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.
FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During 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.
We know that there are a number of approved products that contain caffeine. But now, as noted in a recent article by the Associated Press found on Yahoo health (here), the FDA is gearing up for a legal battle to reduce the availability of caffeine powder being sold as a dietary supplement.
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.”
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.
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.
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”.
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.
In the past, members of Congress have criticized the FDA for a lack of aggressiveness and swift action when it came to debarment actions….
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.
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.
FDA usually does not make comments on pending new drug applications (NDAs) nor do they usually publicly discuss conversations with sponsors. However, in this instance, FDA has made a rather interesting disclosure relative to a pending NDA for a serious and devastating disease, Duchenne Muscular Dystrophy (DMD).
On October 21, 2014, FDA announced the availability of its Final Guidance for Industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (here). This document finalizes Guidance that was published in draft for comment on July 12, 2013. The Guidance is intended to fulfill FDA’s obligation in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to define the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit inspection, actions that FDASIA established as causing drugs to be adulterated.
While it is well recognized that any pharmaceutical company implicated with data integrity issues could have significant impact on its business and survivability, the impact from a similarly implicated CRO would be even greater as it could severely impact all sponsors’ pending and approved products. A case in point is Cetero/PRACS. Lachman Consultants was hired by a number of Cetero’s sponsors in support of these very labor intensive and highly specialized audits and (we are happy to say) successfully completed many audits for affected studies.