Statement from Ralph G. Neas, president and CEO, Generic Pharmaceutical Association:
"Patient safety is the foremost concern for manufacturers of generic medicines, which is why both brand and generic companies comply with federal law and strict FDA labeling rules and regulations.
To avoid confusion for patients and their doctors and pharmacists, generics manufacturers are required by law to have the exact same label as the brand or Referenced Listed Drug. Providing identical language that includes uniform safety information assures practitioners that they are receiving consistent labeling they can rely on when prescribing medicines for patients.
This underscores a critical point—once generic medicines pass through extensive FDA review, and they are proven scientifically equal to the brand medicine in terms of safety, efficacy and quality, they are approved by the FDA and required by law to have the identical label.
Multiple, different versions of critical data would lead to unnecessary confusion and uncertainty for prescribers, with potentially harmful consequences for patients. Indeed, the Supreme Court has repeatedly held that generic manufacturers must duplicate the language on brand labels and cannot make changes to a label without FDA approval.
As the FDA considers a rule change for labeling, our member companies support the rational communication of important safety information to health care practitioners. While it is premature to discuss what these changes may be, it is important to note that the impact of such a change could create chaos if multiple sponsors for the same product are expected to distribute revised labeling to reflect new safety information.
Generics currently make up 84% of prescriptions dispensed in the United States and save the health care system $200 billion annually. In a time when the public and private sectors are seeking out health savings, regulatory changes that could drive up costs should be approached very carefully.
The generic pharmaceutical industry continues to work with the FDA and other stakeholders to make sure that any changes to labeling rules and regulations align with federal laws, protect patient safety, and do not hinder patient access to more affordable generic medicines."
Statement from Teva Pharmceuticals, generic manufacturer of metroclopramide:
The safety of our products is of the utmost importance to Teva and we take our commitment to the millions of patients that take our products seriously. We comply with all federal regulations to report adverse events and give the FDA the information they need when any injury is reported. Unfortunately, all medications carry risks. Manufacturers of prescription drugs provide warnings about those risks in the FDA-approved labeling.
Since 1985, the FDA-approved labeling for the brand drug Reglan® has included a detailed warning about the possible risk of tardive dyskinesia. That warning makes clear that the risk of developing tardive dyskinesia from metoclopramide may increase with longer duration of treatment. In compliance with federal law, the FDA-approved labeling for Teva's generic metoclopramide included that same detailed warning.