On June 15, 2012, the U.S. House of Representatives Committee on Oversight and Government Reform issued a Staff Report, detailing the problem of drug shortages for key lifesaving drugs. According to the Report, the shortages are largely affecting the availability of generic injectable medications. Despite finding a variety of factors responsible for the shortages, including the scarcity of raw materials and increasing demands, the House Oversight Committee concluded that the shortages were largely precipitated by the actions of the U.S. Food and Drug Administration (“FDA”).The full text of the Staff Report may be accessed here.
In detailing how the FDA’s actions have been a key factor prompting the drug shortages, the House Report is largely critical of FDA Commissioner Margaret Hamburg. In particular, the Committee noted that “. . . it appears FDA’s enforcement and regulatory activities were unhinged from 2009 to 2011.” Hamburg became Commissioner of the FDA in June 2009. In citing Hamburg and her regime’s hypervigilance, the Committee pointed to the dramatic increase in FDA warning letters during this time and the significant decrease in manufacturing capacity at the country’s major production facilities for these drugs. According to the Report,
[i]n the first year that Margaret Hamburg was FDA Commissioner, the number of warning letters increased 42% – from 474 letters to 673 letters. In Margaret Hamburg’s second year as FDA Commissioner, the number of warning letters increased a staggering 156% – up to 1,720 letters.
Further, with regard to decreased manufacturing capabilities, the Committee found a “30% decrease in manufacturing capacity at America’s primary production facilities for generic injectable drugs.” Ultimately, the Committee concluded that while the FDA’s regulatory actions do have potential benefits for consumers, this recent zeal in enforcement has resulted in the costs outweighing those benefits.
In light of the FDA stepping up enforcement measures, companies must be prepared to respond by establishing and maintaining compliance with FDA regulations. Although the Oversight Committee Report focused narrowly on drug shortages, the statistics highlighting the increase in warning letters is representative of the letters issued to individuals and companies across all FDA-regulated industries. Thus, given the recent enforcement environment and its reach on all FDA-regulated industries, it is important now more than ever to maintain compliance with FDA regulations.