Wednesday, January 2, 2013

Statement by the Press Secretary on H.R. 5949

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Office of the Press Secretary

For Immediate Release December 30, 2012 Statement by the Press Secretary on H.R. 5949

On Sunday, December 30, 2012, the President signed into law:

H.R. 5949, the "FISA Amendments Act Reauthorization Act of 2012," which provides a five-year extension of Title VII of the Foreign Intelligence Surveillance Act.

Blog posts on this issue December 30, 2012 11:44 AM ESTThe Year in Review: Joining Forces to Hire American HeroesThe Year in Review: Joining Forces to Hire American Heroes

In 2012, working with Joining Forces, American businesses exceeded the President's challenge to hire 100,000 veterans and military spouses and made a greater commitment for the future.

December 29, 2012 5:45 AM ESTWeekly Address: Congress Must Protect the Middle Class from Income Tax Hike

President Obama urges Congress to meet its deadlines and responsibilities, protect the middle class from an income tax hike, and lay the groundwork for future progress on more economic growth and deficit reduction.

December 29, 2012 5:05 AM ESTA Digital Milestone in 2012: 100,000,000 Video Views

Take a look at the videos that have been viewed the most.

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Obama To Introduce Immigration Reform Bill In 2013

President Obama reiterated his call for comprehensive immigration reform during an interview on Meet The Press, claiming that the effort will be a top goal in his second term. “Fixing our broken immigration is a top priority. I will introduce legislation in the first year to get that done,” Obama said.

Administration officials have hinted that Obama will “begin an all-out drive for comprehensive immigration reform, including seeking a path to citizenship” for 11 million undocumented immigrants, after Congress addresses the fiscal cliff.

The Obama administration’s “social media blitz” will start in January and is expected “to tap the same organizations and unions that helped get a record number of Latino voters to reelect the president.” Cabinet secretaries and lawmakers from both parties are already holding initial meetings to iron out the details of the proposal and Obama will to push for a broad bill.


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Idaho gets $2.9 million in drug company settlement

BOISE, Idaho -- Idaho will be collecting $2.9 million as part of the latest settlement with two national pharmaceutical companies.

Idaho Attorney General Lawrence Wasden announced Thursday an agreement reached with Pfizer Inc. and Pharmacia Corp.

The agreement stems from a 2007 lawsuit filed by Idaho and other states over allegations the companies were inflating the average wholesale prices of drugs. Idaho and other states alleged the flawed pricing system was causing Medicaid programs to overpay for drugs like Zyrtec and Celebrex.

The settlement is intended to reimburse taxpayers for the excessive prices Idaho Medicaid paid for prescription medicines.

So far, Wasden and his office have recovered more than $25 million in similar settlements with 36 drug makers. Lawsuits are still pending against two other companies.


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FDA clears anticlotting drug Eliquis

WASHINGTON -- The Food and Drug Administration said Friday that it approved an anticlotting drug called Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc. It's a potential blockbuster in a new category of medicines to prevent strokes.

The agency previously rejected the drug twice, most recently in June, awaiting additional data from company trials.

The FDA cleared the pill for treating the most common type of irregular heartbeat, atrial fibrillation, in patients at risk for strokes or dangerous clots.

About a quarter of all people aged 40 and older develop atrial fibrillation, a condition in which the heart's two upper chambers contract irregularly and don't pump blood efficiently. This can persist for years or only happen occasionally. The condition increases the risk of a stroke fivefold.

For decades atrial fibrillation patients were treated with the blood thinner warfarin, sold under brands that included Coumadin. While warfarin is cheap, users must get frequent blood tests to ensure they're getting enough to prevent strokes but not too high a dose, which can cause dangerous internal bleeding.

In the last two years drug regulators in the U.S. and other countries have approved two other new anticlotting drugs for patients with atrial fibrillation: Pradaxa, from German drugmaker Boehringer Ingelheim, and Xarelto from partners Johnson & Johnson and Bayer Healthcare.

Some analysts have said Eliquis, known chemically as apixaban, is the best of the three new drugs, but Pradaxa and Xarelto got a big head start in building U.S. market share. That means that Pfizer and Bristol-Myers could have a tough job persuading doctors and patients who already have switched from warfarin to Pradaxa or Xarelto to again switch medication.

Eliquis is manufactured by Bristol-Myers Squibb and co-marketed with Pfizer. Both companies are based in New York.

The FDA said it approved the drug based on an 18,000-patient study conducted by the drugmakers. The trial showed that patients taking Eliquis had fewer strokes than those taking warfarin.

The agency warned that patients with artificial heart valves should not take the drug because it was not studied in that population.

In after-hours trading Bristol-Myers rose 60 cents to $32.50. Pfizer picked up 13 cents at $25.02.


