Amgen pagará 762 millones por vender un medicamento para usos no autorizados

Nueva York, 19 dic (EFE).- El gigante estadounidense de la biotecnología Amgen pagará una sanción de 762 millones de dólares tras declararse culpable de introducir en el mercado un medicamento para usos no permitidos por las autoridades federales.
La compañía aceptó hoy en un tribunal federal de Brooklyn (Nueva York) un acuerdo para declararse culpable, clausurar el caso y pagar 150 millones en sanciones criminales y 612 millones para cubrir las solicitudes de compensación a programas públicos de seguro médico, como Medicare o Medicaid.
El caso se refiere al "Aranesp", un medicamento aprobado por la Administración de Fármacos y Alimentos (FDA, por sus siglas en inglés) para favorecer la formación de glóbulos rojos en los tratamientos de anemias.
"A fin de incrementar las ventas de Aranesp y lograr más beneficios, Amgen ilegalmente vendió el medicamento con la intención de que se usara con dosis que la FDA había estudiado y rechazado, y para tratamientos que la FDA nunca aprobó", señaló el tribunal federal en un comunicado.
El acuerdo supone la mayor sanción por fraude a una compañía de biotecnología en la historia de Estados Unidos.
El fiscal federal Marshall Miller señaló que "en lugar de trabajar para alargar y mejorar la vida humana, Amgen buscó ilegalmente los beneficios empresariales mientras ponía en peligro la seguridad de consumidores vulnerables que sufrían enfermedades". EFE

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"Fiscal cliff" talks turn sour, Obama threatens veto

 Talks to avoid a fiscal crisis appeared to stall on Wednesday as President Barack Obama accused Republicans of digging in their heels due to a personal grudge against him, while a top Republican called the president "irrational."
As the clock ticks toward a year-end deadline, Obama and House of Representatives Speaker John Boehner, the top Republican in Congress, are trying to reach a deal to avert harsh tax hikes and spending cuts that could trigger a recession.
Obama said he was puzzled over what was holding up the talks and told Republicans to stop worrying about scoring "a point against the president" or forcing him into concessions "just for the heck of it."
"It is very hard for them to say yes to me," he told a news conference in the White House. "At some point, you know, they've got to take me out of it."
The rise in tensions threatens to unravel significant progress made over the last week in the so-called fiscal cliff talks.
Boehner and Obama have each offered substantial concessions that have made a deal look within reach. Obama has agreed to cuts in benefits for seniors, while Boehner has conceded to Obama's demand that taxes rise for the richest Americans.
However, the climate of goodwill has evaporated since Republicans announced plans on Tuesday to put an alternative tax plan to a vote in the House this week that would largely disregard the progress made so far in negotiations.
Obama threatened to veto the Republican measure, known as "Plan B," if Congress approved it.
Boehner's office slammed Obama for opposing their plan, which would raise taxes on households making more than $1 million a year and is a concession from longstanding Republican opposition to increasing any tax rates.
"The White House's opposition to a backup plan ... is growing more bizarre and irrational by the day," Boehner said through his spokesman, Brendan Buck.
Boehner expressed confidence the House would pass the legislation, known as "Plan B," on Thursday. He urged Obama to "get serious" about a balanced deficit reduction plan.
Global investors are on edge over the talks, and U.S. stocks fell on Wednesday following Boehner's comments.
An acrimonious presidential campaign that culminated in Obama's re-election on November 6 has added to the bad blood in Washington between Obama and congressional Republicans.
The two sides also clashed bitterly last year over the government's limit on borrowing - known as the debt ceiling - an episode that nearly led the nation to default on its debt.
On Wednesday, Obama said the fiscal cliff must not get bogged down with negotiations over the debt ceiling, an issue that must be dealt with again early next year.
LITMUS TEST
Voting on Plan B will be a litmus test for Republicans on Boehner's concession to raise tax rates. In a sign conservatives are coming around to Boehner's position, anti-tax activist Grover Norquist gave his blessing to the bill.
Obama and Boehner appear to have bridged their biggest ideological difference but remain hung up on the mix of tax hikes and spending cuts meant to narrow the budget gap.
"What separates us is probably a few hundred billion dollars," Obama said.
The White House wants taxes to rise on incomes above $400,000 a year, a concession from Obama's opening proposal for a $250,000 income threshold.
If a deal is not reached soon, some $600 billion in tax hikes and spending cuts are set to begin next month.
Senior administration officials described negotiations as at a standstill and Obama warned he would ask everyone involved in the talks, "what it is that's holding it up?"
Still, the top Republican in the Senate said resolution could come by the end of the week.
"There's still enough time for us to finish all of our work before this weekend, if we're all willing to stay late and work hard," said Senate Republican leader Mitch McConnell.
Any deal by Obama and the Republican leadership would need the support of their parties' rank and file.
Many Democrats dislike the president's offer to reduce benefits to seniors, although some political allies of Obama have given signs they feel they could swallow this concession.
"I don't like these particular changes," said Democratic Representative Chris Van Hollen, a member of the House leadership from Maryland. But he added: "What people are seeing is the president willing to compromise in order to get things done.

