Statement by the President on the Passing of Van Cliburn

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For Immediate Release March 03, 2013 Statement by the President on the Passing of Van Cliburn

This week, we mark the passing of Van Cliburn, one of the most talented pianists of the last century and a musical artist of rare distinction. At the young age of 23, Mr. Cliburn swept the world off its feet with his winning performance at the first International Tchaikovsky Competition in Moscow, and he quickly became a beloved ambassador of American culture around the world – especially in the former Soviet Union. His music transcended the challenges of international politics and contributed to an unlikely thaw in Cold War relations. He was truly a man of his moment. Like every President since Harry Truman, I enjoyed the privilege of hearing Mr. Cliburn play, and I am confident that the enduring beauty of his art will sustain his legendary status for years to come. Michelle and I send our thoughts and prayers to Mr. Cliburn’s loved ones.

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The Open Government Partnership publishes the text of the President's directive extending whistleblower protections to the intelligence and national security communities, as requested by the community.

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GAO: Health Law Will Increase Deficit If Cost-Cutting Steps Stop

The Affordable Care Act's long-term deficit impact depends on the law's cost-cutting measures and whether they survive over the next several decades, government auditors said Tuesday.

In a new report, the nonpartisan Government Accountability Office (GAO) found that President Obama's signature law could increase or decrease the deficit over the next 75 years depending on whether its cost-saving provisions survive.

In addition to creating certain healthcare benefits and requiring most people to carry insurance, the Affordable Care Act includes measures aimed at curbing the projected growth in U.S. healthcare costs.

Among these measures are Medicare productivity adjustments and the Independent Payment Advisory Board (IPAB), the panel Republicans believe unfairly wrests legislative authority from Congress in its charge to cut Medicare payments when the program's spending grows too quickly.

The GAO said Tuesday that the success of these provisions will determine whether the Affordable Care Act affects the deficit for good or ill.

Assuming the law is enforced as-is, the U.S. deficit will decline 1.5 percent as a share of the economy over the next 75 years, according to the GAO. Auditors attributed 1.2 percent of this improvement to the Affordable Care Act.

Under a different set of assumptions, the law has the opposite effect over time, the GAO said — the deficit will increase by 0.7 percent of gross domestic product (GDP) if the law's cost-containment measures are phased out.

The report attributed this potential increase in part to the law's most expensive features — the Medicaid expansion and the provision of insurance subsidies.

The report was requested by Sen. Jeff Sessions (Ala.), the top Republican on the Senate Budget Committee. On Tuesday, he and his office jumped on the figures to say that the healthcare law will increase the deficit by $6.2 trillion over 75 years.

To arrive at this figure, Sessions's office assumed the second scenario, in which the law's cost-containment measures end, and added up 75 year's worth of deficits using GDP projections from the Centers for Medicare and Medicaid Services.

Republicans have argued since the law's passage that it will prove a major liability for the federal budget.

"The big tax increases in the bill come nowhere close to covering the bill's spending," Sessions said Tuesday during a Budget Committee hearing.

"The big-government crowd in Washington manipulated the numbers to get the financial score they wanted, to get their bill passed and to increase their power and influence," Sessions said.

In its 59-page report, the GAO said there remain "significant uncertainties" surrounding the law's effect on U.S healthcare spending, which in turn impacts the national deficit.

The "development and deployment of medical technology, future policy decisions, and cost and availability of insurance" all contribute to the state of total healthcare costs, the GAO said.

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UPDATE 1-India board rules against Bayer in cancer drug patent case

* Bayer's appeal against licence for generic Nexavar dismissed

* Royalty payment to Bayer raised to 7 pct on Nexavar sales * Natco Pharma fined for presenting incorrect data

(Adds details, background, quotes)

By Anupama Chandrasekaran

CHENNAI, March 4 (Reuters) - An Indian patent appeals board upheld on Monday a decision to allow a domestic company to sell a generic version of Bayer AG's cancer drug Nexavar, in a blow for global drugmakers' efforts to hold on to monopolies on high-price medicines.

The ruling paves the way for the issue of more so-called compulsory licences as governments, particularly in emerging markets such as China and Thailand, battle to bring down healthcare costs and provide access to affordable drugs to treat diseases such as cancer, HIV-AIDS and hepatitis.

Bayer, Germany's largest drugmaker, said it would continue to fight to overturn the decision, which it said weakened the international patent system and endangered pharmaceutical research.

Under a global Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, countries can issue compulsory licences on certain drugs that are deemed unaffordable to a large section of their populations.

India's $13 billion drug market is seen by drugmakers as a huge opportunity, but there are concerns about the level of protection for intellectual property in the country -- where generic medicines account for more than 90 percent of drug sales -- after a series of judicial setbacks for "big pharma".

COMPULSORY LICENCE CHALLENGED

Last year, the Indian patents office allowed Natco Pharma

to sell generic Nexavar at 8,800 rupees ($160) for a month's dose -- a fraction of Bayer's price of 280,000 rupees.

