Former OGD Deputy Director Sides with GPhA on Proposed Labeling Rule

Kent Johnson, former Deputy Director of the Office of Generic Drugs (OGD) and perhaps the biggest influence on the labeling review process since the passage of the Hatch-Waxman Act believes that the proposed labeling rule is bad for patients and pharmacists and will only cause confusion in the marketplace.  In recent comment to my blog posts (here and here and here), Kent, a well-respected advocate of generic drugs and the generic drug program at OGD, provided his thoughts on the issues associated with implementation of the Proposed Rule as currently written:

1) There would be no correlation between what a prescriber sees in online labeling and the labeling of the specific product given to the patient at the pharmacy.

2) A prescriber has no knowledge of the labeler of the product dispensed pursuant to his/her prescription.

3) A pharmacy, irrespective of size or type, typically has an inventory of product (often specific marketer) based upon pharmacy contracts and wholesaler programs.  There would be no pharmacy that would wish to chase a product based upon some information found in revised labeling.  Cost of a generic is a key purchasing consideration for a pharmacy, as reimbursement is often determined in by Maximum Allowable Cost (MAC) programs in managed care.

4) There is not a practical way for a prescriber to determine labeling sameness/differences among labelers.  The long standing premise that all labeling for a given product is the same is a very useful and practical assumption.  THE GREAT ADVANTAGE OF COMMON LABELING FROM ALL MARKETERS OF A GIVEN PRODUCT SEEMS TO OVERRIDE OTHER STATED CONCERNS, AND EVERY ATTEMPT SHOULD BE MADE TO RETAIN THIS CONCEPT.

5) Safety information is most valuable when it is relevant and documented.  Safety information becomes less valuable when it is diluted by poorly documented events.  There should be great concern for a plan that encourages revising labeling with new safety information, for this will trigger constant labeling changes.

6) New safety concerns can well go from the marketer to FDA.  FDA must be the reviewer and determine clinical importance and quality of the report.  FDA should then drive down any changes to all labelers.  This assures “sameness” among different manufacturers.  New safety information going directly into generic labeling to be later reviewed by FDA will lead to confusion and lack of assurance of quality and support for the changes.

Kent also noted that there may be a problem when the NDA leaves the marketplace and the reference listed drug (RLD) designation is shifted to an ANDA holder.  But remember, there is nothing in the statue or regulations that ascribe additional responsibilities to an ANDA holder when this occurs.  The RLD is merely the product that the subsequently submitted ANDA must rely upon for bioequivalence testing.  There is a regulatory process in place under the current rules that require the FDA (since they have access to all of the information submitted by multiple ANDA applicants for a specific drug product) to evaluate the need for label changes when new information becomes available.  Also, typically, by the time a generic product is approved, most of what is known about the drug is already covered in the label.  Often label changes are made to older products to revise warnings based on new risk-benefit analysis (something the FDA is likely to do best) based on approval of other therapies that may have fewer side effects used to treat the same ailment.

In discussions with my former colleagues at OGD, I have not found one that was in favor of the Proposed Rule as currently drafted.  Most of them found out about the Rule at the same time we in the industry did, when the rule was published in the Federal Register.  One might think that the experts on generic drug labeling would have been involved in the formation of the Rule or at least asked for their input, another indication that this rule appears to be more politically than scientifically motivated.  Let’s hope cooler heads prevail and some revisions are placed into the proposal prior to finalization to avoid the unintended consequences previously written about.  Let’s be realistic about this, folks, and do something that is good for the public and not the politicians and lawyers.