FDA Product Testing May Go Private: Under...

FDA Product Testing May Go Private: Under proposals for Food and Drug Administration reform being considered by both houses of Congress, companies seeking approval of new drugs and medical devices would be able to pay contractors of their choosing to conduct the safety and effectiveness reviews that until now have been the responsibility of the FDA. Hearings began Wednesday in the House of Representatives on three FDA reform bills. Proponents of the measures, and of a similar but more moderate Senate version, contend that thousands of lives have been lost because FDA bureaucrats have delayed the approval of important new products. Opponents predict thousands of lives will be lost if the government’s oversight of the nation’s drugs, medical devices and food supply is weakened. The Senate bill would allow makers of medical devices to hire private companies to review applications for government approval of all new devices, including heart pacemakers, implantable catheters and others whose safety is considered most critical. The FDA would make decisions based on the contractors’ findings. Under the Senate bill, if the FDA fails to meet tight drug-approval deadlines, then a review system involving the use of private contractors would be created for drugs as well. Two House bills would also allow makers of drugs and medical devices to seek private-sector review.