Right to Experimental Treatment: FDA New Drug Approval,Constitutional Rights,and the Public's Health

Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach , 445 F.3d 470 (D.C. Cir. 2006), panel rehearing denied, November 21, 2006 (vacating opinion and granting en banc rehearing).

Id., at 472.

Volokh E. , “Medical Self-Defense, Prohibited Experimental Therapies, and Payment for Organs,” Harvard Law Review 120, no. 7 (2007): 1813–1846; Calfee J. E. , Regulating Access to Developmental Drugsfor Terminally Ill Patients: Abigail Alliance v. FDA , Brief 07–01, January 2007, amicus brief, available at <http://www.aei-brookings.org/admin/authorp-dfs/page.php?id=1352> (last visited March 27, 2009).

Benderly B. L. , “Experimental Drugs on Trial,” Scientific American , October 2007, at 93; Groopman J. , “Medical Dispatch; The Right to a Trial,” The New Yorker , December 18, 2006, at 40; Jacobson P. D. Parmet W. E. , “A New Era of Unapproved Drugs: The Case of Abigail Alliance v Von Eschenbach,” JAMA 297, no. 2 (2007): 205–208.

Food and Drug Administration, U.S. Department of Health and Human Services, “Proposed Rule, Expanded Access to Investigational Drugs for Treatment Use,” Federal Register 71, no. 240 (2006): 75147–75168.

Senator Sam Brownback, Legislation Will Ensure Terminally Ill Patients Get Treatment , News Release, November 3, 2005, available at <http://brownback.senate.gov/pressapp/record.cfm?id=248248> (last visited March 27, 2009); Anand G. , “Saying No to Penelope; Father Seeks Cancer Drug, But a Biotech Firm Says Risk Is Too High,” Wall Street Journal, May 1, 2007, at A1.

See Benderly , supra note 4, at 93–99 (suggesting that current FDA new drug approval process may take over eight years but is the “gold standard” of drug testing).

Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach , 445 F.3d 470 (D.C. Cir. 2006); panel rehearing denied, November 21, 2006 (vacating opinion and granting en banc rehearing).

Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach , 495 F.3d 695, 697 (2007) (citing Washington v. Glucksberg, 521 U.S. 702, 720–21 [1997]).

Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach , 552 U.S.___, 128 S. Ct. 1069 (Mem.) (January 14, 2008), case no. 07–444, cert. denied (summary disposition); see Savage D. G. , “Justices Uphold Ban on Test Drugs for the Dying,” Los Angeles Times , January 15, 2008; Walker S. , “A Different ‘Right to Life,’” Wall Street Journal, January 11, 2008, at A10 (Abigail Alliance co-founder commenting on Supreme Court's decision whether to review their petition).

Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach , 445 F.3d 470 (D.C. Cir. 2006).

For more information about the Abigail Alliance for Better Access to Developmental Drugs, see <http://abigail-alliance.org/> (last visited March 27, 2009). The Washington Legal Foundation (WLF) is “the nation's preeminent center for public interest law, advocating free-enterprise principles, responsible government, property rights, a strong national security and defense, and a balanced civil and criminal justice system.” See <http://www.wlf.org/> (last visited March 27, 2009).

See Kovach S. , The Abigail Alliance: Motivated by Tragic Circumstances, Families Battle an Uncaring Bureaucracy, available at <http://abigail-alliance.org/LEMSEP07pAbigailLR.pdf> (last visited March 27, 2009).

See Abigail Alliance, 445 F.3d at 472 (noting that “the right at issue, carefully described, is the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor's advice, even where the medication carries risks for the patient.”)

Id., at 486; Hill B. J. , “The Constitutional Right to Make Medical Treatment Decisions: A Tale of Two Doctrines,” Texas Law Review 86, no. 2 (2007): 277–345, at 314 (discussing panel decision, which “surprised many commentators.”)

