- In 2013, the FDA proposed a controversial rule that could allow generic drug companies to update their labels with new safety information, even if the information is not part of the label for the reference product.
- Currently, federal regulations do not allow for a generic drug company to update its label to reflect new adverse events or safety information if the brand-name drug company that manufactures the reference product has not done the same, as RAPS reports. Theoretically, the goal of this regulation is to convey equivalence—that the generic drug is not more or less effective than the reference drug.
- There is disagreement around the usefulness of this regulation, and there are many who dislike the proposed law, claiming that it is not consistent with the landmark 1984 Hatch-Waxman Act.
Many generic drug manufacturers oppose the proposed law, claiming that it could end up costing billions of dollars in increased legal liabilities and pharmacovigilance monitoring costs.
In fact, many are questioning the legality of the proposed rule. At one point last year, the FDA basically put off the decision until 2015, leaving many to wonder whether this law would ever resurface. This week, however, the FDA announced that it would be reopening the comment period for the proposed law, as Alec Gaffney notes.