Endo's Opana ER has been involved in overdoses.

By Clifton Leaf and Sy Mukherjee
June 9, 2017

Greetings and happy Friday, readers. This is Sy.

There’s been a lot of renewed attention this month on the opioid overdose epidemic ravaging the nation. And for good reason—the Drug Enforcement Agency (DEA) released new guidelines warning that the synthetic opioid fentanyl is so deadly that first responders need to be extremely careful about the chance of an accidental overdose; a New York Times analysis found that that overdose deaths continued to rise in 2016 and that this year could be yet another record; a slew of overdoses in Georgia have been linked to a “mystery pill” containing fentanyl and other substances; and Ohio’s Attorney General is suing five drug makers over the epidemic.

On Thursday, the Food and Drug Administration (FDA) took one step meant to address the scourge by asking Endo International to withdraw its Opana ER long-lasting opioid from the U.S. market. Regulators had previously concluded that the treatment’s risks outweigh its benefits. “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,” said new FDA commissioner Dr. Scott Gottlieb in a statement.

The big question now is: What will Endo do? The company’s initial response suggested that it rejects the FDA’s implication of the drug’s dangers. “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,” said the company.

Endo shares tumbled 13% in Friday trading.

Read on for the day’s news, and enjoy your weekend.

Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

DIGITAL HEALTH

Chicago health system adopts Proteus Digital Health’s smart pill tech. Chicago’s Rush University Medical Center has become the eighth system in the country to use Proteus Digital Health’s sensor-equipped smart pill technology in a bid to boost patient compliance with prescribed drug regimens. (Proteus was one of the firms we highlighted in our recent digital health revolution feature.) Proteus’ tech contains a tiny sensor which is activated when it hits the stomach acid, which is in turn detected via a small Bluetooth-enabled patch and transmitted to an app. A massive share of patients—as much as half by some counts—with chronic illnesses don’t take their medicines as prescribed, leaving them sicker and more likely to return to the hospital. (FierceHealthcare)


INDICATIONS

Executive shakeup grows at flailing Teva. Drug giant Teva hasn’t been having the best couple of years. The generic medicine-focused company has had to deal with a rash of patent losses and pricing pressure on its products which have slammed sales, leading to the exit of CEO Erez Vigodman and the upcoming departure of CFO Eyal Desheh. Now Teva is looking to nominate four new board directors in a continued executive shakeup. “We are evolving the board to meet new challenges both within Teva and the business [of generic drugs]”, board chair Dr. Sol Barer told the Wall Street Journal in an interview. (Fox Business)

EU clears J&J’s $30 billion deal for Actelion. European regulators have given the go-ahead (with some conditions) for Johnson & Johnson’s acquisition of the EU’s largest biotech, Actelion, clearing the way for the deal to close on June 16, according to J&J. Multiple drug makers, including France’s Sanofi, were eagerly pursuing the company before J&J swooped in and struck an acquisition agreement. Current Actelion CEO Jean-Paul Clozel will lead a spinoff company called Idorsia. (Reuters)


THE BIG PICTURE

Powerful GOP House chair says Congress should make Obamacare insurer payments. The Trump administration’s ambivalence toward making insurer payments meant to reduce poorer Americans’ out-of-pocket medical costs under Obamacare has been cited by several health insurance firms as a reason to ditch the program or substantially hike premiums. But one powerful GOP lawmaker is calling for an end to the uncertainty, which has been wreaking havoc on the health law’s individual insurance markets. “We should act within our constitutional authority now to temporarily and legally fund cost-sharing reduction payments as we move away from Obamacare,” said House Ways and Means Committee chairman Rep. Kevin Brady of Texas. “Insurers have made clear the lack of certainty is causing 2018 proposed premiums to rise significantly.” (New York Times)


SPONSORED FINANCIAL CONTENT

You May Like