Griswold v. Connecticut , 381 U.S. 479 (1965) (holding that Connecticut law forbidding use of contraceptives unconstitutionally intrudes upon the right of marital privacy); Eisenstadt v. Baird, 405 U.S. 438 (1972) (holding that law allowing distribution of contraceptives to married but not single people violated Equal Protection clause).

Roe v. Wade , 410 U.S. 113 (1973) (holding that constitutional right of privacy encompasses woman's decision whether to terminate pregnancy); Casey v. Planned Parenthood of Southeastern Pennsylvania, 505 U.S. 833 (1992) (affirming Casey but replacing trimester approach with “undue burden” test).

Cruzan v. Missouri Dir. of Health , 497 U.S. 261 (1990) (recognizing 14th Amendment liberty interest in refusing life-sustaining treatment).

Lawrence v. Texas , 539 U.S. 558 (2003) (holding Texas criminal prohibition on two persons of same sex engaging in certain intimate sexual conduct impinged on 14th Amendment liberty interests).

See Abigail Alliance, 445 F.3d at 484 (discussing Cruzan and noting that “[a] similar analysis leads to the conclusion that the Due Process Clause protects the liberty interest claimed by the Alliance for its terminally ill members.”)

521 U.S. 702 (1997); see Abigail Alliance, 445 F.3d at 476–477 (discussing Glucksberg).

Glucksberg , 521 U.S. at 720–721.

See Abigail Alliance, 445 F.3d at 481–483; Furmanksy L. N. , “Just Say No to Drugs: The Abigail Alliance and the Attempted Abolition of the Food and Drug Administration,” Biotechnology Law Report 26, no. 2 (2007): 108–117, at 109–110.

445 F.3d at 483 (“Despite FDA's claim to the contrary, therefore, it cannot be said that government control of access to potentially life-saving medication ‘is not firmly ingrained in our understanding of the appropriate role of government’” [quoting Appellee's brief]).

Id., at 483.

Id., at 486.

Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach , 495 F.3d 695, 697 (D.C. Cir. 2007).

Id., at 711.

Id., at 702.

Id., at 703.

Id., at 704 and n.7 (tracing history of drug regulation in England, beginning in 1447), id., at 706 and n.12 (discussing U.S. history of regulation of scientific, mathematical, and medical advances).

United States v. Rutherford , 442 U.S. 544, 558 (1979).

See Abigail Alliance, 495 F.3d at 710 (citing medical marijuana cases rejecting statutory, if not constitutional, challenges to FDA's authority).

Id., at 710, n.18; see Hill , supra note 16, at 303–304 (discussing Rutherford, Walen v. Roe, 429 U.S. 589 [1977], and other cases on right to make medical treatment decisions).

See Abigail Alliance, 495 F.3d at 714 (Justices Rogers and Ginsburg dissenting).

Id., at 714–715.

See Abigail Alliance, 445 F.3d at 486, 477 (remanding to district court); see Glucksberg, 521 U.S. at 721; Reno v. Flores, 507 U.S. 292, 302 (1993); see Volokh , supra note 3, at 1837 (acknowledging that right to medical self-defense may be limitable and noting panel's remand to district court to determine “whether the FDA rules were narrowly tailored to some compelling government interest.”)

See Furmanksy , supra note 24, at 117 (“Desperately ill terminal patients should not be allowed to take so many other lives into their own hands”); Jacobson Parmet , supra note 4, at 207–208 (urging court to reexamine “panel's aggressively individualistic view, one that breathtakingly slights the public's interest in drug safety”); Hill , supra note 16, at 277; Volokh , supra note 3, at 1828–1832.

