A Confusing Attempt to Cure Compounding PharmaciesPaul M. Barrett
Remember the panic about compounding pharmacies? These are state-licensed retail businesses that mix and sell medications, but without the federal safety approval required for mass-produced drugs. No? How about the scandal last year involving a Massachusetts pharmacy whose tainted back-pain steroids led to hundreds of serious infections and more than 60 deaths, many related to meningitis?
Oh, yes, that you recall. Scary stuff.
Now that you’re focused, here’s the news: Congress has finally moved to give the Food and Drug Administration greater authority over compounding pharmacies. This week, negotiators from the House and Senate came up with a compromise bill designed to prevent another fiasco like last fall’s misadventure with the since-closed New England Compounding Center in Framingham, Mass.
Unfortunately, the compromise seems convoluted, requires only voluntary participation by compounding pharmacies, and has already provoked a vow of resistance from the targeted businesses. In other words: more confusion ahead.
Lawmakers said they aimed to give the FDA greater authority to oversee and inspect compounding pharmacies in the way the agency already supervises traditional drug manufacturers. In a twist, though, compounding pharmacies wouldn’t be required to submit to this oversight. The proposed legislation would rely on market forces to provide the incentive for pharmacies to open up to the FDA. Presumably, doctors and hospitals would prefer to acquire specially designed remedies from businesses willing to host FDA inspectors.
Well, maybe. Or maybe cut-rate, low-quality pill-and-serum mills would remain in the shadows, hoping to sell to just enough customers to stay in business. Given the terrifying experience in Massachusetts last year, it seems odd that the option would remain with the manufacturers.
In any event, if you assume that the compounding industry would welcome hybrid oversight-cum-voluntarism, you’d be wrong. On Friday the International Academy of Compounding Pharmacists, the industry’s politically potent trade group, vowed to fight the proposed legislation. “This bill, in its failure to recognize the very real problems in the draft legislation that we have identified over many meetings, will without question result in patients’ inability to obtain access to needed medications,” David Miller, the academy’s chief executive, said in an e-mailed statement. “Although states have long had sufficient authority to regulate compounding, the bill grants the FDA sweeping, unprecedented authority in determining what pharmacies can compound.”
Given the lag since last year’s scandal, the public’s limited attention span, and the compounders’ track record of pushing back against federal oversight, it’s far from a sure bet that this bill will become a law. Caveat emptor.