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CLSA Wire

What’s Next? Federal Legislative Outlook for the Remainder of 2018

By Jenny Nieto Carey
August 17, 2018

Upon Congress’ return from its August Recess after Labor Day, the House will have 19 legislative days and the Senate 35 legislative days to conduct important business ahead of the midterm elections on November 6. Importantly, the 2018 fiscal year ends on Sept. 30, leaving the House just 11 legislative days and the Senate only 19 legislative days to act on any priorities with a Fiscal Year (FY) 18 end date. With the legislative clock running out, Congress is expected to focus its remaining time on advancing “must-pass” priorities that can garner bipartisan support for action regardless of the midterms’ outcomes.

Specifically, we expect Congress to continue its work to renew the Pandemic and All-Hazards Preparedness Act (PAHPA), which must be renewed before the current programmatic authority ends on Sept. 30. Congress will also need to pass appropriations bills or a Continuing Resolution to fund the government past the end of the current fiscal year, which ends Sept. 30.

Meanwhile, the Administration continues to push for modifications to the Renewable Fuel Standard (RFS), including allowing year-round sales of 15% ethanol blend (E15), with a strong likelihood that a bipartisan agreement may be reached by end of summer. Further, Senate Republicans and the Administration have prioritized filling the vacant Supreme Court seat as soon as possible.  It is also worth noting that the ongoing Mueller investigation has demanded much attention from Democrats and Republicans alike, energy which would otherwise be spent on advancing other legislative issues.

Below is a highlight of what we expect to see for the rest of 2018 as it pertains to the California life sciences sector.

Government Funding

As Fiscal Year 2018 winds down, Congress remains hard at work to move appropriations bills that will provide funding for critical government programs in FY 2019.  This is likely to be an uphill climb, with a strong likelihood that Congress will need to pass a short-term funding bill (Continuing Resolution) to fund the government beyond Sept. 30, or even past the midterms. Nonetheless, the House has 11 legislative days in September (the Senate has 16) to keep working on a deal to ensure the lights stay on past Sept. 30.

California’s life sciences sector relies on support from the National Institutes of Health (NIH) to conduct basic, clinical and translational research. A strong, transparent and well-resourced Food and Drug Administration (FDA) is also critical for ensuring timely decisions on product applications, such as for biopharmaceuticals, medical devices, generic drugs, and biosimilars. CLSA is strongly supportive of increased funding for NIH and FDA, and we are pleased our advocacy is likely to be successful in bolstering funding for both agencies in FY19.

  • NIH: With broad bipartisan support, Congress appears likely to increase NIH budget yet again in FY19. The Senate is poised to authorize $39.1 billion for NIH in FY19, a $2 billion increase from FY18. The House is currently proposing a $1.25 billion increase, meaning the NIH’s eventual increase will likely rest within the range of $38-39.1 billion.
  • FDA: In another case of good news or great news, FDA is also likely to see meaningfully increased funding in FY19. The House is supporting a $308 million increase for FY 19, while the Senate has proposed a $159 million increase.

CLSA continues to work directly with our California Congressional delegation, as well as in collaboration with our national trade association partners and a range of other stakeholders, to advocate for both agencies to receive the highest funding levels possible.

Pandemic and All-Hazards Preparedness (PAHPA) Reauthorization

PAHPA, first enacted in 2006 and renewed in 2013, established new federal entities (e.g. Assistant Secretary for Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA)) with authority to oversee preparedness efforts, and also authorizes funding for chemical, biological, radiological and nuclear (CBRN) priorities, like the Project BioShield Special Reserve Fund, funds to combat emerging infectious diseases and pandemic influenza, and funds for advanced R&D of medical countermeasures through BARDA.  PAHPA’s current authorities expire at the end of September, and Congress must renew the legislation in order for these critical operations to continue.

CLSA has endorsed pending legislation in the House and Senate, and continues to strongly advocate for a swift reauthorization of PAHPA before it expires on Sept. 30to ensure the U.S. is prepared to respond to CBRN threats.

Renewable Fuel Standards

Over the past several months, the Administration has convened a series of discussions with lawmakers and stakeholders on modifying the RFS. CLSA is supportive of making E15 available year-round but has concerns about the effect some proposed changes (such as implementing a price cap on renewable identification numbers (RINs), and counting RINs from exported renewable fuels) will have on the development of advanced biofuels.  CLSA will continue working with our partners at BIO, Fuels America, the Advanced Biofuels Business Council, and others to encourage congressional leadership to ensure the RFS continues to promote production and use of homegrown biofuels.

Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (jcarey@califesciences.org).