FDA bill up in the air over proposed changes

FDA bill up in the air over proposed changes-politico.com:
The only health legislation that has any chance of passing before the elections this fall will be marked up by both chambers later this week, but key differences over proposed amendments to the FDA user fee bill in the House and Senate could lead to a protracted fight

FDA user fees: AdvaMed lauds progress in Congress ahead of mark up

FDA user fees: AdvaMed lauds progress in Congress ahead of mark up-massdevice.com:
Med-tech industry lobby AdvaMed lauds Congressional progress toward reauthorization of the Medical Device User Fee & Modernization Act as the U.S. Senate and House prepare to mark up the bill.

If health care is undecided…

If health care is undecided…politico.com:


If America is hoping a Supreme Court ruling will end the legal uncertainty hanging over the health care system once and for all, there’s a chance it could be sorely disappointed.

Device tax opposition gaining steam?

Device tax opposition gaining steam? -massdevice.com:
Opponents of the impending 2.3% medical device levy appear to be gaining steam as an increasing number of outlets are reporting on repeal efforts and the measure's potential to hurt jobs and innovation.

It's still the U.S. economy, stupid - Ben White - POLITICO.com

It's still the U.S. economy, stupid - Ben White - POLITICO.com: "Here are POLITICO’s Five Economic Questions That Will Decide 2012"

GOP Sens. Burr and Coburn team up for PATIENTS' FDA Act

GOP Sens. Burr and Coburn team up for PATIENTS' FDA Act


Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) team up again in calling for reforms to the FDA's authority, transparency and management in reviewing medical devices.

Democratic "buyers' remorse" for health care law?

Democratic "buyers' remorse" for health care law?-MassDevice.com
A growing number of Democratic legislators are raising concerns about President Barack Obama's landmark health care reform ahead of election season

AdvaMed unveils new 3-year plan

AdvaMed unveils new 3-year plan-massdevice.com:

New AdvaMed chairman David Dvorak unveils his 3-prong, 3-year strategy for helping the medical device industry through tough times by capitalizing on emerging markets, building research capacity and increasing stakeholder engagement.

FDA: Safety, efficacy, public health – and economy?

FDA: Safety, efficacy, public health – and economy?-massdevice.com:

The U.S. House version of a bill reauthorizing FDA review user fees would add employment and economic considerations to the federal watchdog agency's mission statement.

Medical device tax: Price hikes, layoffs, budget cuts ahead

Medical device tax: Price hikes, layoffs, budget cuts ahead-massdevice.com:
A survey of med-tech financial executives finds that most expect to see negative effects from the impending 2.3% medical device tax, including layoffs, price hikes, budget cuts and general confusion about how to comply by the new tax code.

Medical Device Tax: Will Elizabeth Warren's support for repeal send a signal to other Dems?

Medical Device Tax: Will Elizabeth Warren's support for repeal send a signal to other Dems?-massdevice.com:

Will support for repealing the medical device tax repeal from Elizabeth Warren, who's dazzled liberals and raised big bucks from left-wing groups across the country in her run for the U.S. Senate, help generate more support among Democrats for killing the medical device tax?

Senators Grassley and Kohl Send Another Letter to CMS Regarding Implementation of the Sunshine Act

Senators Grassley and Kohl Send Another Letter to CMS Regarding Implementation of the Sunshine Act-massdevice.com:
Senators Charles Grassley and Herb Kohl have sent a letter to Marilyn Tavenner, Acting Administrator of the Centers for Medicare and Medicaid Services ("CMS"), regarding implementation of the "Transparency Reports and Reporting of Physician Ownership or Investment Interests" section of the Patient Protection and Affordable Care Act ("PPACA"). This section of PPACA, commonly referred to as the Sunshine Act, was co-authored and co-sponsored by Senators Grassley and Kohl.

Budget: Flash in the Pan-nationaljournal.com

Budget: Flash in the Pan-nationaljournal.com:
The frenzied popularity of “cutting loopholes” to wring revenue from the tax code is akin to the first days of the California gold rush. Caught up in the excitement, lawmakers talk as if they’re just one pan away from getting rich. But few have the will, or the backing, for the intensive work of blasting rock and digging mines. And, in some ways, eliminating tax expenditures on the scale imagined in more than one budget proposal on Capitol Hill is the equivalent of moving mountains.

Health Law Can Keep Its Beat Without a Mandate: BGOV Insight

Health Law Can Keep Its Beat Without a Mandate: BGOV Insight
...the individual mandate, for all its controversy and potential impact on the U.S. health care system, doesn’t cover the depth and breadth of the law’s full intent. The individual mandate is intended as one means to the desired end of universal coverage. It isn’t the heart of an effort to transform the way health care is delivered and paid for.

This is subscription only content, to see full article e-mail: amelia_kelly@edwards.com

Medical Device Tax: Ten companies in line for a whack

Medical Device Tax: Ten companies in line for a whack-massdevice.com:

Ten of the companies slated to take a 2.3% hit to their top lines next year could also see huge whacks to their bottom lines, according to a MassDevice.com analysis.

Obama ‘confident’ Supreme Court will uphold health care law

Obama ‘confident’ Supreme Court will uphold health care law-washingtonpost.com:
President Obama challenged the Supreme Court on Monday to uphold his administration’s sweeping health-care reform legislation, arguing that overturning the law would amount to an “unprecedented, extraordinary step” of judicial activism.

MDUFMA: Shuren, Burr renew hostilities over FDA's medical device reviews

MDUFMA: Shuren, Burr renew hostilities over FDA's medical device reviews-massdevice.com:

The FDA was back on Capitol Hill Thursday, selling the benefits of its $600 million promise to the medical device industry to get better, the same day that a GAO report called the watchdog agency out on being "inconsistent" in its reviews of complex medical devices.

Medical device tax becomes a political pinball

Medical device tax becomes a political pinball-massdevice.com:

The 2.3% medical device tax set to start next year has become a political pinball, surfacing in the run for the Republican nomination and at least 2 Senate races.

GAO: FDA "inconsistent" in meeting performance goals

GAO: FDA "inconsistent" in meeting performance goals-massdevice.com:

The FDA met most performance goals between 2003 and 2010, but was inconsistent in its review of pre-market approval applications, especially those marked "expedited," according to a Government Accountability Office report.