U.S. Asks Drug Maker Endo To Withdraw Opioid Amid Abuse Crisis

As the United States battles a growing opioid abuse crisis, the Food and Drug Administration on Thursday asked Endo International Plc to withdraw from the market its long-lasting opioid painkiller, Opana ER, sending Endo?s shares down more than 12 percent.

The move marks the first time the agency has called for the removal of an opioid painkiller for public health reasons and comes after a panel of advisers concluded in March that the drug?s benefits did not outweigh the risks.

?We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,? Dr. Scott Gottlieb, the FDA?s newly appointed commissioner said in a statement.

Opioids were involved in more than 33,000 deaths in 2015 and opioid overdoses have quadrupled since 1999, according to the Centers for Disease Control and Prevention.

It remains to be seen whether Endo will comply with the FDA?s request. The company said in a statement it is ?evaluating the full range of potential options as we determine the appropriate path forward.?

If Endo refuses to withdraw the product, the FDA could offer the company an opportunity for a hearing to make the case for why the product should not be removed. If, after the hearing, the FDA decided to withdraw its approval, Endo could, in theory, sue the agency.

?Despite the FDA?s request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product?s safety or efficacy when taken as prescribed,? the company said.

Opana ER was approved in 2006 and a reformulated version was introduced in 2012.

In March a panel of advisers to the FDA voted 18-8, with one abstention, that the drug?s benefits no longer outweighed the risks. Data showed that while nasal abuse rates fell, the rate of intravenous abuse increased.

The drug has also been associated with a serious outbreak of HIV and hepatitis C, the agency said, as well as a serious blood disorder known as thrombotic microangiopathy.

?If Endo resists taking this off the market immediately, the people who are injured or killed as a result of it being on the market longer than it should, there will be a wave of product liability litigation against the company,? said Sidney Wolfe, founder and senior adviser to consumer watchdog Public Citizen.

Ohio filed a lawsuit in May against the pharmaceutical industry, charging that a number of companies, including Endo, Purdue Pharma, Teva Pharmaceutical Industries Ltd, Johnson & Johnson and Allergan Plc conducted misleading marketing campaigns that downplayed the drugs? addictiveness. Other states and cities have filed similar lawsuits.

Gottlieb said the agency will ?continue to take regulatory steps when we see situations where an opioid product?s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.?

Randall Stanicky, an analyst at RBC Capital Markets, said Opana ER is a declining asset whose sales are expected to fall to $97 million in 2019, down from an estimated $134 million in 2017.

Endo?s shares fell 12.2 percent to $12.10 in extended trading.

 

(Reporting by Toni Clarke in Washington; additional reporting by Ankur Banerjee; Editing by Chris Reese and Lisa Shumaker)

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The Funniest Tweets From Parents This Week

Kids may say the darndest things, but parents tweet about them in the funniest ways. So each week, we round up the most hilarious 140-character quips from moms and dads to spread the joy. Scroll down to read the latest batch and follow @HuffPostParents on Twitter for more!

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Infrastructure Public-Private Partnership Pushed By Mike Pence While Governor Fails

On Wednesday, Vice President Mike Pence cancelled an interview with PBS out of the blue, provoking speculation. The growing controversy around former FBI director James Comey must?ve gotten to the man known for having a stone face.

But there may have been another reason.

On Monday, the state of Indiana announced it would take control of a troubled highway construction project, Interstate 69, between Bloomington and Martinsville. The contractor, the Spanish firm Insolux Corsan, is facing bankruptcy and had been missing deadlines for months.

Who brought Insolux Corsan to the state? Pence. As governor, he signed a 35-year public-private partnership with the firm in 2014 to finance, construct, and maintain a section of the highway. Pence said it would provide ?better value for taxpayers? than if the state used the traditional ? and cheaper ? method of public financing. But with only half the project completed and taxpayers left cleaning up the mess, one wonders what he?d say now.

Monday also happened to be the kickoff of a weeklong rollout of the Trump administration?s infrastructure plan, which would rely heavily on public-private partnerships. On PBS, Pence was supposed to talk infrastructure ? drawing attention to his failed project wouldn?t have been good for business.

The I-69 failure highlights the dangers of Trump?s plan. Rather than the $1 trillion the president promised on the campaign trail, the plan only commits $200 billion in direct federal spending, leaving cities and states desperate for funding and therefore more dependent on local taxes and the private sector to make up the difference.

Public-private partnerships are far more expensive than public financing and ? without very strong protections ? can hand control of infrastructure to private investors.

Public-private partnerships are far more expensive than public financing and ?without very strong protections ? can hand control of infrastructure to private investors.

Trump?s plan wouldn?t rebuild America; it would encourage communities to make shortsighted deals with Wall Street and global corporations like Insolux Corsan.

Not only that, it would put a giant ?for sale? sign on the country?s roads, bridges, water systems, and other infrastructure. Through a program based on a scheme pioneered in Australia?which crashed and burned?the federal government would pay a bonus to cities and states to outright sell public assets.