Gunvalson v. PTC Therapeutics Inc. , Civ. No. 08–3559, letter op. at 9 (D. N.J. August 21, 2008); Gold J. , “Judge: Company Must Give Experimental Drug to Teen,” Associated Press , August 21, 2008, available at <http://ap.google.com/article/ALeqM5h133TDYq6e6RvF2LtTioSFjCMGfAD92M995G6 (last visited September 12, 2008); Goldstein J. , “Judge Rules PTC Therapeutics Must Give Experimental Drug to Teen,” Wall Street Journal Health Blog, August 21, 2008, available at <http://blogs.wsj.com/health/2008/08/21/judge-rules-ptc-therapeutics-must-give-experimental-drug-to-teen/> (last visited March 27, 2009); Grynbaum M. M. , “Judge Orders Drug Maker to Provide Experimental Treatment to Terminally Ill Teenager,” New York Times, August 21, 2008.

See Food and Drug Administration, supra note 5; Talbott M. K. , “The Implications of Expanding Access to Unapproved Drugs,” Journal of Law, Medicine & Ethics 35, no. 2 (2007): 316–318, at 317.

Id. (FDA), at 75156.

Access, Compassion, Care and Ethics for Seriously Ill Patients (ACCESS) Act , S 1956, 109th Cong. (2005); Office of Sam Brownback, Legislation Will Ensure Terminally Ill Patients Get Treatment , Press Release, November 3, 2005, available at <http://brownback.senate.gov/pressapp/record.cfm?id=248248> (last visited March 27, 2009); see Okie S. , “Access Before Approval – A Right to Take Experimental Drugs?” New England Journal of Medicine 355, no. 5 (August 3, 2006): 437–440, at 437, 439.

ACCESS Act , S 3046, 110th Cong. (2008); Office of Sam Brownback, Brownback Introduces ACCESS Act , Press Release, May 21, 2008, available at <http://brownback.senate.gov/pres-sapp/record.cfm?id=298216> (last visited March 27, 2009); FDA Law Blog, ACCESS Act Reintroduced by Sen. Brownback; Previous Tiered Approval Nomenclature Scrapped and New Immunity Provision Added , June 4, 2008, available at <http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/06/access-act-rein.html> (last visited March 27, 2009).

ACCESS Act, HR 6270, 110th Cong. (2008) (introduced June 12, 2008).

See Anand , supra note 6, at A1 (noting that House Speaker Nancy Pelosi lobbied the company to make drug available).

Id. (“Urged on by [Penelope's] family, patient groups and politicians, including the staff of House Speaker Pelosi and Pennsylvania Gov. Edward Rendell, lobbied on behalf of giving the drug to the child.”)

See supra Section III (discussing the Abigail Alliance opinions).

Abney v. Amgen, 443 F.3d 540, 544 (6th Cir. 2006) (describing Amgen's decision to terminate all clinical trials of Parkinson's drug, “GDNF”); Annas G. J. , “Faith (Healing), Hope and Charity at the FDA: The Politics of AIDS Drug Trials,” Villanova Law Review 34, no. 5 (1989): 771–797, at 785 and n.51 (citing example of DuPont AIDS drug, Ampligen); Noah B. A. , “Adverse Drug Reactions: Harnessing Experimental Data to Promote Patient Welfare,” Catholic University Law Review 49, no. 2 (2000): 449–502.

See infra Section IV, at sub-section E (listing examples of distortions in drug trials).

See Food and Drug Administration, supra note 5 (“making investigational drugs available for expanded access for treatment use is potentially costly, especially when many patients are involved”); Anand , supra note 6 (describing experience of small biotech firm, Netropix, Inc., and noting that “in a small company with limited financial resources and a high risk profile, you really have to reduce the risks to drug development”); Okie , supra note 43, at 440 (quoting pharmaceutical industry representative, “One of he biggest limitations [to access to experimental drugs] is manufacturing capacity”); Talbott , supra note 41, at 318 (noting cost concerns).

