Sunday, November 23, 2003

AHLA's Health Law Highlights: House Clears Bill Allowing FDA To Require Pediatric Drug Testing.

On November 19, the House passed by voice vote a bill that would give the Food and Drug Administration (FDA) clear statutory authority to require drug companies to conduct appropriate pediatric clinical trials on medicines taken by children. The measure (S. 650) cleared the Senate by a unanimous vote in July. The bill would restore the FDA's so-called pediatric rule, which was invalidated by the U.S. District Court for the District of Columbia in October 2002. The court found that the FDA had exceeded its authority in imposing certain pediatric testing requirements on drug manufacturers. (Association of Am. Physicians & Surgeons v. Food and Drug Admin., No. 00-02898 (D.D.C. Oct. 17, 2002)). To read the "Pediatric Research Equity Act of 2003," search for S. 650 here.
posted by tommayo, 3:12 PM

Health care law (including public health law, medical ethics, and life sciences), with digressions into constitutional law, poetry, and other things that matter