Life Science Compliance Update

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February 16, 2016

Senate HELP Committee Moves Closer to Creating Corollary to 21st Century Cures

Last week, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved a series of seven bills to work up medical innovation legislation that will eventually likely become the Committee's response to the 21st Century Cures Act passed by the House of Representatives.

Last month, HELP Committee Chairman Lamar Alexander of Tennessee estimated that the Senate's version will not mirror the House bill, and that the Senate's effort will focus on priorities that are identified by the Committee's members, such as improving federal electronic health record programs.

Last week's productive meeting was not the last meeting for the Committee on this topic, either. The panel is set to consider approximately twenty pieces of innovation-related legislation, and there are meetings set for March 9, 2016, and April 6, 2016.

During Chairman Alexander's opening statement last week, we saw a preview of his expectations for the process of how to move the innovation bills through the panel all the way to the Senate floor. He emphasized the bipartisan nature of the fifty proposals included in the twenty bills, and that he would personally ensure that consideration of each proposal would include an opportunity for debate and open amendment. Chairman Alexander is hoping that he can work to create a consensus on the measures while they are in the Senate panel, holding off the contentious debates until they reach the Senate floor.

The Advancing Targeted Therapies for Rare Diseases Act of 2015

This bill aims to speed up the approval process of genetically targeted drugs by allowing companies to use evidence from already-approved drugs. As per the text of the bill, this legislation would "facilitate the development, review, and approval of generically targeted drugs to address an unmet medical need in one or more patient sub-groups (or gene variant subpopulations) with respect to rare diseases or conditions that are serious or life threatening; and maximize the use of scientific tools or methods, including surrogate endpoints and other biomarkers for such purposes." This approach is different from the 21st Century Cures Act in that the 21st Century Cures bill would provide a six-month extension of exclusivity periods and patent protection for an already-approved drug if the sponsor works to obtain approval for a new indication for either a rare disease or rare condition.

The FDA Device Accountability Act of 2015

This bill is similar to the 21st Century Cures Act and attempts to eliminate "burdens" that are slowing down the FDA's consideration of new, innovative, medical devices. This bill asks for FDA reviewers to use least burdensome requirements in their review, permits centralized, non-local institutional review boards for device trials, and also requires the FDA to update their guidance on Clinical Laboratory Improvements Act (CLIA) waivers. The Senate goes further than the House, however, by allowing reliance on post-market information for premarket approval devices as part of the least burdensome requirements.

The Next Generation Researchers Act

This bill works with the NIH and establishes a Next Generation of Researchers Initiative, where policies and programs would be coordinated to promote and provide research opportunities for new researchers and work to give researchers earlier independence. The legislation also calls for the National Academy of Sciences to study and report on the barriers that are likely to be faced by the next generation of researchers, the impact of sequestration and federal budget constraints, and recommendations for ways to improve entry into, and sustain careers in, research.

The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act

This bill calls for the National Center for Medical Rehabilitation Research (NCMRR) to develop and update a research plan for medical rehabilitation research. Under this bill, the NCMRR is also required to annually report on the progress of achieving the objectives, benchmarks, and guiding principals described in the research plan. The bill mandates HHS enter into interagency agreements to better coordinate medical rehabilitation research.

The Advancing Research for Neurological Diseases Act of 2015

This bill amends the Public Health Service Act to require the Centers for Disease Control and Prevention to enhance and expand infrastructure and activities to track neurological diseases. The bill also mandates that CDC incorporate that information into a National Neurological Diseases Surveillance System, and requires that HHS provide for the collection and storage of information on neurological diseases, including incidence and prevalence rates, to the extent practicable.

The Preventing Superbugs and Protecting Patients Act

This bill mandates that the FDA publish a list within six months following enactment of a reusable device that would need to provide proposed cleaning instructions as part of a 510(k) premarket submission. The devices on the list would also be required to provide the FDA with the validation data that shows that the proposed cleaning instructions are sufficient for safe cleaning, disinfection, and sterilization of the devices between patient use.

The Improving Health Information Technology Act

This bill scrapped an earlier plan of setting up a new health IT committee to replace current committees. This proposal eases requirements on physicians who enter data into electronic health systems by permitting nurses and other healthcare provider teams to enter and document the information as well. The bill also establishes a rating system for health information technology to help professionals in choosing products and facilitating information sharing between providers. This most recent draft also strikes fines and compensation fund found in earlier proposals.

These bills are a start for the Senate to work towards a companion bill to the House 21st Century Cures Act. We will monitor the Senate's progress and try our best to keep our readers abreast of any developments.

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