In this thread, there are many informative and insightful posts with respect
to RA’s responsibilities and functions at the pre-approval phase of the
drug life circle. In addition, RA plays a significant role in post-approval
phase during which the concentration of a RA professional’s job is a little
different. I personally think the pre-approval responsibilities are more
related to R&D with the ultimate goal of obtaining Market Authorization,
which has been thoroughly discussed in other posts, while the post-approval
RA activities have more connection with business with the general goals of
maintaining product quality (through ensuring compliance with quality
standards), assuring promotion and marketing activities in line with
regulations, extending market exclusivity (through pediatric use, etc) and
exploring opportunities to maximize the profitability of a approved drug (
through international markets, line extension, Rx to OTC switch, etc) .
Simply put, post-approval RA activities are all about MONEY, sometimes with
tens of million dollars or even billion dollars at stake. Remember the 2.3
Billion dollar settlement between Pfizer and the US government because of
the alleged illegal promotion and marketing of Bextra?
Much discussion was dedicated to the “coordination” role of RA. I
completely agree that this is a big part of RA, however, it is probably not
the most interesting or challenging part. RA professionals can significantly
impact the business decision by providing necessary guidelines and
executing appropriate plans. For example, to staff off generic competition,
RA can propose and execute a Rx to OTC switch for a prescription drug near
the end of its patent and market exclusivity protection. By doing so, the
brand name company hopes to maintain its market share by expanding patient
access to its OTC version of the drug and promoting brand association. RA
professionals are in a unique position to influence decision-making by
helping the management navigate the maze of complex regulations.
RA responsibilities differ vastly depending on projects and stage and phase
of the product. RA professional come from various backgrounds, chemistry,
biology, business, English… Lack of a particular knowledge shouldn’t be
the roadblock that prevents anyone from doing RA. If you have a chemistry
background, you can do CMC; medical background, clinical; English, project
management…
