By Melanie Zanona and Melissa Attias, CQ Roll Call
January 4, 2016 -- With no looming deadlines, there may be little legislative action on the health care front in 2016.
One item left on many lawmakers' wish lists is a bipartisan effort to overhaul the drug approval process at the Food and Drug Administration (FDA) and revitalize research at the National Institutes of Health. The House passed the so-called 21st Century Cures bill (HR 6) last summer on a strong bipartisan vote. Leaders of the Senate Health, Education, Labor, and Pensions (HELP) Committee hope to unveil their own draft in early 2016.
"We're in the midst of a review, first, to see if there is anything we can do to make it easier to move devices and treatments through the FDA process more rapidly — and still safely and effectively—so they can get into medicine cabinets more quickly," says HELP Chairman Lamar Alexander, a Tennessee Republican.
Advocates say the initiative could be achieved even in the divisive atmosphere of an election year because of the overwhelming support for disease research and developing new cures more quickly. Several presidential candidates have mentioned the issue on the campaign trail.
However, the legislation is still likely to be a heavy lift. The HELP panel already blew by self-imposed deadlines to release a draft and hold a markup before the end of 2015—though Alexander has long maintained that the measure wouldn't hit the floor until 2016.
Disputes over whether to create a mandatory pool of money—and how to pay for it—still need to be resolved. The House version designated $8.75 billion for the National Institutes of Health (NIH) and $550 million for the FDA over five years, mostly paid for by drawing down the Strategic Petroleum Reserve, a step that has since been used to offset the cost of the surface transportation law and budget deal. Senate committee aides have said offsets could be found elsewhere.
Still, efforts could be further complicated by the $2 billion boost NIH got in the omnibus spending bill, bringing its budget to $32 billion. Some fiscal hawks may argue that further increases should be done through the appropriations process. Ranking HELP Democrat Patty Murray of Washington has made her support contingent for the new bill on a mandatory NIH funding increase—even with the additional discretionary bump.
Majority Leader Kevin McCarthy, a California Republican, said in December that he is still "hopeful" the initiative will be enacted into law, but suggested some pieces of the bill may move separately. One slice of the nearly 400-page House package already passed on its own in late 2015: a measure (HR 639) to lift some export restrictions on U.S. companies operating abroad that manufacture drug products containing controlled substances.
"This is a place that we had strong bipartisan agreement, and it unfortunately sounds as though a lot of things pass here but slow down in the Senate," McCarthy told reporters last month. "I think part of that would probably come into law maybe through the [omnibus] and the rest we'll continue to look at and try to move forward where we can."
House GOP leaders have also expressed interest in moving ahead with mental health legislation in response to a series of mass shootings rather than wading into the gun control debate.
Both Speaker Paul D. Ryan of Wisconsin and McCarthy have highlighted a wide-reaching bill (HR 2646) spearheaded by Pennsylvania Republican Tim Murphy that the Energy and Commerce Health Subcommittee advanced mostly along party lines in November.
The measure includes provisions that would address privacy rules for people with serious mental illness, Medicaid billing for adults in psychiatric hospitals and funding for states with court-ordered community treatment programs.
"One common denominator in these tragedies is mental illness," Ryan said at a Dec. 1 news conference following a shooting at a Planned Parenthood clinic in Colorado, at which he highlighted Murphy's bill. "I'm sure that members of both parties have lots of ideas in this area, but we should make this a priority to prevent the violence and to protect our citizens."
Murphy's measure has the support of a few dozen Democrats, though most of those on the Energy and Commerce panel have expressed opposition to components they say would curtail patients' civil rights.
McCarthy told reporters that lawmakers are trying to work through concerns raised by both parties.
Across the Capitol, legislation (S 1945) similar to Murphy's bill is sponsored by Louisiana Republican Bill Cassidy and Connecticut Democrat Christopher S. Murphy. It awaits action by the HELP Committee.