Under fire, Young again apologizes

Rep. Don Young (R-Alaska) offered a formal apology on Friday for his use of a racial slur on Hispanics that drew denunciations from his own party.

"I apologize for the insensitive term I used during an interview in Ketchikan, Alaska," Young said in a second statement on the controversy.  "There was no malice in my heart or intent to offend; it was a poor choice of words."

In a local radio interview on Tuesday, Young used the term "wetbacks" to refer to Hispanics who had worked on his father's ranch.

"That word, and the negative attitudes that come with it, should be left in the 20th century, and I’m sorry that this has shifted our focus away from comprehensive immigration reform," Young said Friday.

Young first apologized for the incident on Thursday, but a number of top lawmakers continued to urge Young to issue a strongly worded apology.

Young used the slur while he was discussing immigration reform legislation in an interview with KRDB-FM radio.

"My father had a ranch. We used to have 50 to 60 wetbacks to pick tomatoes," Young said "It takes two people to pick the same tomatoes now. It’s all done by machine."

Later on Thursday Young issued an apology saying he meant "no disrespect." But the first apology did not stop lawmakers from criticizing Young or urging him to again express regret.

"Congressman Young’s remarks were offensive and beneath the dignity of the office he holds," House Speaker John Boehner (R-Ohio) said Friday. "I don’t care why he said it. There’s no excuse, and it warrants an immediate apology."

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FDA rejects United Therapeutics' oral hypertension drug again

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said its oral drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down 6 percent before the bell to $57.

The drugmaker did not say it would quit pursuing a marketing approval for the tablet.

"We remain confident that oral treprostinil will play an important role in treating pulmonary arterial hypertension," Chief Executive Martine Rothblatt said.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension, a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

Remodulin, the company's lead product, accounted for half of United Therapeutics's revenue last year. The company also sells Adcirca, an oral tablet to treat PAH.

Oral versions are usually preferred over other forms due to their ease of administration.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

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Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG

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UPDATE 1-FDA rejects United Therapeutics' oral hypertension drug again

* Rejects resubmission filed in February

* Co likely to conduct fresh late-stage trial - analyst

* Shares down about 6 pct in early trade

(Adds analyst comment) By Vrinda Manocha

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said its oral drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down about 6 percent in early trade on the Nasdaq.

The drugmaker did not say it would quit pursuing a marketing approval for the tablet.

"We remain confident that oral treprostinil will play an important role in treating pulmonary arterial hypertension," Chief Executive Martine Rothblatt said.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration (FDA) in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

The company would probably conduct another late-stage trial for the drug as it had originally planned, Wedbush analyst Liana Moussatos told Reuters.

"After the first rejection,the company thought they'd have to do another late-stage trial and it would take four years before they could resubmit the marketing approval application," she said.

"They did some additional analysis and brought in some historical data and thought they would give it another shot."

The drug will not be approved before 2017 if the trial and the review takes four years.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension, a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

Moussatos said United Therapeutics did not need oral treprostinil to maintain its growth. She had earlier projected $399 million in peak annual sales for the drug, but had not included the oral variant in her model.

Remodulin, the company's lead product, accounted for $458 million in revenue last year, about half of United Therapeutics's net revenue. The company also sells Adcirca, an oral tablet to treat PAH.

Oral versions of drugs are usually preferred over other forms due to their ease of administration.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

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Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG

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UPDATE 2-FDA rejects United Therapeutics' oral hypertension drug again

* Rejects resubmission filed in February

* Co likely to conduct fresh late-stage trial - analyst

* Shares down 2 pct

(Adds company comment, details)

By Vrinda Manocha

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said the oral version of its drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down as much as 7 percent in morning trade on the Nasdaq.

The drugmaker had resubmitted its marketing approval application last month, and an analyst said the fresh rejection was likely to necessitate new trials and a delay of about four years before the company tried again.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration (FDA) in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

The company would now probably conduct another late-stage trial for the drug as it had originally planned, Wedbush analyst Liana Moussatos told Reuters. After the first rejection, the company had said that it could take four years to conduct a new trial and make a new application, she said.

