Biznes · 16.03.20001 min czytania
Decision in Washington Legal Foundation v. Henney
Automatyczne tłumaczenie lokalne · Oryginalny język źródła
Streszczenie
In the Federal Register of August 12, 1999 (64 FR 44025), the Food and Drug Administration (FDA) published in its entirety an order entitled "Final Amended Order Granting Summary Judgment and Permanent Injunction." The order was entered by the United States District Court for the District of Columbia in Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (1999). The Court of Appeals subsequently vacated the district court decision and injunction (and earlier decisions and injunctions) insofar as they declared unconstitutional (1) Statutory provisions concerning the dissemination by manufacturers of certain written materials concerning new uses of approved products (21 U.S.C. 360aaa et seq.), and (2) an FDA guidance document concerning certain industry-supported scientific and educational activities known generally as industry-supported continuing medical education or "CME." Washington Legal Foundation v. Henney, No. 99-5304, 2000 WL 122099, slip op. (D.C. Cir. Feb. 11, 2000). Consequently, these statutory provisions now constitute a "safe harbor" for manufacturers that comply with them; the CME guidance document details how the agency intends to exercise its enforcement discre