Four Republican senators are asking FDA commissioner Dr. Margaret Hamburg for some answers on the federal watchdog agency’s practice of issuing draft guidances to cover medical device and drug review policies.
Preventable hospital injuries claim as many as 440,000 patients’ lives each year, representing a woefully under-met area of clinical need, according to a new report released by Sen. Barbara Boxer (D-Calif.).
Sen. Boxer called on hospitals and clinics to devise and share ways to minimize common hospital injuries, such as infections and adverse drug events, in order to prevent needless deaths.
Senator Joe Donnelly (D-Ind.) is hoping to garner the support of new Senate Finance Committee Chairman Ron Wyden (D-Ore.) in efforts to repeal the medical device tax.
In an open letter issued yesterday, Donnelly congratulated Wyden on his new role and voiced concerns that the medtech tax is hurting American innovation.
A bipartisan bill that would repeal the medical device tax sponsored by Sen. Orrin Hatch (R-Utah) gained 2 more Republican sponsors in recent weeks.
Sens. Lindsay Graham (R-S.C.) and Ron Johnson (R-Wis.) each signed on to the "Medical Device Access and Innovation Protection Act," which would do away with the 2.3% excise tax levied on U.S. sales of medical devices as part of the Affordable Care Act.
MASSDEVICE ON CALL — Sen. Lamar Alexander (R-Tenn.) is ramping up his opposition to the medical device tax, spending some time with his medtech stakeholders to renew his call to repeal the tax.
MASSDEVICE ON CALL — A group of Senators is looking for more information on the FDA’s plans for mobile medical applications, querying federal official in attempts to "clarify any uncertainty with respect to assigning risk level of medical software."
MASSDEVICE ON CALL — Senator Chuck Grassley (R-Iowa) reanimated his inquiry into an Illinois university hospital and a surgeon-inventor who used his device there, following reports from an erstwhile whistleblower that claimed she was fired for providing evidence to federal investigators and for challenging the university’s star surgeon.
A comprehensive tax reform plan put together by Rep. Dave Camp (R-Mich.) would do away with the medical device tax contained in Obamacare, but the package appears to be a dead letter in Washington after Republican leaders cast doubt on its chances for a vote this year.
Camp, chairman of the House Ways & Means Committee, said it’s high time the U.S. overhauled its tax code, which hasn’t seen a major revision since 1986.