FDA to generic drug makers: Looks matter
- The FDA is concerned that differences in size, shape, and color between branded drugs and their generic equivalents could negatively impact compliance and lead to medication errors.
- Since 2013, the FDA has pushed generic drug manufacturers to be aware of these differences and to take them into consideration when making generic drugs. Historically, this has not been an issue, but it has become a major concern as the FDA continues to learn more about which factors affect compliance.
- The FDA is also encouraging generic drug manufacturers to take other factors into consideration, including film coatings, taste-enhancing excipients, and the smell, weight, surface area, and shape of the drugs.
The FDA is so concerned about the physical differences between branded and generic drugs—and the impact those differences have on compliance and medication errors—that the agency is fielding polls of both pharmacists and patients on the issue.
Patients are being asked how differences in appearance affect them. Pharmacists will be polled about how often they change generic drug suppliers and which, if any, strategies they use to support their patients as they transition between pills. According to the Regulatory Affairs Professional Society, a comment period is open for the next 60 days.
- Regulatory Affairs Professional Society FDA Wants to Study if Drug Color, Shape and Size Affect Patient Adherence