It was only last month that the FDA published a report titled “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.” The study called for more outreach to small businesses, greater access to FDA data for data mining, biomedical job training, and the clarification, streamlining, and more consistent application of FDA regulations.
The report also acknowledged that the lack of FDA staff with business backgrounds has been an impediment to understanding the needs of the small biomedical businesses that drive innovation, and seemed to suggest a recognition on the part of the administration that FDA policies often create challenges for life-science innovation.
In contrast to the approach laid out in the biomedical innovation report, the new shortages EO calls for the DOJ to pursue more prosecutions, for the FDA to force more notification from manufacturers, and to politely ask the FDA if at all possible to do their job on a timely basis. It is not clear how exactly these three reiterations of existing law solve the problem of drug shortages. Furthermore, the deregulatory aspect of the EO, to the extent that there is one, is carefully curtailed, while the big government elements of the EO are fairly open ended. At the same time, the Obama administration is pursuing policies in other areas, such as the rebates, that will likely cut back on both pharmaceutical jobs and the development of new life-saving and life-extending products.
It was not that long ago that the Obama administration issued an EO that told government agencies to cut back on regulatory burdens. Perhaps the administration should revisit that approach for dealing with the issue of drug shortages.
— Tevi Troy is a senior fellow at Hudson Institute and a former Deputy Secretary of Health and Human Services.