Sunday, May 19, 2013

PDL BioPharma forecasts greater 1Q royalties

INCLINE VILLAGE, Nev. -- PDL BioPharma Inc. said Monday that it expects about $92 million in royalty payments during the first quarter. That's more than analysts expected.

The company said its royalty revenue will grow about 19 percent compared to the first quarter of 2012. The increase comes from higher payments from the cancer drugs Avastin and Herceptin, eye drug Lucentis, and multiple sclerosis drug Tysabri. PDL helped develop those drugs and gets royalty payments based on sales in the previous quarter.

Analysts expect PDL to report $86 million in revenue, according to FactSet.

Avastin, Herceptin, and Lucentis are sold by Swiss drugmaker Roche. Biogen Idec Inc. sells Tysabri. PDL said Herceptin sales grew 11 percent and Avastin sales rose 10 percent compared to a year ago, but Roche is making and selling more of the drugs overseas than it has before. That gives PDL smaller royalty payments. The company said Tysabri sales rose 16 percent and Lucentis sales increased 12 percent.

PDL BioPharma lost 18 cents, or 2.6 percent, to $6.88 in morning trading.


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Federal Appeals Court: Anti-Immigrant Arizona Law Violates First Amendment

Last year, the Supreme Court struck down much of Arizona’s harsh immigration law SB 1070, and stripped its “show me your papers” provision of many of its teeth. Earlier this week, another provision of this anti-immigrant law bit the dust. A bipartisan panel of the United States Court of Appeals for the Ninth Circuit blocked SB 1070's restrictions on drivers seeking to hire day laborers:

Two provisions in Arizona’s Senate Bill 1070 make it unlawful for a motor vehicle occupant to hire or attempt to hire a person for work at another location from a stopped car that impedes traffic, or for a person to be hired in such a manner. These provisions raise First Amendment concerns because they restrict and penalize the commercial speech of day laborers and those who would hire them. Arizona defends the provisions as traffic safety measures, designed to promote the safe and orderly flow of traffic. We acknowledge that Arizona has a real and substantial interest in traffic safety. Arizona, however, has failed to justify a need to serve that interest through targeting and penalizing day labor solicitation that blocks traffic, rather than directly targeting those who create traffic hazards without reference to their speech, as currently proscribed under the State’s preexisting traffic laws. Laws like this one that restrict more protected speech than is necessary violate the First Amendment.

As the court notes, the day laborer provisions had at least as much to do with discouraging immigration as it did with any concerns over traffic. The provisions’ lead sponsor claimed the provision would “discourage the ‘shadow economy’ of day labor and address illegal immigration because ‘[a] large number of these people are illegal immigrants and this is the way they get work, and this work is one of the anchors that keeps them in the country.’”


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When Did We Forget About the Patients?

When Did We Forget About the Patients? - Hal Scherz - Townhall Finance Conservative Columnists and Financial Commentary - Page 1   Townhall Magazine

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With each passing day, more is discovered about the Affordable Care Act (ACA, Obamacare) confirming all of our worst fears about this law. The majority of discussion regarding Obamacare has been concentrated on issues involving implementation, such as state health insurance exchanges or Medicaid expansion.

It has also focused on the crushing financial implications of the law, such as the 18 new taxes created by the ACA, or the dramatic rise in healthcare insurance premiums, or the projected $2.7 trillion price tag. This narrative is understandable because the majority of people doing the reporting are pundits, talking heads and policy wonks.

The missing piece in this narrative is the havoc that this law is creating in the lives of so many patients. Despite minimal implementation of the ACA thus far, the effects on many patients is already devastating- something very much under-reported.

Last month we learned that cancer clinics were turning away Medicare patients as a result of cuts brought about by the sequester. The cuts would result in a decrease in Medicare reimbursement to these private clinics by as much as 28%. This has forced these clinics to find alternative treatment facilities for these patients, which in some cases may be thousands of miles away from their homes. This is tantamount to a death sentence for some patients, for whom travel is not possible because of both economic and health reasons.

The creation of high risk pools for patients with pre-existing or expensive medical problems was touted as one of the achievements of Obamacare (Pre-Existing Condition Insurance Plan, PECIP). It has never lived up to its expectations. The predictions were that by this time, over 1 million people would be participating, but it stalled at about 100,000 because this coverage was more expensive than anyone had anticipated. And further enrollment was halted because the money ran out. Now it appears that the shortage of funds may jeopardize the continued coverage for those patients currently enrolled.

The GOP leadership in the House of Representatives, sensitive to the needs of these patients, introduced HR 1549, which would transfer money from other ACA programs into the PECIP. President Obama however, threatened a veto if this bill reached his desk. He apparently has little concern for these patients and if it means that they need to be sacrificed in order to proceed with continued implementation of the law, then this may be the price that needs to be paid. Try telling that to the patients though.

Next21View Full Article Hal Scherz Hal Scherz Dr. Hal Scherz is the Founder and President of Docs4Patient Care. Most Recent Articles Braves 5, Dodgers 2 Commuters warned of traffic mess for up to 1 week 2 FBI agents killed in training accident in Va. Jennifer Johnson wins Mobile Bay LPGA Classic Obama walks a fine line with Myanmar president's landmark visit Spurs rout Grizzlies 105-83 in West finals opener Official: Va. driver likely had medical condition AP CEO calls records seizure unconstitutional Sign-Up to receive Updates from TH Join the Debate 12 Comments So Far Login in to Post Your Comments Newest First Oldest First sbrown Wrote: May 13, 2013 1:33 PM 2014 will be even more interesting. Many major elements of Obamacare are supposed to kick in. The states have, for a variety of smart or apathetic reasons, not been active in setting up the state insurance exchanges. Perversely this may protect a swath of Americans for a few more years, if their employers continue to carry health insurance as opposed to paying the fine and telling their employees to go to the exchanges for insurance. Login to Reply Flag as Offensive

