FDA authority to remove products from market would be undermined by S 1035, agency testifies.
This article was originally published in The Gray Sheet
Executive Summary
FDA AUTHORITY TO REMOVE PRODUCTS FROM MARKET WOULD BE COMPROMISED by "The Access to Medical Treatment Act" (S 1035), FDA Executive Assistant to the Commissioner Jerold Mande asserted at a July 30 hearing on the bill before the Senate Labor and Human Resources Committee. The bill, sponsored by Minority Leader Tom Daschle (D-S.D.), would allow health practitioners to administer unapproved drugs, devices, foods or dietary supplements as long as there is no evidence that the treatment causes harm and the patient is informed about the treatment and its possible side effects.