FOR YOUR INFORMATION 201 medicine's week national AMERICAN MEDICAL NEWS MARCH 24, 1975 2 RECEIVED MAR 21 1375 world Drug Research Board did not intend a resolution it passed last October to be a position favoring or opposing anti-substitution drug laws, according to people who attended a DRB meeting this month in Washington, DC. They said the DRB made it clear it believes physicians should have the responsibility for selecting drugs for their patients. A press release issued in January by the National Research Council had indicated that the DRB resolution called for changes in anti-substitution laws, and the inisinterpretation was widely disseminated by the American Pharmaceutical Assn., which is seeking repeal. At this inonth's DRB inecting, AMA Board Chairman Richard Palmer, MD, and Trustce Jere Annis, MD, explained the AMA position opposing repeal of anti-substitution laws. Maryland pharmacies have agreed to compromise legislation that would require pharmacies to post the prices of the 100 most commonly prescribed prescription drugs. Bill also provides for the posting of a list of services the pharmacy provides--such as delivery, patient profiles, and late hours of operation-that may lead to price differences. Legislation calling, for unified federal action and information exchange on investigations of nursing homes was introduced by Sen. Frank Church (D., Idaho) and Sen. Frank Moss (D, Utah). Resolution urges President Ford to submit a multiagency plan that provides close surveillance of state and federal actions related to nursing home abuses, complete reporting of possible links between scandals or problems in various areas, and developing better care and cost controls. Pennsylvania Dept. of Transportation has rejected a request by the Pennsylvania Chiropractic Society that chiropractors be authorized to perform physical examinations for driver's license appli cants. Nationwide home care course for families of multiple sclerosis patients will be developed by American Red Cross and National Multiple Sclerosis Society. Organizations will share resources and expertise in the project. Thermography is not an adequate screening method for diagnosing breast cancer when used alone, American Thermographic Society said. So cięty statement said, "Thermography is a complementary diagnostic tool which is useful in the evaluation of breast disease when combined with other modalities, such as physical examination conducted by a physician or mammography performed by a radiologist." Five hospitals have joined Blue Cross-Blue Shield of Maryland's HomeCare Program. Under the plan, hospitals provide inedically necessary home health services to eligible plan members. The plans then directly reimburse the hospital. The plan is designed to cut the lengths of some hospital stays. Based on a state regulation, a new court ruling says all inental patients admitted involuntarily to Maryland state hospitals must be represented by a lawyer at commitment hearings. All patients committed without a lawyer since Oct. 1, 1973 will get new hearings. Missouri Supreme Court upheld the exemption from property tax of not-for-profit hospitals. The court ruled that three Kansas City, Mo., notfor-profit hospitals should retain their tax exempt status because they make treatment "available to both rich and poor." A trial court carier had held that St. Luke's Hospital, Baptist Memorial Hospital, and Research Hospital and Medical Center should not be exempt from property taxes because they were not operated "regularly and exclusively" for "purely charitable" purposes. Public education program by Illinois State Medical Society, Illinois Hospital Assn., and Illinois Dept. of Public Health is encouraging people who received x-ray treatment of the neck and face during the 1930s-1960s period to seek medi cal examinations. Patients who had such therapy are being informed of the fact that they run an increased risk of developing thyroid tumors. Sin ilar campaigns also are under way in Detroit anc Milwaukee. Research on socioeconomic aspects of surgery will be conducted by American College of Sur geons' new Dept. of Surgical Practice. Department to be headed by James Haug, will westigate such issues as medical manpower, professional hability quality assurance, and health planning. Drug position change rejected A resolution passed March 14 by the Drug Research Board to clarify the DRB position on drug anti-substitution laws was rejected three days later by the Executive Committee of the Assembly of Life Sciences of the National Research Council. Last October, the DRB had passed a resolution that was interpreted, in a press release from the National Research Council, as calling for changes in the laws. The interpretation was disseminat · ed by the American Pharmaceutical Assn., which is seeking repeal of antisubstitution laws. In its March 14 resolution, the DRB said, "In retaining to the physician the responsibility for drug selection, the DRB adopted no position with respect to changes in, or repeal of, drug anti-substitution laws." IN A MEMO to DRB members, Thomas J. Kennedy, MD, executive director of the Assembly of Life Sciences, said his committee "explicitly rejects the actions which the Drug Research Board took at its meeting of March 14, 1975, to amend its resolution of Oct. 25, 1974, since at least one of these amendments is patently inconsistent with the original position of the DRB. The Executive Committee of the ALS approved this original position several months ago and today