The working group will propose options for using FDA's existing authorities and may develop legislative proposals to respond to changes in technology and in the marketplace that have occurred since the Hatch-Waxman Act was enacted in 1984. For example, it will consider whether and how ANDAs for complex products, such as those combining a drug and a device, may include clinical data. This isn’t a simple change. It’s a revolution in generic drug labeling – recognizing what pharmacologists and physicians have known for decades – that “bioequivalent” doesn’t mean “identical” – and that for some products, that’s more important than for others.
Just as the agency recognizes that biosimilar labeling can recognize both similarity and differences, that recognition will now be used to help determine the appropriate use of generic medicines. Gottlieb has expressed concern for years that FDA policies don’t adequately support the development of generic versions of complex products. To paraphrase Dr. Harry Lever of the Cleveland Clinic, we mustn’t lose control of what patients are swallowing.
Per the FDA, “Consistent labeling will assure physicians, health professionals, and consumers that a generic drug is as safe and effective as its brand-name counterpart.” But “consistent” doesn't mean “identical” – especially when the data says otherwise. We live in the Information Age. Knowledge is power.
Working group members will include Elizabeth Dickinson, an attorney in FDA's Office of the Chief Counsel who served as the agency's Chief Counsel during the Obama administration; Grail Sipes, director of the Office of Regulatory Policy at FDA's Center for Drug Evaluation and Research (CDER); and Maryll Toufanian, deputy director of CDER's Office of Generic Drug Policy.