See, e.g., United States v. Rutherford, 442 U.S. 544, 558 (1979) (“Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerin and limburger cheese; mineral tablets; and ‘Fountain of Youth’ mixtures of spices, oil, and suet.”); Benforado A. Hanson J. Yosifon D. , “Broken Scales: Obesity and Justice in America,” Emory Law Journal 53, no. 4 (2004): 1648–1806, at 1786–1787 (quoting then-FDA Commissioner Mark McClellan on FDA's role in “rooting out modern purveyors of snake oil.”)

See ACCESS Act, supra note 45, at 3(a)(10) (2008) (“A sponsor or investigator may charge for a … drug without notifying the Secretary or seeking or obtaining prior approval of the amount charged.”); ACCESS Act, supra note 44, at 3(a)(10) (2008) (same); Proposed Rule, supra note 41, at 75170–75171.

See Talbott , supra note 41, at 318.

See ACCESS Act, supra note 45, at, 3(a)(12) (2008) (prohibiting state and federal “claims of property personal injury, or death caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispersing, prescribing, administration, efficacy, or use of a drug, biological product, or device” subject to the Act); ACCESS Act, supra note 44, 3(a) (12) (2008) (same).

See Abigail Alliance, 445 F.3d 470 (finding constitutional Due Process right to access); see also Gunvalson v. PTC Therapeutics Inc., Civ. No. 08–3559, letter op. (D. N.J. August 21, 2008) (recognizing common law claims). But see Abney, 443 F.3d at 553 (rejecting patients' state law claims for injunction compelling pharmaceutical company to continue supplying experimental drugs).

Bohrer R. A. , “The Abigail Alliance and the Role of the FDA,” Biotechnology Law Report 26, no. 2 (April 2007): 107 (noting that panel's decision “fired a broadside salvo at the FDA's fundamental regulatory role”); see Furmanksy , supra note 24, at 108 (regarding “The Attempted Abolition of the Food and Drug Administration”); Jacobson Parmet , supra note 4, at 207 (noting that panel decision would subject “FDA's authority to further erosion”).

442 U.S. 544 (1979).

Id., at 553 (“The Federal Food, Drug, and Cosmetic Act makes no special provision for drugs used to treat terminally ill patients.”); see Annas , supra note 49, at 789–792 (“FDA was correct on laetrile and should continue to insist on a scientifically valid randomized clinical trial before certifying drugs as safe and effective” for both terminal and non-terminal patients).

Rutherford , 442 U.S. at 549.

See Annas , supra note 49, at 789 (quoting Levine R. , Ethics and Regulation of Clinical Research , 2nd ed. [Baltimore: Urban & Schwarzerberg, 1986]: At 211); Benderly , supra note 4, at 94 (“The ‘gold standard’ of drug testing, the doubleblind controlled clinical trial, compares an experimental drug against the best standard treatment or, sometimes, against an inactive placebo.”); Gilhooley M. , “Vioxx's History and the Need for Better Procedures and Better Testing,” Seton Hall Law Review 37, no. 4 (2007): 941–968, at 964 (“Long-term clinical tests provide the best evidence about the safety risks of drugs for chronic use, as the history of Vioxx indicates.”); Kulynych J. , “Will FDA Relinquish the ‘Gold Standard’ for New Drug Approval? Redefining ‘Substantial Evidence’ in the FDA Modernization Act of 1997,” Food and Drug Law Journal 54, no. 1 (1999): 127–149, at 131 (“the properly conducted [random clinical trial] permits an accurate, objective, and scientific assessment of whether a treatment works – and if so, how effective is it.”); Jacobson Parmet , supra note 4, at 207 (“the panel's opinion usurped the FDA's responsibility to balance the risks and benefits of new drugs and strikes at the core of the FDA's raison d'etre.”)

Society for Clinical Trials Board of Directors, “The Society for Clinical Trials Opposes U.S. Legislation to Permit Marketing of Unproven Medical Therapies for Seriously Ill Patients,” Clinical Trials 3, no. 2 (2006): 154–157, at 155, available at <http://www.sctweb.org/positionpapers/S.1956-clinical-trials.pdf> (last visited March 27, 2009) [hereinafter cited as Society for Clinical Trials].

