Daily Archives: May 17, 2013
In the wake of last year’s horrific meningitis outbreak stemming from unsanitary practices at a Massachusetts-area compounding pharmacy — facilities where certain drug batches are mixed and prepared — the U.S. Food and Drug Administration (FDA) launched a comprehensive investigation into compounders in 18 states. These facilities are largely out of the purview of federal oversight, which is why FDA director Margaret Hamburg has begged Congress to give her agency more power and clearer guidance to regulate them. But even though the FDA revealed last Thursday that its investigation had found unsafe practices at nearly every facility it audited, House Republicans aren’t sold on Hamburg’s request, and question whether stronger FDA oversight of compounders is warranted.
During a hearing before the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigation, Republican lawmakers expressed skepticism that giving more power to the FDA would accomplish much. GOP committee members pointed out the FDA’s past failure to avert crises such as the meningitis outbreak that killed over 50 Americans. “Ten years of warning signs, alarm bells and flashing red lights were deliberately ignored. Ultimately, the FDA knew [the compounding facility] was breaking the law but chose to do nothing,” said subcommittee chairman Rep. Tom Murphy (R-PA). Read More