I wonder how much the FDA is responding to an unrealistic public expectation. It sounds like the general public wants drugs that have no known side-effects, no potential downfalls and make everyone as healthy as a lark. Are FDA employees really willing to do their darndest to ensure their own job security by attempting to achieve the impossible? Frankly, I know enough hard-working FDA folks who would probably like to avoid strange, unscientific mandates from some ineffable special interest.
Moreover the article's prime example is quinine, a drug in use for well over a century. Guaifenesin, one of the most benign drugs ever invented, has come under review in an attempt to get all these old drugs under FDA control. The last time I looked, Thompson's proprietary Micromedex ($$, sorry the University dropped the subscription) began its section on this common cough medicine with the sentence "Guaifenesin has no known side effects."
So let's see if I understand the reason for the FDA attacking legacy drugs.
- No drug can ever be shown to be 100% safe.
- Post-marketing (Phase IV) surveillance provides some assurance, more so than all the studies conducted prior to marketing (Phase I - III).
- Drugs that have been in existence for more than a century and have been used in millions of patients (so necessarily we have seen hundreds of rare events) have more safety information available than any drug since penicillin.
- Since we don't have Phase I - III studies on these legacy drugs, we will ignore a century of Phase IV data in the interests of safety.