Post Comment dheath Wrote: May 11, 2013 6:12 AM I went for my annual physical this week, to the same doctor I have been going to for years. They have always had the nurse take my blood pressure, do an EKG, and then take care of the medical questions. However, now the medical questioning has become so burdensome, that they went streight to the questioning and forgot to do the EKG. Later, my doctor reminded them that they needed to do that. He is a Libertarian. If you think you can trust either of these parties, any of these parties, you need to think again. It is time to get the brightest together and form the right party along the lines of the Tea Party Principles, get on the ballot in all states, put out principled candidates and get the job done. If you haven't read or... Login to Reply Flag as Offensive

Post Comment Maximus2 Wrote: May 10, 2013 3:41 PM Inarticulate , Sarah? No she was right on! Perhaps the columnist should have talked to some more Doctors, however he wrote a good piece and hit what is all wrong with Obama care except for the fact that health care for seniors with problems will be dropped over board to save his agenda to insure illegals and totally destroy the best healthcare system In the World. Login to Reply Flag as Offensive

Post Comment mshreve Wrote: May 10, 2013 2:06 PM WHO screamed when 720 BILLION was STOLEN from Medicare to help fund Obamacare. Certainly NOT the AARP. Sequestration resulted in an DECREASE in the INCREASE of spending only. 415 BILLION was cut from PROVIDER payments. Login to Reply Flag as Offensive

Post Comment mshreve Wrote: May 10, 2013 2:05 PM WHO screamed when 720 BILLION was STOLEN from Medicare to help fund Obamacare. Certainly NOT the AARP. Sequestration resulted in an DECREASE in the INCREASE of spending only. 415 BILLION was cut from Login to Reply Flag as Offensive

Post Comment Bluebonnet Wrote: May 10, 2013 1:36 PM Remember, this bill was "deemed" passed by Nancy Pelosi, still not knowing what was in the bill. How unconstitutionally corrupt, arrogant and stupid is that?!!
And, speaking of health care, the pharmaceutical companies donate heavily to members of Congress. Why don't we know more about what is in these drugs that cause deadly side effects? Do statin drugs cause diabetes? A real winner for pharma. Which drugs cause pancreatic cancer? What named drugs causing heart attacks are still allowed on the market? The accusations are there. Where is the follow-up and data? 10,000 deaths before one drug was removed. Now 80,000 deaths thought from another. Why can't staph be eliminated from hospitals? You see, the health care bill and... Login to Reply Flag as Offensive

Post Comment None1257 Wrote: May 10, 2013 1:00 PM This is real simple to understand. When you decided that you wanted someone else to pay for our needs and wants, you also gave them the right not to pay. Login to Reply Flag as Offensive

Post Comment Ronald E Wrote: May 10, 2013 10:08 AM The mission of a physician hasn't changed. We are trained for years to do whatever we can for others to the best of our ability. I will never sell out to bureaucrats who haven't had my 11 years of medical training. If that means dropping all government and private insurance plans, so be it. We are trained to think independently and practicing medicine is a complex interaction that can't be reduced to a cookie-cutter approach.
The ACA will wreak havoc on American medicine, including the unwarranted transition to electronic records that are not ready for prime time.
We have always been patient-centric, though others don't seem to think so.
Login to Reply Flag as Offensive

Post Comment ryoung292 Wrote: May 10, 2013 9:27 AM Welcome to "Logans RUN!" Login to Reply Flag as Offensive

Post Comment Charles52 Wrote: May 10, 2013 8:55 AM ObamaCares real name should be POPULATION CONTROL CARE. That is because it was nothing but a major political lie drafted by lawyers for the benefits of lawyers who are politicians and there was never any intentional benefit for people. Pelosi said it all when she gleefully said " let's pass the bill, then we can find out what is in it". That tells us what politicians thinks about what they do...pass junk they know nothing about, then leave the thing open to amendments as time goes on and there in lies the real disasters. obamacare was never intended to lower cost, nor to protect people, but more to contol people, except politicians who were exemted because they know upfront it was a disaster....for them. Login to Reply Flag as Offensive

Post Comment lgoldhammer Wrote: May 10, 2013 7:25 AM The health care solution is simple: go back to what we were doing before there was a health care problem. Go back to major medical care insurance that is used as insurance was intended: for an unplanned major medical problem with big price tags like surgery or disease. In 1984 I joined the Navy. Before going in it cost me $25 to go to the OB/GYN. I was only making $5-6/hour and could afford to pay this out of pocket. In 1988 when I got out of the service and called for an appointment they wanted $150. I was still making only $5-6/hour, but I couldn't afford to pay a doctor a whole weeks salary to be seen. What had happened in those 4 years to make medical care unaffordable? HMO's. I still only had Major Medical insurance, and... Login to Reply Flag as Offensive

Post Comment Ann Anon Wrote: May 10, 2013 7:55 AM A lot of us feel the way you do but the Politicians do not feel that way. Don't vote for incumbents. Congress needs new blood. Login to Reply Flag as Offensive

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Novo confident insulin Tresiba will get U.S. approval-chairman

* Novo chairman says U.S. approval of Tresiba a top priority

* Says stock split not currently on the agenda

* Says company exploring an increase in dividend

By Shida Chayesteh

COPENHAGEN, March 8 (Reuters) - Denmark's Novo Nordisk , the world's biggest insulin producer, is confident U.S. authorities will approve its new long-acting product Tresiba, its incoming chairman said on Friday.

U.S. regulators last month unexpectedly refused to approve Tresiba until the group conducts extra tests for potential heart risks, dealing a blow to one of its key products as well as to its share price.

The drugmaker shed about $14 billion in market value on Feb. 11 after the decision by the U.S. Food and Drug Administration (FDA) was published, although the shares have since recovered much of the fall.

Goran Ando, who will take over as chairman of the board at Novo Nordisk after the annual general meeting on March 20, told Reuters that getting Tresiba approved by the FDA is one the most important short term goals for the group.

