POLICY BRIEFINGS


NIH Researchers Now Required to Share Data


Applicants for federal research funding will now be required to submit plans for how they will share the data resulting from their work with the public, according to an announcement from Director of the National Institutes of Health (NIH) Francis Collins. He said that the agency is still trying to determine how to standardize the policy across the different NIH centers. The data sharing requirements are a part of a larger effort by the administration to make the results of government research more transparent. The open sharing of data is also a main focus of the Cancer Moonshot Initiative.


FDA Examines Abuse-Deterrent Opioids


During a two-day meeting held last week, officials from the Food and Drug Administration (FDA) and representatives of both the generic and brand name pharmaceutical industries met to discuss development of abuse-deterrent opioid painkillers. Participants discussed the agency’s draft guidance for the development and evaluation of generic versions of the drugs. There are currently no approved generic abuse-deterrent opioids. Branded industry voiced concerns that FDA’s draft guidance does not go far enough to ensure that generic versions are no less abusable than the reference painkiller, arguing that assessment should not be based only on in vitro testing. The development of a standard in vitro testing method to characterize abuse-deterrent properties was also discussed. Questions about the effectiveness of abuse-deterrent properties, as well as their expense, have limited the uptake of abuse-deterrent opioids by insurers. The seven opioid products with abuse-deterrent properties only make up approximately two percent of the overall market for opioids. A component of FDA’s strategic plan for addressing the opioid epidemic is incentivizing the development of more effective abuse-deterrent opioids, and transitioning to greater use of these products.


Upcoming Congressional Meetings and Hearings


Senate Judiciary Committee hearing to explore potential Mylan-Justice Department Settlement Over EpiPens; 10:00 a.m., November 30



November 7, 2016: | Page 1 Page 2

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