* Martha Ann Holt is the Senior Production Editor of the Boston College International & Comparative Law Review.
1 See Robert H. Ballance, Market and Industrial Structure, in Contested Ground: Public Purpose and Private Interest in the Regulation of Prescription Drugs 95, 103–04 (Peter Davis ed., 1996).
2 Id.
3 See Scott Hensley & Joni James, How Pfizer Gained an Edge in Battle over Drug Prices, Wall St. J. Eur, July 9, 2001, at A1, available at 2001 WL-WSJE 21832589.
4 Christiane Sauter, Drug Companies Out for Themselves, The Post-Standard (London), Jan. 18, 2002, at A11, available at 2002 WL 5979242 (letter to the editor).
5 See David J. Gross, et al., Prices for Prescription Drugs: The Roles of Market Forces and Government Regulation, in Contested Ground, supra note 1, at 124, 134.
6 Tom Buerkle, EU Weighs Lifting of Price Controls—Bid to End Market Distortions, Int’l Herald Trib., Nov. 18, 1998, at A20, available at 1998 WL 4795412.
7 See Review & Outlook: Europe’s Addiction, Wall St. J., Jan. 2, 2002, at A18, available at 2002 WL-WSJ 3381809 [hereinafter Europe’s Addiction].
8 See Patricia M. Danzon, Pharmaceutical Price Regulation: National Policies Versus Global Interests 3–4 (1997).
9 See Ballance, supra note 1, at 95.
10 Gross, supra note 5, at 124.
11 Id.
12 Id. at 124–25.
13 Id.; Danzon, supra note 8, at 11.
14 See Gross, supra note 5, at 126.
15 Danzon, supra note 8, at 11–12.
16 Id. at 12.
17 See id.
18 Id.
19 See id. at 11.
20 See Danzon, supra note 8, at 11.
21 Stuart O. Schweitzer, Pharmaceutical Economics and Policy 104 (1997).
22 See id.
23 See id.
24 See id.
25 See id.
26 See Schweitzer, supra note 21, at 104.
27 Id.
28 Id.
29 See id.
30 Gross, supra note 5, at 124.
31 Danzon, supra note 8, at 15–16. A secondary goal of price regulation is to promote the domestic development and production of drugs. Id.
32 See id. at 30.
33 See id. at 15, 30.
34 Schweitzer, supra note 21, at 149.
35 Id.
36 See Trudy Lieberman, Health Matters: Why Health Costs Sting Again, L.A. Times, Jan. 21, 2002, at S1, available at 2002 WL 2447989. At least one state is pursuing criminal charges against major pharmaceutical companies, alleging that the companies used bogus pricing schemes to defraud both the state and consumers of tens of millions of dollars. Brendan Riley, Nevada Sues Major Drug Firms, AP Online, Jan. 18, 2002, available at 2002 WL 10032815.
37 Lieberman, supra note 36.
38 Schweitzer, supra note 21, at 97.
39 See generally Danzon, supra note 8.
40 See John Stossel, The Price of Medicine: Quit Blaming the Drug Companies, ACNews.com, Jan. 18, 2002, available at http://abcnews.go.com/sections/2020/daily-news/gmab_ drugco_020118.html [hereinafter Price of Medicine].
41 Id.
42 Id.
43 See Europe’s Addiction, supra note 7.
44 See Danzon, supra note 8, at 2.
45 See id.
46 See id.
47 Ballance, supra note 1, at 95.
48 Albert Wertheimer, et al., Pharmacy in the Western World Health Care Systems, in Contested Ground, supra note 1, at 159, 169.
49 See id. at 169–70.
50 Id.
51 Id. at 170.
52 Schweitzer, supra note 21, at 171.
53 Id. at 174.
54 Id. at 174–77.
55 Id. at 175.
56 Id.
57 Schweitzer, supra note 21, at 175.
58 Id.
59 Id.
60 Id.
61 Id.
62 Schweitzer, supra note 21, at 175.
63 Id.
64 Id.
65 Id. at 176.
66 Id.
67 Schweitzer, supra note 21, at 176.
68 Id.
69 Id.
70 Id. at 177.
71 See id.
72 Schweitzer, supra note 21, at 177.
73 Wertheimer, supra note 48, at 170.
74 Id.
75 Id.
76 Id.; see generally Laying the Groundwork for a Medicare Prescription Drug Benefit, Before the House Comm. on Ways and Means, 107th Cong.(2001) (statement of Dan L. Crippen, Director, Cong. Budget Office), available at http://www.cbo.gov/testimony.cfm [hereinafter CBO Medicare Testimony].
