Paul Offenheiser: It takes 10 years and hundreds of millions of dollars for a pharmaceutical company to bring a new drug to market. Why doesn't the FDA defer to clinicians for condition A?

Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already approved, a phenomenon called "drug lag" Congress passed the Food, Drug , and Cosmetic Act (FDCA) in 1938 to ensure drug safety.

The FDA forces drugmakers to prove that a drug works for condition A but defers to clinical researchers in private sector and academia to determine whether it works for conditions B through Z.