A bill that would give the Food and Drug Administration more power to police compounding pharmacies passed its final hurdle in Congress on Monday.
The bill, which cleared the Senate without opposition, stops short of giving the FDA complete authority over pharmacies that tailor-mix drugs for individual patients, a process known as compounding. But the bill still provides significant new safeguards, which have earned it the support of public health advocates around the country.
Passage of the bill comes a year after a meningitis outbreak from contaminated steroid pain injections killed 64 people nationwide and sickened hundreds more. It comes a dozen years after the drug-dilution scandal that put Kansas City pharmacist Robert Courtney in jail.
The Senate approved the bill by voice vote, sending it to the White House, where President Barack Obama is expected to sign it into law.
The bill would create a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and later through electronic codes. The House passed the legislation in September.
The law would mark the first federal legislation to introduce regulation of compounding since Courtney ultimately admitted diluting thousands of doses of chemotherapy medications.
It also follows a Kansas City Star series in 2002 that exposed concerns about the safety of compounded drugs. That series prompted findings from an investigation by the Government Accountability Office, suggesting flaws in the way drug compounding is regulated in the United States.
A first push in the U.S. Senate to change federal law failed amid fierce opposition from the compounding industry, but that opposition was weakened when more than 750 people were sickened by last year’s deadly fungal meningitis. Many victims continue to suffer debilitating pain and nerve damage.
The sickness eventually was traced to a now-closed pharmacy in Framingham, Mass., the New England Compounding Center, where inspectors found mold, standing water and other unsterile conditions. The company shipped more than 17,600 doses of the implicated steroid injection to 23 states.
Jurisdiction over such large-volume compounders has been murky. Pharmacies that fill individual prescriptions from a doctor or other health professional typically are regulated by state boards, but the federal Food and Drug Administration regulates manufacturers of medicines.
The compromise bill gives the FDA authority to inspect and close down large-volume compounders, but it doesn’t require the pharmacies to register with the FDA, as manufacturers of prescription drugs must do.
Without the bill, a legal gray area allowed the Massachusetts pharmacy and similar businesses to skirt state and federal regulations. The measure clarifies the FDA’s authority over high-volume compounding pharmacies that mass-produce medications, rather than fill doctors’ prescriptions.
Sarah Sellers of theWorking Group on Pharmaceutical Safety
, called the measure “long overdue.”
“Moving forward, the challenge for lawmakers, patient advocates and the public health community is to ensure that this comprehensive legislation is appropriately implemented, and that state and federal regulators have the resources they need to support necessary surveillance and enforcement priorities,” Sellers said in a statement.
Sen. Pat Roberts, a Kansas Republican, said he became an advocate for regulatory change after the Courtney case. Roberts credited reports about the contamination from the Massachusetts operation for changing the political atmosphere surrounding the issue.
“This legislation protects traditional pharmacies, while giving patients more confidence in the quality and safety of their compounded drugs,” he said in a statement.
Under the bill, pharmacies can register voluntarily with the FDA and submit to federal quality standards and inspections. FDA officials previously said requiring compounding pharmacies to register with the agency was crucial to preventing future outbreaks.
The bill’s supporters acknowledge that a voluntary approach will succeed only if doctors and hospitals prefer to do business with FDA-registered pharmacies.
Safety advocates say the bill leaves the door open for more rogue pharmacies such as the one that caused last year’s outbreak.
“This voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA,” Rep. Rosa DeLauro, a Connecticut Democrat, said after the House passed the bill.
FDA officials told Congress last year that regulating businesses such as the NECC has been a struggle because of a “patchwork” of conflicting court decisions over the agency’s authority to deal with pharmacies.
State pharmacy boards would continue to regulate traditional compounding pharmacies, which generally are small operations that fill individual doctors’ prescriptions. Pharmacies that expand into shipping drugs without doctors’ prescriptions would be able to voluntarily register with the FDA as “outsourcing facilities,” subject to quality standards and reporting requirements similar to manufacturers.
The FDA would retain the power to shut down any outsourcing pharmacy, registered or not, that does not meet quality standards or engages in illegal compounding, such as mass-producing copies of manufactured drugs.
Experts who helped craft the bill predict that nearly all large compounding pharmacies will register with the FDA as a cost of doing business, but critics question how the agency will be able to identify businesses that aren’t following regulations.
Even the compounding industry’s chief lobbying group said the bill would not stop pharmacies like the one that caused last year’s outbreak, and it said the bill could lead to more confusion over pharmacy regulations.
“If the goal of this legislation is to prevent another NECC, which has been stated many times over, then the American public must know that this bill will not accomplish that goal. A voluntary category of outsourcing facilities is not the answer,” theInternational Academy of Compounding Pharmacists
said in a statement.
The voluntary approach to regulation was a compromise forged by Republicans and Democrats in the GOP-controlled House. Earlier versions of the bill drafted in the Democratic-controlled Senate would have made registration mandatory.
Despite criticisms of the approach, the bill has garnered broad support, in part because it was bundled with separate legislation to track prescription drugs throughout the U.S. supply chain.
The “track-and-trace” system, long sought by doctors and patient groups, is designed to help authorities catch counterfeit or stolen drugs that increasingly have made their way into the U.S. from overseas.