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.

Now That the Foundation Has Been Laid, OGD is Making Moves to Crank Up the Machine

On December 11, 2014, Dr Kathleen (Cook) Uhl, Acting Director, Office of Generic Drugs (OGD) sent the following memo to all OGD and CDER Ops staff announcing some personnel changes and revisions in the way OGD will be approaching the significant backlog of applications and how it will approach the GDUFA goals it must meet.

Obtaining Samples for BE Testing for Products with Restricted Distribution Systems or REMS

The generic industry has been having a hard time (to say the least) in obtaining samples of certain Reference Listed Drugs (RLDs) that have Risk Evaluation and Mitigations Strategies (REMS) with elements to assure safe use (ETASU) upon which to conduct the necessary bioequivalence (BE) studies to support ANDA approval. Today, FDA has published a draft guidance entitled, “How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD”.

First-Time ANDA Approvals Represented 25% of All ANDAs Approved in FY 2013

It is clear that the Office of Generic Drugs (OGD) wants to assure that first-time generic submissions also translate into first-time generic approvals. In FY 2013, OGD approved a total of 440 ANDAs. Of that total, there were 108 ANDAs reported on the OGD First-Time Generic Drug Approval lists for the year. So it appears that OGD’s goal of getting first time approvals to the American public as quickly as possible at least translates into the percentage of first-time generic approvals (e.g., 1 in 4 ANDA approvals in FY 2013 was for a first-time generic approval of the product or 25%).

Transparency Window Shuts Further At OGD – Hopefully Only Temporarily

We are almost two months into FY 2015 and the first year of metrics for GDUFA, but have you noticed that the Generics Activity Report of the Generic Drug Program has not yet published for the October? As we understand it, the new OGD/CDER IT platform, noted by Dr. Woodcock as having some problems at the GPhA Fall Technical Workshop, is perhaps the culprit.

Here’s a Shock – Alpha Male Contains Undeclared, Hidden Drug Ingredient

Today, FDA issued a Public Notification indicating that the supplement Alpha Male, marketed with a tag line of “Knock it out of the Park with Alpha Male!” contains derivatives of both tadalafil (the active ingredient in Cialis) and derivatives of sildenafil (the active ingredient in Viagra). This is just another in a long line of supplemental products containing adulterants that makes them not only new drugs, but also dangerous.

Someone Won the Race for Abuse-Deterrent Hydrocodone Bitartrate Single Ingredient Tablets!

With all of the publicity (mostly negative) about the approval of the first (non-abuse-deterrent) hydrocodone bitartrate single entity extended-release (ER) product, Zohydro, by Zogenix, the race was on for the development of an abuse-deterrent formulation. On November 20, 2014, Purdue Pharma won that race with the approval of Hysingla (hydrocodone bitartrate) ER-Tablets with abuse-deterrent properties. Purdue obtained approval for 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100mg, and 120 mg tablets.

FDA Annual Report Reviews Delays and Activity for 505(q) Petitions

The FDA has released its 2013 report to Congress regarding delays caused by 505(q) petitions. As most of you know, a 505(q) petition was created by Food and Drug Administration Amendments Act (FDAAA) of 2007 to require certain response times to petitions submitted to the FDA that would potentially delay the approval of a 505(j) or a 505(b)(2) application. Congress took this action because FDA response times to Citizen Petitions sometimes took years and industry complained that these delays in response caused delays in approvals for ANDA and (b)(2) applications.
FDA has done very well since the FDAAA in meeting the timeframes for response.

What Price Could the Public be Paying for the Slow Down in Generic Drug Approvals?

CBS Morning Rounds recently ran a piece on the soaring cost of certain generic drug prices. Despite the potential divisiveness of the topic, the piece was very balanced…The CBS piece cites potential reasons certain price increases have occurred as a decrease in the amount of competition for a particular drug product, temporary exit from the product market due to manufacturing problems, or decreases in the supply of active ingredients.

Rx vs OTC- the Debate Continues

On November 12, 2014, the FDA responded (here) to a September 23, 2014 correspondence to Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research and also submitted the same to Docket No. FDA-2012-P-0566 regarding the safety of PEG 3350 for pediatric patients. The big debate is a bit broader than just pediatric safety; it involves an Agency determination stating that, when a product is completely switched from prescription to OTC status,, the product can no longer be marketed by prescription.

Done and DUNS!

After years of FDA assigning unique establishment numbers to FDA inspected facilities, the Agency has published a procedural Guidance today entitled, “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration: Guidance for Industry”, identifying their choice of the Data Universal Numbering System D-U-N-S (DUNS) number, assigned and managed by Dun and Bradstreet.