77 Wertheimer, supra note 48, at 170.
78 Id. at 171.
79 Schweitzer, supra note 21, at 183.
80 Id.
81 Id.
82 Id.
83 Id.
84 Schweitzer, supra note 21, at 183–84.
85 Id. at 184.
86 Wertheimer, supra note 48, at 162.
87 Id. at 161.
88 Id.; Europe’s Addiction, supra note 7, at A18.
89 See id.
90 Id. at 162.
91 Wertheimer, supra note 48, at 162.
92 Id.
93 Id. at 162–63.
94 Id.
95 Id. at 163.
96 Wertheimer, supra note 48, at 163.
97 Id. at 164–65.
98 Id. at 164.
99 Id.
100 Id. at 165.
101 Wertheimer, supra note 48, at 165.
102 Id.
103 Id.
104 Id.
105 Id.
106 Wertheimer, supra note 48, at 165.
107 Id.
108 Id. at 166.
109 Id.
110 Id.
111 Wertheimer, supra note 48, at 166.
112 Id. at 166–67.
113 Id. at 167.
114 Id.
115 See id.; Christine Huttin, Price Control Policies in the Pharmaceutical Industry: A Selection of Case Studies, in Studies in Pharmaceutical Economics 275, 276 (Mickey C. Smith, ed., 1996).
116 Huttin, supra note 115, at 276. Britain’s National Health Service only monitors pharmaceutical firms that have over $500,000 in sales a year. Wertheimer, supra note 48, at 167.
117 Huttin, supra note 115, at 276.
118 Wertheimer, supra note 48, at 167–68.
119 Id.
120 Id. at 167.
121 Id.
122 Id.
123 Wertheimer, supra note 48, at 168; Huttin, supra note 115, at 277.
124 Wertheimer, supra note 48, at 168; Huttin, supra note 115, at 277.
125 See Wertheimer, supra note 48, at 168; Huttin, supra note 115, at 277.
126 See Wertheimer, supra note 48, at 168.
127 Id. at 168–69.
128 Id.
129 Id. at 168.
130 See e.g., PhRMA, Pharmaceutical Company Patient Assistance Programs, at http://www. phrma.org/pap/more.cfm (last visited Jan. 1, 2003) [hereinafter PhRMA Assistance Programs]; RxHope.com, About RxHope.com, at http://www.rxhope.com/about/main.asp (last visited Jan. 1. 2003) [hereinafter RxHope]; RxAssist, Accessing Pharmaceutical Patient Assistance Programs, at http://www.rxassist.org/default.cfm (last visited Jan. 1, 2003).
131 See PhRMA Assistance Programs, supra note 130; RxHope, supra note 130.
132 See, e.g., Act to Establish Fairer Pricing for Prescription Drugs, Me. Rev. Stat. Ann. tit. 22, � 2681 (2002) [hereinafter Maine Bill]; Pharm. Researcher & Mfrs. of Am. v. Dep’t of Cmty. Health, 2002 WL 31810210 (describing the Michigan supplemental and basic rebate programs for prescription drugs) [hereinafter Michigan Program]; S.R. 55 (Wis. 2001), H.R. 144 (Wis. 2001) [hereinafter Proposed Wisconsin Bill].
133 See, e.g., Medicare Program: Medicare-Endorsed Prescription Drug Card Assistance Initiative, 42 C.F.R. � 403 (US Dep’t of Health and Human Svcs., proposed Nov. 5, 2002), available at http://www.nacds.org/user-assets/PDF_files/feb02_pdc_initiative.pdf [hereinafter HHS Medicare Initiative].
134 Id.
135 See generally, CBO Medicare Testimony, supra note 76; see also Medicare Reform: Providing Prescription Drug Coverage for Seniors, Before the House Comm. on Energy and Commerce, 107th Cong. (2001) (statement of Dan L. Crippen, Director, Cong. Budget Office), available at http://www.cbo.gov/testimony.cfm.
136 See PhRMA Assistance Programs, supra note 130.
137 Id.
138 PhRMA, Directory of Prescription Drug Patient Assistance Programs, at http://www. phrma.org (last visited Jan. 1, 2003) [hereinafter PhRMA Directory].
