Keya: I realize this subject can be a bit confusing for some outside of the US since in many countries the government has a much larger role in healthcare than in the US. In the end, the market is the biggest driver of what is produced in the US. While FDA has authority over the approval of pharmaceuticals and their labeling and, in the case of prescription drugs, their advertising, the FDA does not have anything to do with the amount of drug the pharma industry can produce in the US. The FTC regulates the advertising of many products FDA regulates including over the counter drugs but not prescription drugs. FDA regulates prescription drug advertising. The Drug Enforcement Administration probably has the largest impact on how much of a drug that is also a controlled substance (e.g. hydrocodone) is produced since they do establish limits and firms need to apply for quotas to buy APIs and produce finished product.
Chris
-------------------------------------------
Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.259.8877 (land)
910.789.1232 (mobile)
chrissmith@ec.rr.com -------------------------------------------
Original Message:
Sent: 08-14-2012 15:27
From: Keya Bandyopadhyay
Subject: Annual Prescription Drug Production
I am curious to know who decides that how much prescription drug will be produced in US per annum?
Is it FDA/FTC?
Whether the dug manufacturer has to take prior permission from FDA that they are going to produce XX amount of drugs based on the consumer demand.
Thanks in advance.
Keya