However, "they did some additional analysis and brought in some historical data and thought they would give it another shot," she added.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension (PAH), a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

The FDA's latest rejection letter did not contain any new issues, the company's vice president for business development, Martin Auster, told Reuters.

"Our infused and inhaled versions have only penetrated a fraction of the market," Auster said. "We believe an orally delivered offering would be preferred by patients and physicians."

Wedbush's Moussatos said United Therapeutics did not need oral treprostinil to maintain its growth. She had earlier projected $399 million in peak annual sales for the drug, but had not included the oral variant in her model.

Remodulin, the company's lead product, accounted for $458 million in revenue last year, about half of United Therapeutics's net revenue. The company also sells Adcirca, an oral tablet to treat PAH.

United Therapeutics' PAH drugs compete with Gilead Sciences Inc's Letairis, Pfizer's Revatio and Swiss biotechnology company Actelion Ltd's Tracleer and Veletri.

United Therapeutics shares, which have risen about 14 percent since the drug was first rejected last year, were down about 2 percent at $59.73 on the Nasdaq.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

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Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG

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Congressional Democrats Again Pressure Obama To Sign Nondiscrimination Executive Order

Rep. Frank Pallone (D-NJ)

Congressional Democrats have once again pressured President Obama to issue an executive order that would prohibit federal contractors from discriminating on the basis of sexual orientation and gender identity. Today, 110 members of the House, led by Reps. Frank Pallone (D-NH) and Jared Polis (D-CO), signed a letter urging Obama not to delay the order any longer, regardless of the potential for the Employment Non-Discrimination Act (ENDA) to pass:

OUr request begins with a simple premise. It is unacceptable that it remains legal to fire or refuse to hire someone based on his or her sexual orientation or gender identity. Federal law continues to allow this and discrimination based on sexual orientation is legal in 29 states and discrimination because of gender identity is legal in 34 states. Action at the federal level can put a stop to these unfair and discriminatory workplace practices in every state. [...]

Executive Order 11246, signed by President Lyndon Johnson in 1965 and subsequently amendment, prohibits federal contractors from discriminating against employees based on race, color, religion, sex or national origin. The executive order gave millions important workplace protections and to this day continues to stand as an important protection that is enforced by the Office of Federal Contract Compliance Programs at the Department of Labor. According to the Williams Institute at the UCLA School of Law, an executive order prohibiting federal contractors from discriminating based on sexual orientation and gender identity would protect more than 16 million additional workers.

Last year, 72 Representatives sent a similar letter, as did 37 Senators last month. Despite a campaign pledge to sign such an order, Obama has avoided doing so, claiming he would prefer the legislative solution of ENDA. But even if ENDA were to pass (which it likely won’t while the House is Republican-controlled), an executive order would still be needed to protect employees in businesses with less than 15 employees. It was rumored Obama might use the State of the Union to speak out for nondiscrimination protections, but he did not.

It remains unclear what the Obama administration gains by continuing to deny these protections to the LGBT community.

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McConnell: GOP Will Likely Take Debt Ceiling Hostage For Spending Cuts — Again

Republicans and Democrats agreed to increase the debt ceiling for three months at the end of January, but with another deadline approaching in May, the top Senate Republican is hinting that the GOP will again demand spending cuts in exchange for any increase.

That is par for the course for Republicans, who have repeatedly threatened to let the nation default on its obligations if President Obama and Senate Democrats don’t agree to cut spending, but this time, Senate Minority Leader Mitch McConnell (R-KY) said the GOP will likely demand cuts to America’s entitlement programs — Medicare, Medicaid, and Social Security — to agree to an increase in the borrowing limit, The Hill reports:

“Until we make our entitlement programs fit the demographics of our country, you can’t save America, you can’t save the healthcare system,” McConnell said. “There is no revenue solution, I would say to you.”

“We all anticipate that the president’s request of us to raise the debt ceiling, which we’ll probably do sometime this will generate another, hopefully, another discussion about solving the real problem,” he said.

