Tuesday, November 22, 2011
Supercommittee announces failure in effort to tame debt
Supercommittee announces failure in effort to tame debt-washingtonpost.com: A special congressional committee created to try to curb the national debt abandoned its work and conceded failure Monday, the latest setback in a long effort by Washington to overcome ideological differences and stem the rising tide of red ink.
Thursday, November 17, 2011
Republican senators grill FDA medical device chief Dr. Jeffrey Shuren
Republican senators grill FDA medical device chief Dr. Jeffrey Shuren-massdevice.com:FDA Center for Devices & Radiological Health chief Dr. Jeffrey Shuren got pummeled by Republican members of the Senate Health, Education, Labor & Pensions committee this week.
GOP supercommittee members’ tax plan gives party an identity crisis
GOP supercommittee members’ tax plan gives party an identity crisis-washingtonpost.com: Growing Republican support for raising taxes to help reduce the deficit has prompted a GOP identity crisis, sparking a clash within the party over whether to abandon its bedrock anti-tax doctrine.
Tuesday, November 15, 2011
Supreme Court to hear challenge to Obama's health-care overhaul
Supreme Court to hear challenge to Obama's health-care overhaul-washingtonpost.com: The Supreme Court decided on Monday to review President Obama’s 2010 health-care overhaul, promising a high-profile hearing on the question dominating American politics: the constitutional limits of the federal government’s power.
Graphic: Cases that have been appealed to Supreme Court
Graphic: Cases that have been appealed to Supreme Court
Florida's push for specific waiver in health-care law could have big implications
Florida's push for specific waiver in health-care law could have big implications-washingtonpost.com: A seemingly obscure regulatory battle in Florida could upend efforts to implement health-care reform nationwide.
Supercommittee looks to count savings on war spending-washingtonpost.com:
Supercommittee looks to count savings on war spending-washingtonpost.com: With a Thanksgiving deadline fast approaching, supercommittee members are still struggling toward a compromise on the broader package.
Wednesday, November 9, 2011
Public Split on Parties’ Super Committee Ideas
Public Split on Parties’ Super Committee Ideas-National Journal.com: With the super committee scheduled to report its findings to Congress in just two weeks, a new survey finds that slightly more Americans favor a Democratic proposal to pare the deficit with cuts and revenue increases on the wealthy rather than a cuts-only approach.
Camp Seeks Income Shifting Curbs to Pair with Overseas Tax Cuts
Camp Seeks Income Shifting Curbs to Pair with Overseas Tax Cuts- Bloomberg.com: U.S. Representative Dave Camp, the top House tax writer, is offering a multiple-choice solution to a complex international tax problem.
Camp, chairman of the Ways and Means Committee, started a debate in the tax policy world last month by proposing three ways that the U.S. could prevent companies from shifting profits offshore under a system with lighter taxes on global earnings.
The ideas are aimed at a potential byproduct of Camp’s proposal to exempt from taxation 95 percent of profits from active business operations that U.S.-based companies earn outside the country. Critics say that change could provide an incentive to move profits outside the U.S., particularly by locating intellectual property in low-tax jurisdictions.
Camp, chairman of the Ways and Means Committee, started a debate in the tax policy world last month by proposing three ways that the U.S. could prevent companies from shifting profits offshore under a system with lighter taxes on global earnings.
The ideas are aimed at a potential byproduct of Camp’s proposal to exempt from taxation 95 percent of profits from active business operations that U.S.-based companies earn outside the country. Critics say that change could provide an incentive to move profits outside the U.S., particularly by locating intellectual property in low-tax jurisdictions.
