The Adderall Shortage: DEA versus FDA in a Regulatory War

by Alex Tabarrok

A record number of drugs are in shortage across the United States. In any particular case, it’s difficult to trace out the exact causes of the shortage but health care is the US’s most highly regulated, socialist industry and shortages are endemic under socialism so the pattern fits. The shortage of Adderall and other ADHD medications is a case in point. Adderall is a Schedule II controlled substance which means that in addition to the FDA and other health agencies the production of Adderall is also regulated, monitored and controlled by the U.S. Drug Enforcement Agency (DEA).

The DEA aims to “combat criminal drug networks that bring harm, violence, overdoses, and poisonings to the United States.” Its homepage displays stories of record drug seizures, pictures of “most wanted” criminal fugitives, and heroic armed agents conducting drug raids. With this culture, do you think the DEA is the right agency to ensure that Americans are also well supplied with legally prescribed amphetamines?

Indeed, there is a large factory in …

How will Medicaid pay for cell and gene therapies?

Jason Shafrin

One approach CMS has is the Cell and Gene Therapy (CGT) Access Model. Under the CGT Access Model, CMS (at the federal level) will negotiates outcomes based agreements (OBAs) with manufacturers, which will include pricing terms and outcomes to be evaluated. Then states can elect to participate in the contract terms negotiated by CMS or they can opt out and negotiate on their own. From CMS’s perspective, they are hoping that the increased purchasing power will lead to lower prices (or equivalently, more negotiated rebates). For manufacturers, they are hoping that the CGT access model will expedite access for patients and reduce transaction costs since manufacturers would have to negotiate with much fewer than 50 State Medicaid Agencies. For both parties, outcomes-based contracts are burdensome to implement; having CMS will support …