The Food and Drug Administration Safety and Innovation Act, more commonly known as FDASIA, was signed into law on July 9, 2012 (Public Law 112-144) and has been getting increased publicity as the provisions in the Act are getting more action and traction.
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.
In a previous post, we reported that FDA had finalized its revised Orphan Drug Regulations. Those regulations further explained how and when a firm may be eligible for a second period of ODE for the same drug and the same indication. FDA exempted quality of life issues as a factor in determining significant clinical improvement; however, they allowed as a factor for consideration products that significantly improved patient compliance.
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.