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.
With an anemic start to the month (only 3 ANDA approvals through 10/26/14), the Office of Generic Drugs (OGD) kicked it into high gear during the last days of the month to end the month with 31 total final ANDA approvals.
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).
Remember when you only had to call to OGD to get ANDA statuses? Remember when these was a chemistry contact, a bioequivalence contact, a labeling contact, and a micro contact? Well, now, not only do you have to try to figure out who your contact is, but what you can all them about. The regulatory Project Manager in the Office of Generic Drugs is your primary point of contact for your ANDA. But now you also need to know who your “Quality” contact is in the Office of Pharmaceutical Quality’s (OPQ) Office of Programs and Regulatory Operations (OPRO). In addition, you need to learn a whole bunch of new acronyms!
A number of presenters from Office of Generic Drugs (OGD) at the GPhA Fall Technical Workshop noted that “We have listened to what you have said and we hear you” and have indicated that MaPP 5200.3 that addressed communication with industry (see previous post here) will be revised. Industry representatives have indicated that the transparency in the communication with OGD is something that is essential to being able to make reasonable business decisions in a timely manner and are needed to appropriately run their business organization.
In a presentation to the Generic Pharmaceutical Association Fall Technical Workshop today, Dr. Janet Woodcock, Director, Center of Drug Evaluation and Research (CDER), told the audience that the new CDER quality initiatives under GDUFA are designed to have an Integrated team review to Chemistry Manufacturing and Controls, microbiology, dissolution and inspections through the new Office of Pharmaceutical Quality. The inclusion of dissolution review appears to remove that assessment from the bioequivalence review within the Office of Generic Drugs’ (OGD) team.
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.
The Office of Generic Drugs (OGD) listed 6 first-to-file (FTF) ANDAs with Paragraph IV (PIV) challenges yesterday. It is interesting to note that all were originally submitted in 2014-the oldest submission date was in April 2014 and the newest in July of this year. We know that OGD gives priority acceptance review to FTF ANDAs and the 2014 dates may signify that the priority acceptance review of PIV submissions is in full swing.
A day after writing a post about abuse-deterrent products and their potential impact on patients, the generic drug industry and the FDA, the Agency approved the third opioid extended-release product with abuse-deterrent information in its labeling approved via a supplemental new drug application, the drug Embeda (morphine sulfate/naltrexone hydrochloride) Extended-release Capsules.
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.
In the case of abuse-deterrent products, the FDA has waded into some deep water and it seems the water continues to deepen. Clarity around what FDA really wants and expects from such products remains murky at best.
FDA announced in today’s Federal Register (FR) that they will conduct a survey of patients and pharmacists to gain an understanding of both groups’ perception of certain attributes of differences in generic medicines for the same drug product.This survey comes on the heels of Office of Generic Drug Guidance (OGD) on size, shape and color of generic products, issued last December. FDA has received complaints and feedback from numerous patient and health care providers on various aspects related to differences in the physical characteristics of generics when they are initially switched from the brand name product (when initial substitution occurs) as well as when switching to other generic manufacturers of the product on subsequent refills.
Today, FDA published its final guidance on New Chemical Entity (NCE) Exclusivity Determinations for Certain Fixed-Combination Drug Products. The Guidance comes about 7.5 months after the February 2014 Federal Register notice first announcing the new Agency position was published. While some parties are happy with the decision to award NCE exclusivity if one of the components is a first time approval (the previous Agency position was that if one component had been previously approved, then the combination was not eligible for the 5-year protection), others are crying in their soup (and in Federal Court) about the change.
With a record number of ANDAs received by the Office of Generic Drugs (OGD) and a modern day record low number of approvals, we move into FY 2015 still looking for the bright spot.