House Committee Report Finds Fault with FDA on Drug Shortages

According to a House Committee on Oversight and Government Reform report, the blame for the recent nationwide shortages of critical drugs, especially in oncology agents, resides largely with the FDA.

The June 15, 2012, report notes that since 2010, “the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs.”  Interestingly, the committee seemed to correlate FDA’s activities and the drug shortages with the appointment of current FDA Commissioner Margaret A. Hamburg to the position. 

In discussing FDA actions compounding drug shortages, the committee stated that when the FDA responds to a manufacturing problem involving producers of generic injectable drugs, the result is that “companies producing generic injectable drugs have taken their manufacturing off-line simultaneous to other generic competitors also going off-line.”  The simultaneous shutdowns of these generic manufacturers impact the supply stream.

As a result, the FDA’s actions are viewed as regulatory interference in the production process.  The committee attributed the agency’s actions as essentially forcing the shutdown of 30 percent of the total manufacturing capacity of four of the largest manufacturers of injectable drugs:  Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals.

Drug shortages in general have garnered attention from the administration, as President Obama issued an executive order late last year to spotlight and attempt to address the problem.  In December, the Government Accountability Office recommended that the FDA be allowed to mandate that drug companies be required to warn the agency when they think a shortage of a particular drug is imminent, so plans could be made to alleviate the shortage. That idea was incorporated into the Senate version of the recently passed user fee bill.

 The House committee recommended that when problems that are not an immediate public safety threat are detected at drug manufacturers, facilities should be directed to make targeted improvements under close FDA investigation.  The belief is that this approach would be more appropriate then shutting down manufacturing lines in its entirety. 

However, the committee suggested that proposals to let drugmakers share information about their manufacturing capabilities and product availability might be worth considering, although that might leave open the possibility for collusion among the companies.