There?s no question we need to invest in rebuilding our infrastructure for the 21st century. But federal support should help cities and states maintain public control, avoid tolls and fees, create good jobs, and protect the environment.

Trump?s plan helps clearly someone else: Wall Street and global corporations.

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This Was The Day James Comey Truly Became FBI Director

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James Comey testified today and 100% validated your opinion of Trump and Russia. At this point, we?re pretty sure all Paul Ryan is capable of doing is rolling up his sleeves and telling you that, hey, man, people make mistakes, but why don?t we rap about getting your grandmother off the dole. And British voters went to the polls to vote for one of two potential leaders, each of whom speak in full sentences, control their emotions, read books, treat women with respect, know geograph ? wow, what is that like. This is HUFFPOST HILL for Thursday, June 8th, 2017:

TIMID BRITISH VOTERS POLITELY SPREAD POWER TOO EVENLY – Imagine if something like this happened if, say, the president of a country didn?t win the popular vote. Samuel Chamberlain: ?An exit poll projected a hung parliament following Britain?s general election Thursday, in what would be a crippling political defeat for Prime Minister Theresa May?s Conservative government. The exit poll, commissioned by the U.K.?s three main broadcasters and released after the polls closed at 10 p.m., projected the Tories to hold 314 seats, down 16 from their total at the end of the last Parliament. The Labour Party was forecast to gain 37 seats for a total of 266, the Scottish National Party was projected to lose 20 seats for a total of 34, and the center-left Liberal Democrats were projected to have 14 seats, up five from the last Parliament.? [Fox News]

What is a hung parliament? ?A hung parliament means no party has won enough seats in a general election to have a majority in the House of Commons.  In a hung parliament, the incumbent PM stays in office ? and lives in Downing Street ? until it is decided who will attempt to form a new government?. [T]he incumbent PM is entitled to attempt to form a government then stay in office until Parliament meets, when they can ask MPs to approve his Queen?s Speech. Parliament is expected to meet for the first time after the election on Tuesday, June 13.? [Telegraph?s Asa Bennett]

COMEY, COMEY, COMEY, COMEY, COMEY?S A (POLITICAL) CHAMELEON – He comes and goes, he cooooomes and gooooooes. Ryan J. Reilly: ?Trump was not under criminal investigation himself when Comey was fired last month, Comey told the Senate Intelligence Committee. What could put the president in hot water with Special Counsel Robert Mueller now are his alleged attempts to lean on Comey to end the FBI?s investigation into former national security adviser Michael Flynn. Rather than facing an FBI probe that might have ended with Flynn, the president is now looking at an expanding and independent investigation.Comey said he is ?sure? that whether Trump engaged in obstruction of justice is a focus of Mueller?s investigation. ?I don?t think it?s for me to say whether the conversation I had with the president was an effort to obstruct,? he added.? [HuffPost]

THESE TAPES GET JAMES COMEY ALL HOT AND BOTHERED – Mollie Reilly: ?White House deputy press secretary Sarah Huckabee Sanders said Thursday that she has ?no idea? whether there is a recording system in the Oval Office, despite President Donald Trump suggesting he may have recordings of his conversations with then-FBI Director James Comey. Sanders? remarks came during Thursday?s press briefing, according to reporters in attendance. Three days after he fired Comey, the president hinted on Twitter that he had recorded their conversations. While testifying before the Senate Intelligence Committee on Thursday, Comey encouraged the president to release any such tapes that might exist.  ?Look, I?ve seen the tweet about tapes,? Comey said. ?Lordy, I hope there are tapes.? ?Release all the tapes,? he continued. ?I?m good with it.?? [HuffPost]

Guess what Fox News will be discussing: ?Comey said he leaked details of an Oval Office meeting with President Donald Trump to prompt an independent investigation of Russia?s possible collusion with the Trump campaign. The leak was indirect, Comey said during testimony before the Senate Intelligence Committee on Thursday. Comey said that after Trump fired him in May and threatened that he had tapes of their meetings, Comey told a friend and faculty member of Columbia Law School to share details from his own memo of the meetings.? [HuffPost?s Elise Foley]

 Get off my lawn? wait, is this my lawn? ?Sen. John McCain said that his decision to stay up late watching an Arizona Diamondbacks baseball game contributed to his confusing series of questions to former FBI Director James Comey on Thursday. ?I get the sense from Twitter that my line of questioning today went over people?s heads. Maybe going forward I shouldn?t stay up late watching the Diamondbacks night games,? the Arizona Republican said in a statement.? [Washington Examiner?s Kelly Cohen]

This event was covered: ?Sen. Martin Heinrich (D-N.M.), in his pinstriped navy suit, pale blue shirt and yellow-and-blue power tie, tended to keep his arms crossed in front of him as he questioned Comey, showing off a set of distractingly well-groomed nails. So even and shiny.? [WaPo?s Robin Givhan]

