A U.S. Senate panel yesterday advanced a bill that would create a fast-track program at the FDA for breakthrough medical devices. The Senate Health, Education, Labor & Pensions committee sent the bill, S. 1077 or “A bill to provide for expedited development of and priority review for breakthrough devices,” to the Senate floor. The bill, introduced last […]
Capitol Hill
Congress targets FDA’s pre-market reviews, clinical trials for medical devices
By Stewart Eisenhart, Emergo Group Legislation advancing through both houses of the U.S. Congress would require “least burdensome” training of FDA staff involved in pre-market reviews of medical devices. Originally introduced in the Senate last year, the FDA Device Accountability Act of 2015 would impact US regulators’ premarket review process as well as requirements for Institutional […]
UPDATE: AdvaMed confirms ex-BIO COO Whitaker is new CEO
UPDATED Feb. 19, 2016, with confirmation of Whitaker’s appointment. AdvaMed, the national lobby for the medical device industry, confirmed that it tapped the chief operating officer at BIO, Scott Whitaker, to be its new CEO. Whitaker is due to replace Steve Ubl, who left last year to take the reins at PhRMA, effective April 4. […]
House GOPers fail to knock down Obama veto of anti-Obamacare bill
(Reuters) — The U.S. House of Representatives yesterday failed to override President Barack Obama’s veto of legislation that would have dismantled his signature healthcare law, the Affordable Care Act. At least a two-thirds vote of the House was needed to knock down Obama’s veto; the Republican-majority House fell short by more than 36 votes. The vote was […]
Markey puts hold on Califf’s nomination for FDA chief
(Reuters) — Sen. Edward Markey (D-Mass.) yesterday put a hold on President Barack Obama’s nominee to head the FDA until the agency agrees to reform its process for approving opioid painkillers. Markey wants opioid-approval matters to be reviewed by an FDA advisory committee and believes the committee should consider the risk of addiction and abuse during the approval […]
UPDATE: Philips forced to spike Lumileds deal on U.S. security concerns
Updated with new information on the proposed sale. (Reuters) — Royal Philips‘s (NYSE:PHG) plan to shed its lighting businesses suffered a setback on Friday when a $3.3 billion deal to offload the components division to Asian buyers was blocked by the United States on security grounds. The agreement to sell an 80% stake in the Lumileds division […]
Senate report faults hospitals, device makers, FDA for deadly ‘superbug’ outbreaks
A report by Democrats on the U.S. Senate’s health committee issued this week blames hospitals, medical device companies and the FDA for the deadly outbreaks of so-called “superbug” infections linked to duodenoscopes. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of […]
GOP tilts at the windmill again: House votes once more to repeal Obamacare
(Reuters) — The U.S. Congress yesterday approved legislation dismantling President Barack Obama’s signature healthcare plan, putting on his desk an election-year measure that faces a certain veto. Republicans have been vowing to gut the Affordable Care Act, also known as “Obamacare,” since 2010, when the then Democratic-majority Congress passed the landmark program designed to provide health […]
PA rep Fitzpatrick wants FDA to launch criminal probe into morcellator deaths
Rep. Mike Fitzpatrick (R-Pa.) wants the FDA to open a criminal investigation of several deaths associated with laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors. The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade […]
Senate health committee to vote on FDA nominee Califf
The U.S. Senate’s health committee is slated to vote Jan. 12 on President Barack Obama’s nominee to be FDA commissioner, Dr. Robert Califf. Califf, a cardiologist and longtime Duke University researcher, joined the FDA as a deputy commissioner in January 2015. Although he’s won praise from Sen. Lamar Alexander (R.-Tenn.), chairman of the Senate Health, Education, Labor & Pensions […]
Paulsen: Medical device tax pause a window for full repeal
The 2-year pause on the medical device tax enacted last week is an opportunity to push through a full repeal of the 2.3% revenue tax, Rep. Erik Paulsen (R.-Minn.) told MassDevice.com. “The next key step is just making sure the device tax repeal is permanent. So we essentially have a 2-year period to make sure that happens,” said Paulsen, who […]