Bayer challenged this decision to grant Natco a compulsory licence at the Intellectual Property Appellate Board (IPAB) in the southern city of Chennai.

On Monday the board dismissed the petition, although it did order Natco Pharma to pay a royalty of 7 percent on sales of generic Nexavar to Bayer, an increase from the 6 percent royalty that had earlier been set.

Also, the board fined Natco Pharma 50,000 rupees for presenting incorrect facts during the legal proceedings. The amount would be donated to a cancer treatment hospital, the board ordered.

Announcing the decision, Justice Prabha Sridevan said the kidney and liver cancer drug should be available at an affordable price to everybody.

Bayer said in a statement it "strongly disagreed" with the conclusions of the board, adding that it would seek to challenge it at the High Court in Mumbai.

"The challenges faced by the Indian healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India's essential drug list are not patented," the company said.

Natco Pharma Company Secretary M. Adinarayana told reporters the board had delivered a "reasoned, detailed" decision that could be "sustained in any court of law".

LEGAL SETBACKS

In a separate case, Bayer has accused another Indian drugmaker, Cipla , of infringing its patent on Nexavar. Cipla had launched its generic version of Nexavar before Natco won the compulsory licence.

Cipla undercut Natco's price in May last year and now sells the drug at 6,840 rupees for a month's dose.

Among other setbacks for Western drug companies, India has revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's hepatitis C drug Pegasys and Merck & Co's asthma treatment aerosol suspension formulation.

Another case involving drug patents is currently in front of the Supreme Court, with Novartis battling against an earlier decision refusing it a patent on cancer drug Glivec.

New Delhi has also taken other measures, such as controlling the prices of generic medicines and providing free medicines at government-run hospitals that cater to the country's poor.

Last week a government panel recommended a formula to curb prices of patented drugs to make them affordable for the world's second-most populous country.

($1 = 54.90 rupees)

(Additional reporting and writing by Kaustubh Kulkarni in MUMBAI; Editing by Alex Richardson)

((kaustubh.kulkarni@thomsonreuters.com)(+91 22 61807399)(Reuters Messaging: kaustubh.kulkarni.thomsonreuters.com@reuters.net))

Keywords: INDIA BAYER/

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U.S. FDA panel votes against approval of Noven's menopause drug

March 4 (Reuters) - A panel of advisors to the U.S. Food and Drug Administration recommended that the agency reject a drug for hot flashes associated with menopause made by Hisamitsu Pharmaceutical Co Inc's subsidiary Noven Pharmaceuticals Inc.

The panel voted 10-4 against approval, with the majority saying the drug's benefit was not sufficient to offset its risks. The panel was evenly divided over whether the drug was in any way effective.

(Reporting By Toni Clarke. Editing by Andre Grenon)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: MENOPAUSE/NOVEN

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Family: Openly Gay Mayoral Candidate Was Beaten, Set On Fire And Dumped Near A River

The family of Marco McMillian, a 33 year-old openly gay candidate for mayor of Clarksdale, Mississippi released a statement yesterday saying that he was beaten and set on fire before his lifeless body was dumped near a river. Last Thursday, police arrested a 22-year old man who, like McMillian, is African-American and charged him with the mayoral candidate’s murder. Although the motive for the murder remains unknown, the circumstances of the murder suggest a possible anti-gay hate crime. According to the family, “[w]e feel this was not a random act of violence based on the condition of the body when it was found.”

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FDA advisers vote against approval for Depomed's menopause drug

March 4 (Reuters) - Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause.

The panel of advisers voted 12-2 against the drug, Sefelsa, which is a long-acting version of the epilepsy drug gabapentin. The panel concluded that the drug's modest efficacy did not outweigh the side effects.

(Reporting By Toni Clarke; Editing by Gerald E. McCormick)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: MENOPAUSE DEPOMED/

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UPDATE 1-Elan offers Tysabri dividend after Royalty approach

(Writes through)

* Elan offers "unique" dividend on top of share buyback

Royalty Pharma made $6.6 bln approach last week

By Padraic Halpin

DUBLIN, March 4 (Reuters) - Irish drugmaker Elan said it will give shareholders 20 percent of the royalty rights for multiple sclerosis drug Tysabri in a bid to stave off an approach for the company by U.S. investment firm Royalty Pharma .

New York-based Royalty made its $6.6 billion approach last week, just two weeks after Elan announced it had sold its 50 percent interest in Tysabri for $3.25 billion plus future royalty payments to U.S. partner Biogen Idec.

Elan said on Monday that the "unique" cash dividend policy would give shareholders the right to enjoy unlimited participation in the upside from Tysabri sales and comes on top of its decision to return $1 billion to shareholders.

(Reporting by Padraic Halpin; Editing by David Holmes)

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