"I have all the confidence in the world that we will do that," Ando said in an interview, without going into further details.

"It will take more time than we thought but we will get there," he told Reuters, adding the board was surprised by the FDA's decision last month.

Most investors had expected a green light from the U.S. watchdog, following a positive recommendation from an advisory panel to the FDA last November, despite earlier signals that there might be heart issues with the medicine.

There has been speculation about a potential stock split as Novo's share price has exceeded 1,000 Danish crowns and the outgoing chairman said in January that approval of Tresiba in the Unites States was a condition for a decision to proceed.

Asked about prospects for a stock split, Ando said: "It is nothing that is currently on the agenda."

He added the board would look into increasing dividends.

"I don't think you will see very dramatic changes. But we will look at this," Ando said.

In January, Novo had raised its sales and profit forecasts for 2013 on hopes that Tresiba, also known as degludec, would soon win approval in the United States and add momentum to surging profits.

But following the FDA decision the drugmaker, which is banking on Tresiba to keep it in the lead in diabetes care, has said the earliest it could provide the data requested by the U.S. authorities is in 2015.

As the world suffers from an epidemic of type 2 diabetes tied to over-eating and lack of exercise, demand for treatments has snowballed. Novo has benefited more than any other company because it is so focused on diabetes, lifting its shares to a lofty premium over other European drugmakers.

COMFORTABLE WITH DIABETES FOCUS

That strategy was not set for any major change under the new chairman.

"Is there a reason to change the fundamental things, I don't think so," Ando said.

"I am very comfortable with our focus on diabetes," he said.

The global diabetes market should grow 10 percent annually through 2020, Citigroup estimates, as Western lifestyles are adopted in emerging markets and obesity affects U.S. citizens at ever-younger ages.

Ando said rising competition would present challenges.

"It is a challenge to continue to grow as fast as we have done," he said.

"In the overall diabetes arena, I think it is fair to say that competition is increasing."

Novo Nordisk has overtaken Norway's Statoil as the Nordic region's biggest company by market capitalisation, dominating its home stock market which last month changed the benchmark, from next week, to a new index that caps Novo's weighting at 20 percent .

Shares in Novo Nordisk traded flat at 1,003.00 crowns per share at 1345 GMT, against a 0.5 percent rise in the Copenhagen stock exchange's benchmark index .

(Reporting by Shida Chayesteh,; Writing by Mette Fraende; Editing by Anthony Barker)

((mette.fraende@thomsonreuters.com)(+4533969649)(Reuters

Messaging: mette.fraende.thomsonreuters.com@reuters.net))

Keywords: NOVONORDISK TRESIBA/ CHAIRMAN


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Obamacare Gets New Court Challenge

Opponents of the health-care overhaul have filed a new lawsuit Thursday against the federal government on behalf of four individuals and three employers in the U.S. District Court for the District of Columbia.

The complaint focuses on the law’s distribution of federal subsidies for Americans to purchase insurance, and whether people can get them if they live in one of the 33 states that have refused to set up their own insurance exchanges and have left that task up to the federal government.

The health law was designed around the idea that states would run exchanges where people could compare insurance plans and apply for the subsidies. Some critics say that language in the legislation bars the Obama administration from allowing those subsidies to be distributed in exchanges run by the federal government.

The individual plaintiffs in the new lawsuit, from Tennessee, Texas, Virginia and West Virginia – states that didn’t set up exchanges — say they should not be considered eligible for the subsidies and should not have to pay a fine if they don’t purchase insurance.

The “subsidies actually serve to financially injure and restrict the economic choices of certain individuals,” the new complaint says. “For these people, the Subsidy Expansion Rule, by making insurance less ‘unaffordable,’ subjects them to the individual mandate’s requirement to purchase costly, comprehensive health insurance that they otherwise would forgo.”

The employers from Missouri, Kansas and Texas are arguing that they should not be subject to penalties that they may have to pay if their workers receive tax subsidies through the exchanges.

Oklahoma’s attorney general, Republican Scott Pruitt, filed a similar challenge in federal court for the Eastern District of Oklahoma on behalf of the state. The Obama administration has argued that the case should be thrown out because Oklahoma cannot show it is being harmed.

U.S. Treasury officials have also said that they believe Internal Revenue Service rules applying the law’s provisions to the federally run exchanges are in keeping with the statute. They have criticized opponents for trying to prevent millions of Americans from getting tax credits.

The new plaintiffs are being represented by Michael Carvin, a former Reagan administration lawyer who helped to represent the Bush campaign in the 2000 presidential election cases.

Mr. Carvin, of Jones Day, also represented the National Federation of Independent Business in its unsuccessful case arguing that the Affordable Care Act was unconstitutional because of its requirement that individuals purchase insurance or pay a fee.

A libertarian think-tank, the Competitive Enterprise Institute, said it is coordinating some of the legal work in the case and helping to fund it.


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Creating a Healthier Future in the US

 Highlight transcript below to create clipTranscript:  Print  |  Email Go  Click text to jump within videoFri 08 Mar 13 | 07:34 AM ET Newark Mayor Cory Booker, (D-NJ), discusses how the private sector is teaming up with First Lady Michelle Obama in a partnership for a healthier America.

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How Everybody Pays The Price Of Wall Street’s Unregulated High-Frequency Trading

During an appearance on CNBC yesterday, Charlie Munger, deputy to billionaire investor Warren Buffett, had some harsh words for high-frequency trading, the practice used by huge financial firms to trade stocks in milliseconds. “Take the rapid trading by the computer geniuses with the computer algorithms,” said Munger. “Those people have all the social utility of a bunch of rats admitted to a granary.”

