Recent Developments in Health Law

Abigail Alliance v. von Eschenbach , 445 F.3d 470, 486 (D.C. Cir. 2006).

Abigail Alliance v. von Eschenbach , 495 F.3d 695 (D.C. Cir. 2007).

Citizen Petition of the Abigail Alliance and the Washington Legal Foundation, June 11, 2003, at 5–6 [hereinafter cited as Citizen Petition].

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).

See Abigail Alliance, supra note 2, at 711.

Id., at 712–713.

Id., at 714.

Skinner v. Oklahoma ex rel. Williamson , 316 U.S. 535, 541 (1942).

Washington v. Glucksberg , 521 U.S. 702, 766 (1997).

Id., at 720–21.

See Abigail Alliance, supra note 2, at 716.

Id., at 716, 728.

See Glucksberg, supra note 9, at 720.

See Abigail Alliance, supra note 2, at 716.

Moore v. City of East Cleveland , 431 U.S. 494 (1977).

Griswold v. State of Connecticut , 381 U.S. 479 (1965).

Roe v. Wade , 410 U.S. 113 (1973).

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.

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).

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.”)

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.

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.”)

21 C.F.R. § 312.7 (1987).

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.

Petition for Certiorari, or Supreme Court review, was filed by Abigail on September 28, 2007.

See Access, Compassion, Care and Ethics for Seriously-Ill Patients Bill (ACCESS Bill) (s. 1956).

See Abigail Alliance, supra note 2, at 713.

Acuna v. Turkish , 930 A.2d 416, 419 (N.J. 2007).

Id., at 420.

Id., at 420–21.

Id., at 424.

Id., at 426.

Id., at 425.

Id., at 426.

Gleitman v. Cosgrove , 227 A.2d 689 (N.J. 1967).

Procanik v. Cillo , 478 A.2d 755 (N.J. 1984).

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.

See Acuna, supra note 1, at 428.

See Gleitman, supra note 13, at 689.

Berman v. Allan , 404 A.2d 8 (N.J. 1979).

Schroeder v. Perkel , 432 A.2d 834, 841 (N.J. 1981).

Id., at 844.

Michelman v. Ehrlich , 709 A.2d 281, 287 (N.J. Super. Ct. App. Div. 1998).

Cansei v. Wilson , 730 A.2d 805, 811 (N.J. 1997).

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.

Food and Drug Administration Amendments Act of 2007 , Public Law 110–85, 121 U. S. Statutes at Large 823 (2007).

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.

H.R. Rep. No. 110–225, at 5 (2007).

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. , “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).

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).

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.

See Government Accountability Office, supra note 6, at 15.

Id., at 28.

See supra note 4, at 6.

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.

See Government Accountability Office, supra note 6, at 4–5.

Id., at 24.

FDA, “Prescription Drug User Fee Act: Public Meeting,” Federal Register 72, no. 9 (January 16, 2007): at 1743.

Id., at 1745.

See supra note 4, at 2.

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).

See Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110–85, 121 Stat. 823, 828 (2007).

See supra note 4, at 27.

21 U.S.C.A. §355 (West 2007).

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).

21 U.S.C.A. §333 (West 2007).

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).

FDA, “PDUFA Reauthorization Performance Goals and Procedures,” 2007, available at <http://www.fda.gov/oc/pdufa4/pdufa4goals.html> (last visited November 11, 2007).

See Leavitt , supra note 25.

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).

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).

See FDA, supra note 26.

21 U.S.C.A. §355–1 (West 2007).

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).

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-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).