The Chemical World This Week
BILL WOULD REFORM U.S. DRUG LAWS After months of wrangling in Congress and in the executive branch, the Carter Administration early this month set the stage for the first broad legislative rewrite of U.S. drug laws since the original Food, Drug, & Cosmetic Act of 1938. Introduced in the Senate by Edward M. Kennedy (D.-Mass.), the bill (S. 2755) already has been taken up by Kennedy's Human Resources Subcommittee on Health. A lengthy and heated debate is expected over the bill involving the pharmaceutical industry, health care advocates, and members of Congress. Secretary of Health, Education & Welfare Joseph A. Califano Jr., the first Administration booster of the bill to appear before the subcommittee, observes, "The present law contains serious deficiencies." To remedy these perceived shortcomings, Food & Drug Administration officials labored mightily along with Congressional staffers over the past several months and have brought forth what is called the Drug Regulation Reform Act of 1978. Major provisions of the bill, which Califano outlined for the Senate subcommittee earlier this month, include speeding up new drug introduction by eliminating unnecessary regulation in the early phase of drug research. This would eliminate wasteful industry and government efforts on new drugs that often are discarded before marketing.
Califano: present law is deficient 4
C&EN March 27, 1978
The bill also would establish a public monograph system that would replace the current New Drug Application (NDA), which is FDA's approval to market a drug. The monograph would disclose safety and effectiveness data submitted by the developer and would be subject to public hearings. The monograph would ensure a developer's exclusive right to the data for five years, but it would not affect patent protection. Also, the bill would allow limited marketing of breakthrough, or lifesaving, drugs even before all clinical data are in, and at the same time provide for speedy removal from the market of drugs shown to be an "unreasonable risk." In addition, S. 2755 would permit export of drugs not approved for use in the U.S. as long as foreign governments don't object. It would open up FDA's drug approval process to public participation. (Under the current law drug approvals are nego-
tiated only between the drug company and FDA.) And it would prohibit unethical drug promotion activities by salespersons. Predictably, the Administration proposals have not met with an Hallelujah Chorus from the drug industry. Its Washington lobbying group, the Pharmaceutical Manufacturers Association, has some serious reservations about it. One of PMA's major concerns is the disclosure of drug safety and efficacy data which, if the Administration's proposals succeed, could fall into the hands of overseas competitors which could speed into production long before the U.S. developer ever had a chance to market a drug. The drug industry historically has considered such data to be trade secrets. PMA likewise frets over public intervention in the monograph writing process—a provision the association believes could lead to intolerable delays and stalling tactics by industry critics. D
Plan would halve time to build nuclear plants The Administration has sent to Congress legislation that it says will cut in half the 10 to 12 years now required to complete a nuclear power plant. Included in the plan are a "bank" of preapproved sites for nuclear plants, standardized plant designs, and a two-in-one license. Reaction on Capitol Hill can so far be best described as neutral, but hearings on the bill will be held in the next few weeks. Under the Administration plan, utilities could have new sites approved for nuclear plants up to 10 years before a plant is built there. Public hearings on the proposed sites would cover such questions as proposed maximum levels of thermal power and radiological and thermal effluents, and the siesmic, meteorological, hydrologie, and geological characteristics of the proposed sites. Once questions about the appropriateness of a site have been settled, they cannot be raised again in future proceedings. The Nuclear Regulatory Commis sion also would be given the power to approve standardized designs for nuclear power plants, as well as major subsystems, even though no applica-
tion for permission to build such a plant had been submitted. To encourage vendors and engineering firms to submit standardized designs for approval, no license and application fees, which are very high, would be charged on such requests. The designs would be valid for construction permit requests filed within five years of their approval. Thus, utilizing a preapproved site and a standardized design, utilities could obtain a combined construction permit and operating license, avoiding the current two-step process and reducing the cost and time required to complete a project. Under the proposed legislation, the states would be given explicit veto power over the siting of nuclear power plants within their jurisdiction, because NRC could not issue a construction permit for a new plant until the state certified that there was a need for the power the plant would produce. And significant authority would be transferred from NRC to the states by permitting them to discharge some or all of NRC's responsibility to decide under the National Environmental Policy Act if a site is environmentally acceptable. NRC
