The Generic Pharmaceutical Association (GPhA) yesterday released a study showing that patent settlements netted the U.S. healthcare system savings of $25.5 billion dollars over the time period 2005-2012.
We heard it was coming ever since the Department of Justice hinted the FDA was contemplating a change to permit generic application holders to revise their labeling to make safety changes. Something the Supreme Court actually said generic companies could not do in the Mensing and Bartlett decisions.
The Supreme Court of the United States (SCOTUS) again confirmed that labels for generic products must be the same as the innovator drug that they copy. In addition, SCOTUS determined that the claim of design defects claim in a product liability case cannot be asserted against a generic because the generic product must have the same active ingredient(s), dosage form, route of administration and strength as the product that it copies.
At the urging of the FDA, the Department of Justice (DOJ) filed suit against Sage Pharmaceuticals of Louisiana for the marketing of unapproved new drugs. The action comes after numerous warnings and a 2000 injunction against the firm for marketing two unapproved drugs. Failure to recognize that the FDA really meant what it said landed the company and two of its officers in hot water.
