Another beautiful fall day in Bethesda and a great start to this year’s conference.  Since I can only be in one place at a time (although my wife would beg to differ), I will give you some highlights from day 1.  And next year, you should attend this meeting as this is the premiere event for generics and biosimilars in the country. 

The morning started off with Dr. Robert Califf, M.D., Commissioner of the Food and Drug Administration, in a fireside chat with David Gaugh, R.Ph., Interim President and CEO of AAM.  Not surprisingly, the first questions surrounded drug shortages.  Dr. Califf said that he is very concerned about the continuing shortage problem but cautions that one of the big factors impacting shortages is related to the success of the generic program and that is the low prices that have resulted from its success.  He noted that the FDA cannot venture into pricing issues as it has no authority in that area and cannot tell or force a drug company to make a drug or increase production.  He noted that he thinks about the issue of drug shortages all the time and indicated that the FDA is doing everything it can.  But the FDA’s hands are, at times, tied.  The FDA will continue to offer expediated review of supplements and ANDAs, provide assistance to firms, and use regulatory discretion when necessary.  He discussed the importation of unapproved drugs to help relieve severe shortages and the intense FDA oversight in those instances, for example, in the recent shortages of certain critical cancer drugs. 

He also discussed the use of real world data (RWD) in making regulatory decisions and his expectation that we will see more of this as the Agency becomes more comfortable with being able to integrate that type of data into its decisionmaking process.  He also discussed the FDA’s push to harness the endless data sources that are out there as AI becomes more widely available to assist in the evaluation of clinical outcomes and their relevance to RWD.  One of the other topics he mentioned is the relationship of biosimilars and the issue of interchangeability. 

Next up was Dr. Iilun Murphy, M.D., Director of the Office of Generic Drugs.  Dr. Murphy started off her presentation by noting that the OGD’s strategic priorities for the year focus on: 

  • People – hiring and retaining highly qualified staff 
  • Process – modernizing processes to enhance efficiency and consistency of reviews across the entire generic program (Author’s note:  This is something that the industry has been complaining about since the 1984 passage of the Hatch-Waxman Act; it looks like we are getting closer now, but there is still work to be done.) 
  • Innovation – continuously looking at new and efficient development of methods for the approval of safe and effective generic drugs 
  • Lifecycle Management – maintaining generic drug products in a constant state of quality throughout their lifecycle 

She touched on how these strategic issues would be addressed and spoke about the revival (my word, not hers) of the ANDA suitability petition process.  Hopefully under GDUFA III, some life will be breathed into the process (don’t get me started).  In conclusion, in 2024 the OGD hopes to: 

  • Meet our GDUFA III commitments
  • Modernize the generic drug program
  • Actively address ANDAs with missed goal dates
  • Produce research outcomes to guide applicants
  • Communicate how to submit strong ANDAs
  • Support marketed products

Michael Kopcha, Ph.D., R.Ph., Director of the Office of Pharmaceutical Quality, was up next and spoke about dispelling misinformation about pharmaceutical quality.  He spoke at length about the cost of quality and noted that “quality is not a cost at all; it is free.”  Making the investment in quality management maturity and assuring quality from the start may have some costs; however, the saving from fewer recalls, batch failures, and FDA compliance actions will offset any upfront and maintenance costs.  He spoke further about the use of advanced manufacturing methods to achieve the most benefit. 

He noted that the FDA does test drug products, another piece of misinformation that he does not like to hear but notes that you cannot realistically test everything!  He spoke about remote regulatory assessments and indicated that they are “not inspections, not just for surveillance, and they can result in warning letters.”  Another misconception relates to Drug Master Files (DMFs), and he noted that the FDA does not approve DMFs; they are reviewed and must be found acceptable at the time of review.  Interestingly, an FDA participant slipped and said “approved” when referring to a DMF.  Certainly just a slip of the tongue! 

Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance (OC), rounded out the morning session by presenting a CDER Office of Compliance update.  He spoke about what the OC does and its tools, and provided some statistics.  The OC evaluates firms’ compliance with cGMPs, and develops and implements compliance policy to protect the public from adulterated and misbranded drug products.  The tools it has in its toolbox include regulatory meetings, consent decrees, injunctions, untitled letters, seizures, import alerts, warning letters, and administrative detention of products. 

Mr. Goodwin noted that there were sixty-two regulatory meetings, eighty-five warning letters, one consent decree, three untitled letters, 106 regulatory detentions, and eighty-seven import alerts issued through August of FY 2023 (the data for September 2023 was not yet available).  He noted that the OC is making good progress towards meeting its goal of taking compliance actions within six months. 

He spoke about the GDUFA III commitment letter’s goals for post-warning-letter meetings and indicated that, while there were not a lot of meetings requested in FY 2023, the process is working, and he gave some tips on what these meeting are and what they are not. 

And, now, my fingers are tired and this is only the morning session!  I’ll be back with more throughout the week!