See Groopman , supra note 4, at 42; Greenberg M. D. , “AIDS, Experimental Drug Approval, and the FDA New Drug Screening Process,” New York University Journal of Legislation and Public Policy 3, no. 2 (2000): 295–350, at 308–327.

See Annas , supra note 49, at 773; Benderly , supra note 4, at 94 (discussing patients' “therapeutic misconception” that trials aim to cure and offer a good chance of helping, despite being informed of purpose and statistical likelihood to the contrary); Greenberg , supra note 63, at 331 (describing “direct conflict between medical treatment and clinical trial process.”)

See Benderly , supra note 4, at 94.

See Releases Press , supra notes 43 and 44 (“This legislation … would also ensure that dying patients will not be forced to participate in a clinical trial and be given a placebo or sugar pill if another reasonable treatment exists.”)

Annas G. J. , “Cancer and the Constitution – Choice at Life's End,” New England Journal Medicine 357, no. 4 (2007): 408–413, at 408 (“Frustration with the methods and slow progress of mainstream medical research has helped fuel a resistance movement that distrusts both conventional medicine and government” and patients' demands for expanded access to experimental drugs.)

Committee on the Assessment of the U.S. Drug Safety System, Baciu A. Stratton K. Burke S. P. , eds., The Future of Drug Safety: Promoting and Protecting the Public Health (Washington, D.C.: The National Academies Press, 2006); see Gilhooley , supra note 61, at 956–958; Blum J. , “FDA Accepted 19 Drugs in '07, Fewest It Has OK'ed Since 1983,” Arizona Daily Star, January 10, 2008; Berenson A. , “Drug Has No Benefit in Trial, Makers Say,” New York Times, January 14, 2008; Park A. , “Is Vytorin a Failure?” Time, January 15, 2008.

Huber P. , “FDA Caution Can be Deadly, Too,” Wall Street Journal , July 24, 1998, at A14; Leaf C. , “Deadly Caution; How Our National Obsession with Drug Safety Is Killing People – And What We Can Do About It,” CNNMoney.com, February 9, 2006, available at <http://money.cnn.com/magazines/fortune/fortune_archive/2006/02/20/8369155/index.htm> (last visited March 27, 2009) (“The approval process is broken – but not in the way most people think. It is in thrall to a well-intentioned but ultimately misguided national obsession: The quest for certainty about drug safety and efficacy.”); Editorial, “Implants and Science,” Wall Street Journal , November 20, 2006, at A16 (applauding FDA's decision to lift ban on silicone-breast implants as victory of science over politics, by which “[w]omen will at last be allowed to make their own decisions about cosmetic surgery. This is especially welcome news for mastectomy patients.”)

Epstein R. A. , “Regulatory Paternalism in the Market for Drugs: Lessons from Vioxx and Celebrex,” Yale Journal of Health Policy and Ethics 5, no. 2 (2005) 741–770, at 741–745 (describing public pressure to pull drugs from the market and increase regulatory oversight); see Groopman , supra note 4, at 47 (describing concerns of “critics who believe that the FDA needs stricter drug regulations.”)

Sharpe R. , “FDA Tries to Find Right Balance on Drug Approvals,” Wall Street Journal, April 20, 1999, at A24 (“The [FDA] is caught in pincers between two intense political pressures: Demands from the industry and the political right to move faster and faster in approving drugs, and rising insistence from consumer groups and the left to show more caution.”)

U.S. General Accounting Office, Report to Congressional Requesters, Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations , GAO-03-177, October 2002; Fox D. , “Safety, Efficacy, and Authenticity: The Gap between Ethics and Law in FDA Decisionmaking,” Michigan State Law Review 2005, no. 4 (2005): 1135–1197, at 1170–1179.

