On September 30, U.S. District Court (New Hampshire) judge Joseph Laplante decided that Mutual Pharmaceutical was obligated by New Hampshire law to include warnings on its ANDA products not included on the reference listed drug’s labeling. The judge ruled that, although the Hatch-Waxman amendment clearly stated that the the ANDA must contain the same wording as the RLD for approval, the law did not state that the ANDA labeling after approval had to be the same.
The case involved a woman who had taken Sulindac (RLD: Clinoril, Merck), a generic NSAID made by Mutual and had suffered serious injuries, allegedly caused by the medication. She claimed that Mutual had an obligation to warn of the hazard by including suitable language on the labeling. Mutual claimed preemption of state law based on the requirements of federal law, namely, the Hatch-Waxman Amendments of 1984.
In his decision, the judge give a history of the ANDA approval process from 1962 on. He carefully constructs an argument that shows how Mutual is correct in that the ANDA label must be the same at the time of approval. But he goes on to state that 505(j) does not restrict what happens after approval (page 30).
If Mutual cannot or will not change its labeling, the judge suggests that Mutual could “refrain from distributing it at all.” (page 26)
We hope this works its way to the U.S. Supreme court. This decision would result in chaos – each state deciding what the labeling of a drug should be. In effect, state law supersedes FDA labeling review and approval.
Apparently, Congress is working to remedy this situation.