As the year winds down, STAT reporters are taking a look at the stories they’re most eager to track in 2018. Find all our “three to watch” series here.
ealth care dominated the congressional agenda in 2017, as Republicans jumped straight from a failed effort to repeal and replace Obamacare into a tax code overhaul that included major changes to the law’s central policies.
And though those fights sparked intense, near-constant partisan rancor, lawmakers are showing no signs of setting aside health care policy efforts in 2018.
The action will kick off early in the year, since lawmakers left Washington for the holidays without addressing major priorities like funding the government beyond Jan. 19. Those major spending efforts often create opportunities for other, smaller legislative efforts. The medical device industry, for example, wants to see the delay or repeal of a 2.3 percent excise tax their industry faces beginning Jan. 1. Hospitals want Congress to reverse an administrative cut to the so-called 340B program.
And that’s just the plan for January. There are a host of other health policy efforts that will dominate Congress’s agenda — many of them of particular interest to those in pharmaceutical and biotech industries. Here are three to watch.
New user fees for over the counter drugs
The Food and Drug Administration and over-the-counter drugmakers spent years hammering out an agreement that will see industry paying millions in new user fees to the agency, in exchange for speedier and more thorough regulation of their products.
Key Republicans and Democrats in Congress have worked to translate that deal into legislation, and to earn the support of other key players in the debate, including pharmacy benefit managers and consumer groups. Now, in the coming year, lawmakers in both the Senate and the House are ready to introduce their bills and bring them before their respective health committees for consideration.
Since there are no major opponents to the effort, most of the officials involved — on the Hill, in the administration, and on K Street — say the deal will move through Congress without many changes. But the rest of the congressional agenda could affect its timing.
Funding for opioid crisis response
President Trump declared the opioid crisis a public health emergency in October and proposed a long list of programs and policies to help address the epidemic. But as yet, Republican leaders in Congress have no concrete plans to authorize funding for those proposals.
Democrats, especially in the Senate, have called for including some opioid funding in any major government funding package. Some Republicans whose states have been hit hardest by the crisis, like Sens. Rob Portman of Ohio and Shelley Moore Capito of West Virginia, have also called for more spending.
There are already small signs that Congress might sign off on more spending in 2018. Kellyanne Conway, the White House adviser who has been leading a kind of “opioids cabinet,” told STAT she is working with the Office of Management and Budget on a request for more funds. Outside groups have also said there may be more motivation to pass funding to address the opioid crisis in an election year.
House Energy and Commerce Committee Greg Walden of Oregon told STAT he is hoping to work on an opioids measure in the new year. And Rep. Tom MacArthur (R-N.J.), who is co-chair of the Bipartisan Task Force to Combat the Heroin Epidemic, said the group delivered a host of new policy proposals to Republican leadership that are aimed at addressing the crisis. He said that effort should also be paired with new funding.
A reauthorization for PAHPRA
Several major public health funds under the 2013 Pandemic and All-Hazards Preparation Resources Act, which was aimed at improving the United States’ — and particularly, the FDA’s — ability to respond preemptively to a pandemic or biological attack, expire in September, a deadline that will force Congress to reconsider the country’s response capabilities and the associated funding.
The 2013 law, often referred to as PAHPRA, included five years of funding for most of the programs aimed at developing and purchasing vaccines on behalf of the United States, including the Biomedical Advanced Research and Development Authority and the Strategic National Stockpile. It also authorized funds for hospital preparedness programs and a reserve system of emergency responders.
Among the projects that are set to lose funding is Project BioShield, a policy priority for President George W. Bush that was aimed at encouraging the development of medical countermeasures against anthrax, smallpox, botulism, and radiation, among others.
Lawmakers first passed PAHPRA relatively quietly, but recent public health threats — including, most notably, the Ebola crisis — thrust the country’s preparedness into the spotlight. The law and its programs were central to the FDA’s emergency approval of a Department of Defense diagnostic tool that helped responders detect the disease.