Hostname: page-component-586b7cd67f-dlnhk Total loading time: 0 Render date: 2024-11-28T14:59:22.868Z Has data issue: false hasContentIssue false
  • English
  • Français

Recent Developments in Health Law

Published online by Cambridge University Press:  01 January 2021

Won Bok Lee ,
Carmel Shachar  and
Peter Chang
Get access Rights & Permissions [Opens in a new window]

Extract

In May of 2006, the Abigail Alliance for Better Access to Development Drugs (Abigail) appeared to have won a victory when a divided panel of the Court of Appeals for the District of Columbia Circuit (D.C. Circuit) ruled that “terminally ill, mentally competent adult patients” had a constitutionally protected right to access investigational medications. This victory was short lived, however. On August 7, 2007, the D.C. Circuit sitting en banc reversed this earlier decision, marking a setback in Abigail's campaign for removal of the regulatory barriers that currently prevent terminally ill patients from gaining early access to investigational drugs (i.e., experimental drugs). This loss represents a big blow for Abigail's cause, because there is no guarantee that they will have another day in court, and attaining their goal through other branches of the government remains uncertain.

Type
JLME Column
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 1 , Spring 2008 , pp. 191 - 199
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

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

Abigail Alliance v. von Eschenbach, 445 F.3d 470, 486 (D.C. Cir. 2006).Google Scholar
Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007).Google Scholar
Citizen Petition of the Abigail Alliance and the Washington Legal Foundation, June 11, 2003, at 5–6 [hereinafter cited as Citizen Petition].Google Scholar
Food and Drug Administration Docket 2003P-0274, In re Tier 1 Initial Approval Program, available at <http://www.fda.gov/ohrms/dockets/dockets/03p0274/03p0274.htm> (last visited January 2, 2008).+(last+visited+January+2,+2008).>Google Scholar
See Abigail Alliance, supra note 2, at 711.Google Scholar
Id., at 712–713.Google Scholar
Id., at 714.Google Scholar
Skinner v. Oklahoma ex rel. Williamson, 316 U.S. 535, 541 (1942).Google Scholar
Washington v. Glucksberg, 521 U.S. 702, 766 (1997).Google Scholar
Id., at 720–21.Google Scholar
See Abigail Alliance, supra note 2, at 716.Google Scholar
Id., at 716, 728.Google Scholar
See Glucksberg, supra note 9, at 720.Google Scholar
See Abigail Alliance, supra note 2, at 716.Google Scholar
Moore v. City of East Cleveland, 431 U.S. 494 (1977).Google Scholar
Griswold v. State of Connecticut, 381 U.S. 479 (1965).Google Scholar
Roe v. Wade, 410 U.S. 113 (1973).Google Scholar
Strongly believed by many patients as a cure for cancer, Laetrile has since been found ineffective. See United States v. Rutherford, 442 U.S. 544 (S. Ct. 1979); Myers, B. E., “The Food and Drug Administration's Experimental Drug Approval System: Is It Good for Your Health?” Houston Law Review 28, no. 1 (1991): 309–336, at 319.Google Scholar
Kovach, S., “The Abigail Alliance,” Life Extension Special Edition (2007): 25–30, at 30, available at <http://www.abi-gail-alliance.org/> (last visited January 3, 2008).+(last+visited+January+3,+2008).>Google Scholar
Brief of Appellants at 32, Abigail Alliance (2007), 495 F.3d 695 (D.C. Cir. June 30, 2005). (“[I]t is important to recognize that the autonomy interests at stake for these patients cannot be reduced to a simple empirical disagreement with the FDA about exactly how likely it is that a particular investigational drug will help them…. But these decisions often express the patient's philosophical commitments as well as his or her cold assessment of the statistical response rates…. Certainly plaintiffs do not know the right answer for every patient. Neither, with great respect, does the Food and Drug Administration.”)Google Scholar
Terrizzi, L., “The Need for Improved Access To Experimental Drug Therapy: Aids Activists and Their Call for a Parallel Track Policy,” Administrative Law Journal 4, no. 62 (1991): 589–634, at 612–613.Google Scholar
See Citizen Petition, supra note 3, at 6. (“[P]atients who have been found ineligible for or denied participation in a clinical trial for the same drug or who, in the judgment of their physician, are not reasonable candidates for a clinical trial.”)Google Scholar
21 C.F.R. § 312.7 (1987).Google Scholar
Salbu, S. R., “Regulation of Drug Treatments for HIV and AIDS: A Contractarian Model of Access,” Yale Journal on Regulation 11 (1994): 401–453, at 434.Google Scholar
Petition for Certiorari, or Supreme Court review, was filed by Abigail on September 28, 2007.Google Scholar
See Access, Compassion, Care and Ethics for Seriously-Ill Patients Bill (ACCESS Bill) (s. 1956).Google Scholar
See Abigail Alliance, supra note 2, at 713.Google Scholar