139 Press Release, Pfizer, Pfizer to Provide Health Benefits, Including $15 Flat Fee for Pfizer Prescriptions, to Low-Income Seniors Across America (Jan. 15, 2002), at http:// www.pfizer.com/are/news_releases/mn_2002_0115.html [hereinafter Pfizer Press Release].
140 See id.
141 PhRMA Directory, supra note 138, at 1.
142 Id.
143 See id.
144 See id.
145 See id.
146 RxHope, supra note 130.
147 Id.
148 Id.
149 Id.
150 See id.
151 See James Taggart, The World Pharmaceutical Industry 35 (1993).
152 Pfizer Press Release, supra note 139.
153 Id.; Pfizer, Share Card Questions and Answers, at http://www.pfizerforliving.com/ sharecard/nucardqa.jhtml?cardImageOver=5 (last visited Jan. 1, 2003) [hereinafter Share Card Fact Sheet].
154 Share Card Fact Sheet, supra note 153.
155 Id.
156 Pfizer Press Release, supra note 139.
157 NACDS, News Releases: Pharmacy Care Alliance Stacks Multiple Drug Savings Into One Senior Benefit (Mar. 11, 2002), at http://www.nacds.org/wmspage.cfm?parm1=1738 [hereinafter NACDS News Release].
158 Id.
159 Id.
160 Id.
161 See id. As noted earlier, manufacturers that offer drug assistance programs currently send their products to doctors’ offices, and not to the low-income patients. PhRMA Directory, supra note 138.
162 See NACDS News Release, supra note 157; see also HHS Medicare Initiative, supra note 133.
163 See e.g., Michigan Program, supra note 132; Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132.
164 See Michigan Program, supra note 132; Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132.
165 Michigan Program, supra note 132.
166 Id.
167 Id.
168 Id.
169 Id.
170 Proposed Wisconsin Bill, supra note 132.
171 Id.
172 Id.
173 Id.
174 Maine Bill, supra note 132; see also Pharm. Research & Mfrs. of Am. v. Concannon, 249 F.3d 66, 71 (1st Cir. 2001) (upholding Maine’s Act to Establish Fairer Pricing for Prescription Drugs, Me. Rev. Stat. Ann. tit. 22, � 2681 (2002)).
175 Maine Bill, supra note 132.
176 Id.
177 Id.
178 Id.
179 Id.
180 Maine Bill, supra note 132.
181 Michigan Program, supra note 132.
182 Id.
183 See, e.g., CBO Medicare Testimony, supra note 76, at 1.
184 HHS Medicare Initiative, supra note 133.
185 CBO Medicare Testimony, supra note 76, at 1.
186 PhRMA, Congress Should Enact a Prescription Drug Benefit (Sept. 5, 2001), at http:// www.phrma.org/mediaroom/press/releases/05.09.2001.288.cfm.
187 HHS Medicare Initiative, supra note 133, at 7.
188 Id. at 7–8.
189 Id. at 8.
190 Id.
191 Nat’l Ass’n of Chain Drug Stores Complaint at 17, Nat’l Ass’n of Chain Drug Stores v. Thompson (No. 1:01CV01554).
192 HHS Medicare Initiative, supra note 133, at 8.
193 Id. at 20.
194 Id. at 9.
195 See id.
196 Id. at 11.
197 CBO Medicare Testimony, supra note 76, at 1.
198 Id. at 10–14.
199 Id. at 7.
200 See id. at 10–14.
201 See id.
202 See CBO Medicare Testimony, supra note 76, at 10–14.
203 Id. at 8.
204 Id.
205 Id.
206 Wertheimer, supra note 48, at 163.
207 Id.
208 Id. at 164.
209 Id.
210 Id.
211 See Wertheimer, supra note 48, at 163–64.
212 See id.
213 See id.
214 See id.
215 See id. at 165–66.
216 Wertheimer, supra note 48, at 166.
217 Id.
218 Id. at 165–66.
219 Id.
220 See id.; see also Schweitzer, supra note 21, at 177.
221 See Wertheimer, supra note 48, at 165–66.
222 Id.
223 See id. at 166.
224 See id.
225 See Huttin, supra note 115, at 276.
226 See id.; see also Schweitzer, supra note 21, at 104.
227 See Huttin, supra note 115, at 276; see also Schweitzer, supra note 21, at 104.
228 See Huttin, supra note 115, at 276.
229 See Wertheimer, supra note 48, at 164.
230 See Huttin, supra note 115, at 276.
231 See id.
232 See Europe’s Addiction, supra note 7.
233 Id.
234 See Price of Medicine, supra note 41.
235 See H.Th. van Asselt, Policies on Pharmaceutical Patents: The Impact of Patent Protection on R&D, in The Prescription Drug Market 263 (Christine Huttin & Nick Bosanquet, eds., 1992); Schweitzer, supra note 21, at 147.