reaffirms its concurrence with that original position." His memo followed a communication from Duke C. Trexler, DRB secretary, asking members to respond by postcard on whether to conduct a mail ballot or recommend other review procedures. Dr. Kennedy's memo contended that the executive committee action "does not necessitate any additional review or action by the DRB; (the DRB) is free to follow any course of action that it deems appropriate." AMA Board Chairman Richard E. Palmer, MD, and Trustee Jere W. Annis, MD, participated in the March 14 DRB meeting. This week in JAMA "Antiobotics and Gram-Negative Bacteremia," by J. T. Curti, A1, of New York, will be the featured special communication in the March 31 issue of the Journal of the AMA. 10 AMERICAN MEDICAL NEWS MARCH 31, 1975 T&G CLARIFICATION EN ROUTE ON NRC's DRUG SUBSTITUTION PRESS RELEASE and background statement, issued Jan. 21 to announce text of resolution adopted by the Drug Research Board (DRB) at its meeting late last Oct. Exact nature of upcoming clarification action by NRC is not known because members and invited guests at the March 14 semi-annual meeting of the Drug Research Board were warned to keep quiet - almost sworn to oaths of secrecy. But non-substantive discussions with DRB members left the clear impression that something must be in the works - otherwise why all the secrecy and all the accompanying fol-da-ral. 124 REC 9 The known, public facts are simple, clear, obvious, and even elemental to any knowl- When the DRB resolution got to the rarified atmosphere in which the permanent staff functionaries of the Natl. Research Council operate, a press release titled - Drug Board Chat In Drug Substitution Laws and a related background statement were pre MAR 24 13s the vehicle for making DRB's Oct. resolution public. The press release and backolerant represent the kind of over-writing about which scientists always complain Ardy or obscure texts are reported in the press. firmation is required for the fact that DRB couldn't stand still for the kind of LETT MC release issued by NRC, notwithstanding efforts by NRC staff functionaries to Champ on the lid. The secrecy claptrap confirms the following: CIA-type intelligence evaluation: DRB at its March 14 meeting reiterated what it intended by the resolution passed in Oct.; expressed displeasure with the NRC press release and background statement; and demanded an NRC clarification that mong closely reflects its Oct. resolution. EXHIBITS PROVIDED BY THE PHARMACEUTICAL MANUFACTURERS ASSOCIATION Statement of C. Joseph Stetler, President Before the Subcommittee on Monopoly Senate Committee on Small Business March 21, 1975 Mr. Chairman and Members of the Committee: I am C. Joseph Stetler, President of the Pharmaceutical Manufacturers Association. With me today are Bruce J. Brennan, PMA Vice President and General Counsel and Howard L. Binkley, the Association's Vice President for Research and Planning. As you requested, the topic of our testimony is the proposed Maximum Allowable Cost drug reimbursement plan announced by the Department of Health, Education, and Welfare in late 1973 and formally proposed in the Federal Register on November 15, 1974. The PMA submitted comments on this proposal in extensive detail on February 14 to the FDA Hearing Clerk. I would like to request that our longer statement be included in the Record of these hearings. First, let me stress that we fully recognize the need for economy in the design of a drug reimbursement program. And we realize that the task is a difficult one. And yet as we review the present proposal, we feel strongly that its adoption would be a disservice to the public. Fundamental questions are raised regarding overall program costs, the feasibility of assuring the quality and therapeutic equivalence of products having the same chemical composition, and the criteria to be used in considering a drug for inclusion in the program. So long as these basic questions are not answered, and so long as the undesirable effects on physician and pharmacist prerogatives and services and industry innovation persist, adoption of the proposed MAC program would be both unfortunate from a public policy standpoint and, in a number of respects, inconsistent with the requirements of the law. The Equivalency Assumption These regulations, as published, appear to be based on the assumption that multi-source drug products, regardless of the maker, are equivalent. In our opinion, this position cannot be sustained. A program like MAC must be designed so as to require the selected suppliers of drugs to submit proof of their ability to perform effectively and proof that their drugs are in actual conformance to reasonable standards of bioequivalency. In reality, the present regulation goes in the opposite direction. It proposes, in the absence of published bioavailability regulations, to allow a MAC determination to be made entirely on the assumption that products covered are satisfactory, even if some formulations of those products are marketed without the knowledge or approval of the FDA. another way, HEW proposes that unless there is proof of inequivalency, equivalency will be assumed a totally unscientific approach. The Put MAC determination would be made without knowledge of the ability of the supplier to conform to current standards of quality control, or assurance of a capability to recall defective products from the marketplace. Under such circumstances, it is clearly over-sanguine for FDA to offer equivalency assurances. |