Office of Pharmaceutical Quality’s Office of Programs and Regulatory Operations – Wow, That’s a Mouthful!- But Get to Know Them

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!

MaPP to Nowhere to Get New Direction While Sparing on the GDUFA Goals Letter Continues

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.

Woodcock, Cook and Yu Provide Views of CDER/GDUFA Implementation Movement

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.

FDA Issues Final Guidance – Delaying, Denying, Limiting, or Refusing a Drug Inspection

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.

Six First to File Paragraph IV ANDAs Reported By OGD – But Where Are the Approvals?

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.

And Then There Were Three!

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.

Continued Complexity Of A High Profile CRO Data Integrity Case

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.

Patients and Pharmacists to be Surveyed by FDA on Their Perception of Differences in Attributes of Generic Products

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.

Not All Are Happy with FDA’s Final Guidance on NCE Exclusivity for Combination Products!

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.

Acetaminophen Back in the Spotlight, with Draft Guidance for Pediatric Liquid Products

With the FDA’s move to reduce the amount of acetaminophen (APAP) for prescription combination products to no more than 325mg per dosage unit completed, FDA seems to be moving into the Over-the-Counter (OTC) arena to help reduce potential overdose or medication errors with liquid APAP products targeted for pediatric patients. Today, FDA released the draft Guidance Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.

Rare Pediatric Disease Priority Voucher – What Will You Pay for Speed?

Today, the FDA announced the 2015 fee for the use of a Rare Pediatric Disease Voucher in a Federal Register (FR) notice (here). Created by the FDA Safety and Innovation Act (FDASIA), this program provides a voucher to a sponsor that gains approval for an NDA for a product used to treat an indication that has been classified as a rare pediatric disease. There is a price for use of the voucher and it ain’t cheap-the voucher fee for 2015 is fixed at $2,562,000.