House passes DoD bill with room to renegotiate drug, device approval provision

The US House of Representatives this week passed a nearly $700 billion defense policy bill, but left room for negotiating new terms related to a controversial provision which would have given the Dept. of Defense the power to approve medical devices and drugs without FDA clearance. The house voted 356 to 70 to approve the $692 billion National Defense Authorization Act, but left room to renegotiate and narrow the provision before the legislation is passed on to the Senate, according to a report from The Hill. The House approved a rule on Tuesday that requests that the House clerk not send the bill forward until the chamber approves a separate bill to refocus the provision, according to the report. House Armed Services Committee Chairman Mac Thornberry (R-Texas) and ranking committee member Rep. Adam Smith (D-Wash.) said they support a compromise to allow for expedited FDA approval in military medical emergencies in place of giving the Pentagon the authority to approve drugs and devices that had not been cleared by the agency. “Although we still have concerns about the impact it would have on our men and women in the field, we are content to let this compromise move forward in hopes of improvement. To be clear, if the Armed Services Committee does not see evidence that the FDA is doing a better job meeting the needs of our troops, we will not hesitate to take action,” Thornberry and Smith said in a joint statement, according to The Hill. The provision to the bill l...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Healthcare Reform Regulatory/Compliance defensedepartment Source Type: news