Letter to Senate Committee on Generic Labeling Regulations

The Honorable Barbara Mikulski


Committee on Appropriations

United States Senate

S128, US Capitol

Washington, DC 20510

The Honorable Richard Shelby

Ranking Member

Committee on Appropriations

United States Senate

S-146A US Capitol

Washington DC 20510

Dear Chairwoman Mikulski and Ranking Member Shelby:

In November 2013, the Food and Drug Administration (FDA) proposed to revise its regulations to allow generic drug manufacturers to initiate safety updates to their products’ labeling.[1] We strongly support the FDA’s proposal.

Generic manufacturers currently are barred from providing new warning information, except in response to a brand-name update or FDA order.  Yet most prescription drugs sold in the United States are generic versions, and the brand-name manufacturer often stops selling the drug after generic versions come on the market.

Allowing the generic manufacturers to initiate safety updates, as brand-name companies have done for 30 years, is essential to patients and consumers, as promptly updated warnings can provide informed consent to patients and physicians and prevent serious harm to patients.

Recently, the House Committee on Appropriations included a few sentences in its report of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill for fiscal year 2015 that would unnecessarily delay the FDA’s ability to finalize the proposed rule and leave patients and consumers exposed to the current inadequate safegurds.

Patients and consumers deserve up-to-date information about the prescription drugs they use, including the most up-to-date safety warnings.  Allowing generic drug manufacturers the flexibility to update safety labeling as soon as they become aware of new information is important to protect the health of all Americans and maintain the public’s trust in generic drugs.  The FDA’s proposal deserves the strong support of Congress and all those who care about public health in the United States.

We strongly oppose the inclusion of the House Language and ask for your support in making sure that it is not included in any final appropriations report for the Food and Drug Administration, or any other legislation.

Thank you for your consideration.

Alliance for Justice

Alpha-1 Foundation

American Autoimmune Related Diseases Association

American Medical Student Association

American Medical Women’s Association

Annie Appleseed Project

Brain Injury Association of America

Breast Cancer Action

Center for Justice & Democracy at New York Law School

Center for Medical Consumers

Center for Science and Democracy at the Union of Concerned Scientists

Connecticut Center for Patient Safety

Consumers Union

COPD Foundation

Jacobs Institute of Women’s Health

Lupus Foundation of America

Mothers Against Medical Error

National Center for Health Research

National Consumers League

National Eczema Association

National Latina Institute for Reproductive Health

National Physicians Alliance

National Women’s Health Network

New Yorkers for Patient & Family Empowerment

Our Bodies Ourselves

Prevent Blindness America

Public Citizen

Public Justice

Reproductive Health Technologies Project

Sjogren’s Syndrome Foundation

The TMJ Association




The organizations listed above can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org

[1] Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985).

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