Republicans continue to crow about entitlement reform, ignoring that Social Security is fully solvent for at least two decades, that Obama extended Medicare’s solvency by nine years as part of his sweeping healthcare law, and that at least one of the major reforms Republicans favor — raising the retirement age for Medicare enrollees — would do nothing to improve the program’s health. Meanwhile, the GOP refuses to actually put forth specific entitlement reform plans that would do anything other than end the programs as they exist today.

Using the debt ceiling to extract such cuts is an even less reasonable position, given the pain the GOP’s debt intransigence has already inflicted on the economy. The 2011 debt fight led to increased borrowing costs, hampered job growth for months, and created the automatic budget cuts that went into effect at the beginning of March — all of which burdened an economy that is still struggling to fully recover from the Great Recession. That brinksmanship has led leading policymakers like Federal Reserve Chairman Ben Bernanke, as well as a vast majority of economists, to call for the abolition of the statutory debt limit.

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Boehner: House will vote again to block 'ObamaCare'

House Speaker John Boehner (R-Ohio) said Wednesday that the House will vote again soon to repeal or defund President Obama's healthcare law.

"Well I would expect that sometime in the coming months that we will once again move to get rid of ObamaCare," Boehner said in an interview on Sean Hannity's radio show. "We've had a number of votes in the House in the last two years to end ObamaCare or get rid of it."

The House held 33 votes over the last two years to repeal or defund all or part of the Affordable Care Act, but the repeal push has faded since the Supreme Court upheld the law and President Obama's reelection ensured that repeal votes would be futile.

Boehner had said after the election that "ObamaCare is the law of the land," and the House hasn't picked funding battles over the law so far this year.

Hannity pressed Boehner on his decision not to vote on a defunding proposal as part of the House's continuing resolution, which keeps the government operating through the end of the fiscal year. Conservatives in the Senate demanded a defunding vote on the chamber's CR.

"The government runs out of money on March 27 and our goal is to have the spending fight — whether it's ObamCcare and all the rest— is to have that fight over the sequester," Boehner responded. 

Holding a defunding vote at the wrong time, like during consideration of raising the debt ceiling, could jeopardize the country's credit, Boehner argued. 

"There will be opportunities ahead but do you want risk the full faith and credit of the United States government over ObamaCare? That's a very tough argument to make," Boehner added. "The American people are gong to control this."

House Republicans will have no problem passing legislation defunding the law, Boehner said, even if the Senate is certain not to follow suit.

Sen. Ted Cruz (R-Texas) introduced an amendment defunding the healthcare law. The Senate amendment failed Wednesday.

"The Senate's never done anything," Boehner said. "I expect the Senate will have a vote during their budget debate on ObamaCare. I don't expect it'll pass. But we're going to continue to help the American people understand just how devastating this law is going to be, both on the budget side and to the fact that they're not going toe able to keep the lean insurance they like, as the president promised them."

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House To Vote Again On Repealing ‘Obamacare’ Next Week

The House will vote again next week to repeal the 2010 health-care reform law, a decision by top Republican leaders designed in part to appease GOP freshmen lawmakers who have not had an opportunity to take a vote on the issue.

House Majority Leader Eric Cantor (R-Va.). (Jacquelyn Martin/AP)

House Majority Leader Eric I. Cantor (R-Va.), who sets the House schedule, announced on Twitter on Wednesday that the vote will occur next week: “It just keeps getting worse. I am scheduling a vote for next week on the full repeal of #Obamacare.”

Cantor’s decision to schedule the vote comes as he’s devoted most of the House calendar in recent months to a series of bills that fit within his “making life work” agenda that emphasizes kitchen-table issues over slashing federal spending. Among such bills is the “Working Families Flexibility Act,” which would give private employers the option of offering workers additional time off in lieu of overtime pay and is set for a vote Wednesday.

Cantor had to pull another bill, called the “Helping Sick Americans Now Act,” two weeks ago amid opposition from conservatives who didn’t like that the measure would redistribute millions of dollars in funding established by the health-care law, but not repeal the entire law.

