November 18, 2013 – A bill that would grant the U.S. Food and Drug Administration (FDA) greater power in policing compounding pharmacies was cleared by Congress today, in what experts said was a critical step to ensuring a safer drug supply. The bill, known as the Drug Quality and Safety Act, provides significant new safeguards which have earned it the support of health advocates across the country. The legislation was enacted to prevent events like last year’s meningitis outbreak that killed 64 and seriously injured hundreds more.
What’s the Problem?
The new Drug Quality and Safety Act cleared the Senate without opposition, but stopped short of granting the FDA ultimate authority over regulating the operations of compounding pharmacies. But the bill still provides significant new oversight powers over the companies, which tailor-mix medicines for individual patients.
“It has very sharp teeth,” said Sarah Sellers, a drug safety consultant who has tracked compounding pharmacy regulations for years.
Beginning in early September 2012, contaminated injectable steroid medications processed by the New England Compounding Center (NECC) caused an outbreak of fungal meningitis that killed 64 people and injured more than 700 others. The new bill is designed to prevent such catastrophes.
“This bill will improve oversight of high-risk drug compounding,” said Senator Tom Harkin, who was one of the authors of the Drug Quality and Safety Act. President Obama is expected to sign the bill into law.
The practice of using compounding pharmacies has increased dramatically over the past several years, due mainly to the economics of hospitals, which now outsource much of their drug processing requirements. Some compounding pharmacies have grown beyond mixing medicines for individual patients to become mini drug manufacturers.
But while compounding pharmacies were bound by state laws, the federal government had limited power over regulating them. Unlike drugmakers, they were not required to report problems to the FDA or open their records to federal health inspectors.
These regulatory gaps came to the public’s attention after last year’s fungal meningitis outbreak. The FDA said it lacked the power to properly oversee companies like the New England Compounding Center, though some analysts argued that the administration had not been aggressive enough with the authority it had.
The Drug Quality and Security Act represents an effort to clarify this regulatory confusion. The bill would allow compounding pharmacies that mass-produce drugs to register with the FDA as ‘outsourcing facilities.’ Under the new legislation, these companies would be subject to stricter standards for quality control and oversight, not unlike large pharmaceutical manufacturers.
Companies that opt against the new designation would continue operating under a narrower definition of compounding: mixing drugs for individual patients on the basis of a prescription, or making small quantities ahead of a prescription. These pharmacies would not be subject to any new regulations.
The Drug Quality and Security Act would not force compounding pharmacies to register with the FDA. While this might seem like a loophole, many have predicted that market forces would press most of the larger companies into registering. It has been estimated that up to 80% of hospitals outsource a portion of their sterile compounding processing. Having the option of buying from a facility with an FDA seal of approval would likely come as a relief to many.
“Hospitals and doctors would have to seriously consider the implications of buying from a facility that does not meet those quality standards,” said Allan Coukell, senior director of drugs and medical devices at the Pew Charitable Trusts. “This doesn’t necessarily preclude the risky practices we’ve seen in recent years. But it’s a big improvement.”