FDA Law and Drug Regulation
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
A Guide to Resources on the History of the Food and Drug Administration. Rockville, Md. (5600 Fishers Lane, Rockville 20857: Food and Drug Administration, History Office, 1995. Print.
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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