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See Kuhlik, B.N., “FDA's Regulation of Pharmaceutical Communications in the Context of Managed Care: A Suggested Approach,” Food & Drug Law Journal, 50 (1995): At 23. Bruce Kuhlik points out that pharmaceutical manufacturers are transforming research and development, selling techniques in response to challenges of managed care.Google Scholar

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See “Misuse of Prescription Drugs,” Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Government Reform and Oversight, 104th Cong. (1996) (testimony of Sarah F. Jagger, Director of Health Services Quality and Public Health Issues in the Health, Education, and Human Services Division). Sarah Jagger indicates that Congress did not intend to interfere with the practice of medicine that physician can use drugs for purposes not approved by the Food and Drug Administration (FDA).Google Scholar

See Dickinson, J.G., “Off-Label Indications, Something's Got to Give,” Medical Marketing & Media, 30 (1996): At 72 (noting that managed care organizations (MCOs) request information about a then unapproved drug in order to create formularies 12 to 24 months ahead of actual availability).Google Scholar

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See id.; see also Hesselgrave, B., “Pharmaceutical; Drug Lores,” Hospitals, 70, no. 21 (1996): At 46–48, 50. Disease management centers (DMCs) typically focus on one disease, such as a type of cancer, and work on providing all treatment for that disease in one center, rather than through a hospital. This strategy allows patients with long-term illnesses to find all the care and information about that care, such as surgery or drug therapy, in one place.Google Scholar

See “Drug Benefits Under Health Care Reform,” Hearing Before the Senate Comm. on Finance, 103d Congress (1994) (Statement of Judith L. Wagner, Senior Associate in the Health Program of the Office of Technology Assessment).Google Scholar

“Drug Firms Control Prescriptions, Consumer Advocates Charge,” Medical Industry Today, Aug. 15, 1997. Although such substitutions based on price may seem health-neutral, consider the effect the use of pharmacoeconomic data could have. Instead of merely trading price, if the pharmacy benefit management company (PBM) starts to trade price for quality, then more than just the cost of care will be affected.Google Scholar

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See Pub. L. No. 105-115, 11 Stat. 2296, §§ 112, 117, 126.Google Scholar

See id. § 114.Google Scholar

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Id. § 114(a).Google Scholar

See id. § 551(a).Google Scholar

The draft guidance is announced in the Federal Register. See 63 Fed. Reg. N2 236-39 (1998). The document itself is available <http://www.fda.gov/cder/guidance/index.htm>..>Google Scholar

See 21 C.F.R. § 314.81(b)(3)(I) for these requirements for drugs; 21 C.F.R. § 601.12(f)(4) for biologics; and 21 C.F.R. §§ 814.39, 814.82 for devices.Google Scholar

See “FDA Cost-Effectiveness Regs Could Be Tailored to the Sophistication of the Audience,” F-D-C Rep. (The Pink Sheet), May 13, 1996 (Health care economist Mark Pauly argues that FDA should permit information to be disseminated when that information is costly and the intended audience will be critical of that information.).Google Scholar

See Neumann, , supra note 5.Google Scholar

Sensibly, FDA continues to prohibit any advertising of off-label uses directed to patients. The primary assumption in advocating looser restrictions is that MCOs can view such information critically—but this does not hold true for patients. A discussion of how FDA should protect the consumer is beyond my scope here.Google Scholar

See “Advertising and Promotion; Guidances,” 61 Fed. Reg. 52801 (1996).Google Scholar

That is, those drugs that are designed to treat serious and life-threatening diseases for which no known alternatives exist. See Pub. L. No. 105-115, 11 Stat. 2296, § 112.Google Scholar

“Trade & Government Memos,” F-D-C Rep. (The Pink Sheet) July 28, 1997 (William Wardell, Covance Senior Scientific Officer, commenting that MCOs' utilization controls, data bases, and ability to follow-up make certain government controls redundant).Google Scholar

As noted earlier, FDA intends to look to a few broad factors to make these determinations. The lack of clear limits could confuse health care providers and suppress the flow of information about products among health care organizations. See also “FDA Letter, Deputy's Speech, Define a Dilemma, FDA's Failure to Address Pharmaceutical Marketing Issues Involving Managed Care,” Medical Marketing and Media, 31 (1996): At 12 (citing comments by Mary Pendergast, FDA Deputy Commissioner).Google Scholar

See Conlan, M., “Tell All; Full Disclosure in Managed Care Drug-Switch Programs,” Drug Topics, 140 (1996): At 87.Google Scholar

