Generic Drug Labeling
Patient safety is the foremost concern of generic drug manufacturers. That is why generic drug companies proactively participate with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling to ensure doctors and patients have access to the most current information.
Currently, generic medicines are required by law to have the same labels as their brand counterparts. When medicines have the same label, it reassures patients and health professionals that these medicines are proven safe and effective.
Indeed, the safety and sameness of FDA-approved generic drugs is the foundation for their widespread acceptance by doctors and patients alike – generic medicines are 84 percent of U.S. prescriptions, exemplifying the high consumer confidence and more affordable choice that these medicines provide.
On November 13, 2013 the FDA released a proposed rule on labeling changes for approved medicines. The rule takes an unprecedented approach to label changes for generic pharmaceuticals. In its current form, the Proposed Rule would increase healthcare costs for consumers and government payers and lead to vast unintended consequences.
A workable solution is within reach. Together, we can establish a process that does not pose risk to patients and does not upend the balance responsible for 30 years of lower health costs and safe generic medicines.