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Latest From Sue Darcey
Device Week, 17 May 2019 – Gottlieb Talks Reimbursement; DeLauro Breathes New Life Into Medical Device Safety Act
In this week's Medtech Insight podcast, Danny Al-Faruque discusses a recent speech by former FDA head Scott Gottlieb at the National Press Club in Washington, DC, that focused on product reimbursement issues. And Sue Darcey talks about a new push by US Rep. Rosa DeLauro to remove PMA-product liability suit protections for devices, with her reintroduction of the Medical Device Safety Act.
Two duodenoscope manufacturers – Olympus and Pentax – this week joined Fujifilm in saying they are aware of Senate HELP Committee ranking member Patty Murray’s concerns about recently released duodenoscope contamination levels and are working to complete postmarket surveillance studies of their devices, as required by the US FDA.
A US House representative and two co-sponsors have reintroduced the Medical Device Safety Act, which would remove the defense against state product liability suits for premarket-approved devices from the Federal Food, Drug, and Cosmetic Act (FDCA).
In an address to the National Press Club on 10 May, former FDA Commissioner Scott Gottlieb pointed to some of the challenges that CMS would face in supplying coverage for new technology, should a "Medicare for All" bill be adopted by Congress and signed by the president. Medtech Insight analyzed provisions that could impact industry in some of the proposed bills, in a comparative chart.
Sen. Patty Murray sent a letter this week to the three sole US duodenoscope-makers – Olympus, Fujifilm and Pentax – asking the firms to bring the contamination rates on their scopes down to between 0% and 1%. Murray's letter pointed to recent “troubling findings” from the FDA on rates of contamination from high-concern organisms.
US House Would Boost NIH Spending By $2Bn, Support Precision Medicine, BRAIN Initiative, Cybersecurity Funds
The US National Institutes of Health would get a 5% raise of $2bn under a 2020 budget increase to $41.1bn, spending that would go to boost precision medicine research, the BRAIN Initiative, Cancer Moonshot, cybersecurity and other important programs.