Chapter 8.C.2 (or 2.C.3)  Regulating Access to Drugs

 

Notes: Pharmaceutical Regulation

 

Note 1. Federal and State Regulation of Pharmaceuticals.

 

See Gonzales, Attorney General, et al. v. Raich et al. 545 U.S. 1, 125 S.Ct. 2195 U.S.(2005) in which the Supreme Court ruled that Congress’ Commerce Clause authority (regulation of interstate commerce) includes the power to prohibit the local cultivation and use of marijuana for medical purposes even in the 11 states that permit it. The Court concluded that intrastate regulation under the Controlled Substances Act was necessary to address (1) concerns related to medical marijuana being sold illegally and (2) enforcement issues due to the difficulty in distinguishing between local and non-locally cultivated marijuana.

 

The Reimportation Issue: 

 

The Federal Food, Drug, and Cosmetic Act (FFDCA) expressly prohibits reimportation (21 U.S.C s.381(d)(1) “except as provided in paragraph (2) and section 384 of this title, no drug… which is manufactured in a State and exported may be imported into the United States unless the drug is imported by the manufacturer of the drug.”) – ie. even if a particular drug is FDA-approved for use in the United States, it is illegal to bring the drug back into the United States through a Canadian pharmacy. Although reimportation is illegal, the above statute has not been strictly enforced and as such, there has been a problem of reimportation of prescription drugs across the border from Canada. See, United States v. Rx Depot, Inc., 290 F. Supp. 2d 1238 (N.D. Okla 2003) (reimportation law applied).

 

The U.S. Senate recently approved an amendment to the Appropriations bill for FY2007 that would stop Customs and Border Protection from seizing legitimately prescribed, FDA approved drugs being brought across the border from Canada (Department of Homeland Security Appropriations Act, 2007, H.R. 5441, 109th Cong. (2nd Sess. 2006)). See also, Senate Bars Border Guards From Stopping Drug Imports, Bloomberg, July 11, 2006, available:http://www.bloomberg.com/apps/news?pid=20601082&sid=aOW30lzPtqI0&refer=canada  (last visited July 20, 2006).

 

The FDA’s “Hot Topics: Importing Prescription Drugs” web page is a comprehensive resource for current and archived information on the prescription drug reimportation issue. Available at http://www.fda.gov/oc/opacom/hottopics/importdrugs/default.htm (last visited July 20, 2006). For a discussion of the reimportation issue and its implications see generally, Abigail Zuger, Rx: Canadian Drugs, 349 N. Engl. J. Med. 2188 (2003); see also, Richard Frank. Prescription Drug Prices 351 N. Engl. J. Med. 1375 (2004); and Kevin Outersson, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, 5 Yale J Health Pol'y, L & Ethics 193 (2005).

 

Several states have enacted regulations to allow importation of cheaper prescription drugs. The National Conference of State Legislatures tracks state legislation governing prescription drugs:  http://www.ncsl.org/programs/health/drugdisc05.htm (last visited July 20, 2006). The FDA has responded, warning these state initiatives may violate

federal law. See, e.g. http://www.fda.gov/oc/opacom/hottopics/importdrugs/perry061705.html (last visited July 20, 2006).

 

For the Canadian perspective on the reimportation issue see Bill C-282. This “Canada First” policy, although tabled in May 2005, sought to extend existing drug export regulations under the Canada Food and Drug Act in order to ensure the export of drugs could not endanger the supply to Canada and, among other objectives, to ensure the exportation did not contravene any laws of the importing country. Parliament of Canada

online http://www.parl.gc.ca/38/1/parlbus/chambus/house/bills/private/C-282/C-282_1/C-282_cover-e.html (last visited July 20, 2006).

 

Note 3.  Pharmaceutical Choice as a Constitutional Right

In a surprising decision in favor of a patient's liberty rights, a panel of the D.C. Circuit found a limited constitutional right of terminally ill persons to receive experimental drugs without FDA approval.  In Abigail Alliance v. Eschenbach, 445 F.3d 470 (D.C. Cir. 2006), the court held that terminally ill patients can use experimental drugs that have passed successfully through Phase I of the FDA's drug approval process, when no alternative treatment options are available.  Six months later, the decision was vacated, and the en banc court ultimately rejected the claim of a constitutional right to receive experimental drugs.  During the litigation, the FDA proposed a new rule to give terminally ill patients greater access to experimental drugs.  For an edited version of the panel decision, see Abigail AllianceFor the en banc decision, see Abigail Alliance (en banc).

For commentary on Abigail Alliance, see the November-December 2006  issue of the Hastings Center Report for articles by Rebecca Dresser and John Robertson and the January 10, 2007 issue of JAMA for an article by Peter Jacobson and Wendy Parmet.

Note 4. Medical Marijuana.

