Comment by GW
GW also said "Furthermore, there is no obligation on the part of the sponsor to introduce a drug that is safer and more effective than drugs that are already on the market - the drug need only be deemed safe and effective. "
To me this is separate but critical shortcoming of FDA procedure. For a number of reasons, the fewer equivalent drugs used for solving the same clinical problem, the better:
- Post-market surveillance is dramatically simpler when fewer drugs are being prescribed. Each drug is prescribed more times and identification of problems occurs much quicker.
- Providers' depth of knowledge regarding the idiosyncrasies of each drug is more solid when fewer drugs are available for each indication.
- Fewer dosing errors occur when fewer drugs with differing dosages are prescribed.
- Less resources are wasted in R&D and development costs that have to be recouped by the consumer for multiple equivalent drugs.
- Less resources are wasted by pharmacies, etc. having to maintain complex inventories of multiple drugs.
- Developing drug formularies becomes simpler.
I have always felt that in addition to safety and efficacy, no drug should be evaluated by the FDA unless it truly adds to the medical armamentarium. For example, a common side-effect of a class of blood pressure medications called ACE inhibitors is a hacking, dry cough. A new drug class was developed called ARB's. These drugs give much the same benefits as the ACE inhibitors but without the cough and are therefore better tolerated by some patients. They constitute an advance in provider's drug armamentariums.
What we need from the drug companies are drugs that solve previously unsolved problems. We don't need more equivalent drugs in the same class!