Compounding Bill Clears Hurdle
The U.S. Senate voted Tuesday to advance a bill designed to tighten government oversight of pharmacies that custom-mix prescription drugs, in the wake of last year's deadly meningitis outbreak tied to contaminated pain injections.
The bill cleared a parliamentary hurdle on a 97-1 vote, indicating its overwhelming support in the Senate. The legislation, passed by the House in September, also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies. Final passage sending it to President Barack Obama for his signature could come as early as Wednesday.
The lone vote against the measure came from Sen. David Vitter. The Louisiana Republican is championing a measure to make lawmakers disclose which of their aides are enrolling in the president's new health care program as part of an ongoing effort to discredit "Obamacare."
The compounding pharmacy bill is intended to prevent a repeat of last year's fungal meningitis outbreak that killed 64 people and sickened more than 750 others across the U.S. The sickness was traced to a now-closed pharmacy in Massachusetts, the New England Compounding Center, where inspectors found mold, standing water and other unsterile conditions.
"Americans deserve to know that their medications are safe, and by enacting this legislation, we can help make that a reality," said Sen. Tom Harkin, chairman of the Senate Health, Education, Labor and Pensions Committee, in a statement.
Compounded medicines have been tied to contamination problems for years. But jurisdiction over them has been murky. Pharmacies are typically regulated through state boards, but the federal Food and Drug Administration regulates manufacturers of medicines.
The bill attempts to sort out that legal gray area, which allowed the NECC and other large pharmacies to skirt both state and federal regulations. Specifically, the measure would clarify when the FDA can intervene against compounding pharmacies.
Pharmacies that operate as traditional compounders, producing small batches of medications to fill doctors' prescriptions, would continue to be regulated by state pharmacy boards, under the legislation. Pharmacies that expand into shipping drugs without doctors' prescriptions can voluntarily register with the FDA and submit to federal inspections and quality standards similar to manufacturers.
But the bill would not require these large-scale compounders to register with the FDA — a step that the agency's leaders have said is crucial to preventing future outbreaks.
And safety advocates say the voluntary approach leaves consumers vulnerable to more rogue pharmacies like the NECC, which operate like manufacturers under the guise of compounding.
The compounding industry's chief lobbying group also opposes the bill, saying it would further complicate pharmacy regulations.
Despite complaints about the bill's shortcomings it has garnered broad support, in part because it contains a separate measure for tracking prescription drugs. The so-called track-and-trace system is designed to help authorities catch counterfeit or stolen drugs, which have increasingly been making their way into the U.S. supply chain from overseas.
Under the track and trace legislation, drugmakers would be required to add serial numbers to all drug containers within four years. After 10 years the industry would have to upgrade to electronic tracking codes that can be used to trace medicines from factory to pharmacy.