As a new report from Demos makes clear, high-frequency trading definitely is the equivalent of admitting rats to a granary, as it extracts value for traders but without bolstering investment. The price of that is ultimately paid by consumers:

The increasing inefficiency of the Capital Intermediation process is in part attributable to the trading practices of [high-frequency traders] HFTs, which generate high trading volume and no investment. The cost to the system is generated by several factors. First, the illusion of market liquidity provided by HFT volume leads to the inherent instability of market pricing mechanisms. In addition, aggressive HFT tactics mislead market participants in terms fundamental price. Finally, Dark Pools, trading venues that exist because of HFTs, impair price discovery.

All of these distortions extract value for the HFTs. Investors pay the cost initially because their investments are less valuable in conditions of chronic price distortion. However, investors must compensate for the additional cost that results from the extracted value by adjustment of price. This price adjustment is paid for by the consumers of capital.

High-speed trading now makes up more than half of the stock market’s volume. As this chart from the research firm Nanex shows, high-frequency trading has exploded since 2007, spiking in the aftermath of the Great Recession:

The Securities and Exchange Commission voted yesterday to draft new rules to rein in high-frequency trading. Doing so would both drive investment to productive sectors of the economy while removing dangerous volatility from the market like that which caused 2010's “flash crash.”


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Passage of human trafficking bill sends clear message

By David Abramowitz, director, Alliance to End Slavery and Trafficking (ATEST) - 03/08/13 03:45 PM ET

Yesterday, hundreds of advocates, survivors, law enforcement officials and lawmakers gathered to witness President Obama sign legislation that will strengthen protection for women threatened by domestic violence, as well as renew the nation’s most important tool to fight modern day slavery, the Trafficking Victims Protection Act (TVPA).

But this moment didn’t come without political drama. In early February, Sen. Leahy of Vermont, with the support of Sen. Rubio of Florida, added the TVPA reauthorization to the Violence Against Women Reauthorization Act (VAWA), with the amendment passing by a resoundingly bipartisan vote of 93-5. And just last week, the House relented and approved the Senate-passed VAWA, including the TVPA reauthorization.

Congress’ reauthorization of the TVPA re-asserts U.S. leadership in the effort to eradicate modern-day slavery at home and around the world. The legislation bolsters the fight against human trafficking in four significant ways: It renews key federal anti-trafficking programs for the next four years; provides for new partnerships with cooperating countries to protect children and prevent trafficking; adds new protections for survivors of modern slavery; and provides prosecutors with new tools to go after the traffickers who exploit others.

One hundred and fifty years after President Lincoln signed the Emancipation Proclamation freeing slaves during the civil war, it’s astonishing that we still face the need to fight slavery. But the fact is that millions of men, women and children are subject to modern slavery each year, including in the United States, and human trafficking is the world’s second largest criminal enterprise, after drug trafficking.

Slavery today looks much different than it did 150 years ago. Illegal everywhere, it is more often underground and masked so well that it is difficult to recognize. But the reality is that construction workers, housekeepers, farm workers and others in low-paying industries are brought to the United States by labor brokers who promised a job, but enslaved them instead.
Traffickers put those individuals into debt bondage, seize travel documents, threaten retribution by law enforcement or immigration authorities, and promise violence against family members if they try to leave.

Sex traffickers also target the vulnerable, using violence, threats and other coercive means to keep victims involved in sex slavery. Sex trafficking can be found in most major U.S. metropolitan areas and along major interstates at truck stops, on city streets, or in escort services, strip clubs, fake massage businesses and other venues.

Hopefully, signing the reauthorization of the TVPA into law is just the first of many second term efforts by President Obama to assert U.S. leadership and establish his legacy as a leader in the fight to end modern slavery.

In September, President Obama pledged his commitment to renewing the TVPA during a highly public speech at the Clinton Global Initiative; some say it was the longest speech on slavery by a U.S. president since the Emancipation Proclamation. The president also announced an executive order to strengthen U.S. efforts to stop human trafficking in government contracting, pledged to provide relevant officials and agencies with training and guidance programs on human trafficking, and promised to expand resources and services for trafficking survivors.?

The Alliance to End Slavery and Trafficking (ATEST) issued a report late last year that offered dozens of detailed recommendations the Administration should follow in order to ensure President Obama’s pledge is successfully realized. Key recommendations beyond passage of the TVPA include:
1. Develop a National Action Plan based on a “whole-of-government approach” that coordinates all available resources and tools instead of providing piecemeal solutions to human trafficking;
2. Back up the commitment to fighting human trafficking and modern-day slavery with an FY14 budget request that fully funds critical initiatives;
3. Implement the new Executive Order and related legislation by banning recruiting fees and ensuring that federal contractors do not otherwise inadvertently have slavery in their supply chains; and
4. Partner with willing countries to create innovative, focused and comprehensive approaches to combat human trafficking, forced labor, and other forms of modern-day slavery around the world.
Ending modern slavery will not come with one speech, one executive order, or one signed piece of legislation. It will come if all of us—citizens, civil society, governments, corporations, and the philanthropic community—make it the priority it must be. Then we will be on our way to making sure that each of us is afforded the human dignity we deserve, no matter where we were born or what circumstances we find ourselves in.
Abramowitz is vice president, Policy & Government Relations for Humanity United and director of the Alliance to End Slavery and Trafficking (ATEST).

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UPDATE 3-U.S. drugmaker admits misbranding AIDS appetite medicine

* $45 mln payout includes criminal, civil penalties

* Par accused of marketing drug for off-label use

* TPG Capital bought Par for $1.9 bln in September

(Adds interview with US Attorney in New Jersey)

By Linda Federico-O'Murchu and Jonathan Stempel

March 5 (Reuters) - Par Pharmaceutical Cos, a generic drugmaker, has pleaded guilty to improperly marketing a medication intended to address appetite loss in AIDS patients, and agreed to pay $45 million to resolve a federal criminal probe and related civil litigation.

The company pleaded guilty to a misdemeanor charge for misbranding the drug Megace ES for uses not approved by the U.S. Food and Drug Administration, at a hearing before U.S. Magistrate Judge Madeline Cox Arleo in Newark, New Jersey.