 

See Gonzales, Attorney General, et al. v. Raich et al. 545 U.S. 1, 125 S.Ct. 2195 U.S. (2005) in which the Supreme Court ruled that Congress’ Commerce Clause authority (regulation of interstate commerce) includes the power to prohibit the local cultivation and use of marijuana for medical purposes even in the 11 states that permit it. See also, Susan Okie, Medical Marijuana and the Supreme Court, 353 N, Eng. J. Med. 648 (2005); George J. Annas, Jumping Frogs, Endangered Toads, and California’s Medical Marijuana Law, 353 N. Eng. J. Med. 2291 (2005).

 

Note 5. The FDA and Drug Development Efforts.

 

For discussion of FDA drug fast tracking see Thomas Roberts, Jr. & Bruce Chabner, Beyond Fast Track for Drug Approvals, 351 N Engl J Med 501 (2004); see also, Eve Slater, Today’s FDA, 352 N Engl J Med 293 (2005); Susan Okiel, What Ails the FDA? 352 N Engl J Med 1063. (2005).

 

Note 6. The FDA and Nontraditional Regulation

 

For current information concerning dietary supplements and the FDA see United States v. LANE LABS-USA, INC. 324 F. Supp. 2d 547 (2004) (discussing classification of material as either a drug or a dietary supplement); see also, Burke D. and Page A., Regulating the Dietary Supplements Industry: Something Still Needs to Change, 1. Hastings Bus L J 121 (2005);

 

In Nutraceutical Corp. v. Crawford, 364 F.Supp.2d 1310 (D.Utah 2005) ephedra producers challenged validity of the FDA ban. The Court concluded that the FDA had not proven that the substance presents “an unreasonable risk of illness or injury” and the FDA’s reliance on a risk- benefit analysis was not appropriate under the Dietary Supplement Health and Education Act as the Act does not mention such a balance. The FDA further relied on inappropriate medical device provisions of the Food Drug and Cosmetics Act (FDCA). The Court stated that “such a standard would render potato chips illegal” as dietary supplements are considered foods under this Act. 

 

Note 8. Drug Labeling

 

For a discussion about a proposal to tie Medicare reimbursement for off-label prescriptions to the collection of data regarding effectiveness, see Gina Kolata, Medicare Covering New Treatments, But with a Catch, The New York Times, November 5, 2004, at A1, col. 5., full text available at Alliance for Human Research Protection online: http://www.ahrp.org/infomail/04/11/05.php (last visited July 20, 2006).

 

The 2005 Anti-Cancer Drug NCD

 

For example, in January 2005 the Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination (NCD). This policy provides for coverage of the off-label use of certain anticancer drugs for  Medicare beneficiaries who enroll in one of the nine specific clinical trials. See the National Cancer Institute’s clinical trial participation information: online: http://www.cancer.gov/clinicaltrials/developments/NCD179N (last visited July 20, 2006).

 

For a discussion about the off-label use of drugs see David Blumenthal, Doctors and Drug Companies, 351 N Engl J Med 1885 (2004); Donald Arbitblit & Wendy Fleishman, The Risky Business of Off-Label Use, 41-MAR Trial 46. (March, 2005); David Nalven, Prescription Drug Litigation: Seeking Reform Through the Courts, 49-FEB BBJ 18 (January/February, 2005); Marshall Kapp, Drug Companies, Dollars, and the Shaping of American Medical Practice, 29 SILULJ 237 (2004-2005).

 

For a discussion about direct-to-consumer advertising in the context of the Vioxx situation, see Ernst Bernt, To Inform or Persuade? Direct-to-Consumer Advertising of Prescription Drugs, 352 N Engl J Med 325 (2005); Henry Waxman, The Lessons of Vioxx – Drug Safety and Sales, 352 N Engl J Med 2576. (2005); Susan Okie, Raising the Safety Bar – The FDA’s Coxib Meeting, 352 N Engl J Med 1283. (2005).

Notes: Federal Regulation of Alcohol and Tobacco

Note 3. Tobacco Litigation.

A summary of tobacco related lawsuits and an analysis of the voluminous Master Settlement Agreement can be found at www.tobacco.neu.edu (last visited July 20, 2006).

 

For a discussion of the Master Settlement Agreement and where the money went see: Sung et. al., A Major State Tobacco Tax Increase, the Master Settlement Agreement, and Cigarette Consumption: The California Experience, 95 Am J Public Health 1030 (2005); Steven Schroeder, Tobacco Control in the Wake of the 1998 Master Settlement Agreement, 350 N Engl J Med 293 (2004).

Note 5. State and Local Tobacco Regulation.

For a global perspective see Ruth Roemer, Allyn Taylor & Jean Lariviere, Origins of the WHO Framework Convention of Tobacco Control, 95 Am J Public Health 936 (2005).