See Annas , supra note 67, at 408; Greenberg , supra note 63, at 312; Center Watch, “Search Clinical Trials,” available at <http://www.centerwatch.com/patient/trials.html> (last visited March 31, 2009); Novartis , “Clinical Trial Information,” available at <http://www.novartisclinicaltrials.com/webapp/etrials/home.do> (last visited March 31, 2009).

In re Norplant Contraceptive Products Litigation, 165 F.3d 374 (5th Cir. 1999) (applying doctrine to prescription drugs advertised directly to patients); Alm v. Aluminum Co. of America , 717 S.W.2d 588, 591–592 (Tex. 1986); Terhune v. A. H. Robins Co. , 577 P.2d 975, 977–978 (Wash. 1978) (citing cases).

See, e.g., Robbins v. Footer, 553 F.2d 123, 126 (D.C. Cir. 1977) (“Whether a defendant has or has not conformed his conduct to a customary practice is generally only evidence of whether he has acted as a reasonably prudent person. In a malpractice case, however, the question of whether the defendant acted in conformity with the common practice within his profession is the heart of the suit.”)

See Jacobson P. D. , “Litigating the Science of Breast Cancer Treatment,” Journal of Health Politics, Policy and Law 32, no. 5 (2007): 785–817, at 799 (discussing routine use of HDC/ABMT among oncologists, resulting in judges finding the treatment was the standard of care, despite experimental status); Palumbo F. C. Mullins C. D. , “The Development of Direct-to-Consumer Prescription Drug Advertising Regulation,” Food and Drug Law Journal 57, no. 3 (2002): 423–442, at 438 (describing pressure on physicians to prescribe advertised drugs and strain on professional responsibilities and practice standards).

See Brownback Press Releases, supra notes 43 and 44 (describing ACCESS Act); Society for Clinical Trials, supra note 62, at 155 (describing ACCESS Act's prohibition on “placebo-only or no-treatment-only concurrent controls in any clinical investigations” conducted under the Act).

See Annas , supra note 67, at 412 (“The drug companies are right to worry that the approaches of the judiciary, Congress, and the FDA will probably make clinical trials more difficult to conduct, because few seriously ill patients who have exhausted conventional treatments would rather be randomly assigned to an investigational drug than have a guarantee that they will receive the investigational drug their physician recommends for them.”); Furmanksy , supra note 24, at 113; Salbu S. R. , “Regulation of Drug Treatments for HIV and AIDS: A Contractarian Model of Access,” Yale Journal on Regulation 11, no. 2 (1994): 401–453, at 436 (describing randomized, doubleblind, placebo-controlled experiments as “undoubtably the most scientifically sound means” producing statistically significant data on safety and effectiveness, although arguing for more open access and value of other information sources).

See Greenberg , supra note 63, at 297.

Bernstein A. , “Hymowitz v. Eli Lilly and Co.,” in Rabin R. L. Sugarman S. D. , Tort Stories (New York: Foundation Press, 2003): At 153 and n. 9, 155.

Dieckmann W. J. , “Does the Administration of Diethylstibestrol during Pregnancy Have Therapeutic Value?” American Journal of Obstetrics and Gynecology 66, no. 5 (1953): 1062–1081 (describing non-randomized DES trials); Bernstein , supra note 80, at 153 and n. 9.

See Bernstein , supra note 80, at 155.

Lubeznik v. Healthchicago, Inc. , 644 N.E.2d 777 (Ill. 1994) (describing treatment history).

See, e.g., id. But see Fuja v. Benefit Trust Life Insur. Co. , 18 F. 3d 1405 (7th Cir. 1994) (denying coverage); Harris v. Mutual of Omaha Cos., 992 F.2d 706 (7th Cir. 1993) (same).

See Morreim E. H. , “From the Clinics to the Courts: The Role Evidence Should Play in Litigating Medical Care,” Journal of Health Politics, Policy, and Law 26, no. 2 (2001): 409–426, at 411–413; Antman K. H. Heitjan D. F. Hortobagyi G. N. , “High Dose Chemotherapy for Breast Cancer,” JAMA 282, no. 18 (November 10, 1999): 1701–1703.

