Senators Urge FDA to Clarify Biosimilar Policies

Eight Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee have written a letter to FDA Acting Commissioner Stephen Ostroff asking that the agency provide additional clarity on the biosimilar approval pathway. The lawmakers express concerns that current unresolved questions about biosimilar approvals are detrimental to industry and patient access to safe and effective medications. The senators question whether FDA is following its own draft guidance when reviewing and approving biosimilars, as the product labeling on the first biosimilar approval did not match current guidance. “FDA’s failure to issue complete and final guidance before beginning to review and approve biosimilar applications raises significant questions. In particular, it is not clear to what extent FDA staff has been following draft guidance when reviewing biosimilar applications. And, if FDA staff has been following draft guidance when reviewing applications, it is not clear what agency policies, if any, have been governing the process,” the senators write. “FDA has not provided sufficient guidance on important issues relating to the review and approval of license applications for biosimilar products, such as naming, interchangeability, and production of patent information.” The letter calls on the FDA to publish and finalize additional guidance regarding biosimilar drugs in order to provide additional certainty on the approval process. The letter was signed by Chairman Lamar Alexander (R-Tenn.) and Sens. Michael Enzi (R-Wyo.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.), Mark Kirk (R-Ill.), Orrin Hatch (R-Utah), Pat Roberts (R-Kan.), and Bill Cassidy, M.D., (R-La.).

Upcoming Congressional Meetings and Hearings

Senate Caucus on International Narcotics Control: hearing on the quota system used to manage controlled substances; 10:00 a.m., 226 Dirksen Bldg.; May 5

Senate Committee on Health, Education, Labor and Pensions: hearing titled “Continuing America’s Leadership: Realizing the Promise of Precision Medicine for Patients;” Francis Collins, MD, PhD, Director, National Institutes of Health, Karen DeSalvo, MD, MPH, MSc, National Coordinator for Health Information Technology, and Jeff Shuren, MD, JD, Director, Center for Devices and Radiological Health, Food and Drug Administration will testify; 2:30 p.m., 430 Dirksen Bldg.; May 5

Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies: hearing on rural health; 10:00 a.m., 124 Dirksen Bldg.; May 7

Senate Agriculture, Nutrition and Forestry Committee: hearing on the reauthorization of the Child Nutrition Act; 10:00 a.m., 216 Hart Bldg.; May 7

House Veterans’ Affairs Committee: hearing titled “Assessing the Promise and Progress of the Choice Program;” 10:30 a.m., 334 Cannon Bldg.; May 13

House Veterans’ Affairs Health Subcommittee: markup to consider pending health legislation; 9:45 a.m., 334 Cannon Bldg.; May 15 (markup will precede the hearing below)

House Veterans’ Affairs Health Subcommittee: hearing titled “Overcoming Barriers to More Efficient and Effective VA [Veterans Affairs] Staffing;” 334 Cannon Bldg.; May 15

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