Several Republican aides say that Cantor’s decision to hold a vote on repealing the law will serve two mutually beneficial purposes for House Republicans: It will give about 30 House GOP freshmen who’ve never voted on such a bill the opportunity to do so — and then likely secure Cantor enough support to finally pass the “Helping Sick Americans Now Act.” In turn, those freshmen will be able to go home and tell constituents that they’ve voted to repeal the unpopular law, and Cantor will have succeeded in advancing his agenda.

Depending on which congressional aides are asked, next week’s vote will be anywhere between the 33rd or 37th attempt to repeal all or part of the law since its passage in 2010. The count is disputed because Republican House and Senate lawmakers have tried in vain to use a series of legislative gimmicks — procedural moves, budgeting provisions and outright legislation — to undo the law.

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Republicans Once Again Try To Ban Same-Sex Weddings On Military Bases

Rep. Tim Huelskamp (R-KS)

For the past two years, House Republicans have attempted to use the National Defense Authorization Act to solidify some anti-gay principles into military codes, including a ban on same-sex weddings on military bases, a “license to bully” that encouraged anti-gay harassment, and redundant conscience protections for military chaplains. Some of these conscience protections advanced in the final version of the bill this past fall, and Obama criticized them in a signing statement, calling them “unnecessary” and “ill-advised.” Now, Rep. Tim Huelskamp (R-KS) is once again trying to enshrine discrimination into the nation’s military.

His new bill, H.R. 914, the “Military Religious Freedom Protection Act,” contains more redundant protections for military chaplains, ensuring — as is already the case — that they cannot be penalized if their religious beliefs are not pro-gay. What seems evident is that those redundancies are simply a guise for the last little provision in the bill: a ban on same-sex marriages on military bases:

A military installation or other property owned, rented, or otherwise under the jurisdiction or control of the Department of Defense shall not be used to officiate, solemnize, or perform a marriage or marriage-like ceremony involving anything other than the union of one man with one woman.

Furthermore, if there is any concern that chaplains’ consciences are not already protected, it seems that these reiterated provisions could only serve to protect outright anti-LGBT harassment.

In the year after Don’t Ask, Don’t Tell was repealed, only two individuals — both chaplains — left the military in protest. Nothing about this bill supports the military or its members.

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Undeterred By Court Order, Iowa Official Tries Again To Push Through Voter Purge

Iowa Secretary of State Matt Schultz

When Secretary of State Matt Schultz attempted to purge voters from the rolls in advance of the November 2012 election, a county judge temporarily blocked the move, finding that the rules issued by Schultz created fear and uncertainty and could deter legitimate voters. But that risk of voter suppression hasn’t stopped Schultz from proposing a new slightly tweaked rule to remove registered voters in the name of alleged voter fraud.

The rule would allow Schultz’s office to challenge the legitimacy of registered voters who are listed as noncitizens in the Department of Transportation database. Citing a DOT list of some 3,000 registered voters labeled noncitizens, Schultz said, “I have to do something. I can’t just sit back and do nothing when we know people are taking advantage of the system.”

But Schultz’s testimony just last month before the Senate Judiciary Committee shows that he doesn’t know people are taking advantage of the system. When probed by Senate Majority Whip Dick Durbin (D-IL) for evidence of voter fraud, Schultz cited just six arrests — not convictions – out of 1.6 million votes cast. And this was after a special agent was designated to specifically target voter fraud.

As for the list of 3,000 people, that claim was easily dismissed by the Mexican American Legal Defense Fund’s Nina Perales during the same hearing:

Secretary Schultz … said he had identified 3,500 noncitizens using the driver’s license rolls. He did not. He identified 3,500 people who were noncitizens at the time that they obtained their driver’s licenses. And we know that since that time and before they registered to vote, the overwhelming majority and perhaps all of them have become naturalized citizens. So at this point, anyone who undertakes to accuse people of non-citizenship based on driver’s licenses should be on notice that this is not correct and should not be done. It’s fundamentally unfair.

Attempts to prove voter fraud nationwide have fallen similarly short, with less than 20 instances of fraud charges offered in most states. Florida GOP officials have even publicly admitted voter suppression was the goal of that state’s aggressive and inaccurate purge.

