As Congress considers a bill that would prevent brand-name drug makers from thwarting generic competition, Maine lawmakers are refusing to wait. The legislature recently passed a bill of its own and is now hoping the governor will sign the legislation into law.
The bill attempts to address an issue that has frustrated generic drug makers for years — tactics by brand-name companies that make it difficult, if not impossible for generic companies to obtain needed samples for developing equivalent versions.
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If memory serves, the first REMS was the FDA’s method of allowing Celgene to get a thalidomide project back on the market. And now this ‘burdensome obligation’ against innovation has become a cherished barricade ‘against innovation’ or ‘copycats’ – not just for Celgene but they are/were first in this matter as I remember.