References

Acuna v. Turkish, 930 A.2d 416, 419 (N.J. 2007).Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 420.Google Scholar
Id.Google Scholar
Id., at 420–21.Google Scholar
Id., at 424.Google Scholar
Id., at 426.Google Scholar
Id., at 425.Google Scholar
Id., at 426.Google Scholar
Id.Google Scholar
Gleitman v. Cosgrove, 227 A.2d 689 (N.J. 1967).CrossRefGoogle Scholar
Procanik v. Cillo, 478 A.2d 755 (N.J. 1984).Google Scholar
Hensel, W. F., “Disabling Impact of Wrongful Birth and Wrongful Life Actions,” Harvard University Civil Rights-Civil Liberties Law Review 40, no. 1 (Winter 2005): 141–195.Google Scholar
See Acuna, supra note 1, at 428.Google Scholar
See Gleitman, supra note 13, at 689.Google Scholar
Berman v. Allan, 404 A.2d 8 (N.J. 1979).Google Scholar
Schroeder v. Perkel, 432 A.2d 834, 841 (N.J. 1981).Google Scholar
Id., at 844.Google Scholar
Michelman v. Ehrlich, 709 A.2d 281, 287 (N.J. Super. Ct. App. Div. 1998).Google Scholar
Cansei v. Wilson, 730 A.2d 805, 811 (N.J. 1997).Google Scholar

