WASHINGTON Representative Edward Markey, a Democrat from Massachusetts, on Thursday became the latest lawmaker to propose legislation that would give the U.S. Food and Drug Administration greater regulatory authority over drug compounding.
U.S. lawmakers, responding to a deadly meningitis outbreak in 2012, continue to wrestle with ways to regulate the pharmacies that compound large volumes of drugs for hospitals, individuals and clinics.
The meningitis outbreak, which has killed 53 people and sickened more than 700, was linked to tainted steroid injections distributed by the Framingham, Massachusetts-based New England Compounding Center.
Markey's proposal differs from legislation approved by a Senate committee on Wednesday that would give the FDA oversight only over compounding pharmacies that make sterile products and ship them across state lines. The agency would not have primary authority over compounding pharmacies, even very large ones, that operate within the confines of a single state.
A number of experts have said the risk of contamination of a sterile product does not substantially change based on whether it travels across a state line, although the longer a product is left to sit the greater the potential for bacteria to grow.
The Senate plan places a considerable burden on state boards of pharmacies who sometimes have limited knowledge of what individual pharmacies are selling and where.
"State pharmacy regulators vary widely in their ability to oversee large-scale non-traditional compounding," the Pew Charitable Trusts, an independent research and public policy organization wrote in comments earlier this month to the Senate health committee drafting the bill.
Under the Senate bill, if a compounding pharmacy makes and ships both sterile and non-sterile products across state lines, the FDA would have authority over the sterile products, while the state would have authority over the non-sterile products.
Markey's bill would give the FDA authority over both.
The FDA has expressed broad support for the Senate bill, with a number of caveats.
The Senate bill would create a new class of drug company, called "compounding manufacturers," that would be regulated by the FDA and not by state pharmacy boards. However, they would be exempt from many of the federal requirements governing pharmaceutical and biotechnology companies.
The agency is concerned that the Senate bill as written would allow some companies to masquerade as compounding manufacturers to skirt regulations that would otherwise require them to get prior FDA approval before selling a new drug.
In a statement on Wednesday, the FDA said the proposed bill "does not yet provide the clarity necessary to appropriately oversee this industry and may limit FDA's ability to effectively protect the public health." It said it is working with the committee to address the issues.
It is unclear when the full Senate will take up the compounding bill, or whether Markey's proposal will advance, but it appears likely that new rules of some sort will be established.
"I'm pretty confident the House will pass some legislation," said Glenn Engelmann, a former executive with drugmaker AstraZeneca Plc who now works for the law firm of McDermott Will & Emery. "There seems to be a lot of momentum to do something here."