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).
As Hamburg pointed out in her testimony, that’s a very skewed version of the facts. Even if the FDA had known about the offending pharmacy, a combination of conflicting statutes and stratified jurisdictional authority would have made it impossible to do much about it. The failure to prevent public health emergencies such as last year’s meningitis outbreak is actually an argument for increasing the FDA’s authority, as the current dynamic is confusing, conflicted, and leaves the agency vulnerable to uncooperative drug makers:
Hamburg said the authority the agency currently possesses is too limited and not enough to properly ensure the safety of some compounding pharmacy products. In particular, she said her biggest concern amongst such pharmacies is with those making what she called “high-risk, sterile” products that are often made in high volumes despite not having an individual prescription and sent out of state. Hamburg estimated about 3,000 compounding pharmacies engage in making sterile products.
She added that there have been several occasions where the FDA has been rebuffed by compounding pharmacies to conduct inspections, saying that the agency does not have such authority, and have sued to prevent access.
In response to questioning from one committee member, Hamburg said she agreed that the International Academy of Compounding Pharmacists, a trade association, has stepped in the way of inspections, adding that “the IACP has for many years questioned our authority.”
House Democrats introduced legislation to crack down on these unregulated pharmacies soon after the meningitis outbreak. That bill — dubbed the SAFE Act — incorporates FDA requests for a federal database of compounding facilities and subjects the drug makers to a minimum level of production standards. Hamburg has warned that, barring additional oversight authority, the FDA is largely powerless to prevent the next outbreak of this kind.