By David Williams and Amy DeLong
U.S. Congress
House speaker Boehner cautions Obamacare de-funders | MassDevice.com On Call
MASSDEVICE ON CALL — House speaker John Boehner warned hard-line GOP members who want to defund healthcare reform not to go through with their dramatic gestures.
Speaking to his cohorts last week, Boehner warned that holding federal functions hostage to healthcare reform negotiations could result in backlash from the public. Boehner issued his advice after receiving a letter with signatures from 80 Republicans in Congress urging him to block Obamacare at all costs.
Obamacare leaves autism coverage to states | MassDevice.com On Call
MASSDEVICE ON CALL — Advocate groups for autism, a disease which now affects 1 in 88 U.S. children, are disappointed with the Obama administration’s decision to leave autism coverage up to each state.
FDA proposes fiscal 2014 user fee rates
The FDA wants to raise the user fees paid by medical device companies for the watchdog agency’s review by 4.2% across the board.
The FDA’s Center for Devices & Radiological Health said today that it proposes to boost the fees for both small businesses making less that $100 million annually and for their larger brethren.
The increases would cover applications for 510(k) clearance, the more stringent pre-market approval process and a raft of other applications to the FDA.
Pryor introduces Senate bill shielding FDA user fees from sequestration
Sen. Mark Pryor (D-Ark.) has introduced a bi-partisan bill to protect user fees paid by medical device and drug companies to the FDA from federal budget cuts forced by sequestration.
In March, the federal watchdog agency lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, as a result of sequestration, a bargain between the White House and Congress. Included in those cuts were the user fees medical device and pharmaceutical companies pay in order to ensure timely reviews of new devices and drugs.
Congress: House bill seeks to shield user fees from sequester with FDA S.O.S bill
Lawmakers on Capitol Hill have floated a proposal to protect user fees paid by medical device and drug companies to the FDA from federal budget cuts forced by sequestration.
In March, the federal watchdog agency lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, as a result of sequestration, a bargain between the White House and Congress. Included in those cuts were the user fees medical device and pharmaceutical companies pay in order to ensure timely reviews of new devices and drugs.
Resolving disputes concerning FDA and medical devices
By David S. Buckles, PhD, FACC, and Lawrence “Jake” Romanell
Disagreements are inevitable in science, medicine – and even life. As part of a regulatory agency committed to public health, the FDA’s medical devices center occasionally confronts scientific and policy disagreements among our staff and with the various stakeholders we strive to serve.
Disputes can occur at any stage of a particular interaction, from an initial inquiry or pre-submission review to a final regulatory decision on an application or submission.
Study: Cocky CEOs make risky investments | MassDevice.com On Call
MASSDEVICE ON CALL — Stephen Ferris, finance professor at the University of Michigan, led a study examining corporate merger and acquisition patterns, concluding that over-confident CEOs often put their companies at risk.
Ferris cautioned investors to consider a CEO’s personality when shopping for a new interest, and that companies with over-confident CEOs maintain independent boards of directors.
Medical device tax: “Citizen Cosponsors” take to web to support repeal
Since its launch last month, House Majority Leader Eric Cantor’s (R-Va.) Citizen Cosponsor website has listed nearly 3,000 bills, among them "Protect Medical Innovation Act of 2013," a measure to repeal the 2.3% medical device tax that took effect at the start of this year.
Medical device tax: Congressional duo launches tax reform tour
Medical device industry lobbying groups rallied behind Sen. Max Baucus (D-Mont.) and Rep. Dave Camp (R-Mich.) as the Congressional duo embarked on a nation-wide tax reform tour, a possible boon to efforts to repeal the medical device tax.
E.U. regulators dishing out fewer CE Marks, study finds | MassDevice.com On Call
MASSDEVICE ON CALL — European regulators have become increasingly coy with their CE Markings, especially for new medical devices, according to a report by the European Assn. for Medical Devices of Notified Bodies, or TEAM-NB.
A survey comparing data from 2010 to 2012 showed a decrease in CE Mark certificates overall and a "significant" decrease in new CE Marks, TEAM-NB reported. The trends are consistent among Europe-based as well as non-European companies, they added.