FDA

Alexander, Murray outline plan to lower health costs
Alexander he hopes it will get a committee mark up next month and the Senate will debate a bill in July

Chairman Lamar Alexander, R-Tenn., and ranking member Sen. Patty Murray, D-Wash., conduct a Senate Health, Education, Labor and Pensions Committee hearing in Dirksen Building titled "Vaccines Save Lives: What Is Driving Preventable Disease Outbreaks?" on March 5, 2019. (Tom Williams/CQ Roll Call file photo)

Two influential senators released draft health care legislation Thursday, a package of narrowly tailored proposals that will likely be part of a measure to lower health care costs that lawmakers hope to pass this year.

The draft bill, from Health, Education, Labor and Pensions Chairman Lamar Alexander, R-Tenn., and ranking member Patty Murray, D-Wash., targets five areas: banning surprise medical bills; speeding low-cost generic drugs to market; increasing transparency; improving public health; and enhancing health information technology, according to a summary.

McConnell introduces bill making the legal smoking age 21
“Youth vaping is a public health crisis,” Kentucky Republican says

Senate Majority Leader Mitch McConnell, R-Ky., introduced legislation Monday that would raise the minimum age to buy tobacco to 21. (Tom Williams/CQ Roll Call)

Senate Majority Leader Mitch McConnell on Monday introduced a bill to raise the federal age for purchasing tobacco products, including e-cigarettes, to 21, increasing the chances that Congress will clear a significant smoking-related bill for the first time since a major tobacco control law was enacted a decade ago.

The bill comes amid growing concerns about the youth use of e-cigarettes, which reached record levels in 2018. That marked a troubling reversal of declines in smoking traditional cigarettes.

House health care bill puts generic drug industry in bind
Low-cost generic drug makers expected a floor vote on a signature bill, but the law is being packaged with two measures industry opposes

Rep. Buddy Carter, R-Ga., attends a House Energy and Commerce Environment Subcommittee hearing in Rayburn Building. Carter is a sponsor of a bill that would make it harder to stretch out a six-month exclusivity period awarded to the first generic version of a brand-name drug. Generic drug pricing bills will be taken up by the House Thursday. (Tom Williams/CQ Roll Call file photo)

This was supposed to be a good week for the makers of low-cost generic drugs, as a bill that is one of their top priorities gets a House floor vote. Instead, the industry finds itself clouded by allegations of price fixing, and its signature bill is being packaged with two measures they oppose.

The bill that the House will take up Thursday combines three drug pricing measures with bills to strengthen the individual health insurance market.

FDA grapples with AI medical devices
New approach to artificial intelligence extends the agency’s controversial fast-track process

The FDA has already approved “locked” artificial intelligence-based devices, such as one that analyzes images of a patient’s retina for signs of diabetic retinopathy. Now the agency is weighing how to certify devices that learn and evolve. (iStock)

Imagine a not-too-distant future when medical devices powered by artificial intelligence continuously adapt to new symptoms presented by patients and learn how to make accurate diagnoses much like a well-trained physician would.

The Food and Drug Administration is preparing for such a future and weighing how to assess and certify such medical devices, seeing them more like living things that can’t be regulated in the same manner as old-fashioned equipment.

Trump administration swayed by conservative think tank on abortion, LGBT decisions, group says
Ties between administration and The Heritage Foundation correlate with several health policy decisions, liberal watchdog group says

HHS Office of Civil Rights Director Roger Severino speaks at a news conference at the Department of Health and Human Services on January 18, 2018 in Washington, DC. Severino, a former director of The Heritage Foundation’s DeVos Center for Religion and Civil Society, joined HHS as the director of OCR in late March 2017. Close ties between the administration foundation correlate with several Trump administration health policy decisions, a liberal think tank says. (Aaron P. Bernstein/Getty Images)

Close ties between the administration and a prominent conservative think tank correlate with several Trump administration health policy decisions, according to new information from a liberal government watchdog group shared exclusively with CQ Roll Call.

