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BIO Summarizes Legislation Ready for Obama to Sign

Friday, December 18, 2015  
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BIO recently communicated a summary of packages that were recently passed by the Senate, the combined omnibus appropriations and tax extenders package 65-33 (27 Rs and 38 Ds). The omnibus passed the House 316-113 and the extenders package was completed 318-109. The legislation now goes to President Obama to be signed into law. That concludes all major Congressional business for the rest 2015.

Included in BIO’s summary is a breakdown of the omnibus and extenders bill:

Summary of Relevant Sections in the Omnibus:

National Institutes of Health (NIH): The bill includes a program level of $32 billion for the NIH, $2 billion above the 2015 enacted level (This matches BIO’s ask for NIH). It includes specific increases for Alzheimer’s disease research, brain research, antibiotic research, and the Precision Medicine Initiative. Plus, it provides a general increase to all NIH Institutes and Centers to continue basic bio-medical research and translational research through programs like the Clinical and Translational Science Awards and Institutional Development Award program to help scientists discover cures.

Food and Drug Administration (FDA): The FDA receives a total of $2.72 billion in discretionary funding in the bill, an increase of $132 million over the fiscal year 2015 enacted level and $14 million below the President’s budget request (BIO had requested $2.8B). This is roughly $90 - $100 million above the House and Senate committee bills passed earlier this year. Total funding for the FDA, including revenue from user fees, is $4.68 billion. Within this total, food safety activities are increased by $104.5 million, and various medical product safety activities – including additional funds for the Combating Antibiotic Resistant Bacteria initiative, orphan product development grants, foreign high-risk inspections, and precision medicine – are increased by over $24.3 million.

Public Health Preparedness and Response:

• Biomedical Advanced Research and Development Authority (BARDA) received $511M (BIO requested $521M) and includes moneys for Combating Antibiotic-Resistant Bacteria (CARB).

• BioShield Special Reserve Fund (SRF) received $510 million, an increase of $255 million above FY2015 (BIO’s ask was $646M).

• Strategic National Stockpile (SNS) received $575M (BIO’s request amount $571M).

• Pandemic Influenza received $72M which is (BIO’s request was $400m).

• Medical Countermeasures Inactive (MCMi) - $25M which matches BIO’s request.

Prescription Drug Report: Rep. Kaptur offered this amendment during the mark-up of the L-HHS Approps bill, and it was accepted by the Chairman. BIO voiced concerns with the language and, working with PhRMA, tried to get the language removed from any final bill. Unfortunately, we were unable to get it removed, but BIO and PhRMA submitted language to the Committee to improve the language, and most of our suggestions were accepted. The language now directs the Secretaries of HHS and the VA to submit the report to the Committee using only data accessible under current law, and removes the reporting requirement for drug pricing information in countries boarding the US and other nations.

340B Drug Program: HRSA is requested to provide a briefing to update the Committees on Appropriations of the House of Representatives and the Senate on the status of 340B guidance, the secure website, and covered entities in the 340B drug program. The proposed user fee was dropped.

Genomic Editing: This provision prevents FDA from reviewing applications related to genome-editing tools to modify the DNA of human embryos – the human germline – until “serious and unquantifiable safety and ethical issues can be resolved”. BIO worked to strike or improve this language, however we were unsuccessful.

Summary of Relevant Sections in the Tax Extenders:

All of BIO’s six key issues in the Extenders Package were included in the final bill.

Research and Development (R&D) Tax Credit: The R&D Credit was made permanent. In addition, it was expanded to pre-tax startup companies by allowing them to use the R&D Credit against their payroll tax liability.

Second Generation Biofuels Production Credit: The production tax credit for second generation biofuels was extended for two years (1/1/15 to 12/31/16).

Special 50 Percent Bonus Depreciation Allowance for Second Generation Biofuel Plant Property: The 50 percent bonus depreciation incentive for second generation biofuel plant property was extended for two years (1/1/15 to 12/31/16).

Controlled Foreign Corporation (CFC) Look Through Treatment: The CFC look through treatment was extended for five years (1/1/15 to 12/31/19).

Bonus Depreciation: The broad 50 percent bonus depreciation incentive was extended for five years under a phase-out schedule. Property placed in service in 2015, 2016 and 2017 can take 50 percent. Property placed in service in 2018 can take 40 percent. Property placed in service in 2019 can take 30 percent. Bonus depreciation will not be available in 2020 and later.

Capital Gain Exclusion for Small Business Stock: The 100 percent exclusion of the capital gain on certain qualified small business stock was extended for two years (1/1/15 to 12/31/16).

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