More Than 40 Lawmakers Urge FDA To Overhaul Device Review Policies
More Than 40 Lawmakers Urge FDA To Overhaul Device Review Policies- Gray Sheet:
A slew of lawmakers in both chambers are advocating major changes to FDA device reviews, with the group urging the agency to embrace a “least burdensome” approach that involves tracking device approvals in real time, harmonizing requirements with international standards, addressing new conflict-of interest rules and creating a product review tracking system, among other changes. These proposals, many of which are already tucked into pending legislation, are expected to take center stage when Congress considers reauthorizing the device user fee program next year, with lawmakers for months already raising device-related concerns.
These ideas have been included in recent bills or proposals from key lawmakers, including members of the House Energy and Commerce Committee and Senate health panel. Sen. Richard Burr (R-NC), for example, has pushed for FDA review times to include periods when firms are answering agency questions and for the clock not to pause, while Rep. Michael Burgess (R-TX) has drafted legislation to repeal advisory committee conflict of interest rules implemented as part of the last iteration of user fees.
The device industry has long argued that it faces unclear and overly burdensome device review requirements, but recent data suggest that those concerns have merit, according to the lawmakers, who pointed to information demonstrating that 510(k) review times increased 43 percent from the 2003-2007 time period to 2010, with premarket approval times jumping 75 percent.
The lawmakers -- members of the Congressional Medical Technology Caucus -- even leveraged a recent report issued by the Obama administration's Jobs Council outlining the declining investment in life sciences due to increased development costs and risk.
“Increased review times, inconsistent expectations, and poor communication from the FDA are causing a lack of confidence and instability in the industry,” the lawmakers wrote in a letter to FDA Commissioner Margaret Hamburg. “The total review times for both 510(k)s and PMAs are now actually longer than they were before the user fee program was instituted. … Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system.”
Signatories of the recent letter include Sens. Dick Lugar (R-IN), Al Franken (D-MN), Amy Klobuchar (D-MI) and Scott Brown (R-MA), and Reps. Anna Eshoo (D-CA), Erik Paulsen (R-MN), Burgess, Michele Bachmann (R-MN) and Jan Inslee (D-WA). In sum, 41 lawmakers signed the letter, which was also sent to HHS Secretary Kathleen Seblius. -- Ben Moscovitch ( bmoscovitch@iwpnews.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it )
A slew of lawmakers in both chambers are advocating major changes to FDA device reviews, with the group urging the agency to embrace a “least burdensome” approach that involves tracking device approvals in real time, harmonizing requirements with international standards, addressing new conflict-of interest rules and creating a product review tracking system, among other changes. These proposals, many of which are already tucked into pending legislation, are expected to take center stage when Congress considers reauthorizing the device user fee program next year, with lawmakers for months already raising device-related concerns.
These ideas have been included in recent bills or proposals from key lawmakers, including members of the House Energy and Commerce Committee and Senate health panel. Sen. Richard Burr (R-NC), for example, has pushed for FDA review times to include periods when firms are answering agency questions and for the clock not to pause, while Rep. Michael Burgess (R-TX) has drafted legislation to repeal advisory committee conflict of interest rules implemented as part of the last iteration of user fees.
The device industry has long argued that it faces unclear and overly burdensome device review requirements, but recent data suggest that those concerns have merit, according to the lawmakers, who pointed to information demonstrating that 510(k) review times increased 43 percent from the 2003-2007 time period to 2010, with premarket approval times jumping 75 percent.
The lawmakers -- members of the Congressional Medical Technology Caucus -- even leveraged a recent report issued by the Obama administration's Jobs Council outlining the declining investment in life sciences due to increased development costs and risk.
“Increased review times, inconsistent expectations, and poor communication from the FDA are causing a lack of confidence and instability in the industry,” the lawmakers wrote in a letter to FDA Commissioner Margaret Hamburg. “The total review times for both 510(k)s and PMAs are now actually longer than they were before the user fee program was instituted. … Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system.”
