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Patient Advocates, Physicians, Pharmacists Urge OMB to Work with FDA to Finalize Naming Policy

March 24, 2015

March 24, 2015

The Honorable Shaun Donovan
Director, Office of Management and Budget
The White House
725 17th Street, NW
Washington, DC 20503

Dear Director Donovan:

We are writing to urge the Office of Management and Budget to work with the U.S. Food and Drug Administration (FDA) to implement a policy of unique naming for all biosimilars and biologics. This is urgent, given that FDA has now approved the first biosimilar in the United States. The five groups submitting this letter – the American Autoimmune Related Diseases Association, Biologics Prescribers Collaborative, Hematology/Oncology Pharmacy Association, National Alliance for Hispanic Health, and National Organization for Rare Diseases – represent a broad spectrum of patients, providers, and pharmacists in favor of unique naming.

We commend the FDA for its careful deliberation on the naming issue and particularly for its carefully-crafted decision to give Zarxio (filgrastim-sndz) a temporary distinguishable name while the policymaking process continues.

We welcome the availability of biosimilars in the U.S. and believe the success of this class of medicines hinges on prescriber, patient, and pharmacist confidence. Every patient who depends on biologic drugs deserves to know the exact drug they are using in order to make the best medical decisions in terms of both efficacy and safety. Given that no two biologics drugs can ever be the same, unique naming provides transparency that supports confidence in, and ultimately utilization of, these new medicines as well as critical post-market surveillance and tracking.

Attached with this letter are four letters previously submitted to FDA from our respective organizations and one statement that details our case for unique naming. Thank you for your attention to this important patient safety matter. Given that biosimilars will be available in the U.S. imminently, we look forward to guidance on naming in the near future.

Respectfully,

American Autoimmune Related Diseases Association
Virginia T. Ladd, President and Executive Director

Biologics Prescribers Collaborative
Dennis R. Cryer, MD, Lead-Physician Co-convener

Hematology/Oncology Pharmacy Association
J. Michael Vozniak, PharmD, BCOP, President

National Alliance for Hispanic Health
Jane L. Delgado, Ph.D., M.S., President and CEO

National Organization for Rare Diseases
Peter L. Saltonstall, President and CEO

CC:
The Honorable Sylvia Burwell, Secretary, U.S. Department of Health and Human Services
The Honorable Margaret Hamburg, Commissioner, Food and Drug Administration
Mr. Howard Shelankski, Director, Office of Administration and Regulatory Affairs
Ms. Cecilia Muñoz, Director, Domestic Policy Council
Dr. Jonca Bull, Director, Office of Minority Health
Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research
Dr. Karen Midthun, Director, Center for Biologics Evaluation and Research
Dr. John Jenkins, Director, Office of New Drugs, Center for Drug Evaluation and Research
Dr. Anne Pariser, Associate Director for Rare Diseases, Center for Drug Evaluation and Research
Dr. Gayatri Rao, Director, Office of Orphan Products Development

NORD Letter to FDA on Distinguishable Naming

National Alliance for Hispanic Health Letter to FDA

Biologics Prescribers Letter to FDA on Distinguishable Naming

Follow-up Biologics Prescribers Letter to FDA on Distinguishable Naming

HOPA Statement on First Biosimilar Product Approved in the United States

Society for Women’s Health Research (SWHR) and patient advocates Letter to FDA