Big day for politically minded alcoholics. ?Hundreds gathered before 10am at the local brunch spot in north-west Washington DC to watch James Comey testify that Donald Trump attempted to interfere with the FBI investigation into the president?s former national security adviser Michael Flynn. ?To see this you?d think it?s the Super Bowl,? said Jonah Wolff of the assembled masses.? [The Guardian?s Lucia Graves and Amanda Holpuch]

TRUMP DISPATCHES ANGRY LAWYER TO PLAY DEFENSE Have you been injured in a widely watched Senate intelligence hearing? Marc Kasowitz will fight for you. Paige Lavender Alana Horowitz Satlin: ?President Donald Trump?s lawyer responded to former FBI Director James Comey?s testimony to the Senate Intelligence Committee on Thursday by suggesting that Comey broke the law by leaking information to The New York Times. ?It is overwhelmingly clear that there have been and continue to be those in government who are actively attempting to undermine this administration with selective and illegal leaks of classified information and privileged communications,? Marc Kasowitz said. ?Mr. Comey has now admitted that he is one of the leakers.? ?We will leave it the appropriate authorities to determine whether this leaks should be investigated,? he added. Trump has long vowed to crack down on leakers, and his administration made its first leaks-related arrest earlier this week.? [HuffPost]

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HOUSE PASSES DOOMED DODD-FRANK REPEAL – Just the sort of debate Richard Cordray wants Washington to have as he mulls a run for governor in Ohio. Matt Fuller and Ben Walsh: ?House Republicans [jammed]  through a bill that would largely gut the financial regulations in Dodd-Frank, the landmark banking legislation passed in 2010 after the worst financial crisis since the Great Depression. But instead of quietly sneaking the legislation through, Republicans were loudly touting the bill ? which passed, 233-186, with all Democrats and one Republican (Walter Jones of North Carolina) voting no ? as a major victory. Speaker Paul Ryan (R-Wis.) spent most of the week pointing to the measure as a win for community banks, calling the so-called Financial CHOICE Act the ?crown jewel? of a GOP effort to peel back regulations and bolster the economy…Specifically, the bill would subject the Consumer Financial Protection Bureau to the appropriations process, meaning lawmakers could substantially cut, or even defund, the consumer watchdog. Democrats say subjecting the CFPB to congressional appropriations is the first step in eviscerating the agency.? [HuffPost]

TRUMP: I?M BASICALLY MOSES Igor Bobic: ?President Donald Trump did not respond to former FBI Director James Comey?s congressional testimony in his first public appearance on Thursday, but he seemed to allude to the event by telling supporters his administration was ?under siege.? Speaking at a conference hosted by the Faith & Freedom Coalition, an annual gathering of conservative evangelicals and activists in the nation?s capital, Trump thanked attendees for working to elect him and promised ?the truth? would come to light about his presidency. ?As you know, we?re under siege. You understand that. But we will come out bigger and better and stronger than ever. You watch,? he said. ?As the Bible tells us, we know that the truth will prevail,? he continued, to applause. ?We are winners. We are going to fight, and we are going to have an unbelievable future.?? [HuffPost]

The first lady moving into the White House constitutes news nowadays.

PAUL RYAN EXPLOITS OUR DEPRESSINGLY LOW EXPECTATIONS OF DONALD TRUMP – Remember this the next time any House Republican candidate accuses their opponent of lacking experience. Matt Fuller: ?Speaker Paul Ryan (R-Wis.) shrugged off the bombshell testimony of former FBI director James Comey with a mix of claimed ignorance and overwhelming sympathy toward President Donald Trump?s neophyte political status. Ryan said it was important to have independence between the Department of Justice, the FBI, and the White House. But he defended Trump and acted as if the president?s apparent attempts to influence Comey and have him drop an investigation into former National Security Adviser Michael Flynn should be excused because the commander in chief is ?new at this.? ?He?s new to government,? Ryan said. ?And so he probably wasn?t steeped in the long-running protocols that establish the relationships between DOJ, FBI, and White Houses. He?s just new to this.?? [HuffPost]

BECAUSE YOU?VE READ THIS FAR – Here?s a dog watching ?Planet Earth.?

HOW THE MEDIA PLAYED THE COMEY HEARING – Hadas Gold: ?Accord to many right-wing outlets, Comey not only cleared Trump by confirming that he was not personally under investigation, he also helped stir up old drama around the FBI probe into Hillary Clinton?s emails and admitted he orchestrated leaks to the media after his firing. Much of the rest of the media, however, focused on Comey saying he took Trump?s statement that he ?hopes? the FBI would drop the investigation into Michael Flynn as a directive, that Trump ?lied? and ?defamed? Comey and the FBI, and that Comey took detailed notes about his meetings with Trump because he was concerned that Trump would later lie about them.? [Politico]

COMFORT FOOD

 – We may be heading toward and impeachment crisis, but at least Horsey McHorseFace is thriving.

– Incredible Jupiter flyby.

– Huskies without body hair?yikes.

TWITTERAMA

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