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.
At the Generic Pharmaceutical Association’s Fall Technical Conference on October 29, 2013, speakers from the Office of Generic Drugs (OGD) provided a glimpse into the review accomplishments for the first year since GDUFA was passed, and as to how OGD will change its process to assure timely OGD review.
Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER) noted that her vision of the reorganization for the Center is to have “one voice for quality across all drug products including biotech.” She also indicated that while this has been a need of CDER for a while, she gave GDUFA credit as a major driver of this current effort.
Speaking at the Pre-Meeting Project Manager Workshop, OGD staff reminded participants of the fact that in year 1 and 2 of GDUFA, there are no real metrics, and reviewed the GDUFA goals for years 3-5 of the five year program. Along with this reminder, OGD GDUFA Implementation Team Member Christina Kirby noted that all amendment goals are incremental, meaning that pre-FDA Action Amendments results in an adjustment of goal date and post-FDA Action Letter submissions sets a new goal date.
On October 24, 2013 the FDA announced its intent to recommend to the Drug Enforcement Administration (DEA) that Hydrocodone-containing combination products be rescheduled into the more restrictive Schedule II. Such a move will make it more difficult for patients to obtain the products, as well as for healthcare practitioners to prescribe these products.
