Drug Safety Expectations

I am not a big fan of drug companies whose marketing practices can push the envelope of propriety and potentially run counter the public interest. On the other hand, this CNN article highlights how 65 millions prescriptions are filled for drugs that have not been FDA approved. It turns out the drugs in question never went through an FDA approval process because they were grandfathered into the Pharmacopeia at the FDA's inception.

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.

Hey, my mom's the regulatory expert in the family, not me. Maybe someone can explain it to the rest of us?