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Sanofi to pay $109 million to settle U.S. kickback charges

French drugmaker Sanofi has agreed to pay $109 million to settle charges that it violated the False Claims Act by providing free drugs as a form of kickbacks to physicians, the U.S. Justice Department announced on Wednesday.
The settlement resolves allegations that Sanofi submitted false average sales price reports for the drug Hyalgan, a knee injection to treat arthritis, that did not account for free units distributed contingent on future purchases.
Average sales prices are used to determine reimbursement rates by government health programs, such as Medicare. The Justice Dept said the practice caused government programs to pay inflated amounts for Hyalgan and a competing product.
Sanofi sales representatives were given thousands of free "sample" Hyalgan syringes and used the free drug as kickbacks with a promise to provide negotiated numbers of the syringes in order to lower Hyalgan's effective price, the government claimed.
The drugmaker said it had taken "strong, proactive and effective steps" to address the issue and voluntarily halted the Hyalgan sampling program in 2009.
The settlement with the U.S. Attorney's Office, District of Massachusetts, the U.S. Department of Justice and several states resolves all claims arising out of the investigation into sampling of Hyalgan, Sanofi said.
In addition to the $109 million payment, Sanofi said it expects to enter into a Corporate Integrity Agreement with the Office of the Inspector General of the United States Department of Health and Human Services that will place its operations under enhanced scrutiny.
There are no criminal charges against the company related to the Hyalgan allegations.

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Colorado Woman Billed Medicaid for Dead Father

A Colorado woman was convicted this week for felony forgery for submitting fraudulent documents to Medicaid regarding personal health care services provided to her father after he died. It was the second announcement of Medicaid fraud-related convictions made by the Colorado Attorney General's office in less than a week. Here are the details.
* According to the office of Colorado Attorney General John Suthers, 52-year-old Viola Kwong pleaded guilty to felony forgery in Denver District Court on Tuesday. She was sentenced to pay $16,000 in criminal restitution and perform 50 hours of public service. The restitution reflects all of the money illegally received by Kwong.
* Kwong will also be placed on supervised probation for four years, is responsible for all court costs and probation supervision fees associated with her case, and will pay a civil penalty of more than $37,000 to the Colorado Medicaid program, the Attorney General's Office stated.
* The Attorney General's Office stated that Kwong had requested services for her elderly father through a Medicaid program that allows the Medicaid client to direct his or her own home-based medical care.
* Because Kwong's father was too ill to manage his care, Kwong was authorized by the program as his personal representative, in charge of obtaining those services for her father.
* Kwong's father died on July 23, 2010, but Kwong continued to submit documents about personal health care services that were being provided to her father until Nov. 8, 2010.
* Suthers stated that the restitution ordered was "another significant recovery for Colorado's Medicaid program."
* Colorado Department of Health Care Policy and Financing initially referred the case to the Attorney General's Medicaid Fraud Control Unit.
* Last week, the Attorney General's Office announced the conviction of occupational therapist Cheryl Moss, 47, for felony theft and felony forgery. Moss pleaded guilty to forging treatment records and fraudulently billing the Colorado Medicaid program for services she did not perform.
* Moss agreed to repay the program $54,332, serve 60 days home detention and perform 300 hours of community service. She was also ordered to pay an additional $46,000 to resolve any potential civil issues and to report her conviction to the agency charged with licensing occupational therapists in Colorado.
* According to the Attorney General, Medicaid is health insurance for qualifying low-income, disabled individuals, and children and families. Covered services include hospital care, skilled nursing home care, residential adult family care services, hospice, mental health, dental and eyeglass services. Each state administers its own Medicaid program.

