Member Meeting Recap: cGMPs, Draft Guidance, & More from AAHP
Eric Foxman, AAHP Secretary
AAHP held a very successful Annual Member Meeting on March 6 using a video-conferencing application.
Our keynote speaker was Larry Stevens of The FDA Group. Based on more than 20 years’ experience working within FDA, Larry spoke about the importance of good manufacturing practices and quality management, and stressed that these are areas of focus in FDA inspections. As examples, he cited common issues raised in FDA Warning Letters to homeopathic manufacturers.
Larry presented six questions that companies should ask themselves to better understand their cGMP and quality management system compliance. To help firms effectively self-evaluate, Larry presented examples from both past inspections and his own extensive on-site experiences; from these examples, he hopes companies can better answer the questions he posed.
One example: “Is your company properly managing nonconformances and CAPAs?” Larry pointed out many FDA warning letters include state companies made “inadequate, incomplete, and undocumented investigations”. This shows the tendency is to focus on an immediate correction, instead of investigating and performing a corrective action to prevent such occurrences from re-happening. To further help focus a company’s self-evaluation, Larry suggests asking the following questions in-house: How does our nonconformance/CAPA management system conform to regulatory expectations? Who performs nonconformance investigations? Are they properly trained on root-cause-analysis tools? Who reviews and approves deviations? Are they qualified to do so? (Download Larry’s presentation here.)
After his prepared remarks, Larry responded to a few questions asked by attendees; his responses showed the scope of information and experience he has at his fingertips. Larry’s presentation was well received. A sampling of post-meeting feedback included: “really appreciated Larry’s presentation and candidness;” “Larry was great; I hope the group understood the importance of his comments;” and “Larry[‘s] information … was useful [and he] was a good choice for the membership.”
Al Lorman, AAHP counsel, gave a brief overview of the past 5 years of FDA attention and general activity towards the homeopathic sector. He then presented the feedback received from membership regarding AAHP’s draft comments to FDA and a change made in response to the feedback. There was also ample time for questions from members.
Pete Evich, AAHP’s Congressional lobbyist, spoke about recent events of importance to our industry. He informed membership of recent meetings between congressional members and FDA staff discussing homeopathic drug products; these meetings are pivotal to inform the Agency of priorities and concerns in Congress. Through in-person visits, we have learned of Congressional staff members who are familiar with, and who use, homeopathic products. Pete noted the time is not appropriate to begin any concerted legislative effort, but the on-going contact creates a foundation that can be built upon.
The meeting concluded with Board elections. Thanks to Alissa Gould (Boiron) and Tim Clarot (Matrixx) who stepped in to handle the remote voting process. (We can be delighted to know there was no hint of any Iowa-like issues.) The following were re-elected to the Board for additional two years terms: Mary Borneman, Denise Eaton, Eric Foxman and Dan Quail. They join the rest of the Board: Mark Land, Mark Phillips, Guillaume Lois, Tim Clarot, Travis Borchardt, and Mary Beth Watkins (emeritus).
With the cancellation of the ExpoWest trade show only four days prior to our planned meeting, members responded quickly to the sudden change of plans and made it an effective meeting. Approximately 55 people were “present” during the video conference call. Thanks to all who attended and participated in the AAHP’s Annual Membership Meeting.