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Lindsay Graham: I Will Destroy America’s Solvency Unless The Social Security Retirement Age Is Raised

Although official Washington is currently fixated on the so-called “Fiscal Cliff,” the biggest threat to American prosperity is the debt ceiling, which must be raised in February to prevent economic catastrophe. If Republicans refuse to reach a deal on the so-called cliff, the Congressional Budget Office predicts that they will spark a new recession in 2013. But if Republicans block action on the debt ceiling, they will make that potential recession look quaint. Without raising the debt ceiling, the United States will be forced to embrace austerity so severe it will lead to “a bigger GDP drop than that experienced during the Great Recession of 2008.”

But in an interview on Fox News Sunday this morning, Sen. Lindsey Graham (R-SC) threatened to oppose this must-pass bill unless Social Security benefits are taken away from millions of future retirees:

I’m not going to raise the debt ceiling unless we get serious about keeping the country from becoming Greece, saving Social Security and Medicare [sic]. So here’s what i would like: meaningful entitlement reform — not to turn Social Security into private accounts, not to take a voucher approach to Medicare — but, adjust the age for Social Security, CPI changes and means testing and look beyond the ten-year window. I cannot in good conscience raise the debt ceiling without addressing the long term debt problems of this country and I will not.

Watch it:

This is extortion, plain and simple. It is the budgetary equivalent of threatening to break America’s legs unless Congress agrees to break the backs of millions poised on the edge of retirement. Graham’s position is that seniors should have to wait longer for their retirement benefits — even if they work in physically demanding jobs that literally tear the body apart by the time a worker reaches age 65 — and that those benefits should be reduced in the future.

And if Congress won’t agree to this deal, then Graham is prepared to thrust the nation into an economic calamity unheard of since the Great Depression.


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The Best Calls You've Never Heard

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Did You Hear About the 'Doctor' Cliff?

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Bristol-Myers, Pfizer's Eliquis approved in Japan

TRENTON, N.J. -- Regulators in Japan have approved sales of an anticlotting drug called Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc., that's a potential blockbuster in a new category of medicines to prevent strokes and heart attacks. But that's only if it can win U.S. approval, as two rival drugs have done.

Pfizer and Bristol-Myers said Wednesday that Japan approved use of Eliquis for treating the most common type of irregular heartbeat, atrial fibrillation, in patients at risk for strokes or dangerous clots called systemic embolisms. Already approved for sale in Canada and the European Union, Eliquis has twice been rejected by the U.S. Food and Drug Administration.

About a quarter of all people aged 40 and older develop atrial fibrillation, a condition in which the heart's two upper chambers contract irregularly and don't pump blood efficiently. This can persist for years or only happen occasionally. It increases the risk of a stroke fivefold, and strokes caused by atrial fibrillation are more severe than other strokes, with half of patients who suffer them dying within a year if not treated.

For decades, atrial fibrillation patients were treated with the blood thinner warfarin, sold under brands including Coumadin. While warfarin is very cheap, users must get frequent blood tests to ensure they're getting enough to prevent strokes but not too high a dose, which can cause dangerous internal bleeding.

In the last two years, drug regulators in the U.S. and other countries have approved two new anticlotting drugs for patients with atrial fibrillation and other conditions: Pradaxa, from German drugmaker Boehringer Ingelheim, and Xarelto, from partners Johnson & Johnson and Bayer Healthcare.

Some analysts have said Eliquis, known chemically as apixaban, is the best of the three new drugs, but Pradaxa and Xarelto got a big head start in building U.S. market share. That means that if Eliquis is approved by the FDA, Pfizer and Bristol-Myers will have a tough job persuading doctors and patients who already have switched from warfarin to Pradaxa or Xarelto to again switch medication.

The FDA originally was to decide whether to approve Eliquis last March, but said it needed more time to review new data. In June, the FDA said it couldn't approve the drug until the companies provided more information on "data management and verification" from a huge international study called ARISTOTLE. That was submitted in September. The FDA is scheduled to rule by March 17.

Approval in Japan, the world's second-biggest market for prescription drugs after the U.S., will boost sales of Eliquis, but U.S. sales are needed to reach blockbuster status _ annual sales of more than $1 billion.

The makers of all three drugs must persuade doctors and consumers that their pill is the most effective and safest, and that it's worth the extra cost. Xarelto and Pradaxa both cost roughly $250 per month. Pfizer and Bristol-Myers have not disclosed a price for Eliquis. Warfarin typically costs less than $10 per month, plus at least $1,600 a year for frequent tests of its level in the blood.

Johnson & Johnson has not has not yet reported sales figures for Xarelto. However, partner Bayer reported Xarelto sales totaling about $235 million in the first nine months of this year. Boehringer Ingelheim reported Pradaxa sales of about $615 million worldwide in the first half of 2012.

In afternoon trading, shares of Bristol-Myers were down 12 cents at $32.34, and Pfizer shares were up 11 cents at $25.19.

___

Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma.


