Tevi Troy dissects for National Review Online’s “Corner” blog a new Obama administration executive order targeting the “growing problem of drug shortages.”
This is undoubtedly a complex subject and there are a variety of factors at work, but the text of the EO reveals something quite different from what most reports suggest, namely that the administration plans to work with industry to make it easier for pharmaceutical companies to address the problem of product shortages.
In essence, the EO calls for three things: for more reporting by manufacturers when they think there will likely be shortages of their drugs; for expedited regulatory review in certain, limited circumstances; and for the FDA and the Department of Justice to seek out criminal activity, such as hoarding or price gouging.
The first idea — early reporting — may well be helpful. But it is unlikely to solve the underlying issues. And there is also some question as to whether the FDA has the administrative authority to require earlier notification without the prerequisite legislation to grant that authority. In addition, there are some concerns from the industry that these notifications be kept confidential, so as not to give a competitive advantage to rival companies.
As for the second recommendation, the expedited reviews are carefully delimited in the EO text, and specifically fail to mention product approvals. …
… The third point, encouraging the FDA to work with the DOJ to detect illegal activity by pharmaceutical companies, is not really anything that the FDA or DOJ need much encouragement to pursue, and nor is it likely to encourage greater cooperation from companies targeted in this manner.
For real results on addressing the drug shortage problem, Troy suggests that the Obama administration “revisit” an earlier executive order telling government agencies to “cut back on regulatory burdens.
