GPhA speaks out on generics labeling, access
WASHINGTON — This week, the Generic Pharmaceutical Association released statements related to the current state of generics, specifically proposed changes to rules regulating labels on generic drugs from the Food and Drug Administration, as well as steps it believe lawmakers should take to ensure affordable medication access for Americans.
When it comes to accessibility, the organization recommended that lawmakers should encourage the FDA to review the approximately 3,800 generic drug applications awaiting action in a timely manner. GPhA also recommended wider use of generics among low-income Medicare beneficiaries, which it estimates could save $17.7 billion over the course of 10 years.
The organization also recommended passing the FAST Generics Act, which it says will keep drug companies from using Risk Evaluation and Mitigation Strategies to keep generics from hitting the market, and called for a repeal of a Medicaid rebate increase for generic drugs included in this year’s budget agreement.
The organization’s president and CEO, Chip Davis, discussed regulations concerning labeling of generics, as the organization says currently, branded and generic drugs have the same label, but a proposed change to generic labeling requirements would require manufacturers to update labels without first getting FDA approval. As a result, GPhA has proposed the Expedited Agency Review (EAR), which relies on the FDA to review new safety information and take action on label changes.
“The FDA is the only entity with all of the data needed to recommend a safety information change,” David said. “Instead, the EAR suggests time parameters for the FDA to take action and encourages the adoption of e-labeling for real time information sharing rather than continuing the reliance on paper label changes that take months or years to adopt. The EAR also takes important steps to make sure that multiple different labels do not exist for products with the same active ingredients, safety and efficacy.”