The U.S. FDA has been scrutinizing surgical meshes for safety considerations for longer than a decade, but litigation continues to dot the legal landscape. An appeals court in the state of California decreed recently that Johnson & Johnson of Franklin Lakes, N.J. must pay more than $300 million over allegations that its Ethicon subsidiary had downplayed to patients the risks associated with its pelvic meshes, but J&J said its next step is to appeal the outcome in the state’s highest court.
The U.S. FDA’s draft device user fee agreement was months late in arriving on Capitol Hill, a fact which also delayed the public meeting on the draft, an event that finally took place April 19. The meeting kicked off with an acknowledgement by second-time FDA commissioner Robert Califf of the growing role of user fees in FDA finances, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said that the quality of FDA reviews was at least as important as the timeliness of those reviews even though the user fee deals include many deadline-based metrics.
The FDA’s June 2021 draft guidance for remanufacturing of medical devices wades into a highly complicated area of compliance for third-party servicing organizations that may not be familiar with FDA regulations, but the draft has sparked another set of concerns. Two trade associations said the draft would seem to suggest that original equipment manufacturers (OEMs) must disclose confidential trade secrets to give these third parties the information needed to service these devices, a suggestion that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (AdvaMed) said is clearly out of bounds.
The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.
The FDA and device makers have finally wrapped up what may be the most contentious set of negotiations in the history of the device user fee program. Despite industrial antipathy to a recurrent doubling of user fee volumes, the fifth device user fee deal will provide the FDA with as much as $1.9 billion in user fees, roughly double the fees collected under the current agreement.
Though the Ukraine war has had an impact on the availability of medical devices and diagnostics, a number of companies based in the U.S. and Europe have announced measures to ensure their products will reach the war-torn nation. Device companies are donating millions to nongovernmental organizations for humanitarian assistance, while the Advanced Medical Technology Association (Advamed) said its member companies are tracking the situation and are eager to pitch in with desperately needed supplies and medical equipment.
The Biden administration has posted a request for information (RFI) about the conditions necessary for the in vitro diagnostic industry to sustain testing capacity for communicable disease outbreaks, although the letter commits to no specific actions. The Advanced Medical Technology Association responded to the RFI with the recommendation that the administration quickly commit to the provision of resources as a means of ensuring that “market volatility will no longer determine test availability.”
The U.S. Senate narrowly voted 50-46 to confirm Robert Califf as the next commissioner of the FDA, a critical outcome for an agency that has lacked a fully anointed commissioner for a year. Califf, who was previously FDA commissioner under President Barack Obama from February 2016 to January 2017, faces several challenges in the coming year, however, including the agency’s accelerated approval program for prescription drugs, which has added drag to the process of registering him as the new commissioner.
The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER.
U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay.
