Alza contraceptive close to market - Chemical & Engineering News

Jun 16, 1975 - Women who don't want to get pregnant soon will have another way not to. Alza Corp., Palo Alto, Calif., says the Food & Drug Administrat...
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program to resolve the issue" of possible ozone depletion in the stratosphere by chlorofluorocarbons. It also had to determine which federal agency should regulate the compounds. IMOS says that no new research needs to be initiated at this time, because a "considerable amount of research already is completed or under way" at various federal agencies. Further, chlorofluorocarbons producers also have been sponsoring and conducting "relevant" research. Regulation of these compounds, the task force adds, falls within the jurisdiction of three agencies. Fluorocarbons used as propellants in foods, drugs, and cosmetic products "can b e " regulated by the Food & Drug Administration; pesticide products by the Environmental Protection Agency; and products for use by consumers by the Consumer Product Safety Commission. It says that at the present time there is no federal authority for regulating fluorocarbons used in automobile and in industrial and commercial air conditioning and refrigeration equipment. However, the task force expects that with the passage of toxic substances control legislation in Congress, there will be adequate authority to regulate these uses. D

views the OSTP as a significant first step, and urges consideration of a Cabinet-level department of science, technology, energy, and materials (STEAM). Handler says that he is "delighted" with the President's decision, and that although an NAS panel had recommended a council of science and technology advisers, "we would not hold out for the council." G

Alza contraceptive close to market

Women who don't want to get pregnant soon will have another way not to. Alza Corp., Palo Alto, Calif., Rockefeller: keynote commentary says the Food & Drug AdministraScience Advisory Conference" sev- tion has notified it that its Progestaeral days before Rockefeller was sert system for birth control is scheduled to appear before the "approvable." Final approval awaits FDA review Teague committee. Rockefeller appeared not as a witness, but to offer of proposed labeling. If all goes well, "keynote commentary" to the the product could go on the U.S. House committee. Rockefeller's re- market early in 1976. Alza plans to marks were essentially the same at introduce the new system this year both places. And the reception ac- in Canada, Mexico, the U.K., and corded the Vice President might West Germany. Regulatory requirements already have been met in well be characterized as a love-in. In essence, Rockefeller said that those countries. Progestasert is a small (32 by 36 the director of OSTP also will serve as the President's adviser on sci- mm), T-shaped, flexible, memdrug reservoir. ence and technology. He added that brane-enclosed Ford is leaning toward Senate con- Placed in the uterus by a physician, firmation of the adviser's post. The it normally remains there for a year, new director (adviser) will be as- releasing a continuous low dose of sisted by a deputy director and a the female hormone progesterone. staff of up to 15 professionals. Asked According to Alza, it prevents conin the House how the number 15 was ception by acting directly on "the That Office of Science & Technol- arrived at, Rockefeller said that to target organ," the uterus, rather ogy Policy President Ford says he tell the "honest truth," the number than by suppressing ovulation. The wants Congress to create for the was "drawn out of the air." He said user has a normal menstrual cycle. White House, turns out to be mostly such a number provided "evidence" Because the dosage is so small, a reincarnation of the old Office of that the "Administration was seri- systemic effects of the hormone are Science & Technology abolished by ous about the matter." The Vice undetectable. Clinical tests on more President Nixon about two years President had recommended a staff than 6000 women have revealed no ago. The new OSTP will have no of five. (OST had a staff of 25 to 30 signs of the blood clotting disorders more clout on federal R&D budget professionals.) OSTP will have a that can cause strokes and other matters than did the old OST, budget of $1.5 million in its first vascular problems in women using which was limited at best. However, year, compared to OST's $2.1 mil- oral contraceptives, Alza says. unlike the existing arrangement, lion budget in its last year. And inProgestasert resembles—in fact, where the director of the National stead of a formalized President's is—an intrauterine device. As with Advisory Committee "conventional" IUD's, some women Science Foundation serves as "sci- Science ence adviser," the new OSTP and (PSAC) that existed with the old will experience cramping and extra its director will have military R&D OST, Ford proposes that outside menstrual bleeding. But, Alza expert advice be obtained on an ad points out, it's the drug that preunder their purview. Details of what the President hoc basis. vents conception, not the physical wants were conveyed to Congress By press time last week, three of irritation of the device itself. earlier this month in historic meet- the 16 witnesses scheduled for the The pregnancy rate among ings between Vice President Nelson House hearings had testified: H. women using the Progestasert sysRockefeller and Senate and House Guyford Stever, Rep. Mike Mc- tem is about 1.5% per year. With committees concerned with science Cormack (D.-Wash.), and Dr. Philip oral contraceptives, in a controlled and technology matters. Sen. Ed- Handler, president of the National situation, the rate is only about ward M. Kennedy (D.-Mass.) one- Academy of Sciences. All backed 0.5%. "But in the real world," an upped the House Science & Tech- the President's action. Among other Alza spokesman says, "the figure is nology Committee, chaired by Rep. things, Stever says that the return of more like 6%, mainly because Olin E. Teague (D.-Tex.), by get- an OST is a good move, noting that women forget to take the pills." ting the Vice President to appear at the "climate" for science adviser is With IUD's, the annual pregnancy a Kennedy-arranged "White House much better now. McCormack rate averages about 4%. G

Rockefeller outlines science office plans

June 16, 1975 C&EN

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