Consumer advocates complain that the agency has become too dependent on the companies it regulates. They say they were shut out of the discussions.
The nonprofit Consumers Union lobbied Congress for a year over what it calls loopholes in FDA’s approval process for medical devices. Of particular concern to the consumer group was that the FDA routinely clears some medical implants that are similar to older devices — even if the older products were recalled for safety reasons.
‘‘This was an opportunity to improve the oversight of devices, and Congress has missed that opportunity,’’ said Lisa McGiffert, who directs Consumers Union’s Safe Patient Project.
As with prior reauthorizations, companies succeeded in adding a number of measures designed to speed approvals of their therapies.
A measure supported by medical-device makers requires the FDA to provide a rationale for denying approval of medical implants within 30 days. Medical-device lobbyists complain that the FDA has become overly cautious when reviewing routine medical devices.
Drug manufacturers also won faster approval for drugs that appear to have breakthrough potential. The FDA would be able to accept smaller, shorter clinical studies when reviewing first-of-a-kind medicines for life-threatening diseases.