AAM Session on Bioequivalence Provides Food for Thought and Good Recommendations

The Path to Bioequivalence – Great Progress – Great Opportunities, was presented by Charlie DiLiberti, President, Montclair Bioequivalence Services LLC, at this week’s Association for Accessible Medicines (AAM) meeting.  Charlie pointed out the great progress FDA has made in developing new bioequivalence techniques or alternate methods through the GDUFA regulatory science initiative.  He pointed to the many new BE guidance recommendations, some for complex products, initiatives in in vitro methods over bioequivalence studies with clinical endpoints, and novel approaches for historically challenging products, among others.

But there are problems with the rapid progress the Agency has made.  Bioequivalence recommendations are often revised numerous times before FDA is satisfied, leaving firms in a difficult position in having to often repeat bio studies or move in a totally different direction. The revision can be disruptive to the review and approval process and cost hundreds of thousands of dollars to firms.  It was suggested that the FDA make product-specific determination as to when there is a scientific basis to repeat a study done by the old recommendation, and this decision should be based on the clinical significance of the proposed change.  A suggestion from the audience was for FDA to provide a revision history, much like is done with changes in MaPPs (and is usually required for cGMP documentation and SOPs, etc.) so firms can readily see where changes are made in the revised guidance.

The presentation provided an outline of comments Charlie received from an informal survey of about 70 industry representatives.  There were many items presented and many recommendations of potential solutions for both FDA and industry.  If you are interested in the issue of bioequivalence but did not attend the AAM meeting, I suggest you obtain a copy of the presentation from Charlie!  It has good food for thought which can be used to open a dialog with the FDA regarding the issues identified in the presentation.