Coach K Gets 1000 Wins and FDA Gets Califf from Duke

Dr. Robert Califf was appointed FDA Deputy Commissioner for Medical Products and Tobacco. As such, Dr. Califf will oversee the “Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.”

So What’s Wrong with OGD Workload Reporting?

Lots! Here we are in mid-January, almost one-third of the way through the first GDUFA metric year and year three into the GDUFA program itself. As we have reported previously, CDER is having trouble with its new IT platform and, thus, reporting its statistics to the industry has been difficult at best and, at most, very confusing for anyone outside of FDA.

Uhl Named Permanent OGD Director

In what was a long-anticipated action, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) announced that Dr. Kathleen “Cook” Uhl will take over the reigns of the Office of Generic Drugs (OGD) on a permanent basis.

Office of Pharmaceutical Quality Standing on Own Two Feet

Well, it’s January 2015 and the Office of Pharmaceutical Quality (OPQ) is about to be stood up (“FDA speak” for official) and will be addressing quality issues across the New Drugs and Generic Drugs arenas. The concept is of one quality voice and one standard, but more about this in a bit. The new leaders of OPQ are outlined in a CDER posting relative to the new organization.

New or Revised Guidances to Look for from FDA in Calendar Year 2015

FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”. This document gives us an idea of what is new and what changes we can expect on various issues over the coming year. It is not specific as far the specific changes that are upcoming, but at least it provides direction as to where changes or new advice may be forthcoming from FDA.

What, No More Paper? The FDA is Going Green on Labeling!

Well, after a lot of talk and years of discussion, “The Food and Drug Administration (FDA) is proposing to amend its labeling regulations at 21 CFR 201.100, 201.306, 201.310, 606.121, 606.122, 610.60, and 610.61 for human prescription drugs and biological products, and blood and blood components intended for transfusion, to require that the prescribing information (commonly referred to as the package insert) intended for health care professionals be distributed electronically and, with few exceptions, not in paper form.”

Will the Acura Petition Force FDA to Make a Decision on Oxecta and/or Other 505(b)(2) Submission Strategies?

A December 10, 2014 petition filed by Wiley Rein LLP on behalf of Acura Pharmaceuticals (here) asks the FDA to require Purdue to file an ANDA rather than a 505(b)(2) application for a duplicate version of an immediate release oxycodone tablet with abuse-deterrent properties. The petitioner argues that,because the abuse-deterrent characteristics of the proposed Purdue product are similar to those of its Oxecta product, and because both products are pharmaceutical equivalents, that a firm should not be able to circumvent the listed patents on the Oxecta reference listed drug (RLD).

Look in Those Stockings – Is it Coal or a New Approval?

Just a few days ago, I posted a memo from Cook (Acting Director, Office of Generic Drugs [OGD]) about the new personnel changes there and the vision of how OGD will drive applications to approval. The plan sounds good and I believe we will see movement in the coming year (remaining 9.5 months of GDUFA year three). But today is December 15th and, thus far, we have seen only one approval in December.

OGD Continues Tightening BE Requirements for Extended-Release Products

Just weeks after the Office of Generic Drugs (OGD ) released a revised bioequivalence (BE) guidance for extended-release generic equivalents of Concerta and took action to revise the therapeutic equivalence code for the two generic approved products to BX (non-substitutable/not therapeutically equivalent), OGD released a new fairly onerous draft BE guidance for Budesonide Extended-Release Tablets.