FDA Commissioner, Scott Gottlieb, has announced that the agency will be releasing new guidance that will help bring more complex generic drugs to market. The guidance will focus on generic treatments that combine a drug and a device, such as inhalers for conditions of the lung or auto-injectors for conditions like diabetes.
These treatments are particularly complex because, not only does the drug itself have to be identical to the branded product, but under current regulation, the device too must be exactly the same. If there is any difference in the device, the treatment cannot be considered a true generic. This means the generic cannot be dispensed at the pharmacy as a substitute for the more expensive branded product, unless the prescription specifically calls for the generic version.
This issue often arises when the patent awarded to a branded drug company for the drug expires before the patent awarded for the device. Under such circumstances, a generic company can copy the branded drug but must make alterations to the branded device to avoid infringing the existing patent.
The new guidance, to be released by the FDA in the coming months, will eliminate this issue. According to Gottlieb, the guidance will stipulate that a generic device can be different in design to the branded device, so long as there is data to show that the difference does not alter the clinical effect or safety profile of the drug. Under this rule, a treatment with a different device can be considered a true competitor to the branded treatment, if all other requirements for generic approval are met.
This new guidance is the latest in a series of efforts made by the FDA to facilitate the development and approval of generic products. To find out more about these efforts, check out previous WEP Clinical blog posts: FDA announces another strategy to spur generic drug development, and, FDA tries to encourage development of generic versions of complex drugs