As the year winds down, STAT reporters are taking a look at the stories they’re most eager to track in 2016. We’ll be running these daily through Dec. 31. Look for more New Year’s predictions here.
WASHINGTON — The new year will bring challenges for national political leaders grappling with health and medical issues.
A new head of the pharmaceutical lobby will have to deal with heavy pressure to bring down drug prices. The next commissioner of the Food and Drug Administration will have to balance competing pressures to speed approvals of new drugs without compromising safety.
And they’ll all be watching the campaign debate on medical science — which is being driven right now by Democratic presidential candidate Hillary Clinton, but could also turn to Republican priorities once the shape of the GOP race is more clear.
Here are three key players in national politics to watch in 2016:
Stephen Ubl, new president and chief executive, PhRMA
No lobbyist in Washington is likely to draw as much scrutiny in 2016 as Stephen Ubl, who took over as president and CEO of the pharmaceutical lobby in November.
Ubl’s group, PhRMA, short for the Pharmaceutical Research and Manufacturers of America, is used to having its way in the nation’s capital.
But the political tide has turned against the industry in the last two years. Satisfaction with drug makers is way down from where it was two decades ago. The industry’s main talking points — including the argument that high prices are justified by hefty research spending — are not resonating with the public.
And both politicians and broad swaths of the public want action to make drugs more affordable. Clinton is making it a centerpiece of her presidential campaign, and the Republican candidates have also started to give the issue some attention.
Ubl cut his teeth leading a medical device lobby that — just shortly after his departure — finally secured a victory it had long sought: the temporary suspension of a device tax in the Affordable Care Act. Ubl can take a lot of credit for that.
But he’ll have his work cut out for him in the year ahead.
Ann O’Leary, adviser to Hillary Clinton
Clinton is talking a lot about rising prescription drug prices, and when she has to flesh out the details of her plan to bring costs down, she’s going to turn to Ann O’Leary, one of her senior campaign policy advisers.
O’Leary leads the work on Clinton’s health care policies, including her recently announced plan to boost funding for Alzheimer’s research in hopes of finding an effective treatment by 2025. She shares the domestic policy portfolio with Jake Sullivan, another senior policy adviser.
Other presidential candidates also have health care policy advisers, of course, but O’Leary is the one most likely to end up working for a presidential nominee, given the unpredictability of the Republican race right now and Clinton’s strong lead among Democrats.
So O’Leary is the most likely to have to figure out how campaign rhetoric would actually work in practice — and to find strategic ways to keep the issue in front of voters.
O’Leary, who lives in Oakland, is a longtime Clinton policy hand: She was Clinton’s legislative director in the Senate and worked on the “Too Small to Fail” program, an early childhood development initiative cosponsored by the Clinton Foundation and the advocacy group Next Generation.
Now, she’ll play a big role in determining whether Clinton can sell her drug prices plan, and her other life science policies, to voters nationwide.
Robert Califf, FDA nominee
President Obama’s nominee to lead the Food and Drug Administration is likely to get confirmed by the Senate sometime next year.
Once he’s in, though, he’ll be under constant pressure from key Democrats — including Senators Bernie Sanders and Elizabeth Warren — to prove that he’s not too close to the pharmaceutical industry.
Califf was the founding director of the clinical research center at Duke University, and some Democrats are wary of him because the pharmaceutical industry funded some of the studies he oversaw at Duke. They want to make sure he won’t be tempted to allow the FDA to rush new drugs through the approval process without due diligence.
At his confirmation hearing in November, Califf promised he would never lower safety standards. But he will face pressure from lawmakers in both parties who want to push the FDA to move faster. The House has passed legislation to speed approval times, and Senators Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.) are working on their own version, which will be released in 2016.
Califf’s other big challenge: Alexander wants him to do more to cut the backlog of generic drugs waiting for approval — a backlog Califf has blamed in part on incomplete applications filed by the drug companies.
