UPDATE 1-FDA advisers vote to reject approval of Depomed's menopause drug

(Updates with details) 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 13-1 that company failed to prove convincingly that the drug worked. They voted 12-2 that its efficacy, when balanced against risk, did not warrant approval. The drug, Sefelsa, is a long-acting version of the epilepsy drug gabapentin. A short-acting version of gabapentin made by Pfizer Inc and marketed as Neurontin was approved in 1993. Clinical trials of Depomed's drug showed it only partially reduced the frequency and severity of hot flashes while side effects included dizziness, sleepiness, headache and nausea. Gabapentin has also been shown to increase the risk of suicide. The FDA does not have to follow the recommendations of its advisory panels but it generally does. Sefelsa is one of two drugs designed to reduce hot flashes being considered on Monday. The second is a drug from a unit of Hisamitsu Pharmaceutical Co Inc that comprises a low dose version of the antidepressant paroxetine. Depomed's drug was approved in the United States in 2011 to treat shingles-related pain and is marketed under the brand Gralise. Depomed's shares were halted pending the panel's vote at $6.52 on Nasdaq.

(Reporting By Toni Clarke; Editing by Gerald E. McCormick and Sofina Mirza-Reid)

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ObamaCare and the '29ers'

Here's a trend you'll be reading more about: part-time "job sharing," not only within firms but across different businesses.

It's already happening across the country at fast-food restaurants, as employers try to avoid being punished by the Affordable Care Act. In some cases we've heard about, a local McDonalds has hired employees to operate the cash register or flip burgers for 20 hours a week and then the workers head to the nearby Burger King or Wendy's to log another 20 hours. Other employees take the opposite shifts.

Welcome to the strange new world of small-business hiring under ObamaCare. The law requires firms with 50 or more "full-time equivalent workers" to offer health plans to employees who work more than 30 hours a week. (The law says "equivalent" because two 15 hour a week workers equal one full-time worker.) Employers that pass the 50-employee threshold and don't offer insurance face a $2,000 penalty for each uncovered worker beyond 30 employees. So by hiring the 50th worker, the firm pays a penalty on the previous 20 as well.

These employment cliffs are especially perverse economic incentives. Thousands of employers will face a $40,000 penalty if they dare expand and hire a 50th worker. The law is effectively a $2,000 tax on each additional hire after that, so to move to 60 workers costs $60,000.

A 2011 Hudson Institute study estimates that this insurance mandate will cost the franchise industry $6.4 billion and put 3.2 million jobs "at risk." The insurance mandate is so onerous for small firms that Stephen Caldeira, president of the International Franchise Association, predicts that "Many stores will have to cut worker hours out of necessity. It could be the difference between staying in business or going out of business." The franchise association says the average fast-food restaurant has profits of only about $50,000 to $100,000 and a margin of about 3.5%.

Because other federal employment regulations also kick in when a firm crosses the 50 worker threshold, employers are starting to cap payrolls at 49 full-time workers. These firms have come to be known as "49ers." Businesses that hire young and lower-skilled workers are also starting to put a ceiling on the work week of below 30 hours. These firms are the new "29ers." Part-time workers don't have to be offered insurance under ObamaCare.

The mandate to offer health insurance doesn't take effect until 2014, but the "measurement period" used by the feds to determine a firm's average number of full-time employees started last month. So the cutbacks and employment dodges are underway.

The savings from restricting hours worked can be enormous. If a company with 50 employees hires a new worker for $12 an hour for 29 hours a week, there is no health insurance requirement. But suppose that worker moves to 30 hours a week. This triggers the $2,000 federal penalty. So to get 50 more hours of work a year from that employee, the extra cost to the employer rises to about $52 an hour—the $12 salary and the ObamaCare tax of what works out to be $40 an hour.

Moving to 33 hours a week costs the employer about $10 an hour more in ObamaCare tax. Look for fewer 30-35 hour-a-week jobs. The law that was sold as a way to help business and workers is thus yanking a few more rungs from the ladder of economic upward mobility.

Many franchisees of Burger King, McDonalds, Red Lobster, KFC, Dunkin' Donuts and Taco Bell have started to cut back on full-time employment, though many are terrified to talk on the record. Activist groups have organized boycotts against Darden Restaurants, which owns Olive Garden and Red Lobster, for daring to publicly criticize ObamaCare. It's safer to quietly dodge the new costs and avoid becoming a political target.

But the damage won't be limited to franchisees or restaurants. A 2012 survey of employers by the Mercer consulting firm found that 67% of retail and wholesale firms that don't offer insurance coverage today "are more inclined to change their workforce strategy so that fewer employees meet that [30 hour a week] threshold." This week Nigel Travis, the CEO of Dunkin' Donuts, asked Congress to change the health law's definition of full-time to 40 hours a week from 30 hours so worker hours won't have to be cut.

The timing of all this couldn't be worse. Involuntary part-time U.S. employment is already near a record high. The latest Department of Labor employment survey counts roughly eight million Americans who want a full-time job but are stuck in a part-time holding pattern. That number is down only 520,000 since January 2010 and it is 309,000 higher than last March. (See the nearby chart.) And now comes ObamaCare to increase the incentive for employers to hire only part-time workers.

Democrats who thought they were doing workers a favor by mandating health coverage can't seem to understand that it doesn't help workers to give them health care if they can't get a full-time job that pays the rest of their bills.

Printed in The Wall Street Journal, page 15 A version of this article appeared February 23, 2013, on page A12 in the U.S. edition of The Wall Street Journal, with the headline: ObamaCare and the '29ers'.

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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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Blog posts on this issue March 04, 2013 6:52 PM ESTHanging Out with First Lady Michelle Obama

Mrs. Obama joins a virtual conversation about Let’s Move!, her initiative to ensure our nation’s kids grow up healthy and reach their full potential.

March 04, 2013 3:52 PM ESTFulfilling our Commitment to Open Government: We Hear You

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.

March 04, 2013 3:01 PM ESTU.S. Department of Labor Celebrates 100 Years of Helping American Workers

The Department of Labor celebrates its centennial anniversary and looks forward to continuing its important work on behalf on America's workers.

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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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