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U.S. teen smoking declines to record low in 2012: study

 Cigarette smoking among American teenagers dropped to a record low in 2012, a decline that may have been partly driven by a sharp hike in the federal tobacco tax, researchers said on Wednesday.
An annual survey of about 45,000 students in the eighth, 10th and 12th grades found that the overall proportion of those saying they had smoked in the prior 30 days fell by just over a percentage point to 10.6 percent.
"A one percentage point decline may not sound like a lot, but it represents about a 9 percent reduction in a single year in the number of teens currently smoking," Lloyd Johnston, the principal investigator in the study, said in a statement.
He said reductions on that scale can translate into the prevention of thousands of premature deaths and tens of thousands of cases of cancer and other serious disease.
More than 400,000 Americans are estimated to die prematurely each year as a result of cigarette smoking - the No. 1 cause of preventable U.S. deaths - and most smokers begin their habit as adolescents, experts say.
Healthcare advocates hailed Wednesday's findings as evidence that higher cigarette taxes were paying off, combined with federal curbs on youth-oriented tobacco marketing and sales and a sweeping anti-smoking media campaign.
The researchers also cited the increase in federal cigarette taxes, raised by 62 cents a pack in 2009, as a likely contributing factor. The findings were part of an annual survey by University of Michigan researchers released by the National Institute on Drug Abuse.
Smoking rates fell for each of the individual age groups surveyed, most notably among eighth graders - from 6.1 percent in 2011 to 4.9 percent in 2012, the survey found.
Longer-term trends showed teen smoking rates dropping by about three-fourths among eighth graders, two-thirds among 10th graders and by half among 12th graders since a peak in the mid-1990s, researchers said.
One reason cited by experts is that the proportion of students who have ever tried smoking has declined sharply. Whereas nearly half of all eighth graders had tried cigarettes in 1996, just 16 percent had done so this year.
Teen attitudes toward smoking also continued to become more negative. For example, 80 percent of teens said they preferred to date nonsmokers in 2012.
But anti-tobacco advocates said their battle to stamp out teen smoking was far from over, noting that 17 percent of high school seniors still graduate as smokers.
Researchers singled out concerns over new forms of smokeless tobacco, including dissolvable products like Camel-branded "Orbs" and "Strips," and a fine, moist form of snuff called snus (rhymes with "loose"), which users place under their upper lip.
They said a significant portion of older teens have experimented with small cigars and water pipes called hookahs, which are becoming popular among young adults.
"We cannot let our guard down when the tobacco industry still spends $8.5 billion a year - nearly $1 million ever hour - to market its deadly and addictive products and is pushing new products ... that entice youth," said Susan Liss, executive director for the Campaign for Tobacco-Free Kids.

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Muni tax break under threat from bipartisan scrutiny in congress

 The tax break that U.S. states, cities and counties get on the bonds they issue is in growing jeopardy now that Republicans, in addition to Democrats, are considering limits on the exemption.
As part of the "fiscal cliff" negotiations to raise more federal government tax revenue, Republican lawmakers have joined Democrats in reevaluating the costly tax break, said Republican congressional aides and lobbyists.
Municipal bonds issued by states and localities are a $3.7 trillion U.S. market underpinned by a law that exempts their interest income from taxation. This allows states and localities to tap capital markets more cheaply than private-sector borrowers such as banks and corporations.
"The muni bond exemption is on the table, not only during tax reform, but also during the 'fiscal cliff,'" said Mike Nicholas of the Bond Dealers of America, a lobbying group for fixed-income securities dealers and banks.
That the tax break - deeply embedded in the economy and vital to state and local governments - would draw the interest of Republicans shows how far Washington has come in a short time in considering potentially dramatic tax-and-spending changes.
As the United States grapples with a huge budget deficit and a complex tax code that has not been revamped in 26 years, even once politically untouchable tax breaks are being questioned.
The "fiscal cliff" refers to sharp tax increases and spending cuts that take effect in 18 days unless Congress intervenes soon.
Some lawmakers from both parties are calling for a comprehensive tax code overhaul in 2013 and groups concerned with the muni bond exemption are worried.
"We have not felt this threat level being this real in a long time," said David Parkhurst, legislative director with the National Governors Association, which represents the leaders of U.S. states that rely heavily on the muni bond tax exemption.
SUBSIDIZING STATES, LOCALITIES
The exemption benefits bond investors on one side of the market and state and local governments on the other. Effectively a subsidy for states and localities, the muni exemption cost U.S. taxpayers about $26.2 billion in 2011.
President Barack Obama in 2011 included the exemption among items subject to his proposed 28-percent cap on deductions and other tax breaks for individuals earning more than $200,000.
That proposal alarmed muni bond issuers and investors, who were already on edge because of a proposal to kill the exemption entirely in 2010's Simpson-Bowles deficit reduction plan.
Now, Republicans are rethinking their traditional reluctance to tinker with muni bonds, largely because they want to find ways to increase federal revenues without raising tax rates.
Phasing out the muni bond tax break for individual taxpayers earning more than $200,000 could raise about $10 billion a year - or about $100 billion over a decade - Republican aides said.
In the fight over the "fiscal cliff," Republicans hope to refute Obama's argument that real deficit reduction cannot be achieved without raising tax rates on high-income Americans.
Senator Orrin Hatch, the top Republican on the Senate Finance Committee, said tax breaks of all sorts need to be weighed in the effort to raise revenue and cut the deficit, but that "they are not easy to get rid of."
FROM STATES TO SCHOOLS
New issuance of tax-exempt bonds is expected to hit about $400 billion in 2013, up from about $370 billion this year, according to investment bank Loop Capital Markets LLC.
Jurisdictions that issue tax-exempt bonds range from states to cities, counties and school districts. They defend the bonds as vital to transportation, infrastructure and other public projects, which would be threatened by an exemption roll-back.
"It certainly couldn't come at a worse time," New York State Comptroller Thomas DiNapoli told Reuters last week, referring to the devastation the region suffered during Hurricane Sandy.
"Even before the storm, we had tremendous infrastructure needs that localities were trying to address and now we're going to have even more."
It is unclear exactly what sort of limitations Republicans have in mind. The Obama proposal would apply to all bond issues.
Citigroup Inc muni bond strategist George Friedlander has estimated that Obama's cap, if enacted, would raise state and local government borrowing costs.
The "fiscal cliff" talks and a possible tax code overhaul next year pose "a clear and present danger" for muni bond issuers and investors, Friedlander said in a recent research report.

