D. Searle & Co. American Hospital

Supply Corp.

Marion Labs Knoll

Pharmaceutical Co.; Searle Labs

Us·

Prepare babies with congenital heart disease for surgery

Anxiety Potassium-sparing diuretic for hypertension

Potassium-sparing diuretic for hypertension

Anxiety Release through skin for angina Intravenous treatment of congestive heart

disease or severe angina; blood pressure reduction during surgery

Duodenal ulcer Abnormal heart rhythms

passed on to FDA commissioner Ar­thur H. Hayes Jr. Although many of the new approvals are of such routine items as different dose sizes and forms or of old drugs for newly mar­keting firms, at least nine are signifi­cant products for serious condi­tions.

So far, this improved performance at FDA has resulted from more effi­cient use of established procedures rather than from setting up of new procedures or changes in the law. By 1983, however, current efforts at FDA could result in further increases in speed of approval because of new regulations and possible reforms in the law.

One recent approval was of al­prostadil, a prostaglandin used to strengthen for surgery babies with congenital heart defects. Alprostadil was submitted by Upjohn Co. (C&EN, Nov. 2, page 27).

Upjohn's newly approved alpra­zolam, a minor tranquilizer for anxi­ety, is made more potent by fusion of a triazole ring to the benzodiazepine system that is the heart of Valium and Librium. Another benzodiaze­pine minor tranquilizer, halazepam, also was approved for marketing by Schering Laboratories.

Merck Sharp & Dohme won ap­proval for amiloride, a diuretic that inhibits potassium excretion, to be used by doctors in conjunction with other diuretics to treat high blood pressure. The firm also got approval for a combination of amiloride with the long-known diuretic hydrochlo­rothiazide.

A nitroglycerine-laden skin patch, a product of G. D. Searle & Co., was approved to deliver the drug through the skin over long periods to treat or prevent chest pains associated with

heart disease. American Hospital Supply Corp. got approval for the first commercially available intrave­nous nitroglycerine for use in hospi­tals against congestive heart failure and chest pains of heart disease, as well as to lower blood pressure during surgery.

Another drug for heart disease, verapamil, became the first of the calcium antagonists (C&EN, Aug. 24, page 6) to be approved in the U.S. Approval went to both Knoll Phar­maceutical Co. and G. D. Searle.

Marion Laboratories received ap­proval for sucralfate to treat an esti­

mated 2.5 million to 3.5 million suf­ferers of duodenal ulcer in the U.S. The drug acts by coating the ulcer to promote healing.

The current new atmosphere at FDA got a start in 1979, when staff members at the Bureau of Drugs started rewriting internal procedures for processing investigational new drug (IND) applications, which ap­prove clinical testing, and new drug application (NDA) submissions, which approve drugs for marketing. But the push for faster, more thor­ough reform began with the coming of current FDA commissioner Hayes.

With Hayes setting the tone, su­pervisors have been meeting with FDA's in-house reviewers, urging them to adopt more positive attitudes toward drug firms, and to look for what's right in company applications rather than what's wrong. "There's been an improvement in communi­cations and exchange of information," one company manager tells C&EN. "There's a willingness to work with the companies to get something out rather than hold it back."

In addition to turning around re­viewers' attitudes and continuing rewrites of IND and NDA procedures, Hayes has set up a task force among FDA and other health agencies (with himself as chairman) to revise the whole body of FDA drug regulations and possibly suggest changes in the law to Congress. D

npany/campus ties The signs at Rochester were en­

couraging. So far about 20 major companies and about 60 universities have joined CCR. Most of the com­panies have pledged to increase their academic support for three years by an amount based on the number of chemists and chemical engineers they employ domestically. The amounts involved are considerable. For in­stance, for Dow Chemical it is just over $700,000 per year. For both Monsanto and Exxon it is about $600,000 per year.

Most of these monies still will be handled directly by the donor com­panies. The majority of the funds will be for support of specific research projects, although some funds will finance fellowships. However, five of the companies joining CCR have committed 25% of their pledges to a central fund. Most of this will be dis­tributed among all university mem­bers of CCR as unrestricted grants. So far this central fund has reached about $500,000 per year. D

Group formed to boost cor After several years of not entirely painless gestation, a new mechanism designed to enhance industry/aca­demic ties in chemistry formally took shape last week in Rochester, N.Y., with the first annual meeting of the Council for Chemical Research (CCR).

The brainchild of M. E. (Mac) Pruitt, recently retired head of R&D for Dow Chemical, CCR has three main purposes: to help generate bet­ter communication, understanding, and cooperation between industrial and academic chemists and chemical engineers; to advance education in chemistry; and to act as a new source of industrial funds for university-based chemical research.

The viability and eventual success of the new organization will depend on this last point—its ability to demonstrate that it can cause an in­crease in industry financial support for academic research, an increase that otherwise would not have hap­pened.

8 C&EN Nov. 9, 1981