New FDA Compounding Pharmacy Regs Needed After Outbreak: GAO

In the wake of a recent nationwide fungal meningitis outbreak caused by compounded epidural steroid injections, as well as a number of recalls issued in recent months by different compounding pharmacies, a new report by the Government Accountability Office (GAO) indicates that Congress needs to give the FDA clear direction on what it can and cannot do to regulate compounding pharmacies.  

A GAO report (PDF) released this week confirms concerns raised by FDA officials, who have indicated that the agency’s authority over compounding pharmacies needs to be clarified and reinforced by congressional action. The report comes as several pieces of legislation designed to do just that are continuing to be debated in both houses.

Some lawmakers say the FDA squandered the power it had by failing to act to prevent a Massachusetts compounding pharmacy from distributing thousands of vials of contaminated injections last year, which led to a nationwide fungal meningitis outbreak that killed more than 60 people. The outbreak has been tracked back to the now-defunct New England Compounding Center (NECC).

Reports suggest that both the FDA and Massachusetts state health officials knew for years there were problems with the company and raised concerns a number of times about the safety of drugs distributed by NECC. However, due to failures in coordinated regulatory oversight between the state and federal governments, the company was allowed to continue to operate, causing more than 700 people to be sickened by fungal contamination in epidural steroid injections.

Court Rulings Lead to Inconsistent Regulation

The GAO report highlights court rulings that have left the FDA in an awkward and unclear position about its regulatory power over the pharmacies.

Traditionally, compounding pharmacies are supposed to provide drugs that are otherwise unavailable to local hospitals on a per-prescription basis. However NECC and some other compounding pharmacies have been acting as stealth drug manufacturers, distributing their products nationwide without having to go through the FDA’s new drug approval process which is supposed to make sure that the drugs are safe.

“The authority of the Food and Drug Administration (FDA)…to oversee drug compounding is unclear,” the report states. “Two federal circuit court decisions have resulted in differing FDA authority in different parts of the country. According to FDA officials, these inconsistent decisions and the agency’s limited inspection authority over pharmacies have created challenges in FDA’s ability to inspect and take enforcement action against entities engaging in drug compounding.”

The decisions in the Fifth and Ninth Circuit court cases conflict in certain respects, leaving different parts of the country working under different compounding pharmacy laws. This has led to FDA agents being challenged and delayed when they have wanted to inspect some compounding pharmacies.

As an example, the report notes that from 2002 through 2012, the FDA had to obtain 11 warrants to get its inspectors inside compounding pharmacies that challenged its authority. Since the outbreak, the agency has attempted to crack down on pharmacies nationwide, resulting in a number of drug recalls due to safety concerns. However, the FDA continues to face resistance from the industry.

The agency identified 31 compounding pharmacies that it considered “high risk.” It found deficiencies at 30 of them and eight of those pharmacies have issued drug recalls.

Most recently, the FDA announced on July 31 that Beacon Hill Medical Pharmacy, which does business as Rxtra Solutions, is recalling all lots of certain drugs that are supposed to be sterile. The Beacon Hill recall, like a number of others recently, was the result of FDA inspections that led to questions about the sterility of the Southfield, Michigan compounding pharmacy’s drugs.

Some observers have suggested that the FDA doesn’t have the resources to keep up the vigorous pace of inspections that have led to the recent recalls.

GAO Recommendations

The GAO report provides congress with a number of recommendations. The report notes that that Congress should clarify the FDA’s authority over compounding pharmacies. It also notes that there is confusion over when compounding becomes drug manufacturing, and that confusion needs to be cleared up. The report also calls on the FDA to ensure it has reliable and timely data on compounding pharmacy inspections that differentiates compounders from drug manufacturers.

Some legislation on the table has raised concerns because it calls for the creation of a new category of compounding pharmacy that participates in drug manufacturing. However, critics say that could lead to a loophole where companies will be able to create new drugs without going through the FDA’s new drug approval process, and thus could place the public at risk.

NECC, the compounding pharmacy that allegedly sparked the fungal meningitis outbreak and the debate over compounding pharmacies, went bankrupt in the face of fungal meningitis lawsuits. A recent court order will allow plaintiffs to pursue medical malpractice lawsuits against doctors and facilities that doled out the 17,000 injections shipped out by NECC.