Private equity firm TPG Capital LP bought Par for $1.9 billion in September.

Federal prosecutors said Megace ES was meant to treat anorexia and other weight loss in AIDS patients, but that Par deliberately promoted it for off-label uses, such as for elderly nursing home residents who were losing weight.

"The conduct of this company was in some real measure flagrant," U.S. Attorney Paul Fishman in New Jersey said in an interview at his office. "The company was told on at least two occasions in 2005 that it did not have permission from the FDA to market this drug as appropriate for senior citizens, and it chose to ignore that. And it made the wrong choice."

Par and its lawyer did not immediately respond to several requests for comment.

WHISTLEBLOWERS

Tuesday's settlement includes an $18 million fine, a $4.5 million criminal forfeiture, and $22.5 million to resolve civil litigation against the Woodcliff Lake, New Jersey-based company.

It also resolves three whistleblower lawsuits brought under the federal False Claims Act, which lets private parties sue on behalf of the United States and share in the government's recoveries.

Par also agreed to enter a five-year "corporate integrity agreement" with the U.S. Department of Health and Human Services. This agreement requires the company to improve oversight, and permits it to take back bonuses from executives who engage in significant misconduct.

The U.S. Department of Justice announced the settlement and the guilty plea, which it said was entered by Par Chief Executive Paul Campanelli on the company's behalf.

At a press conference, Fishman said he was unaware of patients who may have been harmed by the improper off-label use of Megace ES, but that this did not excuse Par's marketing.

"A company looking out too much for profits can lose its perspective and its moral compass," Fishman said in the interview. "And that places the public at risk."

ROLEXES AND MEXICO TRIPS

Par pleaded guilty to a charge of introducing a misbranded drug into interstate commerce.

The alleged improper marketing took place between July 2005 and 2009, according to a court filing describing the government case over Megace ES, whose chemical name is megestrol acetate.

Sales representatives and management at Par "knew that they called on very few, if any, facilities with AIDS patients and very few practitioners that treated AIDS patients," the court filing said.

Par also held contests to spur Megace ES sales, awarding prizes such as Rolex watches and trips to Cabo San Lucas in Mexico to successful sales representatives, the filing said.

Last September, the company said it had set aside $45 million for a possible settlement over Megace ES.

The case is U.S. v. Par Pharmaceutical Cos, U.S. District Court, District of New Jersey.

(Reporting by Linda Federico-O'Murchu in Newark, New Jersey; and Terry Baynes and Jonathan Stempel in New York; Editing by Jeffrey Benkoe, John Wallace, Phil Berlowitz and Nick Zieminski)

((jon.stempel@thomsonreuters.com)(646-223-6317)(Reuters

Messaging: jon.stempel.reuters.com@thomsonreuters.net))

Keywords: PARPHARMACEUTICAL SETTLEMENT/


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Fix the debt: Help the 99 percent

As sequestration takes effect, our lawmakers will be asked to once again step up and pass a major debt-reduction deal.

Let’s be clear: passing a sensible debt deal will be better for every single person in this country, from the Jaguar drivers to the bus-takers. Failure to bring this to a swift and decisive conclusion will be okay for the 1 percent and an absolute disaster for the 99 percent. As a relatively recent entrant to the former group and as a lifelong advocate for the latter, I say this with certainty.

Here’s why:

In this turbulent economic time, the 1 percent benefited disproportionately. Wealthy people in this country are standing at the top of the mountain, enjoying the vista, basically not even breaking a second-home sweat – while the rest of Americans labor up the incline, gasping for breath. Income inequality is at an epic point, the highest since the Great Depression. In 2011, the average income of a person in the top 1 percent was nearly $880,000. For the bottom 90 percent, the average income was just under $30K.

Some investment opportunities are only open to the few. There are certain financial opportunities – like hedge funds – that are only available to those with “accredited investor” status. Essentially, that means if you have a net worth that exceeds $1 million or if you make more than $200,000 a year, these investment opportunities are available to you but not others. If you’re able to take advantage of unique, limited investment opportunities, you get the opportunity to beat the S&P 500, while if you’re one of the 60 million workers invested in a 401(k), your returns are probably tied more to the performance of the S&P 500.

Resources are on call. What goes hand-in-hand with excellent investment opportunities? Resources. The 1 percent typically also has the backing of highly-paid legal and tax advisory firms to ensure that assets are protected, loopholes fully and legally exploited, and that every possible advantage is leveraged. The average American simply does not have the quiver full of resources to target and maximize positive life-altering opportunities.

Cash on hand. There’s a real advantage to having liquid assets. The wealthy know that cash on hand represents another form of power: the ability to reap the benefits of a down economy. When the bottom fell out of the housing market, individuals with cash on hand were able to pounce on extraordinarily cheap real estate, another investment for the future. Even if the real estate market takes longer than anticipated to rebound, these people aren’t relying on these investments for immediate returns.

The wealthy are not one shock away. A 2013 study is troubling: nearly half of American households, more than 132 million people, are one emergency away from financial ruin. In addition to people who don’t have three months of savings – the “liquid asset poor” – another 26 percent are “net worth asset poor,” meaning their debt far surpasses any assets they may have. Translation: no safety nets. That’s simply not the case for the 1 percent, who can typically weather an economic storm.

It’s long past time to come to a resolution on the debt recovery plan that would help all Americans, regardless of financial power. A failure driven by partisanship will be dangerous, risking the livelihoods of people around the world, up and down the economic value chain. The upcoming sequester issue is another opportunity in a long string of chances to show the courage, resourcefulness and fortitude we prize as defining American leadership.

America has unique regenerative capabilities – rallying in times of challenge to emerge on the other side, defiant and ever stronger. I hope and believe our government will be deserving of our confidence as it passes the policies that will enable our country to move into a period of growth and stability for everyone once more.

Fertik is the CEO and founder of Reputation.com and a member of the Campaign to Fix the Debt.

