Congress Approves Short-Term Funding Bill Averting Govt. Shutdown

With minutes to spare, Congress approved a short-term continuing resolution (CR) averting a government shutdown. This legislation funds the federal government through April 28, 2017 at a 0.19% funding level lower than fiscal year 2016. The CR initially sailed through the House of Representatives by a 326-96 vote; however the bill stalled in the Senate due to concerns regarding health benefits for retired coal mine workers. The Senate ultimately approved the bill by a 63-36 vote.

The CR also contains some funding increases for the National Institutes of Health (NIH) which was made possible by the 21st Century Cures Act. The additional funding listed below will be transferred to the Director of NIH for the following initiatives:

  • $40 million for the Precision Medicine Initiative;
  • $10 million for the BRAIN Initiative;
  • $300 million for cancer research; and
  • $2 million for clinical research to further the field of regenerative medicine (with the requirement of a $1 non-Federal match for every $1 of Federal funds).

What is next? January 3, 2017 marks the beginning of the 115th Congress where they will have to finish work on fiscal year 2017 and start to draft legislation to fund the federal government for fiscal year 2018 at the same time.

AADR will work to encourage Congress to provide the highest allocations possible for NIH in FY17 and FY18.

Surgeon General report warns of dangers of e-cig use among youth

This morning, Surgeon General Dr. Vivek Murthy released a 298-page report on the use of e-cigarettes among young adults. Among the major findings of the report are:

  • e-cigarettes are now the most commonly used tobacco product among youth
  • youth who use e-cigarettes are more likely to use traditional tobacco products such as combustible cigarettes
  • nicotine in these products is addictive and may affect the developing brains of young people and increase their likelihood of becoming addicted to other drugs
  • chemicals in e-cigarette liquids may be harmful
  • and marketing and product development of e-cigarettes target young people.

The report advocates for policies aimed at restricting youth access to e-cigarettes, educational campaigns directed at young people, and inclusion of e-cigarettes in smoke-free policies.

This report is especially timely after the deeming rule issued earlier this year by the Food and Drug Administration giving itself authority to regulate electronic tobacco products along with more traditional tobacco products. This rule has been challenged by e-cigarette advocates.

The release of the report was accompanied by a new website where users can find facts about e-cigarettes as well as resources to educate and discourage use among young people.

Congress Overwhelmingly Approves the 21st Century Cures Act

Today, the Senate by a vote of 94-5 and last week the House of Representatives by a vote of 392-26 overwhelmingly approved the 21st Century Cures Act. Importantly, this legislation reauthorizes the National Institutes of Health (NIH) for three years and creates a 10 year $4.8 billion NIH Innovation Account. The NIH Innovation Account will provide targeted funding for the Precision Medicine Initiative, cancer research, BRAIN and regenerative medicine. This legislation also promotes initiatives designed to support the next generation of researchers; increases the loan repayment program; reduces administrative burdens on scientists and calls for recommendations on the rigor and reproducibility of science.

AADR sent a letter  expressing our support for the NIH provisions in the bill and AADR members sent nearly 100 email messages to members of Congress. We firmly believe this legislation is an important step to ensure stability for the biomedical enterprise during the upcoming three years.

President Obama is expected to sign this bill into law.

For additional information about the bill:

  • Click here to read a summary by the Energy and Commerce Committee.
  • Click here to read the Energy and Commerce Committee press release.

FDA approves drug for chemotherapy-resistant head and neck cancers

According to a press release from the National Cancer Institute (NCI), the Food and Drug Administration has approved nivolumab for use in  head and neck squamous cell cancers that are resistant to platinum-based chemotherapy. Head and neck cancers include oral and pharyngeal cancers, among others. According to the Bristol-Meyers Squibb study, patients treated with nivolumab lived longer and fewer patients experienced a decline in quality of life than patients treated with standard chemotherapy.

Cancer cells evade death by the immune system by turning off cytotoxic, or cell-killing, T-cells. Cancer cells display programmed death ligands (PD-Ls) on their cell surface that bind to a protein called PD-1 on the surface of T-cells. This interaction turns off the T-cell and allows the cancer cell to survive. Nivolumab, an antibody immune-checkpoint inhibitor, binds to PD-1 and inhibits this interaction, allowing T-cells to kill cancer cells and shrink the tumor.