The American Civil Liberties Union and other groups are also arguing that Schultz cannot implement a purge without going through the state legislature. The ruling that blocked Schultz’s last attempt said that, at the very least, Schultz should have gone through the proper rulemaking procedure that allows for public input instead of going forward on his own. Schultz is now going through that procedure, but the court could still hold this process insufficient.

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It’s Deja Vu All Over Again With Debt Ceiling Fight

“ Once the Democrats know that the debt ceiling will invariably be raised, they have no incentive to play ball. The end result will be another raw deal that is worse than doing nothing.”

There is much hullabaloo in the media about John Boehner’s shot across the bow in the upcoming battle over the debt ceiling this fall.  Specifically, Boehner warned that he “will again insist” on the” simple principle of cuts and reforms greater than the debt limit increase.”

The question is what Boehner means by insisting “again” on spending cuts greater than the debt ceiling increase.  Does he view the failed Budget Control Act (BCA), super committee, and sequester of defense spending as a success?  He has yet to denounce last year’s failure, so why should we look forward to a repeat performance?

The first step in remedying our debt ceiling strategy is to acknowledge the failures of the past.  When Republicans caved on raising the debt limit last year, we referred to the final Boehner proposal as a ground ball into a double play.  Not only did Boehner fail to secure any transformational downsizing of government in exchange for raising the debt ceiling, he actually stymied our leverage in future budget battles.  As we’ve noted, Mitch McConnell and House appropriators have already signaled that they will never cut one cent below the discretionary budget caps established in the BCA.  Hence, the BCA served only to lock in the record spending levels of the Obama-era.  The only real cuts that originated from that deal were the sequester cuts to the military that Boehner agrees we should now vitiate.  So how would he do things differently this time?

In retrospect, it would have been better to pass a clean increase of the debt ceiling and live another day to fight in future spending battles than to pass the BCA.  The BCA ruined our leverage for the next ten years as Democrats and Republicans alike refuse to spend below those statist levels.  Moreover, it has engendered a gratuitous schism in the conservative coalition by pitting spending hawks against defense hawks and forcing Republicans to go through the embarrassment of undoing their own scheme.  Finally, the deal failed to achieve the primary objectives of averting a credit downgrade and slowing the national debt.  The debt has increased another $1.3 trillion in the 9 ½ months since the debt ceiling was raised.  That’s about $5 billion per day.  After the hyped dollar-for-dollar cuts, there is not a single major program or agency that has been eliminated.

The irony is that the debt has increased so rapidly following last summer’s deal that we are already talking about the next debt ceiling battle.  Do we really want a repeat performance?

Going forward, there are only two options: A) Republicans can telegraph the message to Democrats that they will never raise the debt ceiling without prior passage of something similar to Cut, Cap, and Balance – and that they would be willing to go to the brink.  B) They admit that they are too scared to take this to the brink, and as such, agree to let Obama raise the debt ceiling.  There is no option C, which would repeat the mistakes of last year.  In other words, it is insane to tell the Democrats that you would never let the deadline pass, yet demand concession for the debt ceiling increase.  Once the Democrats know that the debt ceiling will invariably be raised, they have no incentive to play ball.  The end result will be another raw deal that is worse than doing nothing.  This has occurred time and again throughout every budget battle and it’s time we end this insanity.  We don’t need to hear the tough talk and bravado if there is no intent to carry through with it.

Boehner noted at his speech before the Peter G. Peterson Foundation Fiscal Summit that “we shouldn’t dread the debt limit. We should welcome it.”  He punctuated that belief by calling the debt ceiling “an action-forcing event in a town that has become infamous for inaction.”

Undoubtedly, the debt ceiling will provide us with yet another opportunity to expose the Democrats as the statist European-socialists who are apathetic to our debt crisis.  However, there are all sorts of actions; some are good and some are bad.  Grounding into a double play is worse than striking out.  Sadly, based on our painful experience from last year, inaction might be superior to the action that will evolve from the ranks of the consultant class of the Republican Party.

Cross-posted from The Madison Project

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