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An often overshadowed battle for veterans

An often overshadowed battle for veterans - The Hill's Congress Blog @import "/plugins/content/jw_disqus/tmpl/css/template.css"; li.item435,li.item437,li.item439,li.item441,li.item443,li.item497,li.item499,li.item501,li.item503,li.item605,li.item689,li.item691,li.item693,li.item695,li.item697,li.item683,li.item685{display: none;} var _comscore = _comscore || []; _comscore.push({ c1: "2", c2: "10314615" }); (function() { var s = document.createElement("script"), el = document.getElementsByTagName("script")[0]; s.async = true; s.src = (document.location.protocol == "https:" ? "https://sb" : "http://b") + ".scorecardresearch.com/beacon.js"; el.parentNode.insertBefore(s, el); })(); function getURLParameter(name) { return decodeURI( (RegExp(name + '=' + '(.+?)(&|$)').exec(location.search)||[,null])[1] );}(function(d, s, id) { var js, fjs = d.getElementsByTagName(s)[0]; if (d.getElementById(id)) return; js = d.createElement(s); js.id = id; js.src = "//connect.facebook.net/en_US/all.js#xfbml=1&appId=369058349794205"; fjs.parentNode.insertBefore(js, fjs); if (getURLParameter("set_fb_var") == '1') { jQuery.cookie('set_fb_var', 'true', { expires: 7, path: '/' }); return true; } if (!jQuery.cookie('set_fb_var') && d.referrer.match(/facebook.com/i)) { window.fbAsyncInit = function() { FB.init({ appId : '340094652706297', status: true, xfbml: true, cookie: true, oauth: true }); }; }}(document, 'script', 'facebook-jssdk'));if((navigator.userAgent.match(/iPhone/i)) || (navigator.userAgent.match(/iPod/i))) {document.write('Download TheHill.com iPhone App Free!');}if(navigator.userAgent.match(/iPad/i)) {document.write('Download TheHill.com iPad App Free!');}if(navigator.userAgent.match(/Android/i)) {document.write('The Hill Android App Now Available');} The Hill Newspaper !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0];if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src="//platform.twitter.com/widgets.js";fjs.parentNode.insertBefore(js,fjs);}}(document,"script","twitter-wjs");Google+Advanced Search Options » Home/NewsSenateHouseAdministrationCampaignPollsBusiness & LobbyingSunday Talk ShowsCampaignBusiness & LobbyingK Street InsidersLobbying ContractsLobbying HiresLobbying RevenueOpinionColumnistsEditorialsLettersOp-EdWeyants WorldCapital LivingCover StoriesFood & DrinkNew Member of the Week20 QuestionsMy 5 Min. W/ObamaAnnouncementsMeet the LawmakerJobsVideoGossip: In The Know Briefing RoomRegWatchHillicon ValleyE2-WireFloor ActionOn The MoneyHealthwatchTransportationDEFCON HillGlobal AffairsCongressBallot BoxIn The KnowPunditsTwitter Room HomeSenateHouseAdministrationCampaignPollsBusiness & LobbyingSunday Talk ShowsBlogsBriefing RoomRegWatchHillicon ValleyE2-WireFloor ActionOn The MoneyHealthwatchTransportationDEFCON HillGlobal AffairsCongressBallot BoxIn The KnowPunditsTwitter RoomOpinionA.B. StoddardBrent BudowskyLanny DavisDavid HillCheri JacobusMark MellmanDick MorrisMarkos Moulitsas (Kos)Robin BronkEditorialsLettersOp-EdsJuan WilliamsJudd GreggChristian HeinzeKaren FinneyJohn FeeheryCapital LivingCover StoriesFood & DrinkAnnouncementsNew Member of the WeekMy 5 Min. W/ObamaAll Capital LivingVideoHillTubeEventsVideoClassifiedsJobsClassifiedsResourcesMobile SiteiPhoneAndroidiPadLawmaker RatingsWhite PapersOrder ReprintsLast 6 IssuesOutside LinksRSS FeedsContact UsAdvertiseReach UsSubmitting LettersSubmitting Op-edsSubscriptions THE HILL  commentE-mailPrintshare An often overshadowed battle for veteransBy Thomas J. Berger, executive director, Veterans Health Council for Vietnam Veterans of America-03/08/13 03:00 PM ET !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0];if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src="//platform.twitter.com/widgets.js";fjs.parentNode.insertBefore(js,fjs);}}(document,"script","twitter-wjs");

Our veterans, returning from two protracted wars, deserve the very best. Most agree that includes access to jobs, education, affordable housing, quality health care, and equal opportunity employment. After defending our freedom overseas, our soldiers, sailors, airmen and Marines are clearly facing a crisis at home. We need to ensure that those who have taken care of us abroad are taken care of once they transition back to civilian life. One area that is often overlooked is the proper diagnosis and treatment for veterans suffering from chronic pain.

Few Americans truly understand the struggles our veterans faced overseas in recent wars, and in past conflicts like Vietnam. Part of the experience was a generation of veterans returning home with chronic pain problems. While millions of Americans suffer from chronic pain, many are veterans who brought the unfortunate souvenir back from war. According to a May 2011 study by the American Pain Society, about nine in 10 Iraq and Afghanistan veterans who registered for care with the Department of Veterans Affairs are experiencing pain. More than half of these veterans have significant pain, the study asserted. In raw numbers, of the 291,205 who enrolled for VA health care between October 2003 and December 2008, 141,029 received a diagnosis of a painful condition not caused by cancer.
 
Despite the media attention given to post traumatic stress disorder (PTSD) the number one malady suffered by America’s active duty military personnel is musculoskeletal. With all the injuries suffered by troops, it comes as no surprise that chronic pain is a frequent problem among returning military personnel from Operation Iraqi Freedom and Operation Enduring Freedom.
 
