Drugmakers can't charge beyond making costs for compassionate use: FDA

2016-06-02 22:17:45

The U.S. Food and Drug Administration said companies could only charge patients for the cost of manufacturing experimental treatments used under compassionate grounds, and it cannot force government or private health insurers to pay for these drugs."Compassionate use" of experimental drugs allows physicians to prescribe unapproved treatments for patients who have no other satisfactory alternatives in the market.The FDA's move seems to be intended to soften the repercussions of its possible rejection of Sarepta Therapeutics Inc's muscle-wasting drug, analysts said. Sarepta's shares fell as much as 30 percent on Thursday. The FDA last week deferred its decision on whether to approve Sarepta's drug, eteplirsen, after an advisory panel determined that the treatment was not effective. The FDA is trying to create a compromise, saying drug companies can charge for a drug even if its not approved, WBB Securities analyst Stephen Brozak told Reuters. Brozak also added that investors are basically focusing on Sarepta, even though the FDA guidelines affect the whole industry. Eteplirsen was developed to treat Duchenne muscular dystrophy (DMD), a rare condition that typically emerges in boyhood, causing weakness in the arms and legs, and eventually the lungs and heart. There is no other treatment on the market.Sarepta's drug has been in the spotlight over the past few months with patient groups and parents arguing passionately in favor of the treatment to pressure the regulator to approve the drug. Sarepta's shares were down 27 percent at $15.50 on Thursday. (Reporting by Amrutha Penumudi and Natalie Grover in Bengaluru; Editing by Don Sebastian)

Mississippi governor to join suit against Obama transgender policy

2016-05-26 23:13:04

Mississippi's Republican governor said on Thursday he planned to join a lawsuit by officials from 11 states to overturn an Obama administration directive that tells schools to let transgender students use bathrooms matching their gender identity.The lawsuit led by Texas, the most significant legal challenge to this month's directive, said the federal government and Obama administration officials overreached their authority by taking actions that should be left to Congress or individual states."Our office has talked to the Texas attorney general's office and I intend, as soon as possible, to join the lawsuit against this latest example of federal overreach," Mississippi Governor Phil Bryant said in a statement.As with some of the other states, Mississippi's governor and attorney general disagree on the suit, which challenges the administration's interpretation that federal civil rights laws against sex discrimination should apply to transgender people.Mississippi's attorney general, Democrat Jim Hood, declined to participate in the lawsuit, according to Clay Chandler, a spokesman for the governor. Chandler said Bryant will work with an attorney in the governor's office in joining the lawsuit. Hood's office did not immediately respond to a request for comment.Amid a national debate on transgender rights, President Barack Obama's administration on May 13 told U.S. public schools that transgender students should be allowed to use the bathroom of their choice, upsetting Republicans and paving the way for fights over federal funding and legal authority. Texas was joined by Alabama, Georgia, Louisiana, Oklahoma, Tennessee, Utah, West Virginia and Wisconsin, plus Arizona's Department of Education and Maine's governor.The lawsuit said the administration "conspired to turn workplace and educational settings across the country into laboratories for a massive social experiment, flouting the democratic process, and running roughshod over commonsense policies protecting children and basic privacy rights." Transgender rights advocates criticized the suit as a malicious attack, saying there have never been public safety incidents or invasions of privacy related to protections for transgender people."While the department will review the complaint, the federal government has strong legal foundations to uphold the civil rights of transgender Americans," the Justice Department said in a statement on Wednesday. (Reporting by Letitia Stein; Writing by Daniel Trotta; Editing by Will Dunham)

