Nineteen Disability, Patient Advocate, Minority and Veterans Organizations Call on FDA to Reconsider Proposed Generic Labeling Rule

Published Online: Friday, March 14, 2014
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WASHINGTON, DC (March 14, 2014) –Today, 19 organizations representing those populations that most rely on access to affordable generic drugs submitted letters to the FDA raising significant concerns that its Proposed Rule on generic labeling could jeopardize patient access and patient safety.

“Patient advocacy, disability, veterans, minority and provider groups are taking their place at the table and raising serious concerns about the negative impact of the FDA Proposed Rule on Generic Labeling,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association (GPhA.) “The number of voices is mounting; last week, we heard from more than 20 organizations across the healthcare supply chain. Now we are hearing from patient populations historically and currently underserved by our nation’s health care system.

These groups are speaking up because they are worried that by creating a framework under which one drug could have multiple different warning labels, the Proposed Rule would compromise patient safety. Because they speak for millions of Americans who rely on generic drugs, these groups are asking for inclusivity in creating this rule. They do not want to be left behind in the FDA decision-making process.”

Two letters were filed today: one from patient, disability and veterans groups, and a second letter from key African American associations. The letter from patient groups states that the process change proposal should be based on the science, stating:

“As patient advocacy organizations, patient safety is our foremost concern. When it comes to labels for prescription medicines, we have one bedrock principle: drug labels must be FDA-approved and grounded on scientific evidence.”

It also emphasizes the need for consistency, stating:

“Patients and healthcare practitioners must continue to have access to consistent, transparent information in order to best inform treatment decisions and promote safety. The FDA’s rule as presently drafted could severely undermine those goals and lead to unintended consequences.” This letter was signed by the Attention Deficit Disorder Association (ADDA), Easter Seals, Institute for Safe Medical Practices, National Alliance of Mental Illnesses (NAMI), National Association of County Behavioral Health & Developmental Disability Directors (NACBHDD), Scleroderma Foundation, Veterans Health Council, and the Vietnam Veterans of America.

The second letter was signed by the International Association of Black Professional Fire Fighters, National Alaska Native American Indian Nurses Association, National Association of Hispanic Nurses, National Black Chamber of Commerce, National Black Nurses Foundation, National Coalition on Black Civic Participation, National Coalition of Ethnic Minority Nurse Associations, National Dental Association, National Minority Quality Forum, Philippine Nurses Association of America, and the Student National Dental Association.

It states that:

“The FDA and others need to fully explore the potential unintended and harmful consequences that the Rule may have on patient access – particularly those patient populations currently underserved by our nation’s health care system – and national health care costs. Inclusiveness has to be the operating principle. The FDA should hear from providers who serve racial and ethnic minority populations who could offer expertise, experience, and perspective. “

Neas said that this issue has impacts far beyond the generic industry. “The sustainability of our health care system, indeed our national economy, depends on the continued access to safe, effective, more affordable generic medicines in a timely manner. Patients and healthcare practitioners must continue to have access to consistent, transparent information in order to best inform treatment decisions. The FDA’s rule as presently drafted would severely undermine all these goals.”

For more information on the FDA Proposed Rule, visit

Patient Advocates Letter
Minority Organizations Letter
Congressional Testimony of Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association
Los Angeles Times Editorial
The Hill Op-Ed
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