Is drug regulation in the name of safety going overboard? And for those who support “Medicare for all”, how is this supposed to be better than the restrictions that are currently in place? Scott Gottlieb in the WSJ:
Once the FDA is granted the authority to simply impose these RiskMAPs on drug companies, there will be a lot of political pressure on the agency to constrain prescription writing in the name of drug safety.What would this mean? Consider the RiskMAP recently imposed by the FDA on the use of the diabetes drug Symlin. The new medicine can help very serious diabetics control swings in blood sugar and is one of the few drugs that promote weight loss. But Symlin has a narrow therapeutic margin and can sometimes cause dangerously low blood sugar. The FDA did not trust ordinary generalist doctors — who treat most diabetics, especially poor or rural patients — to properly prescribe the medicine or to limit its use to the labeled indication. So Symlin’s RiskMAP tries to keep the drug out of generalist hands by, among other things, limiting promotion to doctors specializing in diabetes and who are also supported by certified diabetes educators.