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Boehner plan would bring top U.S. income tax rate to 39.6 percent: source

 House of Representatives Speaker John Boehner's latest "fiscal cliff" proposal to President Barack Obama would see the top income tax rates rise to 39.6 percent from 35 percent for those with net incomes above $1 million a year, according to a source familiar with the talks.
The source, who asked not to be identified, emphasized that the income tax rate increase would be in exchange for "significant entitlement reforms/spending cuts." Entitlement programs include Medicare and Medicaid healthcare for the elderly and poor and Social Security retirement benefits.
The White House has not accepted Boehner's proposal, according to another source. Under current law, the top tax rate is scheduled to rise to 39.6 percent on January 1, unless Congress extends the current 35 percent, as Republicans had been urging.

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House Republicans eye limited fiscal cliff bill

With time running short before a Dec. 31 deadline, House of Representatives Speaker John Boehner will begin work on legislation that simply would extend current low income tax rates for all families with incomes below $1 million a year, according to an aide.
Negotiations will continue with the White House on a broader tax and spending deal, the Boehner aide said.
Boehner is presenting the plan to rank-and-file Republicans in a closed-door session.
On January 1, income tax increases for most Americans will begin unless Congress acts.
Last July, the Democratic-controlled Senate passed a bill to extend the current low rates for all families with net incomes below $250,000 a year. The House Republican proposal, if passed by the House, would require agreement by the Senate or force a round of negotiations on a compromise between the two chambers.
In excerpts of remarks Boehner was delivering to his Republican members Tuesday morning, the speaker complained that "the White House just can't seem to bring itself to agree to a 'balanced' approach" to deficit-reduction in negotiations. At the same time, Boehner said Republicans were "leaving the door wide open for something better" than just the limited extension of current low tax rates for most Americans.
"Current law has tax rates going up on everyone January 1. The question for us is real simple: How do we stop as many of those rate hikes as possible?" Boehner said.
For months, Democrats have been urging House Republicans to pass a bill protecting middle-class taxpayers from a January 1 rate increase.

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Senator Reid rejects Boehner "fiscal cliff" backup plan

- House Speaker John Boehner's backup plan that would simply extend low income tax rates for households with incomes below $1 million a year "cannot pass both houses of Congress," Senate Majority Leader Harry Reid said on Tuesday.
Reid, a Democrat, said Boehner instead should focus on reaching a broad deficit-reduction deal with President Barack Obama. "Now is the time to show leadership, not kick the can down the road," Reid said.
Last July, Reid's Democrats passed a bill in the Senate that would have continued low tax rates, which are set to expire on December 31, for families with net incomes below $250,000.

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White House defends offer as 'good faith effort'

 The White House is defending President Barack Obama's proposal to set a higher threshold for tax increases than what he vowed to do during his presidential campaign. The White House says Obama has moved halfway to meet House Speaker John Boehner on a "fiscal cliff" deal that raises $1.2 trillion in tax revenue, down from the $1.6 trillion Obama had initially requested.
White House spokesman Jay Carney says that offering to raise taxes on taxpayers earning more than $400,000 rather than the $200,000 he ran on demonstrates, in Carney's words, Obama's good faith effort to reach a compromise.
The new tax proposal is contained in a broader plan that Obama gave Boehner Monday that would cut spending further and lower cost-of-living increases for most Social Security beneficiaries.

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