Signatories of the recent letter include Sens. Dick Lugar (R-IN), Al Franken (D-MN), Amy Klobuchar (D-MI) and Scott Brown (R-MA), and Reps. Anna Eshoo (D-CA), Erik Paulsen (R-MN), Burgess, Michele Bachmann (R-MN) and Jan Inslee (D-WA). In sum, 41 lawmakers signed the letter, which was also sent to HHS Secretary Kathleen Seblius. -- Ben Moscovitch ( bmoscovitch@iwpnews.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it )
Tuesday, November 8, 2011
Medical malpractice reform efforts stalled
Medical malpractice reform efforts stalled-politico.com:
In a bid to win support for health reform from skeptical doctors back in 2009, President Barack Obama pledged action on an item near the top of their wish list — malpractice reform.
And he delivered an initial step: $25 million to test alternatives to the medical liability system. That won praise from the American Medical Association, among others. But since then, tort reform on the federal level has been put on ice, a victim of both tight money and bitter politics.
In a bid to win support for health reform from skeptical doctors back in 2009, President Barack Obama pledged action on an item near the top of their wish list — malpractice reform.
And he delivered an initial step: $25 million to test alternatives to the medical liability system. That won praise from the American Medical Association, among others. But since then, tort reform on the federal level has been put on ice, a victim of both tight money and bitter politics.
Economic Substance May Take Away U.S. Tax Benefits: BGOV Study-bgov.com
Economic Substance May Take Away U.S. Tax Benefits: BGOV Study-bgov.com:
Tax enforcers and U.S. jurists who have relied on a judicial doctrine known as “economic substance” to determine whether a business transaction was undertaken solely to garner a tax benefit now have a statute to govern its application.
A Bloomberg Government Study, “Economic Substance: Age-Old Legal Doctrine Joins the U.S. Tax Code,” introduces the common law doctrine, summarizes the new statute passed by Congress in 2010, and examines Internal Revenue Service’s guidance released in August 2011 on how to apply the economic-substance test to a company’s transaction.
Putting the doctrine into the tax code may have important implications for the tax benefits companies claim, the study concludes. The holding company Altria Group Inc., owner of Philip Morris International Inc., may owe about $2.1 billion in federal and state taxes, excluding potential penalties, due to application of the economic-substance doctrine.
Codification of the doctrine is expected to improve tax compliance and raise $4.5 billion over 10 years, according to the Congressional Budget Office.
Tax enforcers and U.S. jurists who have relied on a judicial doctrine known as “economic substance” to determine whether a business transaction was undertaken solely to garner a tax benefit now have a statute to govern its application.
A Bloomberg Government Study, “Economic Substance: Age-Old Legal Doctrine Joins the U.S. Tax Code,” introduces the common law doctrine, summarizes the new statute passed by Congress in 2010, and examines Internal Revenue Service’s guidance released in August 2011 on how to apply the economic-substance test to a company’s transaction.
Putting the doctrine into the tax code may have important implications for the tax benefits companies claim, the study concludes. The holding company Altria Group Inc., owner of Philip Morris International Inc., may owe about $2.1 billion in federal and state taxes, excluding potential penalties, due to application of the economic-substance doctrine.
Codification of the doctrine is expected to improve tax compliance and raise $4.5 billion over 10 years, according to the Congressional Budget Office.
Monday, November 7, 2011
FDA Overrules Staff Analysis in Approving Anticlotting Drug-wsj.com
FDA Overrules Staff Analysis in Approving Anticlotting Drug-wsj.com: The Food and Drug Administration on Friday approved the latest in a class of new anticlotting drugs to prevent stroke—Xarelto from Johnson & Johnson and Bayer AG—but overruled its own staff's analysis in doing so.
Venture capitalists, trying to curb health-care costs-washingtonpost.com:
Venture capitalists, trying to curb health-care costs-washingtonpost.com: Over the past two decades, venture capitalists helped make possible striking advances in health care, including robotic surgery, cancer vaccines and genomics. But such innovations also fuel higher health-care spending, and now private investors see new opportunities in betting on companies that could curb those costs.
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