Lawmakers float generic drug legislation
Reps. Steve Stivers (R-OH) and Peter Welch (D-VT) have submitted a bill that would require branded drugmakers to share product samples of drugs undergoing REMS treatments with generic drug manufacturers. FDA Law Blog explains that generic drug manufacturers have to be able to compare their version of a branded drug to the branded pharmaceutical to document equivalency when applying to the FDA for approval. However, drugs that are part of a Risk Evaluation and Mitigation Strategy program, which means the FDA has asked the branded drug manufacturer to test an approved drug after approval, are not so readily available.
The Wall Street Journal's Pharmalot blog explains that these REMS drugs are harder to get samples of because they have limited distribution. Critics, such as the generic drug industry, allege that branded drug makers are using REMS to prevent them from having a comparator drug, which keeps them from being able to create generics.
Stivers and Welch's bill would give generics makers a workaround: they would apply for samples through the Department of Health and Human Services. The bill says branded drugmakers could be sued for damages if the HHS approves a sample request and the branded drug manufacturer does not comply.