Obama takes aim at drug shortages

President Obama signed an executive order Monday intended to boost supply and stem the rise in drug shortages. Among his directives: increased staffing for the FDA's Drug Shortages Program to respond to the early notification of shortages by manufacturers that the order requests.

A White House statement describes the order as "one in a series of steps that will help address the shortage of prescription drugs." The directive cites a report by HHS assessing the economic causes of shortages and another from the FDA on its role in responding to them.

The unilateral action, which requires no congressional approval, attempts to persuade manufacturers to report impending shortages to the FDA. The only current requirement is that drugmakers report when they will cease production of a drug of which they are sole provider.

The order aims also to quicken regulatory reviews of drugmaker applications to boost production, according to FoxNews.

Of course, not everyone hailed the news. "President Obama is not responding to the real cause of the problem, which is price controls," said Devon Herrick, in Politico.com. Price controls cut profit margin, he added, enticing fewer manufacturers to produce the drugs.

Though widely seen as a swipe at a hamstrung Congress, which lists increased reporting among other measures similar to Obama's in legislation stalled since February, some see the executive order as implementation of the agenda set by legislators. The executive order activates "a good chunk of a bill co-sponsored by Maine Sen. Susan Collins," reports the Portland [ME] Press Herald. In fact, the report says, Collins got a call Sunday from HHS Secretary Kathleen Sebelius informing the senator that "Obama essentially was putting her bill into effect via executive order," according to a Collins spokesman.

Generics makers APP Pharmaceuticals ($APPX) and Hospira ($HSP) have boosted capacity recently, leading to resolution of shortages of the anesthetic propofol and cancer drug cytarabine. Others are in the process of expanding, "but the government needs to act on the shortages until the increased capacity comes online," Sebelius said in the report.

- see the FoxNews coverage
- here's the Press Herald report
- see the Politico item
- here are the White House release and fact sheet
- and here are the HHS and FDA reports

Special Report: Top Drug Shortages by Treatment Category

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.