The Lighter Side of Food & Drug Law: FDA From A-V to YTD

There is a rather memorable (and hilarious) scene from the movie “Good Morning, Vietnam” in which Robin Williams (playing the role of Airman First Class and disc jockey Adrian Cronauer) questions an Army lieutenant about a 1965 press conference to be given by former Vice President Richard Nixon: “Excuse me, sir.  Seeing as how the VP is such a VIP, shouldn’t we keep the PC on the QT?  ‘Cause if it leaks to the VC he could end up MIA, and then we’d all be put out in KP.”

Although the use of acronyms in the military is ubiquitous and probably not matched in any other sector, the healthcare sector probably comes in a close second.  It not uncommon to read legal memoranda, court documents, or agreements in which a single sentence contains 5 or more acronyms.  Consider the following:  “FDA’s ANDA regulations implementing the FDCA provide that a PE drug product must be shown to be BE to the RLD covered under an approved NDA in order to obtain an AB rating in the OB.”  Translated: “The Food and Drug Administration’s Abbreviated New Drug Application regulations implementing the Federal Food, Drug, and Cosmetic Act provide that a pharmaceutically equivalent drug product must be shown to be bioequivalent to the Reference Listed Drug covered under an approved New Drug Application in order to obtain a substitutable rating in the Orange Book.” 

For those of us who need a guide to wade through the various FDA-related acronyms, FDA has created an Acronyms and Abbreviations Database, beginning with “A-V” (arteriovenous) and ending with “YTD” (year to date).  The database is not complete; however, visitors to FDA’s website may suggest new entries.  (How about “AAD” – Acronyms and Abbreviations Database?)

Click here for previous FDA Law Blog “Lighter Side” posts.

By Kurt R. Karst