The early morning failure of a "skinny repeal" health care bill on July 28 caused by the defection of Republican Sens. John McCain, Lisa Murkowski and Susan Collins was also a setback for device lobbyists, as the bill contained an extended delay of the device tax until Dec. 31, 2020. But with the Obamacare repeal effort over for now, there may be quicker action on another top industry priority –passage of FDA user-fee reauthorization.
A failed last-ditch effort in the Senate by Leader Mitch McConnell, R-Kent., to get his party to accept a "skinny repeal" version of a GOP health care bill early on July 28 could also spell the end of industry's chances to win a device tax repeal or delay this year – unless they can find another legislative vehicle.
But the at least temporary pause in the Senate's focus on health-care reform provides the opportunity for another industry-favored bill...
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
