Overnight Healthcare: FDA toughens safety labels for painkillers

NEW FDA RULES: Exactly one month into his new job, FDA Commissioner Robert Califf outlined a tough new policy requiring drug companies to include blackbox labels on more than 100 types of painkillers.

Califf, and others at the FDA, called it one of the FDA's biggest steps yet to warn patients and providers about the link between painkillers and overdoses amid a growing national opioid epidemic. Painkillers like oxycodone must now come with labels warning specifically of "misuse, abuse, addiction, overdose and death."

But the newly confirmed commissioner also made clear that he wasn't going after the drug companies alone.

ADVERTISEMENT
"I don't mind being relatively explicit about this. We really need practicing docs to step up to the plate here," Califf told reporters Tuesday.

As recently as the day of his confirmation, Califf defended the FDA's drug labels as "pretty clear and strong." The bigger problem, he said, was doctors who have "gotten in the habit of prescribing more opioids than they should."

Califf was confirmed in February with unanimous support of Senate Republicans, who favored his background in the pharmaceutical sector. Two Senate Democrats, Sens. Ed MarkeyEd MarkeyTakata says it failed to report airbag rupture in 2003 Set-top box shenanigans at the FCC Week ahead in tech: Crunch time for internet handoff opponents MORE (D-Mass.) and Joe ManchinJoe ManchinDemocrat vows to go after opioid makers – including daughter's company Overnight Healthcare: McConnell unveils new Zika package | Manchin defends daughter on EpiPens | Bill includes M for opioid crisis Democrat defends daughter after tough EpiPen grilling MORE (D-W.Va.), opposed Califf's nomination, criticizing his approach to fighting opioid abuse as too lax.

The FDA has been stepping up its outreach to patients and doctors about the potentially lethal effects of using painkillers after the number of overdoses reached a record high in 2014.

Last month, the FDA announced a "sweeping review" of its opioid policies in an attempt to quash criticism that the agency has reacted too slowly to the issue – and help Califf's confirmation in the Senate. Read more here: http://bit.ly/1RibI3i

OBAMACARE BACK IN THE SUPREME COURT It's Part IV for ObamaCare in the Supreme Court on Wednesday. This time, it's a challenge to an "accommodation" to the health law's contraceptive mandate.

The challengers in the case, Zubik v. Burwell, argue that the Obama administration is unjustifiably forcing religious groups like the Little Sisters of the Poor to cover birth control, despite an arrangement where insurers provide contraception directly.

"The burden is not on your faith to obey government mandates," Speaker Paul RyanPaul RyanRNC chair: Trump is prepared for debate after 'Apprentice' finales Dem slams House waterways bill over splash parks provision This week: Shutdown deadline looms over Congress MORE (R-Wis.) said Tuesday in a floor speech defending the Little Sisters of the Poor. "The burden is on the government to respect your faith."

The administration counters that the challengers are threatening contraceptive access for women, and say the court risks setting a dangerous precedent if it finds in their favor. Check back at TheHill.com Tuesday night for the full story.

JUDICIARY COMMITTEE FORCED TO HALT TORT REFORM BILL: The House Judiciary Committee on Tuesday was forced to abruptly postpone a markup on a medical tort reform bill after outbursts by several conservatives.  

The committee has yet to reschedule the markup. A spokesperson declined to comment on whether Judiciary Committee Chairman Bob GoodlatteBob GoodlatteInternal memo: Refugee program vulnerable to fraud Sen. Thune slams Dems for protecting Internet transition Top GOP chairmen investigating foreign visa program MORE had been aware of conservative opposition to the bill before holding the markup.

"I believe this issue should be left up entirely in the state courts, in the states," Rep. Ted PoeTed PoeA clear signal on Georgia’s future Overnight Tech: Dem presses Facebook on gun sales | Praise for new librarian of Congress | Fourth Amendment Caucus to push privacy concerns Overnight Cybersecurity: Guccifer 2.0 releases more DNC docs; China hacked banking regulator MORE (R-Texas) said in a rare display of discord on a GOP bill.

"This committee should not, in my opinion, pass legislation that harms state courts and decisions made in state courts because the people in those states don't want limits on liability," he said. His position was then echoed by Rep. Louie GohmertLouie GohmertGOP rep calls Clinton 'mentally impaired' GOP rep: Trump ‘courageous’ for giving Cruz speech GOP bill would block undocumenteds from military service MORE (R-Texas), who also argued against federal tort reform.

The medical malpractice bill, which sets a $250,000 cap on compensation for non-economic damages to a patient, has long been opposed by advocates of states' rights.

The committee's top Democrat, Rep. John Conyers (D-N.Y.), called it a "strong disrespect of federalism." And just before the markup, the committee received a letter protesting the bill from 29 groups, including the Center for Justice & Democracy and Consumer Watchdog.

The bill cuts spending by about $40 billion over 10 years, and it was the committee's response to House Speaker Paul Ryan's call to each committee to identify spending cut during this year's budget process. http://bit.ly/1RjdRcP

HHS: MEDICARE SAVED HALF-TRILLION IN FIVE YEARS: A slowdown in recent healthcare spending helped save $473 billion in Medicare spending between 2009 and 2014, according to the Department of Health and Human Services (HHS).

The announcement comes as HHS is marking the sixth anniversary of the Affordable Care Act, touting delivery system reforms in Medicare and the marketplace to reduce spending.

Other data have shown, however, that much of the healthcare slowdown was a result of the 2008 recession as well as separate cuts to Medicare under ObamaCare. Read more here: http://bit.ly/21FSebw

ON TAP TOMORROW:

The Supreme Court hears arguments on Zubik vs. Burwell at 10 a.m.

House Minority Leader Nancy Pelosi (D-Calif.) will hold a press event on the sixth anniversary of the Affordable Care Act

ProPublica hosts an event on healthcare transparency and patient safety at Kaiser Family Foundation

WHAT WE'RE READING:

CDC urges doctors to prevent Zika spread during labor, delivery (Reuters)

Burwell: Up next for ObamaCare, transforming medicine (Bloomberg View)

Planned Parenthood expands transgender health services (PQ Monthly)

Cecile Richards opens up about fighting for reproductive rights (Vice Magazine)

IN THE STATES:

Alabama governor says he will veto budget over Medicaid (Associated Press)

NYC hospitals, faced with $1.2B funding gap, plea for help as they struggle to survive (NY Daily News)

Hackers take aim at two more California hospitals (Kaiser Health News)

Pence signs bills aimed at curbing drug abuse (Indiana Public Media)

ICYMI FROM THE HILL:

Labor Department set to issue controversial silica rule: http://bit.ly/1UD67bj

Obama touts ObamaCare as a success on anniversary http://bit.ly/1T5Cdvh

Send tips and comments to Sarah Ferris, sferris@thehill.com, and Peter Sullivan, psullivan@thehill.com. Follow us on Twitter: @thehill@sarahnferris@PeterSullivan4