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Senate Waters Down Privacy Protections For Online Video Streaming

Last week, the Senate quietly agreed to allow video streaming companies such as Netflix to share data on of their customers’ streaming histories for up to two years — after only asking their permission once. The Video Privacy Protection Act (VPPA), had previously mandated that consent be obtained from an individual each time their video-watching history was shared. It also requires law enforcement to obtain a warrant, court order, or grand jury subpoena to acquire that history, and prevents companies from sharing it for marketing purposes — provisions which all appear to remain in place.

The new bill has already been adopted by the House, and is now on its way to President Obama’s desk. Adam Serwer at Mother Jones has the latest:

Last Tuesday, the Senate quietly altered a key privacy law, making it much easier for video streaming services like Netflix to share your viewing habits. How quietly? The Senate didn’t even hold a recorded vote: The bill was approved by unanimous consent. (Joe Mullin of Ars Technica was among the first to note the vote.) [...] Video streaming companies that want to share your data now only need to ask for your permission once. After that, they can broadcast your video-watching habits far and wide for up to two years before having to ask again.

VPPA was originally passed in 1988 following outrage at the publication of Supreme Court nominee Robert Bork’s video rental history by a Washington newspaper. (An irony, as Serwer notes, given Bork’s own hostility to privacy rights.) The law caused headaches for Netflix’s attempt to integrate their services with Facebook, an arrangement the company has brought to over 40 countries but has yet to debut in the United States. Netflix recently challenged the application of the law to online streaming video, but was rebuffed by a federal district court.

Both Facebook and Netflix lobbied enthusiastically in the second half of 2012 for the changes to the VPPA, spending $1.6 million dollars and $400,000, respectively. Those efforts paid off with last week’s alteration.

The change was originally intended as a trade-off: Sen. Patrick Leahy (D-VT) inserted language that would’ve strengthened privacy protections for email and other personal online documents under the Electronic Communications Privacy Act (EPCA), even as it declawed the VPPA. But then the House passed a version of the VPPA update without the balancing update to the EPCA. That forced a negotiation, and the Senate eventually gave in to the House’s version.

Leahy has called for the Congress to take up the issue of strengthening EPCA’s online protections again next year. But as Serwer dryly points out, “not even the CIA director losing his job in the wake of an FBI investigation that led to no actual charges could provoke Congress into updating the country’s digital privacy laws. So Leahy’s calls for reform appear likely to go unanswered.”

Wording in the first paragraph has been altered for clarity. As far as ThinkProgress is aware, the provision concerning consent to share data is the only aspect of VPPA that has been altered of those listed.


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Citing Citizens United, Federal Appeals Court Blocks Access To Birth Control

On Friday, a divided panel of the United States Court of Appeals for the Seventh Circuit, in an order joined by two conservative Republican appointees, temporarily immunized a company from the Obama Administration’s rules guaranteeing that employer-provided health plans cover birth control. Judge Ilana Rovner, a George H.W. Bush appointee, dissented.

The order is brief, and it mostly deals with the most significant issue in this case in just a single paragraph — holding that a for-profit corporate employer can claim that its religious liberties were somehow violated:

[T]he government’s primary argument is that because K & L Contractors is a secular, for-profit enterprise, no rights under RFRA are implicated at all. This ignores that Cyril and Jane Korte are also plaintiffs. Together they own nearly 88% of K & L Contractors. It is a family-run business, and they manage the company in accordance with their religious beliefs. This includes the health plan that the company sponsors and funds for the benefit of its nonunion workforce. That the Kortes operate their business in the corporate form is not dispositive of their claim. See generally Citizens United v. Fed. Election Comm’n, 130 S. Ct. 876 (2010). The contraception mandate applies to K & L Contractors as an employer of more than 50 employees, and the Kortes would have to violate their religious beliefs to operate their company in compliance with it.

As a matter of current law, this decision is wrong. As the Supreme Court explained in United States v. Lee, “[w]hen followers of a particular sect enter into commercial activity as a matter of choice, the limits they accept on their own conduct as a matter of conscience and faith are not to be superimposed on the statutory schemes which are binding on others in that activity.” Lee established — with no justice in dissent — that religious liberty does not allow an employer to “impose the employer’s religious faith on the employees,” such as by forcing employees to give up their own rights because of the employer’s objections to birth control.

Nevertheless, the Seventh Circuit’s citation to Citizens United is an ominous sign. Lee was decided at a time when the Court understood that corporations should not be allowed to buy and sell elections. That time has passed, and the precedents protecting against corporate election-buying were overruled in Citizens United. It is not difficult to imagine the same five justices who tossed out longstanding precedent in Citizens United doing the same in a case involving whether employers can impose their religious beliefs on their employees.

It is likely that we will know soon whether those five justices are prepared to do so. The Seventh Circuit’s decision is at odds with a decision out of the Tenth Circuit, and the Supreme Court typically agrees to hear cases where two federal appeals courts disagree.


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