Another day, another early morning on the West coast. While I am an early riser, 5:30AM is even a chore for this old FDA-er!  But here we go!

The morning began at the AAM GRx-Biosims meeting with Dr. Sally Choe, Director of the Office of Generic Drugs, as she provided a current program summary. We did not see the usual data and metric data dump, as the recordings were likely made prior to the release of the final OGD stats for FY 2020.  We already covered some of those statistics in our blog post here so I will just mention a few of the metrics that she covered in her presentation that were not previously mentioned in my blog post.

Dr. Choe noted that there were 74 first time generic approvals in FY 2020, along with over 10,000 supplements and 27 approvals under the competitive generic therapy program.  Regarding activities that are related to COVID actions, OGD expedited 30 ANDAs and over 500 supplements were prioritized based on the need for the pandemic.

OGD exceeded their 90% GDUFA goals on almost all original ANDAs, PAS Supplements, controlled correspondence, and pre-ANDA meetings requests. Dr. Choe spoke of the benefits of the GDUFA Science and Research Program, and how it aids with complex generic drug development and shortens the timeline from concept to development to approval.  Industry is hoping to see real improvement in this area. It was reiterated that 124 product specific bioequivalence recommendations (30 new and 94 revised) on complex generic drugs have been issued to maximize clarity on bioequivalence requirements.  May I point out that, in my opinion, revisions in 94 of the 124 guidances is not exactly maximizing clarity, and may be what is contributing to delays in approvals as often times, additional studies must be conducted to address the guidance revisions OGD makes. Dr. Choe addressed OGD’s engagement efforts with stakeholders and mentioned the various meetings sponsored and held by her Office over the year.

Switching gears into drug product quality, Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality, stated that patients want to be assured that every dose of medicine they take is safe and effective and free from contamination and defects, and that is the real goal of drug product quality. He discussed the challenges that FDA has encountered in the inspection arena associated with the pandemic and FDA’s ability to conduct quality and surveillance inspections, and how reduced inspections can raise quality concerns that can impact drug shortages.  He described the breakdown of the manufacturing market by indicating that 58% of drug manufacturers are overseas, 65% of generic manufacturers are overseas and 72% of active pharmaceutical ingredient manufacturers are overseas which contributes to the difficulty in assuring quality, since on-site foreign inspections are being conducted for only mission-critical inspections because of the pandemic.

Regarding drug shortages, he noted that 62% of drug shortages are related to quality issues.  He also indicated that 61% of ANDAs approved are not marketed, which can lead to drug shortages as well, as it is a real drain on Agency resources to review these products that may never come to market. The biggest areas of drug shortages are related to generics which account for 63% of drug shortages and brand name drugs which account for 30% of drug shortages. Another interesting point is that 79% of health care providers report that their patients had trouble getting a prescription filled because of a drug shortage.

Don Ashley, Director, Office of Compliance, spoke about the Drug Supply Chain Security Act (DSCSA)(lovingly referred to as the Track and Trace Act), and went into the details of the program and the compliance timeline for the remaining phases to be implemented.  DSCSA is designed to facilitate the identification of suspect and illegitimate products (counterfeit, diverted or stolen, subject of fraudulent transaction, or product that are unfit for distribution) from entering the supply chain. There are some exceptions to products that do not have to have identifiers, such as grandfathered drugs, drugs that have waivers or excluded products, the majority of products are covered by the requirements of the Act.  The new deadline for track and trace final requirements identified in FDA guidance documents has been extended for three years to November 27, 2023 due to the pandemic

That’s it for now, and we will be back with some additional highlights as the conference proceeds.