Barringer, F., “FDA Weighs Future of Drug Package Data; Bitter Pill for Consumer Groups,” Washington Post, Aug. 25, 1981, at A17.Google Scholar

60 Fed. Reg. 44,182 (1995). The FDA's August 24, 1995 proposed rule on prescription drug information for patients is promulgated under its general authority to “regulate the marketing of drug products so that the products are safe and effective for their intended uses and are properly labeled.” Id. at 44,210; see 21 U.S.C. 352(a) (1988) (rendering misbranded any drug label that is “false or misleading in any particular”).Google Scholar

Patient Medication Guides have been referred to as “MedGuides,” “Patient Package Inserts” (PPIs), and “Patient Labeling.”Google Scholar

60 Fed. Reg. 44,182, 44,187–88 (1995).CrossRefGoogle Scholar

Id. at 44,230.Google Scholar

Id. at 44,230–32.Google Scholar

44 Fed. Reg. 40,016, 40,017 (1979). Kendellen, R.M., “The Food and Drug Administration Retreats from Patient Package Inserts for Prescription Drugs,” Food Drug Cosmetic Law Journal, 40 (1985): At 174.Google Scholar

44 Fed. Reg. 40,016, 40,018 (1979). Patient labeling requirements were established for: Isoproterenol, 33 Fed. Reg. 8812 (1968) (codified at 21 C.F.R. § 201.305); oral contraceptives, 35 Fed. Reg. 9001 (1970) (codified at 21 C.F.R. § 310.501); estrogen, 42 Fed. Reg. 37,636 (1977) (codified at 21 C.F.R. § 310.515); intrauterine contraception devices, 42 Fed. Reg. 25,854 (1977) (codified at 21 C.F.R. § 310.502); and progestational drug products, 43 Fed. Reg. 47,178 (1978) (codified at C.F.R. § 310.516).Google Scholar

44 Fed. Reg. 40,016, 40,018 (1979).Google Scholar

Id. a: 40,025.Google Scholar

Id. at 40,025–29.Google Scholar

The comments may be summarized as follows: “[g]enerally, individual consumers favored patient package inserts while individual physicians, pharmacists, and other health care professionals opposed them.” 45 Fed. Reg. 60,754, 60,756 (1980).Google Scholar

Reinhold, R., “Pills and the Process of Government,” New York Times, Nov. 9, 1980, at 96; and 45 Fed. Reg. 60,754, 60,756–57 (1980).Google Scholar

45 Fed. Reg. 60,754, 60,756 (1980).Google Scholar

Id; and Reinhold, , supra note 14.Google Scholar

45 Fed. Reg. 60,754, 60,757 (1980).Google Scholar

These criteria asked whether the patient labeling would: (1) “affect the patient's decision to use the drug product“; (2) “help prevent serious adverse effects“; (3) “help increase the patient's adherence to the prescribed course of therapy“; and (4) identify an unsafe or ineffective indication that is not included in the drug product's labeling. 44 Fed. Reg. 40,016, 40,031 (1979). Also considered was the belief that patient labeling would “significantly enhance … safe and effective use” of drug products. 45 Fed. Reg. 60,754, 60,758 (1980). Based on these considerations, PPIs were required for the following ten drug products or classes: Ampicillins, benzodiazepines, cimetidine, clofibrate, digoxin, methoxsalen, propoxyphene, phenytoin, thiazides, and warfarin. 45 Fed. Reg. 60,754, 60,754 (1980). On December 5, 1980, bendectin took the place of warfarin on the list of drug products requiring PPIs. 45 Fed. Reg. 80,740, 80,740 (1980).Google Scholar

44 Fed. Reg. 40,016, 40,030–31 (1979).Google Scholar

See “Pending Regulations: Reagan's Early Opportunity,” The National Journal, Jan. 17, 1981, at 95.Google Scholar

Exec. Order No. 12,291, 46 Fed. Reg. 13,193 (1981).Google Scholar

47 Fed. Reg. 39,147 (1982); and 47 Fed. Reg. 7458, 7459 (1982).Google Scholar

Kendellen, , supra note 8, at 179; and 47 Fed. Reg. 39,147, 39,148 (1982).Google Scholar

“AMA Drug Information Program for Patients,” Public Health Reports, 98 (Jan./Feb. 1983): 97.Google Scholar

“FDA to Stress Rx Patient Information with Publicity Effort in Upcoming Months; Agency Looks to Computerization to Help, Not 1979 Model Patient Package Inserts,” F-D-C Rep. (“The Pink Sheet”), Dec 16, 1991.Google Scholar

