A bill said to increase oversight of compounding pharmacies would let those pharmacies volunteer to be regulated by the U.S. Food and Drug Administration, then charge them a fee for the oversight.
The Drug Quality and Security Act would allow businesses combining elements of two or more drugs to “voluntarily register with FDA and operate under FDA regulation,” explained U.S. Rep. Fred Upton, R-St. Joseph, chairman of the House Energy and Commerce Committee, which oversees the FDA.
The bill, approved in the House last month, would allow large-scale compounders to register to be overseen by the FDA in hopes of preventing another disaster like the nationwide fungal meningitis outbreak linked to New England Compounding Center in Massachusetts.
The outbreak, linked to tainted steroids from the facility, has resulted in 264 cases of related illness in Michigan, including 19 related deaths. Eight of those deaths have been in Livingston County.
The NECC disaster demands mandatory FDA oversight of compounding pharmacies, saidKathy Pugh, whose mother, Evelyn Bates-March, a Hamburg Township resident, is recovering from an injection of tainted steroids from the facility.
“It’s not something that can be volunteered. The same thing’s going to happen,” Pugh said.
“All they’re doing is slapping an itty-bitty Band-Aid and people are still bleeding out. It’s not going to work. It’s not going to solve the problem,” she added.
An 'important step'
Supporters of the bill claim larger compounding pharmacies, which combine elements of multiple drugs, will seek the FDA regulation so they can market their products as FDA-regulated.
The bill maintains existing law exempting FDA approval of compounded drugs, however. Most oversight of compounding pharmacies is left to state boards of pharmacy.
The bill would prevent more deaths stemming from compounding pharmacy mistakes, Upton said.
“The sad truth is that, yes, they could have been prevented. This legislation is an important step in helping to prevent any such tragedy from ever occurring again,” he said before the House approved the bill.
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