References

U.S. Senate Finance Committee, FDA Merck and Vioxx: Putting Patient Safety First?: Testimony before the Senate Committee on Finance, 108th Congress, November 18, 2004; for one consumer protection perspective, see Public Citizen Web site, “Lessons Learned from Vioxx, the Ninth Drug Pulled Off the Market,” October 22, 2004, available at <http://www.citizen.org/pressroom/release.cfm?ID=1813> (last visited January 3, 2007); for one academic perspective, see Institute of Medicine, Committee on the Assessment of the U.S. Drug Safety System, The Future of Drug Safety, September 22, 2006.+(last+visited+January+3,+2007);+for+one+academic+perspective,+see+Institute+of+Medicine,+Committee+on+the+Assessment+of+the+U.S.+Drug+Safety+System,+The+Future+of+Drug+Safety,+September+22,+2006.>Google Scholar
Food and Drug Administration Amendments Act of 2007, Public Law 110–85, 121 U. S. Statutes at Large 823 (2007).Google Scholar
For consistency, I treat both the provision assessing prescription drug user fees and the provisions governing the use of those fees as the PDUFA, despite the fact that the two are not technically equivalent. Title I of H.R. 3580 specifies the allocation of user fees assessed, while Title IX articulates the parameters for the new activities funded by the fees.Google Scholar
H.R. Rep. No. 110–225, at 5 (2007).CrossRefGoogle Scholar
Olson, M. K., “Explaining Reductions in FDA Drug Review Times: PDUFA Matters,” Health Affairs, January 30, 2004, available at <http://content.healthaffairs.org/cgi/content/full/hlthaff.w4.s1v1/DC1> (last visited January 3, 2008); Carpenter, D. et al., “Approval Times for New Drugs: Does the Source of Funding for FDA Staff Matter?” Health Affairs, December 17, 2003, available at <http://content.healthaffairs.org/cgi/reprint/hlthaff.w3.618v1> (last visited January 3, 2008).+(last+visited+January+3,+2008);+Carpenter,+D.+et+al.,+“Approval+Times+for+New+Drugs:+Does+the+Source+of+Funding+for+FDA+Staff+Matter?”+Health+Affairs,+December+17,+2003,+available+at++(last+visited+January+3,+2008).>Google Scholar
See Institute of Medicine, supra note 1; Government Accountability Office, “Drug Safety: Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process,” March 2006, available at <http://www.gao.gov/new.items/d06402.pdf> (last visited January 3, 2008). (last visited January 3, 2008).' href=https://scholar.google.com/scholar?q=6+See+Institute+of+Medicine,+supra+note+1;+Government+Accountability+Office,+“Drug+Safety:+Improvement+Needed+in+FDA's+Postmarket+Decision-Making+and+Oversight+Process,”+March+2006,+available+at++(last+visited+January+3,+2008).>Google Scholar
Kweder, S., Deputy Director, Office of New Drugs, FDA, speaking before the U.S. Senate Committee on Finance, supra note 1; for a critical review, see Institute of Medicine, supra note 1.Google Scholar
See Government Accountability Office, supra note 6, at 15.Google Scholar
Id., at 28.Google Scholar
See supra note 4, at 6.Google Scholar
Hennessy, S. Strom, B. L., “Drug Safety's Golden Moment of Opportunity,” New England Journal of Medicine 356, no. 17 (April 26, 2007): 1703–1704.CrossRefGoogle Scholar
See Government Accountability Office, supra note 6, at 4–5.Google Scholar
Id., at 24.Google Scholar
FDA, “Prescription Drug User Fee Act: Public Meeting,” Federal Register 72, no. 9 (January 16, 2007): at 1743.Google Scholar
Id., at 1745.Google Scholar
Id.Google Scholar
See supra note 4, at 2.Google Scholar
Id.Google Scholar
Letter from William Vaughan, Senior Policy Analyst, Consumers Union, to FDA (Februay 16, 2007), available at <http://www.consumersunion.org/pub/0216%20PDUFA%20statement.pdf> (last visited January 3, 2008).+(last+visited+January+3,+2008).>Google Scholar
See Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110–85, 121 Stat. 823, 828 (2007).Google Scholar
See supra note 4, at 27.Google Scholar
21 U.S.C.A. §355 (West 2007).Google Scholar
Kracov, D., “The Complete Pharm Exec Guide to PDUFA,” Pharmaceutical Executive (September 1, 2007), available at <http://www.pharmexec.com/pharmexec/PE+Features/The-Complete-Pharm-Exec-Guide-to-PDUFA/ArticleStandard/Article/detail/455800?contextCategoryId=418> (last visited January 3, 2008).+(last+visited+January+3,+2008).>Google Scholar
21 U.S.C.A. §333 (West 2007).Google Scholar
Letter from Michael Leavitt, U.S. Secretaryy of Health and Human Services, to Nancy Pelosi, Speaker, H. R., 2 (Mar. 16, 2007), available at <http://www.fda.gov/cder/pdufa/PDUFA_IV.pdf> (last visited January 3, 2008).+(last+visited+January+3,+2008).>Google Scholar
FDA, “PDUFA Reauthorization Performance Goals and Procedures,” 2007, available at <http://www.fda.gov/oc/pdufa4/pdufa4goals.html> (last visited November 11, 2007).+(last+visited+November+11,+2007).>Google Scholar
See Leavitt, , supra note 25.Google Scholar
Conko and Wildermuth note that overregulation at the pre-market drug review phase could lead to lost life-years. See Conko, G. Wildermuth, E., “Drug Review Drag,” Washington Times, October 10, 2007, available at <http://washingtontimes.com/apps/pbcs.dll/article?AID=/20071010/COMMENTARY/110100008/1012> (last visited January 3, 2008).+(last+visited+January+3,+2008).>Google Scholar
California Senate Office of Research, “Monitoring Adverse Reactions to Drugs,” July 2005, at 9, available at <http://www.sen.ca.gov/sor/REPORTS/REPORTS_BY_SUBJ/HEALTH/Adversereaction.pdf> (last visited January 3, 2008).+(last+visited+January+3,+2008).>Google Scholar
See FDA, supra note 26.Google Scholar
21 U.S.C.A. §355–1 (West 2007).Google Scholar
Measuring the possible effect of PDUFA on drug innovation is a difficult, if not impossible task. But at least one crude measure, the number of New Drug Applications (NDAs), shows that steady fee increases in the past have not definitively affected the number of new drug applications. See FDA, “Number of NDAs Received by Calendar Year,” January 16, 2007, available at <http://www.fda.gov/cder/rdmt/numofndareccy.htm> (last visited January 3, 2008).+(last+visited+January+3,+2008).>Google Scholar
See Goldhammer, A., “PhRMA Statement at the Food and Drug Administration's Prescription Drug User Fee Act Public Meeting,” February 16, 2007, available at <http://www.fda.gov/ohrms/dockets/dockets/07n0005/07n-0005-ts00019-goldhammer.pdf> (last visited January 3, 2008); Lawton, A., “FDA Public Meeting on the Prescription Drug User Fee Act,” presentation on behalf of Biotechnology Industry Organization, February 16, 2007, available at <http://www.fda.gov/ohrms/dockets/dockets/07n0005/07n-0005-ts00010-lawton.pdf> (last visited January 3, 2008). (last visited January 3, 2008); Lawton, A., “FDA Public Meeting on the Prescription Drug User Fee Act,” presentation on behalf of Biotechnology Industry Organization, February 16, 2007, available at (last visited January 3, 2008).' href=https://scholar.google.com/scholar?q=33+See+Goldhammer,+A.,+“PhRMA+Statement+at+the+Food+and+Drug+Administration's+Prescription+Drug+User+Fee+Act+Public+Meeting,”+February+16,+2007,+available+at++(last+visited+January+3,+2008);+Lawton,+A.,+“FDA+Public+Meeting+on+the+Prescription+Drug+User+Fee+Act,”+presentation+on+behalf+of+Biotechnology+Industry+Organization,+February+16,+2007,+available+at++(last+visited+January+3,+2008).>Google Scholar