Democrats in the U.S. House, concerned about a pair of high-profile medical devices, want the Energy & Commerce Committee to open a probe into gastric band and vaginal mesh products.
The Dems are waging a partisan battle with the Republicans in control of the committee over the user fees the device industry pays to have the FDA review its products. The fees are set by the Medical Device User Fee & Modernization Act, which is set to be re-authorized this year – provided that the industry and the agencyu can come to an agreement.
Democrats on the panel first called for a hearing on the devices, which they say can develop "serious defects" after implantation, in October, according to The Hill. But the real goal is to cast light on what they see as shortcomings with the approval process that endanger patients’ safety.
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The device industry and its Republican allies on the committee "are pushing hard for a more streamlined and quicker process," according to The Hill.
"We remain concerned that the Committee’s previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation," according to a letter Democrats wrote to top Republicans on the panel. "We hope you will reconsider your approach so that the Committee can have a fuller understanding of these critical issues as we prepare to reauthorize the Medical Device User Fees Act."
Earlier this week, the FDA missed a deadline for submitting the new MDUFMA proposal to Congress.
The “robust exchange” over the MDUFMA re-authorization was to have resulted in a proposal for legislators by Jan. 15. With the Health sub-committee of the House’s Energy & Commerce Committee slated to hold a hearing Feb. 15 over the fees, it’s not clear whether the parties can agree on a proposal by then.
The industry ponied up $295 million in user fees over 5 years. The FDA wants to raise that to between $730 million and $805 million. Med-tech balked at that number, proposing to pay $447 million instead, according to minutes from a Dec. 6 meeting. The industry believes that would cover about 26% of the agency’s medical device review budget for fiscal 2017, according to the minutes of the 45-minute meeting.
“Industry believes that these additional resources would allow FDA to achieve the goals outlined in the commitment letter,” according to the minutes. “FDA noted that industry and the agency remain far apart regarding an appropriate level of resources to support the draft commitment letter. … Both sides expressed concern with how long it is taking to reach agreement on appropriate funding levels but pledged to continue to look for ways to close the gap.”
