Day two of the Association of Accessible Medicine (AAM) Generics and Biosimilars Conference, which took place on November 8, 2022, started with plenary session presentations from Dr. Susan Rosencrance, Acting Director, Office of Generic Drugs (OGD), Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality (OPQ), and Donald Ashley, JD, Director, Office of Compliance (OC) with the FDA.

Dr. Rosencrance shared that, in FY 2022, there were 905 ANDAs approved or tentatively approved, including 115 First Generic Drug Approvals and 60+ generics with the Competitive Generic Therapy (CGT) designation.  The FDA also issued five draft and four final guidances, four MAPPs, and 176 product-specific guidances (PSGs).  The focus of much of this work was to provide additional clarity around the FDA’s current expectations on complex generic drug products.  Dr. Rosencrance also spoke about how the FDA is continuing to collaborate with regulators from other countries for all to enhance understanding of complex generics and to discuss current and complex scientific topics.

Dr. Rosencrance spent some time speaking about new avenues within GDUFA III that can assist industry in obtaining earlier approvals by offering several additional pathways to communicate with the FDA about applications, both pre- and post‑submission.

Dr. Kopcha then brought the conversation around to the future of pharmaceutical quality.  He discussed three areas specifically: Regulatory Remote Assessments (RRAs); Quality Management Maturity (QMM); and Advanced Manufacturing (AM).  Dr. Kopcha shared that, for inspections, CDER’s site and product catalog includes 7,000 human drug manufacturing sites, 2,000 medical gas manufacturers, and 600 hand‑sanitizer sites; these incorporate 170,000 finished dosage forms and 19,000 APIs (inclusive of new drugs, biologics, generics, biosimilars, and over‑the‑counter drugs).  That’s a lot of oversight!

RRAs came more into the forefront due to the pandemic with the use of Remote Interactive Evaluations (RIEs) (as discussed in previous blog post here), which are a subset of RRAs and for which the FDA has recently provided a Draft Guidance for Industry titled “Conducting Remote Regulatory Assessments: Questions and Answers,” published in July 2022 (here) to clarify use of RRAs.  Dr. Kopcha shared that, during the pandemic, approval of over eighty original applications and over 1,500 supplements of drugs and biologics used in the treatments of patients with COVID‑19 were impacted by the use of RRAs.  The FDA explained that the decision as to when to inspect a site is still risk‑based and, for most companies as well as the FDA, it is likely preferable to have an in‑person inspection.  However, it’s great that these options have been and will continue to be available to the pharmaceutical industry.

Dr. Kopcha then transitioned to the topic of QMM.  The goal for the FDA is to move from what he termed “Lagging Indicators” (e.g., quality defect reports, test results, inspection data) to “Leading Indicators” (QMM ratings, quality metrics) for making decisions about the quality maturity of a company.  The idea of a QMM program has been the subject of a lot of dialogue industry and the FDA for several years, and there has been significant momentum in the last two years for creating a QMM rating program, with the most recent activity being a QMM Advisory Committee meeting that was held November 2‑3, 2022.  (You can learn more about this by attending Lachman Consultant Services’ webinar, which will be presented by Patrick Day on November 16 from 1:30 to 3:00 pm EST [register here].)

The last topic that Dr. Kopcha covered was Advanced Manufacturing (AM), which is using novel manufacturing methods to improve robustness and efficiency, using novel dosage forms or delivery systems to improve drug delivery or targeting, or using novel analytical tools to improve product characterization, quality testing, or process monitoring/control.  The discussion on AM encouraged companies to use it where feasible and dispelled the myths that it can cause complications or take longer to get approvals or had to have been/can only be used by the innovator company.  Innovation is open to anyone; the FDA is open to innovation and is rewarding those companies that use it well.  The FDA is willing to work with you to improve products and provide better and more reliable drug products to patients.

Lastly, Donald Ashley, JD spoke about achieving sustainable CGMP compliance.  He did a great job of presenting some of the scary myths that are sometimes all too true about CGMP compliance.  He also presented some realistic solutions, starting with one that we’ve been hearing for years and all of us know to be true: sustainable CGMP compliance requires a corporate quality culture, which starts with the top leadership of a company.  Who is responsible for quality?  Everyone is responsible for quality!

Mr. Ashley spoke about sustainable quality in terms of a student—your site can choose to have average CGMP compliance (C student) or a robust CGMP compliance (A student).  As a C‑student, your usual is a grade C; you will have some situations go very well, resulting in As and Bs, but you will also have some that do not go well, resulting in Ds and Fs (non‑compliances resulting in failed batches, recalls, etc.).  However, as an A‑student, your usual will be an A but the key difference is that your “not so good” grades won’t dip below a B/B- because your systems will be robust enough to catch non‑compliances before sinking to a C, D, or F.  Both sites will have non-compliances; however, the site that maintains sustainable quality (A average) is proactive and prevention‑focused, and, therefore, the non‑compliances will likely not devolve into a catastrophic state.  This is obviously the best case for the patient, the company, and the FDA.

Mr. Ashley spoke about the importance of having an effective supply‑chain management system.  Well‑conceived/implemented quality agreements are key.  He acknowledged that there are times when you may have to work with suppliers that are borderline performers due to single‑source items, for example, but, when this happens, it is your company’s responsibility to provide increased oversight and use risk management to identify areas of concern.  The take‑home point of this all?  Your company is responsible for ensuring the quality of your products, including what goes into your products, including what comes from your suppliers.

If you or your firm are in need of strategic advice regarding CGMP compliance or GDUFA III and interacting with FDA, please reach out to us at