Hostname: page-component-745bb68f8f-l4dxg Total loading time: 0 Render date: 2025-01-11T22:46:55.828Z Has data issue: false hasContentIssue false
  • English
  • Français

Recent Developments in Health Law

Published online by Cambridge University Press:  01 January 2021

Get access Rights & Permissions [Opens in a new window]

Abstract

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Recent Developments in Health Law
Information
Journal of Law, Medicine & Ethics , Volume 26 , Issue 1 , Spring 1998 , pp. 68 - 79
Copyright
Copyright © American Society of Law, Medicine and Ethics 1998

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

References

Food and Drug Administration Modernization Act, Pub. L. No. 105-115, 11 Stat. 2296 (1997 Slip Copy).Google Scholar
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
See Nagy, K., “The Side Effects of Managed Care on the Drug Industry,” Journal of the National Cancer Institute, 87 (1995): At 1279.CrossRefGoogle Scholar
Malinowski, M.J., “Capitation, Advances in Medical Technology and the Advent of a New Era in Medical Ethics,” American Journal of Law & Medicine, XXII (1996): At 331 (citing study by the Boston Consulting Group, The Changing Environment for U.S. Pharmaceutical (Apr. 1993): At 18); see also Montague, J. Pitman, H., “Who's Paying for Prescriptions,” Hospitals, 70, no. 2 (1996): At 21 (describing finding in a Retail Method of Payment Report showing that 50 cents of every dollar spent on prescription drugs is paid by managed care plans).Google Scholar
See Neumann, P.J., “How Should the FDA Regulate Drug Company Claims that Their Products are Cost-Effective?,” Health Affairs, 15, no. 3 (1996): At 54; and Kuhlik, , supra note 2, at 28.CrossRefGoogle Scholar
See Dunne, K.J. Ryan, C.R., “How Management of Medical Costs is Revolutionizing the Drug Industry,” Defense Counsel Journal, 62 (1995): At 188.Google Scholar
21 U.S.C. § 331 (a), (d), (k) (1998).Google Scholar
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
See Nagy, , supra note 3, at 1278.Google Scholar
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
See id.Google Scholar
“PBM ‘Enhanced Services’ Such as Disease Management Used by One-Third of HMOS—HHS IG Survey; HCFA Should Scrutinize HMO Contracts with PBMs, IG Urges,” F-D-C Rep. (The Pink Sheet), May 19, 1997, at 15.Google Scholar
See Pub. L. No. 105-115, 11 Stat. 2296, §§ 112, 117, 126.Google Scholar
See id. § 114.Google Scholar
See id.Google Scholar
See id.Google Scholar
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
See id.Google Scholar
See id.Google Scholar
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

References

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
See id.Google Scholar
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
Fleck, L., “Just Caring: Assisted Suicide and Health Care Rationing,” University of Detroit Mercy Law Review, 72 (1995): At 878.Google Scholar
See Dougherty, , supra note 5, at 164.Google Scholar
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
See id.Google Scholar
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
See Fleck, , supra note 10, at 887.Google Scholar
Coleson, R., “The Glucksberg & Quill Amicus Curiae Briefs: Verbatim Arguments Opposing Assisted Suicide,” Issues in Law and Medicine, 13 (1997): At 87.Google Scholar
See Fleck, , supra note 10, at 886.Google Scholar
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
See Humphry, D., Final Exit: The Practicalities of Self-Deliverance and Assisted Suicide for the Dying (Secaucus: Hemlock Society, 1991): 103–05.Google Scholar
Baron, , supra note 7, at 9–10.Google Scholar
See id. at 10.Google Scholar
See id. at 11.Google Scholar
See id.Google Scholar
See id. at 18.Google Scholar
Id. (emphasis added).Google Scholar
See id. at 18.Google Scholar
See Chochinov, H., “Desire for Death in the Terminally Ill,” American Journal of Psychiatry, 152 (1995): At 1185.Google Scholar
Baron, , supra note 7, at 19.Google Scholar
Id. at 13.Google Scholar