This is not a new trend, however. Vietnam veterans have suffered a variety of sustained and chronic injuries and afflictions, including exposure to the herbicide Agent Orange. Many of these veterans have been living with chronic pain for more than 40 years, and the access they have to medications and treatments is often the difference between being productive and bedridden.
 
We can help veterans, both young and older, by ensuring they have access to improved treatments and medications to better manage their chronic pain.  The fact is every person experiences pain differently and responds to treatments in different ways. Whether the pain stems from head trauma, spinal-cord and eye injuries or an amputation, there must be a variety of options available to treat the unique symptoms our veterans are experiencing. But the rise in prescription drug abuse threatens to stifle these options for fear of the further spread of abuse and misuse. We must not let that happen.
 
Make no mistake, prescription drug abuse is a major concern within the veteran community and we support proactive measures to educate veterans of this threat and to encourage responsible prescribing to ensure these medicines stay out of the hands of those who abuse and misuse the drugs. But we cannot allow for the abuse dynamic to restrict veterans’ access to the highest quality medications and treatments needed to relieve their pain.
 
Prescription medicines are not the only solution for every veteran. But for those who need them, they are critical. Together we can ensure our warriors can live long and productive lives, even if they have to manage pain. Access to quality health care and new options for treatment will protect the next generation of Americans coming back from war from experiencing the same challenges of past generations.
 
Let us not stand in the way of our heroes resuming and fulfilling their dreams.
 
Berger is executive director of the Veterans Health Council for Vietnam Veterans of America.

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Executive Order -- Export Control Reform

The White House

Office of the Press Secretary

EXECUTIVE ORDER

- - - - - - -

ADMINISTRATION OF REFORMED EXPORT CONTROLS

By the authority vested in me as President by the Constitution and the laws of the United States of America, including the Arms Export Control Act, as amended (22 U.S.C. 2751 et seq.) (the "Act"), and section 301 of title 3, United States Code, it is hereby ordered as follows:

Section 1. Delegation of Functions. The following functions conferred upon the President by the Act, and related laws, are delegated as follows:

(a) Those under section 3 of the Act (22 U.S.C. 2753), with the exception of subsections (a)(1), (b), (c)(3), (c)(4), and (f) (22 U.S.C. 2753(a)(1), (b), (c)(3), (c)(4), and (f)), to the Secretary of State. The Secretary of State, in the implementation of the delegated functions under sections 3(a) and (d) of the Act (22 U.S.C. 2753(a) and (d)), is authorized to find, in the case of a proposed transfer of a defense article or related training or other defense service by a foreign country or international organization not otherwise eligible under section 3(a)(1) of the Act (22 U.S.C. 2753(a)(1)), whether the proposed transfer will strengthen the security of the United States and promote world peace.

(b) Those under section 5 (22 U.S.C. 2755) to the Secretary of State.

(c) Those under section 21 of the Act (22 U.S.C. 2761), with the exception of the last sentence of subsection (d) and all of subsection (i) (22 U.S.C. 2761(d) and (i)), to the Secretary of Defense.

(d) Those under sections 22(a), 29, 30, and 30A of the Act (22 U.S.C. 2762(a), 2769, 2770, and 2770a) to the Secretary of Defense.

(e) Those under section 23 of the Act (22 U.S.C. 2763), and under section 7069 of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2012 (Public Law 112-74, Division I) and any subsequently enacted provision of law that is the same or substantially the same, to the Secretary of Defense to be exercised in consultation with the Secretary of State and, other than the last sentence of section 23(a) (22 U.S.C. 2763(a)), in consultation with the Secretary of the Treasury, except that the President shall determine any rate of interest to be charged that is less than the market rate of interest.

(f) Those under sections 24 and 27 of the Act (22 U.S.C. 2764 and 2767) to the Secretary of Defense. The Secretary of Defense shall consult with the Secretary of State and the Secretary of the Treasury in implementing the delegated functions under section 24 (22 U.S.C. 2764) and with the Secretary of State in implementing the delegated functions under section 27 (22 U.S.C. 2767).

(g) Those under section 25 of the Act (22 U.S.C. 2765) to the Secretary of State. The Secretary of Defense shall assist the Secretary of State in the preparation of materials for presentation to the Congress under that section.
(h) Those under section 34 of the Act (22 U.S.C. 2774) to the Secretary of State. To the extent the standards and criteria for credit and guaranty transactions are based upon national security or financial policies, the Secretary of State shall obtain the prior concurrence of the Secretary of Defense and the Secretary of the Treasury, respectively.

(i) Those under section 35(a) of the Act (22 U.S.C. 2775(a)) to the Secretary of State.

(j) Those under sections 36(a) and 36(b)(1) of the Act (22 U.S.C. 2776(a) and (b)(1)), except with respect to the certification of an emergency as provided by subsection (b)(1) (22 U.S.C. 2776(b)(1)), to the Secretary of Defense. The Secretary of Defense, in the implementation of the delegated functions under sections 36(a) and (b)(1) (22 U.S.C. 2776(a) and (b)(1)), shall consult with the Secretary of State. With respect to those functions under sections 36(a)(5) and (6) (22 U.S.C. 2776(a)(5) and (6)), the Secretary of Defense shall consult with the Director of the Office of Management and Budget.

(k) Those under section 36(b)(1) with respect to the certification of an emergency as provided by subsection (b)(1) and under sections 36(c) and (d) of the Act (22 U.S.C. 2776(b)(1), (c), and (d)) to the Secretary of State.

(l) Those under section 36(f)(1) of the Act (22 U.S.C. 2776(f)(1)) to the Secretary of Defense.

(m) Those under sections 36(f)(2) and (f)(3) of the Act (22 U.S.C. 2776(f)(2) and (f)(3)) to the Secretary of State.