60 Fed. Reg. 44,182 (1995).Google Scholar

Id. at 44,198.Google Scholar

Id. at 44,199.Google Scholar

Id. at 44,198.Google Scholar

60 Fed Reg. 44,182, 44,198 (1995). The FDA has proposed the following criteria to determine which products pose such a severe public health concern: (1) “products for which patient labeling could help prevent serious adverse effects“; (2) “products that have significant risks about which the patient should be made aware“; (3) “products that pose risks in particular patient populations“; and (4) “products for which patient adherence is crucial to cither the safety or efficacy of therapy with the product, and for which patient labeling would help increase adherence.” Id. at 44,198.Google Scholar

Id. at 44,198.Google Scholar

Id. at 44,199.Google Scholar

“FDA MedGuide Initiative is Leaning Toward Minimum Standards,” F-D-C Rep. (“The Green Sheet”), Jan. 23, 1995, at 2.Google Scholar

“FDA Mandatory Patient Information Regulation Put Off Until 2000 to Allow Voluntary Approaches Time to Achieve Goals, Commissioner Kessler Tells NCPIE,” F-D-C Rep., (The Pink Sheet”), (May 15, 1995, at 18.Google Scholar

60 Fed. Reg. 44,182, 44,198 (1995).Google Scholar

“US FDA Seeks Patient Data Sheets for All New Scripts,” Marketletter, Sept. 4, 1995.Google Scholar

“Medguide Lives: FDA Requires Pharmacists to Provide at Least 95% of Patients with Clear, Complete Written Info for Every New Rx by 2006,” Drug Topics, Sept. 18, 1995, at 30.Google Scholar

60 Fed. Reg. 44,182, 44,198 (1995).Google Scholar

See supra note 41.Google Scholar

See “FDA Patient Labeling Initiative,” F-D-C Rep. (“The Green Sheet”), Nov. 14, 1994, at 1 (noting that FDA Commissioner Kessler's emphasis on public information campaigns for FDA-regulated products has irked the Republican Congress); and “FDA Medguide Proposal,” F-D-C Rep. (“The Green Sheet”), Apr. 17, 1995, at 1Google Scholar

“Search for Hayes' Successor Will Be a Tough One; Arthur Hull Hayes, Jr.,” Drug Topics, Sept. 5, 1983, at 10.Google Scholar

“Power Politics: Presidential Election Year Is Here; Combatants Are Ready,” Drug Topics, Jan. 8, 1996, at 80.Google Scholar

In spring 1980, prior to the fall publication of the final rule, the House Appropriations Committee “told the agency to move ‘in an orderly, step-by-step’ manner with its plan to require drug manufacturers to inform consumers of drug side effects and other data with ‘patient package inserts.’ No more than 10 such package inserts should be forthcoming in the next two years.” Congressional Quarterly Almanac, 96th Cong., 2d Sess., Vol. XXXVI at 207 (1980); see also Reinhold, , supra note 14.Google Scholar

On March 28, 1995, the Labor and Human Resources Committee accepted Senator Coats's (R-Ind.) amendment to the Food and Drug Administration Performance and Accountability Act of 1995 (S. 1477), an FDA reform bill sponsored by Senator Kassebaum (R-Kan.). Senator Coats's amendment requires a private committee, comprised of industry, health professionals, and consumer groups, to propose a prescription drug labeling plan within four months. The FDA could implement the proposed MedGuide regulation only if the private committee did not meet this deadline, or the results of a private sector program were inadequate. The pharmacy and pharmaceutical industries support the Coats amendment. At the rime of publication, no action by the full Senate had been reported. “FDA Offices of Supplemental Approvals Would Be Established by Amended Kassebaum Bill; MedGuide Would Be Blocked by Coats Amendment,” F-D-C Rep. (“The Green Sheet”), Apr. 1, 1996, at 5–6.Google Scholar

Swartz, K. Brennan, T.A., “Integrated Health Care, Capitated Payment and Quality: The Role of Regulation,” unpublished manuscript (Jan. 31, 1995): At 2.Google Scholar

Woodhall, A.L., Note, “Integrated Delivery Systems: Reforming the Conflicts Among Federal Referral, Tax Exemption, and Antitrust Laws,” Health Matrix, 5 (1995): At 187–88.Google Scholar

42 U.S.C.A. § 1320a-7b(b) (West Supp. 1995).Google Scholar

42 U.S.C.A. § 1395nn (West Supp. 1995).Google Scholar

Physician Ownership and Referral: Hearings Before the Subcommittee on Health of the House Committee on Ways and Means, 104th Cong., 1st Sess. (May 3, 1995) [hereinafter 1995 Hearings] (testimony of Dr.Balfour, Donald C. III, president of the American Group Practice Assn.).Google Scholar