The 35-page Equity Forward report says that The Heritage Foundation’s influence plays a large role in decisions related to abortion, fetal tissue research, contraception and protections for same-sex couples.

Legal challenges are threatening Trump administration changes to the ACA
HHS is facing an increasing number of challenges to its changes to the 2010 health care law

Health and Human Services Secretary Alex Azar testifies during a House Education and the Workforce Committee hearing on June 6, 2018. (Tom Williams/CQ Roll Call file photo)!

The Trump administration, which has already been defeated in a number of high-profile legal cases, is facing an increasing number of challenges to its changes to the 2010 health care law and women’s health issues.

Just last week, the Justice Department filed a brief arguing that the entire health care law should fall, a position that even some conservative legal scholars call risky. Two days later, on Wednesday, a federal judge struck down the administration’s rules requiring Medicaid recipients to report their work hours to keep their coverage. On Thursday, another judge blocked the administration’s expansion of association health plans, which let small businesses band together to buy insurance and do not have to meet all of the 2010 law’s requirements.

Road ahead: Changing Senate rules, reupping Violence Against Women Act
McConnell heads into cloture clash with nothing much to lose

Senate Majority Leader Mitch McConnell has set up votes to make it easier to confirm President Donald Trump’s nominees. (Tom Williams/CQ Roll Call file photo)

Senators are gearing up for a much-anticipated standoff over the debate time for confirming President Donald Trump’s nominees, as the House turns its attention to reviving and updating the Violence Against Women Act.

NATO Secretary General Jens Stoltenberg will address a joint meeting on Wednesday, following an invitation extended by the bipartisan congressional leadership to highlight the importance of the alliance.

Will FDA keep cracking down on teen vaping, other initiatives, after Gottlieb leaves?
Scott Gottlieb, fought teen vaping and approved record numbers of generic drugs will resign next month

The outside of the Food and Drug Administration headquarters is seen in White Oak, Md.(Al Drago/CQ Roll Call file photo)

Food and Drug Administration Commissioner Scott Gottlieb, who launched a campaign against teen vaping and approved a record number of generic drugs, is resigning next month.

The departure raises questions about whether the agency would continue to vigorously seek to curb the exploding use of e-cigarettes among young people, among other Gottlieb initiatives. But the commissioner, in a resignation letter listing accomplishments on this and other issues, said he was “confident that the FDA will continue to advance all these efforts.”

A shining example for today’s House investigators
The late John Dingell was almost frightening to watch on TV when he had corruption in his sights

Rep. John Dingell could teach current House Democrats a thing or two about how to investigate corruption, writes McCloskey. (Tom Williams/CQ Roll Call)

OPINION — The passing of John Dingell this month justifies more than a few words in honor of one of the great public servants — and fiercest investigators — of our time.

John was a dedicated and hard worker in the daily tasks of the House of Representatives for nearly 60 years, and particularly in its committees. He may have been of as much value to the nation as any of the presidents under whom he served, and certainly equal to the value of some of the great senators of his time, modest men like Democrats Mike Mansfield, Gaylord Nelson and Claiborne Pell; Republicans like John Chafee, Bill Cohen and Bob Dole.

FDA commissioner outlines new opioid enforcement action
The agency used, for the first time, a new type of enforcement designed to control the illegal flow of opioids

The outside of the Food and Drug Administration headquarters is seen in White Oak, Md. (Al Drago/CQ Roll Call file photo)

The Food and Drug Administration released a warning letter to a top drug distributor on Tuesday, using for the first time a new type of enforcement authority that the agency’s head called an important step in controlling the illegal flow of opioids.

FDA's letter alleged that distributor McKesson Corp. sent drugs that were supposed to be opioids — but were missing pills or were not even opioids — to multiple pharmacy locations, raising questions about whether potent opioid painkillers were missing and where they may have gone.