Senate Committee Advances Five More Bills as Part of Medical Innovation Package

The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill.

Wednesday marked the third and final hearing by the committee, which is still grappling with a fight over $50 billion in additional mandatory funding for the National Institutes of Health (NIH) that’s supported by Senate Democrats.

“With its 21st Century Cures Act, the House voted 344 to 77 to provide $8.8 billion in paid-for mandatory funding to support such NIH priorities. We continue working on finding an amount that the House will agree to and the president will sign that we can responsibly pay for in a bipartisan way,” Chairman Lamar Alexander (R-TN) said.

Background

In February and March, the committee advanced bills dealing with a wide range of issues that will have a major impact on how the US Food and Drug Administration (FDA) regulates medical devices, drugs and drug-device combination products, including:

• S. 1878 - Advancing Hope Act of 2015, which would extend the priority review voucher program for rare pediatric diseases by one year and add sickle cell to the program.
• S. 1622, The FDA Device Accountability Act of 2015, which would "streamline" FDA reviews of device trial data;
• S. 2503, Preventing Superbugs and Protecting Patients Act, which would require FDA to identify types of medical devices for which premarket notification must include proposed labeling, including validated instructions regarding cleaning, disinfection and sterilization;
• S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015
• S. 2014, Next Generation Researchers Act, to help attract more talented young scientists to NIH;
• S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act to update rehabilitation research for the first time in more than 20 years and require the National Center for Medical Rehabilitation Research (NCMRR) to develop and periodically update a comprehensive research plan for rehabilitation research;
• S. 849, Advancing Research for Neurological Diseases Act of 2015, to among other things, help the CDC expand infrastructure and activities to track the epidemiology of neurological diseases, including multiple sclerosis and Parkinson’s disease;
• S. 2511, Improving Health Information Technology, which deals with a host of health IT provisions, particularly around electronic health records;
• S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015, which would prioritize FDA’s review of breakthrough medical devices; 
• S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act, which would exclude certain types of software from FDA's purview;
• S. 2055, The Medical Countermeasures Innovation Act of 2015, which would set up a priority review voucher program for medical countermeasures;
• S. 1767, The Combination Products Innovation Act of 2015, which requires FDA to provide the sponsor of a product the scientific rationale supporting a determination that the product is not a medical device before making that determination, and prohibits FDA from determining that a combination product (a product that is a combination of drug, device, or biologic) is a drug solely because the product has a chemical action;
• S. 1597, Patient Focused Impact Assessment Act of 2015, which would require the package of information published by FDA upon approval of a new drug to include documentation of efforts to assess patient engagement.

Sen. Al Franken's (D-MN) bill to add the Zika virus to the tropical disease priority review voucher program was also considered one of the companion bills to the House-passed Cures legislation, though that bill has already won Senate approval.

Wednesday Hearing

The bills advanced by voice vote on Wednesday include one that helps FDA and NIH attract top new talent, which newly confirmed FDA Commissioner Robert Califf has said is a priority for his agency.

Other bills include:

• S. 185, Promise for Antibiotics and Therapeutics for Health Act, which requires FDA to establish a program to approve as a limited population antibacterial drug intended to treat a serious medical condition and to address an unmet medical need within an identifiable limited population, among other things.
• S. 2713, Advancing Precision Medicine Act of 2016, which has been a priority for President Barack Obama;
• S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act, which would promote the inclusion of minorities in clinical research;
• S. 2742, Promoting Biomedical Research and Public Health for Patients Act, which is a wide-ranging bill with numerous provisions for NIH, FDA and other HHS agencies.

Although FDA is likely to view the whole package of bills as favorable, the agency may take issue with an amendment from Sen. Pat Roberts (R-KS) on the precision medicine bill that would require FDA to explain why it’s using a non-binding guidance document rather than a rule in each new guidance document issued.

Roberts explained that FDA has issued more than 600 guidance documents since 2007, though these documents are supposed to be issued only to clarify regulations, not to establish new policies.

Sen. Patty Murray (D-WA) opposed the amendment and said that she spoke to Califf, who told her that the guidance documents are necessary for the agency to keep industry updated on ongoing work.

“Califf is concerned this would throw sand into the gears of FDA’s public health work,” Murray said, though the amendment was approved by voice vote. The only additional amendment that passed was one from Sens. Elizabeth Warren (D-MA) and Mike Enzi (R-WY) to add more patient protection rights under the precision medicine initiative.

Warren also made clear that she does not support moving forward on the package of bills until more NIH mandatory funding is established.

“We will lose a generation of scientists because Congress refused to fund their work,” Warren cautioned.