FDA to Use Intercenter Coordination

The Food and Drug Administration (FDA) has decided to begin partnering officials in different agency centers with expertise in oncology products in an attempt to streamline the review process. The largely virtual Oncology Center of Excellence was first proposed in the President’s budget as a part of the Cancer Moonshot initiative, but Commissioner Robert Califf announced last week that he intends to create the Center regardless of whether Congress mandates the change or provides funding for its creation. Currently, the FDA reviews new cancer treatments separately across the drug, device, and biologic centers within the agency. The goal of the Oncology Center of Excellence would be to break down these silos to better engage the disease specific knowledge of regulatory scientists. FDA plans to establish and staff the Center between October 1, 2016 and September 30, 2017.

Policymakers Inquire About FDA Use of Guidance Documents

A group of Republican senators have written to Commissioner of the Food and Drug Administration (FDA) Robert Califf to express concern over the agency’s use of non-binding guidance instead of formal rules and regulations to enact significant policy changes. The lawmakers inquire as to why the FDA has increasingly relied on guidance documents, and urge the FDA to either finalize or withdraw guidances that are still in draft form. The letter was signed by Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-Tenn.), and committee members Johnny Isakson (R-Ga.), Richard Burr (R-N.C.), and Orrin Hatch (R-Utah).

Upcoming Congressional Meetings and Hearings

Senate Finance Committee hearing on “Can Evidence Based Practices Improve Outcomes for Vulnerable Individuals and Families?” 10:00 a.m., 215 Dirksen Bldg.; May 10

House Rules Committee meeting to consider opioid legislation (H.R. 4641 and H.R. 5046); 5:00 p.m., H-313 Capitol; May 10

House Energy and Commerce Health Subcommittee hearing on “Health Care Solutions: Increasing Patient Choice and Plan Innovation;” 10:00 a.m., 2322 Rayburn Bldg.; May 11

House Ways and Means Health Subcommittee hearing on “Implementation of Medicare Access and CHIP Reauthorization Act of 2015 (MACRA);” 2:00 p.m., 1100 Longworth Bldg.; May 11

Senate Finance Committee hearing on the nominations of Charles Blahous III and Robert Reischauer, each to be a member of the Board of Trustees of the Federal Hospital Insurance Trust Fund, member of the Board of Trustees of the Federal Supplementary Medical Insurance Trust Fund, and member of the Board of Trustees of the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund; 3:00 p.m., 215 Dirksen Bldg.; May 11

House Energy and Commerce Oversight and Investigations hearing on “Concussions in Youth Sports: Evaluating Prevention and Research;” 9:30 a.m., 2123 Rayburn Bldg.; May 13

Recently Introduced Health Legislation

H.R. 5164 (introduced by Rep. Jenkins of Kansas): A bill to provide for a permanent extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals; to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned; May 3

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