More Thoughts On FDA and ANVISA

More ThoughtsOne of the problems with trying to respond overnight to big announcements made by regulators is that it’s easy to leave something significant out.  And in the ensuing days you find out what you should have included in those original essays.  That’s what happened with my two essays from last week:  “Brazil Suspends Pharma Serialization And Tracing Requirements” and “FDA Posts Wholesale Distributor and 3PL License Database“.

So let me add a few more thoughts and observations regarding the recent actions by those regulatory bodies.


My essay led several readers to send me their interpretation of the announcement by ANVISA that they were suspending part of their pharma serialization and tracing requirements.  I appreciate receiving that kind of thing from people who, while not being “insiders”, are much closer to the “action”, and speak/read Portuguese as natives of Brazil.

From the information they have provided it is clear that what I was referring to as an “announcement” was really just “non-official outputs” from the recent meeting of ANVISA’s Diretoria Colegiada, a 5-member team of directors.  Being unofficial, we really can’t be totally sure what the extent of the official decisions are until they are published in the next few weeks in the DIario Oficial da União, the formal communication channel of the government.  Until we see that official announcement we can’t be sure how far, wide and deep the decision will impact RDC-54/2013, but clearly changes are coming.

Both of my sources are quite confident that the deadline for the 3-lot pilot will be pushed back, as was clear from the unofficial announcement I reported on in my essay.  But one goes further, assuring me that we can expect a new deadline for the full track & trace implementation, which is currently in December of 2016.  This source also expects a decision to  move the data repository from a private cloud to an ANVISA public system.  Treat this as rumor, but we should not have long to wait to confirm the official details of their action.


I also received a very interesting series of messages from a reader who pointed out that drug manufacturers should also make use of the new U.S. FDA database to ensure that they are complying with the DSCSA requirement to only sell to wholesale distributors who are properly licensed.  That’s a very good point that I failed to think of in my rush to get that essay out late Tuesday night.

That reader also pointed out that at least one Florida license number, known to contain a colon (“:”), is formatted differently in the FDA database.  At first I thought it might just be Excel mis-interpreting the data type of the cell, but I confirmed that the data is being displayed as it exists in the database and it is formatted differently than other comparable Florida wholesale distributor license numbers.

On Thursday and Friday this week I will attend the Healthcare Distribution Management Association (HDMA) Traceability Seminar in Arlington, VA.  If you plan to attend, find me and say hi.