Facebook's Zuckerberg meets U.S. conservatives over bias controversy

2016-05-19 04:13:05

Facebook Chief Executive Mark Zuckerberg heard from more than a dozen U.S. conservative leaders on Wednesday and said he will work to build trust with users who believe the social network displays politically biased news content.After a closed-door meeting at the company's Silicon Valley headquarters, Zuckerberg defended his company's practices but acknowledged that many conservatives believe Facebook is politically liberal. "It doesn't make sense for our mission or our business to suppress political content," Zuckerberg wrote on Facebook after the meeting. "I know many conservatives don't trust that our platform surfaces content without a political bias," he added. "I wanted to hear their concerns personally and have an open conversation about how we can build trust. "The editorial practices at the world's largest social network came under scrutiny after a former Facebook contractor anonymously accused editors there of deliberately suppressing conservative news. The allegations were reported by technology news website Gizmodo, which did not identify the ex-contractor.Facebook has denied the allegations and said it would conduct a full investigation.A Facebook spokeswoman said the meeting produced "a constructive discussion" and some attendees called it productive."I think Facebook is very sincere in wanting to resolve outstanding issues with conservatives," Brent Bozell, president of the Media Research Center, said after the meeting. Attendees were frank about their concerns, but the tone was cordial, Bozell said. "Facebook invited that frank talk. People didn't hold back too much," he said. On her Facebook page, conservative CNN commentator S.E. Cupp said the meeting had produced "strong commitments to address issues, as well as to work together on common goals." Other attendees included former White House press secretary Dana Perino, media personality Glenn Beck and former Republican Senator Jim DeMint.Zuckerberg said that while Silicon Valley has a reputation for being liberal, Facebook's 1.6 billion users span every background and ideology."The reality is, conservatives and Republicans have always been an important part of Facebook," Zuckerberg wrote. Presumptive Republican nominee Donald Trump has more Facebook fans than any other presidential candidate, he said. Fox News "drives more interactions on its Facebook page than any other news outlet in the world," Zuckerberg added. "It's not even close." Fox News is owned by Rupert Murdoch's 21st Century Fox (FOXA.O).Facebook employees who donate to presidential candidates lean Democratic. Seventy-nine percent of employee contributions to 2016 contenders went to Democrats, according to a Reuters analysis of campaign finance data, and 21 percent to Republicans.Zuckerberg has contributed to candidates in both parties. Sixty-percent of his donations during the 2014 midterm elections went to Republicans and 40 percent to Democrats. He has not supported a presidential candidate this cycle. Although a U.S. Senate committee is investigating whether there is liberal bias in selection of trending topics, there is little chance the government will try to regulate Facebook's practices, said Republican Senator John Thune, chairman of the Senate Commerce Committee."I don't have any reason to believe that would be necessary," Thune told reporters on Tuesday.Thune sent a letter to Facebook last week to demand that it explain its editorial decision-making and how stories are chosen for the "trending topics" feature. He said his primary concern was that Facebook was potentially being deceptive about how its news feed curation algorithms work. Facebook last week released its guidelines for choosing trending topics, but the operations of the news feed algorithm remain closely guarded.Legal experts said the government has few tools to dictate how a private company makes news decisions."As a legal matter, Facebook is not required to be even-handed," said Eugene Volokh, a law professor at the University of California, Los Angeles. "Congress can't introduce something that tries to prohibit Facebook from making these kinds of choices." (Reporting by Yasmeen Abutaleb and Dustin Volz; Editing by Jonathan Weber and Tom Brown)

Republicans win Obamacare legal challenge, add to insurer concerns

2016-05-13 06:13:06

WASHINGTON A U.S. judge on Thursday handed a victory to congressional Republicans who challenged President Barack Obama's signature healthcare law, ruling that his administration overstepped its constitutional powers relating to government spending.U.S. District Judge Rosemary Collyer, based in Washington, ruled that the administration cannot spend billions of dollars in federal funds to provide subsidies under the law known as Obamacare to private insurers without the approval of Congress.At issue in the case, brought by the Republican-led House of Representatives, are reimbursements to insurance companies to compensate them for reductions that the law requires them to make to customers' out-of-pocket medical payments.The ruling will not have an immediate effect on the law because the judge put the decision on hold pending an expected appeal by the administration. But it adds to uncertainty over the future of Obama's signature domestic policy achievement ahead of the Nov. 8 presidential and congressional elections, including whether enough health insurers will continue to participate in the program.Insurers have sustained losses from their Obamacare business, saying they have not attracted enough healthy customers to offset the costs of sicker members. Two of the largest players, UnitedHealth Group and Humana Inc, had already said they would not offer plans in many markets next year."If you're going to lose more money, why participate?" asked Steve Halper, an analyst with FBR Capital Markets.Shares in hospital operators such as Community Health Systems Inc fell sharply, while insurer stocks including Aetna Inc, which plans to remain in at least 15 Obamacare markets next year, also declined.In court papers, the administration had warned that a court victory for the House Republicans would lead to a spike in insurance premiums for Americans and force the government to pay more in tax credits to insurance policy-holders.As part of an appeal, the administration is likely to press its argument that the House lacks legal standing to sue. "This suit represents the first time in our nation's history that Congress has been permitted to sue the executive branch over a disagreement about how to interpret a statute," White House spokesman Josh Earnest told reporters."It's unfortunate that Republicans have resorted to a taxpayer-funded lawsuit to re-fight a political fight that they keep losing," Earnest added. "They've been losing this fight for six years, and they'll lose it again."REPEATED CHALLENGES Conservatives have mounted a series of legal challenges to the Affordable Care Act since it was passed by Congress in 2010 over unified Republican opposition. Collyer was appointed to the bench by Republican former President George W. Bush.The law has helped bring insurance coverage to millions of Americans who previously had none, subsidizing the cost of insurance through tax credits. In addition, the federal government helped defray consumers' out-of-pocket costs.The House Republicans argued that the administration's action violated the U.S. Constitution because it is the legislative branch, not the executive branch, that authorizes government spending."BIG win for the Constitution," House Speaker Paul Ryan wrote on Twitter.Jonathan Turley, the lawyer who spearheaded the lawsuit, in a blog post called the ruling "a resounding victory not just for Congress but for our constitutional system as a whole." The appeals court in Washington may be more receptive to the administration's arguments, in part because seven of its 11 active judges are Democratic-appointees, including four picked by Obama.The case focuses on a cost-sharing provision of Obamacare that requires insurers to reduce deductibles and co-pays. Insurers are supposed to be reimbursed for these costs by the federal government. Cost-sharing is determined by the income of the policyholder and is a mechanism for reducing healthcare costs for lower-income households. The Obama administration has interpreted the provision as a type of federal spending that does not need to be explicitly authorized by Congress. The House Republicans who filed the challenge disagreed.Collyer ruled that the cost-sharing provisions cannot be funded through the same permanent appropriation that covers tax credits made available under the law.The judge rejected the administration's contention that the appropriation should be viewed as permanent because the alternative interpretation would lead to "absurd economic, fiscal and healthcare policy results."The U.S. Supreme Court in June 2015, in a ruling authored by Bush-appointed Chief Justice John Roberts, rejected a conservative challenge that could have gutted Obamacare, upholding nationwide tax subsidies crucial to the law. Roberts also wrote a major 2012 ruling preserving Obamacare. (Reporting by Lawrence Hurley; Additional reporting by Susan Cornwell, Ransdell Pierson, Amrutha Penumudi and David Alexander; Editing by Michele Gershberg and Will Dunham)