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Disclosure of a relationship between PBMs and drug manufacturers may be enough for a promotion to health maintenance organizations or medical doctors, but disclosure of this relationship alone would not suffice for patients who are less sophisticated. FDA would need to monitor closely the promotions used by DMCs in which manufacturers directly target the end consumer. Such a discussion is beyond my scope here.Google Scholar

The definitions of these terms are in dispute. I will use physician-assisted suicide (PAS) to encompass the situation where physicians provide the life-ending means to patients, but the patients self-administer those drugs. Euthanasia also entails the active termination of life, but where doctors administer the life-ending drug to and for patients. The right to die encompasses both of these terms—more than merely a right to refuse treatment, it means the right to the active termination of life.Google Scholar

Washington v. Glucksberg, ___U.S. ___, 117 S. Ct. 2258 (1997); Vacco v. Quill, ___ U.S. ___, 117 S. Ct. 2293 (1997). Seven years earlier, in Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261 (1990), the U.S. Supreme Court held that there was no constitutional right to die, but rather a “liberty interest” in refusing treatment. The Court in Quill was aware that allowing the practice of PAS goes substantially beyond “refusing treatment.”Google Scholar

See Iglehart, J.K., Health Policy Report, “Physicians and the Growth of Managed Care,” N. Engl. J. Med., 331 (1994): At 1168. Furthermore, according to InterStudy data, health maintenance organizations have increased in market share from approximately 3 percent in 1980 to 17 percent in 1994.CrossRefGoogle Scholar

Medicare expenditures, 40 percent of which comes in the last year of life, continue to grow dramatically with the increasing life expectancies of the elderly. Furthermore, according to the Health Care Financing Administration, enrollment of Medicare patients in managed care plans has tripled from 3 percent in 1984 to 9 percent in 1994.Google Scholar

Dougherty, C., “The Common Good, Terminal Illness, and Euthanasia,” Issues in Law and Medicine, 9 (1993): At 164.Google Scholar

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Baron, C.H., “A Model State Act to Authorize and Regulate Physician-Assisted Suicide,” Harvard Journal on Legislation, 33 (1996): 1–34.Google Scholar

See Martin, J. Bjerknes, L., “The Legal and Ethical Implications of Gag Clauses in Physician Contracts,” American Journal of Law & Medicine, XXII (1996): At 441–43. See also Penhallegon, J., “Emerging Physician and Organization Liabilities Under Managed Health Care,” Defense Counsel Journal, 64 (1997): At 347; Baron, , id.; and Spiessbach, K., “Protest Against Profit-Driven Health Care,” Reuters, Dec. 3, 1997.Google Scholar

See Martin, Bjerknes, , id. at 441–43. See also Pear, R., “Doctors Say HMO's Limit What They Can Tell Patients,” New York Times, Dec. 21, 1995. Medical ethicists Seth Kreimer and Yale Kamisar independently have warned, “Particularly with the emergence of cost controls and managed care in the United States, the danger of tempting health care providers to persuade chronic patients to minimize costs by ending it all painlessly is no fantasy.” Kreimer, S., “Does Pro-Choice Mean Pro-Kevorkian? An Essay on Roe, Casey, and the Right to Die,” American University Law Review, 44 (1995): At 841; and Kamisar, Y., “The Reasons So Many People Support Physician-Assisted Suicide—and Why These Reasons are Not Convincing,” Issues in Law and Medicine, 12 (1996): 113–32.Google Scholar

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Even without managed care, heated debates rage over the impact of PAS on public confidence in the medical profession. Medical scholars have argued persuasively that the public will lose trust in the profession “when the role of healer becomes conflated with that of killer.” See id. at 163.Google Scholar

See Sulmasy, D., “Managed Care and Managed Death,” Archives of Internal Medicine, 155 (1995): At 133–36.Google Scholar

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For example, Kathleen Foley refers to evidence indicating that the legalization of PAS in the Northern Territory of Australia has eroded the Aborigines' trust in the medical care system. See Foley, K.M., Editorial, “Competent Care for the Dying Instead of Physician-Assisted Suicide,” N. Engl. J. Med., 336 (1997): At 57.CrossRefGoogle Scholar

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The Death with Dignity Act was not the first such experiment. California, Washington, Iowa, Maine, Michigan, and New Hampshire have all addressed the topic of euthanasia or PAS in some manner.Google Scholar

See Baron, , supra note 7.Google Scholar

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See id. at 10.Google Scholar

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Id. (emphasis added).Google Scholar

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Id. at 13.Google Scholar