A year after a meningitis outbreak from contaminated pain injections killed at least 64 people and sickened hundreds, Congress is ready to increase federal oversight over compounding pharmacies that custom-mix medications.
Before the bill gets to President Barack Obama for his signature, it first has to clear a hurdle put in its path by Louisiana Sen. David Vitter in his ongoing campaign to discredit the president's health care overhaul. A test vote is scheduled for Tuesday evening.
The legislation, passed by the House in September, also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and containers and later through electronic codes.
Although the bill enjoys nearly universal support in Congress, Vitter has objected to the Senate voting on it without first voting on his measure to make members of Congress disclose which of their aides are signing up for the health care law, and which are instead being allowed to remain in the Federal Employee Benefit Program.
Vitter objects to an Obama administration decision earlier this year allowing lawmakers to choose between the two programs for their aides, and directing the government to pick up three-fourths of the premium costs for members of Congress and their aides either way. Lawmakers themselves have to switch to coverage under the health care law. Vitter's insistence on ending the employer match earlier this year prompted Senate Democrats to scuttle an energy bill. The issue arose again in last month's showdown over the government shutdown.
The compounding pharmacy bill is intended to avert a repeat of last year's meningitis outbreak associated with the now-closed New England Compounding Center. Subsequent inspections found unsanitary conditions at the company's plant in Framingham, Mass., including mold and standing water.
Contamination problems with compounded medicines have been reported for decades. But jurisdiction over them has been murky. Pharmacies are typically regulated through state boards, but the Food and Drug Administration regulates manufacturers of medicines.
The bill attempts to sort out that legal gray area which allowed the NECC and other pharmacies to skirt both state and federal regulations. The measure clarifies the FDA's authority to shut down pharmacies that become so large they resemble manufacturers, but it doesn't require those pharmacies to register with the agency, a step that would have subjected them higher quality standards and inspections. Instead, pharmacies can volunteer to be regulated by the FDA as a sort of optional "stamp of approval."
Still, public safety advocates who lobbied for the bill say it improves the status quo.
"It's not as far reaching as some of the other proposals Congress considered over the past year, but it is an important step forward," said Allan Coukell, director of the Pew Charitable Trusts' medical group. "It certainly has the potential to provide a more robust source of compounded drugs."
The FDA gets explicit authority under the bill to intervene when compounders are mass-producing medications without prescriptions or are compounding copies of widely available drugs. Compounding pharmacies can elect to register as "outsourcing facilities" subject to FDA oversight or continue to be regulated by state pharmacy boards.
The voluntary nature of new class of pharmacies has drawn criticism from both safety advocates and compounding lobbyists, who seldom find themselves on the same side of an issue.
The compounding industry's chief lobbying group said the bill would not stop pharmacies like the one that caused last year's outbreak, and would actually lead to more confusion over how compounders are regulated.
"Do you honestly think a company like NECC would voluntarily register with the FDA? Our major objection to this piece of legislation is it steps us backward," said David Miller, CEO of the International Academy of Compounding Pharmacists.
The consumer advocacy group Public Citizen, a longtime critic of both the FDA and drug companies, said the bill should have required mandatory labels on compounded drugs warning that they have not been approved by the FDA.
"The answer is for the FDA to step up its enforcement activities and take action against companies that engage in illegal manufacturing under the guise of compounding, and the tragedy of NECC is that they failed to do that," said Dr. Michael Carome, director of Public Citizen's health research team.
Roughly 7,500 pharmacies in the U.S. specialize in compounding medications, though many thousands more perform a small amount of compounding while also dispensing traditional prescription drugs. Compounded drugs account for an estimated 3 percent of all prescriptions filled.
Despite complaints about the bill's shortcomings it has garnered broad support, in part, because it was bundled together with the 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. from overseas. The system is also expected to help companies conduct recalls of defective drugs.
Under the measure, drugmakers would be required to add serial numbers to all drug bottles and 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. Drug distributors, packagers and wholesalers would be required to verify the distribution history of the products they ship.