(n) Those under section 38 of the Act (22 U.S.C. 2778) to:

(i) the Secretary of State, except as otherwise provided in this subsection. Designations, including changes in designations, by the Secretary of State of items or categories of items that shall be considered as defense articles and defense services subject to export control under section 38 (22 U.S.C. 2778) shall have the concurrence of the Secretary of Defense. The authority to undertake activities to ensure compliance with established export conditions may be redelegated to the Secretary of Defense, or to the head of another executive department or agency as appropriate, who shall exercise such functions in consultation with the Secretary of State;

(ii) the Attorney General, to the extent they relate to the control of the permanent import of defense articles and defense services. In carrying out such functions, the Attorney General shall be guided by the views of the Secretary of State on matters affecting world peace, and the external security and foreign policy of the United States. Designations, including changes in designations, by the Attorney General of items or categories of items that shall be considered as defense articles and defense services subject to permanent import control under section 38 of the Act (22 U.S.C. 2778) shall be made with the concurrence of the Secretary of State and the Secretary of Defense and with notice to the Secretary of Commerce; and

(iii) the Department of State for the registration and licensing of those persons who engage in the business of brokering activities with respect to defense articles or defense services controlled either for purposes of export by the Department of State or for purposes of permanent import by the Department of Justice.

(o) Those under section 39(b) of the Act (22 U.S.C. 2779(b)) to the Secretary of State. In carrying out such functions, the Secretary of State shall consult with the Secretary of Defense as may be necessary to avoid interference in the application of Department of Defense regulations to sales made under section 22 of the Act (22 U.S.C. 2762).

(p) Those under the portion of section 40A of the Act added by Public Law 104-164 (22 U.S.C. 2785), to the Secretary of State insofar as they relate to commercial exports licensed under the Act, and to the Secretary of Defense insofar as they relate to defense articles and defense services sold, leased, or transferred under the Foreign Military Sales Program.

(q) Those under the portion of section 40A of the Act added by the Antiterrorism and Effective Death Penalty Act of 1996 (Public Law 104-132) (22 U.S.C. 2781), to the Secretary of State.

(r) Those under sections 42(c) and (f) of the Act (22 U.S.C. 2791(c) and (f)) to the Secretary of Defense. The Secretary of Defense shall obtain the concurrence of the Secretary of State and the Secretary of Commerce on any determination considered under the authority of section 42(c) of the Act (22 U.S.C. 2791(c)).

(s) Those under section 52(b) of the Act (22 U.S.C. 2795a(b)) to the Secretary of Defense.

(t) Those under sections 61 and 62(a) of the Act (22 U.S.C. 2796 and 2796a(a)) to the Secretary of Defense.

(u) Those under section 2(b)(6) of the Export-Import Bank Act of 1945, as amended (12 U.S.C. 635(b)(6)) to the Secretary of State.

Sec. 2. Coordination. (a) In addition to the specific provisions of section 1 of this order, the Secretary of State and the Secretary of Defense, in carrying out the functions delegated to them under this order, shall consult with each other and with the heads of other executive departments and agencies on matters pertaining to their responsibilities.

(b) Under the direction of the President and in accordance with section 2(b) of the Act (22 U.S.C. 2752(b)), the Secretary of State, taking into account other United States activities abroad, shall be responsible for the continuous supervision and general direction of sales and exports under the Act, including the negotiation, conclusion, and termination of international agreements, and determining whether there shall be a sale to a country and the amount thereof, and whether there shall be delivery or other performance under such sale or export, to the end that sales and exports are integrated with other United States activities and the foreign policy of the United States is best served thereby.

Sec. 3. Allocation of Funds. Funds appropriated to the President for carrying out the Act shall be deemed to be allocated to the Secretary of Defense without any further action of the President.

Sec. 4. Revocation. Executive Order 11958 of January 18, 1977, as amended, is revoked; except that, to the extent consistent with this order, all determinations, authorizations, regulations, rulings, certificates, orders, directives, contracts, agreements, and other actions made, issued, taken, or entered into under the provisions of Executive Order 11958, as amended, and not revoked, superseded, or otherwise made inapplicable, shall continue in full force and effect until amended, modified, or terminated by appropriate authority.

Sec. 5. Delegation of Functions under the International Emergency Economic Powers Act. Executive Order 13222 of August 17, 2001, is amended as follows:

(a) Redesignate section 4 as section 6.

(b) Insert the following new sections 4 and 5 after section 3:

"Sec. 4. The Secretary of Commerce shall, to the extent required as a matter of statute or regulation, establish appropriate procedures for when Congress is to be notified of the export of firearms that are subject to the jurisdiction of the Department of Commerce under the Export Administration Regulations and that are controlled for purposes of permanent import by the Attorney General under section 38(a) of the Arms Export Control Act (22 U.S.C. 2778(a)) and appropriate procedures for when Congress is to be notified of the export of Major Defense Equipment controlled for purposes of permanent export under the jurisdiction of the Department of Commerce.

Sec. 5. (a) The Secretary of State is hereby authorized to take such actions and to employ those powers granted to the President by the Act as may be necessary to license or otherwise approve the export, reexport, or transfer of items subject to the jurisdiction of the Department of Commerce as agreed to by the Secretary of State and the Secretary of Commerce.

(b) Notwithstanding subsection (a) of this section, items licensed or otherwise approved by the Secretary of State pursuant to this section remain subject to the jurisdiction of the Department of Commerce."

Sec. 6. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

BARACK OBAMA

Extending Middle Class Tax Cuts

In his weekly address, President Obama says that businesses have created jobs every month for three years straight – nearly 6.4 million altogether, and have added 246,000 new jobs in February. We must keep this momentum going, and that’s why the President recently met with Republican leaders to discuss how we can replace the harmful, arbitrary budget cuts, called the “sequester,” with balanced deficit reduction.

First Lady Michelle Obama and Secretary of State John Kerry Present International Women of Courage Awards

Mrs. Obama and Sec. Kerry celebrate International Women's Day by honoring nine extraordinary women.

President Obama has made promoting gender equality and advancing the status of women and girls central to our foreign policy and national security strategy, including by leading by example at home.

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