Generics

FDA announced the Fiscal Year 2014 User Fees to begin on October 1, 2013. This rise in fees was expected since the number of ANDA projected to be submitted in 2013 appears as if it may drop below the 1103 submitted in 2012. In addition, the number of facilities self-identifying was slightly lower than anticipated. Also remember that, in year one of GDUFA, there was $50 million of the $299 million permitted for 2013 associated with backlog fees to address the logjam of ANDAs in the backlog. That was a one- time fee which must now be made up by increases in the ongoing yearly fees.

In an FDA Safety Alert issued today, the FDA warned of potentially serious liver failure that can result in need for liver transplant, or death and adrenal insufficiency that has been observed with Nizoral (ketoconazole) tablets. This pertains to both the brand and generic versions of the tablet form of the drug.

We have seen recent articles in which both FDA and Office of Generic Drugs (OGD) are touting their progress made under the Generic Drug User Fee Act of 2012 (GDUFA). But we are almost 10 months into year one of the program and hiring is just really ramping up.

The effective “expiry” of a satisfactory inspection and the need to re-inspect a facility before granting of ANDA approval has become a practical problem for the generic industry, which carries the risk of potentially significant consequences including marketing delays, loss of projected revenues and forfeiture of exclusivity entitlement in a worse-case scenario. In light of this continuing challenge, and in light of some existing ambiguities regarding FDA inspection policy, Lachman contacted CDER’s Office of Compliance to determine its current policy regarding conduct of inspections required in support of approval of ANDAs.

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.