236 See van Asselt, supra note 235, at 263; Schweitzer, supra note 21, at 147.
237 See Taggart, supra note 151, at 437.
238 See Wertheimer, supra note 48, at 165–66; Huttin, supra note 115, at 276.
239 See Wertheimer, supra note 48, at 165–66; Huttin, supra note 115, at 276.
240 See Balance, supra note 1, at 95–96.
241 See, e.g., Michigan Program, supra note 132; Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132.
242 See, e.g., Michigan Program, supra note 132; Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132.
243 See, e.g., Michigan Program, supra note 132; Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132.
244 See, e.g., PhRMA Assistance Programs, supra note 130; see also HHS Medicare Initiative, supra note 133, at 1.
245 See, e.g., PhRMA Assistance Programs, supra note 130; see also HHS Medicare Initiative, supra note 133, at 1.
246 See, e.g., PhRMA Assistance Programs, supra note 130; see also HHS Medicare Initiative, supra note 133, at 1.
247 See, e.g., PhRMA Assistance Programs, supra note 130; see also HHS Medicare Initiative, supra note 133, at 1.
248 See Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132; Michigan Program, supra note 132.
249 See Michigan Program, supra note 132; Schweitzer, supra note 21, at 104.
250 See Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132.
251 See Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132; Michigan Program, supra note 132; Wertheimer, supra note 48, at 162.
252 See, e.g., Proposed Wisconsin Bill, supra note 132; see also Schweitzer, supra note 21, at 175.
253 See Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132; Michigan Program, supra note 132.
254 See Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132; Michigan Program, supra note 132.
255 See id.; see also United States Department of Health and Human Services, Medicare-Endorsed Prescription Drug Discount Card (Feb. 28, 2002), available at http://www.nacds.org/ user-assets/PDF_files/feb02_pdc_summary.pdf.
256 See generally CBO Medicare Testimony, supra note 76.
257 See generally HHS Medicare Initiative, supra note 133.
258 See id. at 13.
259 See id.
260 See id. at 20.
261 See generally CBO Medicare Testimony, supra note 76.
262 See id.; see generally Wertheimer, supra note 48.
263 CBO Medicare Testimony, supra note 76, at 8.
264 See id.
265 Id.
266 See id.
267 See Wertheimer, supra note 48, at 165.
268 See id.
269 CBO Medicare Testimony, supra note 76, at 10.
270 See Wertheimer, supra note 48, at 160.
271 Id.
272 See id.
273 See id. at 163.
274 See id.; see also CBO Medicare Testimony, supra note 76, at 10.
275 See generally CBO Medicare Testimony, supra note 76.
276 See Sauter, supra note 4.
277 PhRMA, The Myth of “Rising Drug Prices” Exposed, at http://www.phrma.org/publi-cations/quickfacts/03.04.2001.206.cfm (last visited Jan. 1, 2003).
278 See id.
279 See generally CBO Medicare Testimony, supra note 76; HHS Medicare Initiative, supra note 133.
280 See Wertheimer, supra note 48, at 160.
281 See generally CBO Medicare Testimony, supra note 76.
282 See Ballance, supra note 1, at 95.
283 See Wertheimer, supra note 48, at 175.
284 Schweitzer, supra note 21, at 174–75.
285 See id. See generally CBO Medicare Testimony, supra note 76.
286 See Proposed Wisconsin Bill, supra note 132; Maine Bill, supra note 132; Michigan Program, supra note 132.
287 See Wertheimer, supra note 48, at 167–68.
288 See id. at 167.
289 See id. at 167–68.
290 See id.
291 See id. at 168.
292 See Wertheimer, supra note 48, at 168.
293 See id. at 167–68.
294 See id. at 166; Schweitzer, supra note 21, at 187.
295 Schweitzer, supra note 21, at 181.
296 See id. at 176.
297 See id.
298 See id. at 177.
299 See id. at 190.
300 See Wertheimer, supra note 48, at 168.
301 See id. at 166.
302 See id.
303 See id.
304 See id. at 166–67.
305 See Wertheimer, supra note 48, at 166.
306 See id.