Recent stories about the FDA's good guy role in fighting drug shortages, which had offset criticisms that the agency sometimes causes shortages, appear to be swinging back to the regulator as bad guy. Alex Tabarrok of George Mason University charges that the shortages stem from "systematic factors," among them the policies of the FDA.
"The FDA has inadvertently caused drugs long-used in the United States to be withdrawn from the market and its 'Good Manufacturing Practice' rules have gummed up the drug production process and raised costs," writes Tabarrok, in Marginal Revolution. Some of the market withdrawals stem from the Unapproved Drugs Initiative, which targets those on the market lacking FDA review and approval. Among these are drugs that were being marketed prior to the creation of the agency.
Makers of these drugs often find the new drug application approval process a "disincentive" for maintaining a market presence, found a November drug shortages summit. Attendees came up with two recommendations: Remove barriers faced by the FDA and drug manufacturers to minimize the impact of drug shortages, and improve communications between pharma supply chain members and healthcare providers.
- see the story
- here's the summit report