Steps to shorten drug development lie primarily under the company’s control and the FDA’s role is much more modest in terms of further gains in shortening review times.
There are three types of discovery or development standards to use as guides to judge data and results: ideal standards that describe the perfect product, realistic or desirable standards that describe what a company wants to have in a new product, and minimally acceptable standards which describe the least acceptable standards for a product that the company is willing to market.
In theory, new drugs do not have to beat previous drugs in their degree of safety or efficacy, but regulators sometimes forget this and have to be reminded. If one of the two is not equaled, the other must be far superior to existing therapy.
Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).