See Rettig Richard , False Hope: Bone Marrow Transplantation for Breast Cancer (New York: Oxford University Press, 2007); Benderly , supra note 4, at 99 (noting that “Thousands of women underwent, and some died from, this excruciating and costly experimental procedure, after a lawsuit forced insurers to pay but before clinical trials finally proved it no more effective than standard therapy.”)

See Okie , supra note 43, at 440 (quoting pharmaceutical executive, “the whole purpose of large clinical trials is to fully evaluate benefits and risks … and short-changing that is not in the patients' best interest”); Society for Clinical Trials, supra note 62, at 156 (listing numerous examples, of drugs that showed initial promise, but ultimately harmful effects, evident only after placebo-controlled, randomized trials).

See Kolata G. , “Recruiting Problems in New York Slowing U.S. Trials of AIDS Drugs,” New York Times, December 18, 1988, at 11; Annas , supra note 49, at 786–787.

Id., (Kolata), at 11.

See Annas , supra note 49, at 786–787 (noting that patients' taking drugs outside the trials “on the sly” further undermined results); Kolata , supra note 88, at 11 (quoting study chairman: “We're worried about cheating all the time.”)

See, e.g., Bernstein , supra note 80, at 153 and n. 9; Dieckmann , supra note 81, at 1062–1081.

See Kahn J. , Letter to the Editor, “Misreading Race and Genomics after BiDil,” Nature Genetics 37, no.7 (July 2005): 655–656; Temple R. Stockbridge N. L. , “BiDil for Heart Failure in Black Patients: The U.S. Food and Drug Administration Perspective,” Annals of Internal Medicine 146, no. 1 (January 2, 2007): 57–62, at 59; Chepesiuk R. Jones J. , “Are Race-Specific Drugs Unethical? With BiDil on the Market, Experts Weigh the Moral Implications,” Black Enterprise, November 2005, available at <http://findarticles.com/p/articles/mi_m1365/is_4_36/ai_n15890897> (last visited March 31, 2009).

See Greenberg , supra note 63, at 313.

See Okie , supra note 43, at 440 (quoting pharmaceutical industry representatives that “the whole purpose of large clinical trials is to fully evaluate benefits and risks” and “shortchanging that is not in patients' best interests”); Snead O. C. , “Unenumerated Rights and the Limits of Analogy: A Critique of the Right to Medical Self-Defense,” Harvard Law Review Forum 120, no. 7 (2007), available at <http://www.harvard-lawreview.org/forum/issues/120/may07/snead.shtml> (last visited March 31, 2009) (responding to Volokh, supra note 3) (noting FDA's interests in restricting access to unapproved drugs, including “to maintain a functional clinical trial system [the chief mechanism of bringing safe and effective drugs to the market]”).

Gostin L. O. , ed., Public Health Law & Ethics: A Reader (Berkeley and Los Angeles: University of California Press, 2002), at 23; Weeks E. A. , “Beyond Compensation: Using Torts to Promote Public Health,” Journal of Health Care Law and Policy 10, no. 1 (2007): 27–59, at 33–34.

Jacobson v. Massachusetts , 197 U.S. 11 (1905) (“But it is equally true that in every well-ordered society charged with the duty of conserving the safety of its members the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.”)

See United States v. Rutherford, 442 U.S. 544, 547 (1979) (noting FDA's authority to restrict access to experimental drugs “is within the area of governmental interest in protecting public health”); Furmansky , supra note 24, at 113–114 (“In this case, the good of the many must certainly outweigh the potential, (though not certain), good of the few.”); Snead , supra note 94 (“The FDA restricts access to unapproved drugs (subject to certain exceptions) in the interest of public health, that is, to prevent patient exposure to unsafe or ineffective drugs and to maintain a functional clinical trial system.”).