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FDA Law and Drug Regulation

Also see: Medical Devices, Drugs, Marijuana and Narcotics Laws, general Products Liability, and Federal Preemption of State Law.

Presentations

History of the FDA

Introduction to Drug Regulation

Products Liability for Drugs

Regulation of Labeling and Promotion of Drugs

Statutes and Regulations

Federal Food, Drug, and Cosmetic Act

Public Health Service Act - includes quarantine and regulation of biologic products.

Reports

Pediatric Drug Research: The Study and Labeling of Drugs for Pediatric Use under the Best Pharmaceuticals for Children Act, by Marcia G. Crosse, director, health care, before the Subcommittee on Health, House Committee on Energy and Commerce. GAO-07-898T, May 22, 2007.

Milestones in U.S. Food and Drug Law History

Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs — Summary of FDA Survey Research Results Final Report November 19, 2004

Cases

Ass'n of Am. Physicians & Surgeons, Inc. v. Food & Drug Admin., --- F.Supp.2d ----, 2008 WL 564942 (D.D.C. Mar 04, 2008) - Good standing analysis, including informational standing, in a challenge to an FDA regulation on Plan B

Court approves FDA review of anthrax vaccine, allows military to continue vaccinations - Rempfer v. Eschenbach, Civil Action No. 06-2131, District Court, DC (February 29, 2008)

Supreme Court strengthens federal preemption of state products liability law in medical device cases - Riegel v. Medtronic, Inc., No. 06-179 (2008)

No constitutional right to experimental drugs - Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, 495 F.3d 695 (D.C.Cir. 2007)

FDA Does Not Have The Authority to Require Pediatric Testing of Drugs - Association of American Physicians and Surgeons, Inc. v. U.S. Food and Drug Admin., 226 F.Supp.2d 204 (D.D.C. Oct 17, 2002)

Brief - Clinical Trial Issues Result in Criminal Prosecution - U.S. v. Prigmore, 243 F.3d 1 (1st Cir. 2001)

Brief - 5th Circuit Reaffirms MDA Preemption - Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001)

Brief - Supreme Court Rejects State Law Fraud on the FDA Claim - Buckman Co. v. Plantiffs' Legal Committee, 121 S.Ct. 1012, 148 L.Ed.2d 854 (U.S. 2001)

Brief - The Supreme Court rules that the FDA has no authority to regulate tobacco - FDA v. Brown & Williamson Tobacco Corp., No. 98-1152 (U.S. 03-21-2000)

Brief - Does PMA approval trigger federal preemption of state lawsuits against a medical device supplier? - Haidak v. Collagen Corp., 67 F.Supp.2d 21 (D.Mass. 1999) and Weiland v. Telectronics Pacing Systems, Inc., 721 N.E.2d 1149 (Ill. 1999)

Brief - Can plaintiffs sue medical device manufacturers for defrauding the FDA? - In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781 (3rd Cir. 1999)

Congress Modifies Roche v. Bolar and SC Extends Exception to Devices - Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661, 110 S.Ct. 2683, 110 L.Ed.2d 605, (U.S.1990)

FDA cannot ignore their own findings when making a rule on pasteurization of milk - Public Citizen v. Heckler, 653 F. Supp. 1229 (D.D.C. 1986)

Heckler v. Chaney et al., 105 S. Ct. 1649, 470 U.S. 821 (1985) - Court rejects claim that FDA must regulate drugs used for lethal injections.

Experimental Use Defense Rejected for FDA Testing - Roche Products Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 04-23-1984)

Court finds that FDA regulations preempt state regulation of hearing aid sales - Com. of Mass. v. Hayes, 691 F.2d 57 (1st Cir.(Mass.) 1982)

Supreme Court rejects a constitutional right to use unapproved drugs - laetrile case - U.S v. Rutherford., 99 S. Ct. 2470, 442 U.S. 544 (1979)

Banning Use of Laetrile Does Not Violate Right to Privacy - People v. Privitera, 23 Cal. 3d 697, 591 P.2d 919, 153 Cal. Rptr. 431 (Cal. 1979)

Supreme Court favors reviewability of administrative actions - Abbott Laboratories et al. v. Gardner, 87 S. Ct. 1507, 387 U.S. 136 (1967)

Companion case to Abbott Labs denying pre-enforcement review - Toilet Goods Association v. Gardner, 87 S. Ct. 1520, 387 U.S. 158 (1967)

 

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