Generics

Since the implementation of the Generic Drug User Fee Act (GDUFA), many small facilities have complained about the establishment and facility fees being assessed under the Act. Unlike the Prescription Drug User Fee Act (PDUFA) where establishment (facility fees) are not due or paid until after the respective new drug application (NDA) is approved, GDUFA requires yearly payments of the facility fee while the abbreviated new drug application (ANDA) is pending. With median approval times at about 34 months, that may mean that 3 or more facility fees may be due prior to application approval. At the current rate of $220,152 for domestic facilities and $235,152 for foreign facilities, that could mean close to $700,000 in fees that a facility may have to pay prior to approval of an application that it is named in.

In a letter dated November 27, 2013, the Generic Pharmaceutical Association (GPhA) requested a 60-day extension to provide comments on the FDA’s Proposed Rule – Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.

Two Federal Register notices that will both publish on November 27, 2013, extend the comment period for 14 days on two separate Draft Guidance documents, due to technical problems that occurred on the Regulations.gov website that made it impossible for some commenters to make electronic submissions to the respective Dockets from November 4-13, 2013.

While Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) and Dr. Kathleen Uhl, Acting Director, Office of Generic Drugs (OGD) are kicking around ideas about early communications of deficiencies and potential approvals to firms, the message that OGD is clamping down on phone calls and emails is being heard by Industry loud and clear.

It may be almost too late to assure that the culture of generic companies can change to meet the new more demanding standards and requirements that the Generic Drug User Fee Act (GDUFA) indirectly imposes. But if now is almost too late, tomorrow is for sure!

I am stealing a quintessential line from the movie “The Russians Are Coming, The Russians Are Coming”, to explain the emergent nature of the FDA’s proposed revision to its labeling rule to permit unilateral changes in safety information for certain applications for which the Federal Food Drug and Cosmetic Act (FDCA) clearly precludes such changes. So those of you in industry you have a choice – either raise your voices and raise them loudly, or contact your liability carriers and raise your limits and secure good defense counsel.

Speaking at the GPhA Fall Technical Workshop on October 30, 2013, Dr. Kathleen Uhl, Acting Director of the Office of Generic Drugs (OGD) provided a first look at the structure of the new OGD Super Office. There are a number of new organizational blocks that signal to this old former OGDer that not only more changes are on the way, but that emphasis on certain pre- and post-approval issues are going to be beefed up considerably.

In a passionate presentation before a packed GPhA audience that left some teary-eyed, Dr. Uhl the Acting Director of the Office of Generic Drugs (OGD), whose nickname we learned is “Cook”, outlined her strategy for achieving the demanding goals of GDUFA on time.

Kiran Krishnan (Vice President, Regulatory Affairs, Apotex) presented an overview of the new stability requirements and the implications on the Generic Industry.