U.S. sails warship near Chinese-claimed reef in South China Sea

2016-05-10 11:03:05

BEIJING/HONG KONG A U.S. navy warship sailed close to a disputed reef in the South China Sea on Tuesday, a U.S. Department of Defense official said, prompting anger in Beijing which denounced the patrol as illegal and a threat to peace and stability.Guided missile destroyer the USS William P. Lawrence traveled within 12 nautical miles of Chinese-occupied Fiery Cross Reef, Defense Department spokesman Bill Urban said. The so-called freedom of navigation operation was undertaken to "challenge excessive maritime claims" by China, Taiwan, and Vietnam which were seeking to restrict navigation rights in the South China Sea, he said."These excessive maritime claims are inconsistent with international law as reflected in the Law of the Sea Convention in that they purport to restrict the navigation rights that the United States and all states are entitled to exercise," Urban said in an emailed statement.Beijing and Washington have traded accusations that the other is militarizing the South China Sea as China undertakes large-scale land reclamations and construction on disputed features while the United States has increased its patrols and exercises in the region.Facilities on Fiery Cross Reef include a 3,000-metre (10,000-foot) runway and Washington is concerned China will use it to press its extensive territorial claims at the expense of weaker rivals.Chinese Foreign Ministry spokesman Lu Kang said the U.S. ship illegally entered Chinese waters and was tracked and warned."This action by the U.S. side threatened China's sovereignty and security interests, endangered the staff and facilities on the reef, and damaged regional peace and stability," he told a daily news briefing. SENSITIVE AREAChina claims most of the South China Sea, through which $5 trillion in ship-borne trade passes every year. The Philippines, Vietnam, Malaysia, Taiwan and Brunei also have overlapping claims.The Pentagon last month called on China to reaffirm it has no plans to deploy military aircraft in the disputed Spratly Islands after Beijing used a military plane to evacuate sick workers from Fiery Cross. "Fiery Cross is sensitive because it is presumed to be the future hub of Chinese military operations in the South China Sea, given its already extensive infrastructure, including its large and deep port and 3000-metre runway," said Ian Storey, a South China Sea expert at Singapore's ISEAS Yusof Ishak Institute. "The timing is interesting, too. It is a show of U.S. determination ahead of President Obama's trip to Vietnam later this month," Storey added.Speaking in Hanoi ahead of Obama's visit, Daniel Russel, the Assistant Secretary of State for East Asia and the Pacific, said freedom of navigation operations were important for smaller nations."If the world's most powerful navy cannot sail where international law permits, then what happens to the ships of navy of smaller countries?," Russel told reporters before news of the operation was made public. "If our warships can't exercise its legitimate rights under international law at sea, then what about the fishermen, what about the cargo ships? How will they prevent themselves from being blocked by stronger nations?"China has reacted with anger to previous U.S. freedom of navigation operations, including the overflight of fighter planes near the disputed Scarborough Shoal last month, and when long-range U.S. bombers flew near Chinese facilities under construction on Cuarteron Reef in the Spratlys last November. U.S. naval officials believe China has plans to start reclamation and construction activities on Scarborough Shoal, which sits further north of the Spratlys within the Philippines claimed 200 nautical mile (370 km) exclusive economic zone. The move also comes as tough-talking city mayor Rodrigo Duterte looks set to take the Philippines' presidency. He has proposed multilateral talks on the South China Sea.Criticism of China over the South China Sea will rebound like a coiled spring, a Chinese diplomat said on Friday, as a U.S. warship visited Shanghai against a backdrop of rising tension in the region. (Additional reporting by David Brunnstrom in Paris and My Pham in Hanoi; Writing by Ben Blanchard; Editing by Nick Macfie and Lincoln Feast)

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