61 Fed. Reg. 2122 (Jan. 25, 1996).Google Scholar

42 U.S.C.A. § 1395nn(b)(3) (West Supp. 1995).Google Scholar

See 42 U.S.C.A. § 1320a–7b(b)(3)(B) (West Supp. 1995) (anti-kickback exception); 42 C.F.R. § 1001.952(1) (1994) (anti-kickback safe harbor); and 42 U.S.C.A. § 1395nn(e)(2) (West Supp. 1995) (self-referral exception).Google Scholar

According to McCarty Thornton, D., chief counsel to the inspector general: “Often times, what the hospital is realty interested in is the future flow of business from the practice to the hospital.” McCarty Thornton, D., “Impact of the Anti-Kickback Statute and the Stark Amendment on Vertically Integrated Delivery Systems in the Health Care Industry,” syllabus, Healthcare Fraud and Abuse: Enforcement in the 1990s (Washington, D.C.: National Health Lawyers Assn., Oct. 13–14, 1994): At 7.Google Scholar

See King, K., Comment, “Regulating Physician Investment and Referral Behavior in the Competitive Health Care Marketplace of the '90's—An Argument for Decentralization,” Washington Law Review, 65 (1990): At 657 (“Congress enacted the Anti-Fraud and Abuse statute to address the improper use of federal health care funds. The statute, however, actually promotes the inefficient use of federal funds by discouraging cost-efficient investment and referral arrangements between health care providers.”).Google Scholar

Swartz, Brennan, , supra note 1, at 7.Google Scholar

Valiant, C. Hastings, D., “New Managed Care Safe Harbor Regulations Don't Protect Many Mainstream Managed Care Activities,” HealthSpan, Feb. 1993, at 10.Google Scholar

Woodhall, , supra note 2, at 191.Google Scholar

Id. at 192.Google Scholar

Thornton, , supra note 9, at 9.Google Scholar

Physician Ownership and Referral Arrangements and H.R. 345, “The Comprehensive Physician Ownership and Referral Act of 1993”: Hearings Before the Subcommittee on Health of the House Committee on Ways and Means, 103d Cong., 1st Sess. (Aug. 20, 1993) (testimony of Frederic J. Entin, general counsel and senior vice president, American Hospital Assn.).Google Scholar

United States Bill Tracking, 1995 U.S. H.B. 2491; and 141 Cong. Rec. H13379-01 (Nov. 20, 1995).Google Scholar

United States Bill Tracking, 1995 U.S. H.B. 2491.Google Scholar

Seven-Year Balanced Budget Reconciliation Act of 1995, H.R. 2491, 104th Cong, 1st Sess. (1995), as reprinted in 141 Cong. Rec. H13379-01 (Nov. 20, 1995) [hereinafter Budget Reconciliation Act of 1995], § 8116(a)(3).Google Scholar

Conference Report on H.R. 2491 (H. Rep. No. 104–347), as reprinted in 141 Cong. Rec. H-12509-01 (Pt. 1), H12813 (Nov. 15, 1995) [hereinafter Conference Report].Google Scholar

42 U.S.C.A § 1395nn(b)(3) (West Supp. 1995).Google Scholar

Budget Reconciliation Act of 1995, § 8204(c)(2).Google Scholar

Id. at § 8204(c)(6).Google Scholar

Id. at § 8201(a).Google Scholar

Id. at § 8202(a).Google Scholar

Id. at § 8203(a).Google Scholar

See 42 U.S.C.A. § 1320a–7b(b)(1)-(2) (West Supp. 1995) (providing for criminal sanctions).Google Scholar

42 U.S.C.A. § 1395nn(g) (West Supp. 1995).Google Scholar

See Johnsson, J., “Mess for Integrated Delivery; Stark Self-Referral Ban Raises Unexpected Risks,” American Medical News, Mar. 20, 1995, at 1 (statement of Lewis Harris, deputy associate general counsel at the Office of the Inspector General, that it is easier for the federal government to take action against potential violators under Stark because of the absence of an intent requirement and the fact that it is largely a payment issue).Google Scholar

1995 Hearings, supra note 5 (testimony of Frederick J. Wenzel, executive director and CEO of the Medical Group Management Assn.).Google Scholar

141 Cong. Rec. H10333-01, H10359 (Oct. 19, 1995).Google Scholar

See H.R. Rep. No. 276(1), 104th Cong., 1st Sess. (1995).Google Scholar

See Health Security Act, as reprinted in 139 Cong. Rec. E2571-01 (Oct. 28, 1993), §§ 4041(b)(5), 4042(c)(4).Google Scholar

Homer, L.C., “How New Federal Laws Prohibiting Physician Self-Referrals Affect Integrated Delivery Systems,” HealthSpan, Apr. 1994, at 21, n.19.Google Scholar

1995 Hearings, supra note 5 (testimony of Dr. Donald C Balfour III, president of the American Group Practice Assn.).Google Scholar