Congress Set to Approve New Compounding Pharmacy Regulations

In direct response to a deadly fungal meningitis outbreak that killed dozens of people last year, the House and Senate are prepared to approve a bill that will strengthen the FDA’s regulatory authority over large compounding pharmacies that distribute drugs across state lines. However, the bill will also block the agency’s ability to regulate small facilities that have maintained the traditional role of compounding pharmacies.  

The bill, known as the Drug Quality and Security Act (PDF), has been approved by committees in both the U.S. House of Representatives and the Senate, and it is expected to easily pass a full vote by both houses of Congress.

The legislation would create a new classification of compounding pharmacy for those large pharmacies that ship sterile drugs across state lines. They will become known as “outsourcing facilities” and the FDA will be able to regulate their activities. However, the bill shields traditional compounding pharmacies, which mix drugs otherwise unavailable on a per-prescription basis for local hospitals, from FDA oversight.

The bill will also set up a national system for tracking drugs through the distribution chain, which is designed to make it easy to identify drugs that are causing a problem, as well as counterfeits.

Legislative action was taken in the wake of a fungal meningitis outbreak that surfaced late last year, killing more than 60 people and sickened more than 700. The outbreak was linked back to contaminated epidural steroid injections distributed nationwide by the New England Compounding Center (NECC) in Framingham, Massachusetts, which had a long history of problems that went unaddressed by state and federal regulators.

About a year ago NECC recalled all of its sterile drugs after inspectors found sealed vials with visible fungus in them at the company’s facility. NECC had shipped more than 17,000 of those vials to hospitals and pain clinics in more than 20 states. The U.S. Centers for Disease Control and Prevention (CDC) estimated that 14,000 patients across the U.S. were exposed to the potentially contaminated shots.

The revelation of the scale of NECC’s operation, and the fact that the FDA and Massachusetts health officials had known about problems at the compounding pharmacy and did not act because they were unclear of the extent of their regulatory power, led to a nationwide crackdown on compounding pharmacies.

Since the outbreak, increased scrutiny by the FDA and state officials have identified a number of large compounding pharmacies that have questionable sterilization procedures, and in some cases the operators were found to be distributing drugs that were contaminated. The crackdown has also revealed that numerous compounding pharmacies are acting as “stealth drug manufacturers,” without having their drugs inspected by the FDA to ensure they were safe before shipping them nationwide.

In response to the increased scrutiny from the FDA, many of the pharmacies have pushed back against the federal agency, claiming that the agency had no authority to regulate them. This has given steam to the proposed legislation, as the FDA cited the examples as reason to have its authority clarified.

Big Pharma, Consumer Watchdog Groups, Fight Bill

While it is believed the bill will have an easy time passing through a combined House and Senate vote, the pharmaceutical industry is prepared to fight the bill in an unusual alliance with consumer watchdog groups.

Critics of the legislation say that a new, less secure, group of drug manufacturers will be created, which are not subject to the same safety standards as major drug companies.

Pharmaceutical companies want the bill to give the FDA the power to regulate large scale compounders, or outsourcing facilities, the same way that they are regulated, instead of creating a new set of rules. That would require they be classified as drug manufacturers, not outsourcing facilities.

Consumer watchdog groups like Public Citizen, often at odds with the pharmaceutical industry, agree, saying that the bill could lead to dangerous, unsafe drugs hitting the market and creates the risk of another major, deadly outbreak.

The pharmaceutical industry has pushed back against the legislation with a newly formed lobbying group called the Working Group on Pharmaceutical Safety, which surveyed 800 registered voters and found that most Americans want compounding pharmacies under the purview of the FDA.

NECC has been shut down for almost a year now, and has declared bankruptcy in the wake of numerous fungal meningitis lawsuits. There is still a chance that the company’s owners also may face criminal charges regarding their activity.