Regulatory Focus™ > News Articles > Meningitis Outbreak Places Spotlight on FDA's Regulation of Compounding Pharmacies

Meningitis Outbreak Places Spotlight on FDA's Regulation of Compounding Pharmacies

Posted 05 October 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) regulation of compounding pharmacies has come under fire in the wake of a drug safety problem involving steroid injection shots infected with the meningitis virus.

The tainted drugs, traced back to a Massachusetts pharmacy, have already been implicated in five deaths and 35 cases across 23 states-a number officials said is likely to rise in light of the scope of the drug's distribution.

But almost as much as the crisis itself, the way FDA regulates compounded drug substances is coming under renewed scrutiny as several media outlets raise questions about whether the authority granted to regulators is adequate, or simply a vestige of an outdated system.

As a matter of practice and law, FDA exercises light enforcement over compounding pharmacies, which create pharmaceutical compounds from scratch. The agency has limited statutory oversight authority over compounders, which until recent years had not represented much of a problem as manufacturing capabilities made it cheaper to produce drugs en masse. But with the rise of the Internet and improved logistical networks, compounding pharmacies have experienced a resurgence in business. Recurring drug shortages, too, have spurred demand for smaller and nimbler manufacturing operations that can respond to high demand for specialty products.

FDA regulators have taken notice of the problems, which seem to have been myriad this year. In one instance, a May 2012 recall by Florida-based Franck's Pharmacy was issued after many of its sterile human and veterinary products were found to be infected with fungal and microorganism growths.  After the recall, FDA's Rear Admiral Steven Galson, deputy director of the Center for Drug Evaluation and Research, noted the disparities between established manufacturers and small compounders.

"Not all pharmacists have the same level of skills and equipment," said Galson. "In some cases, compounders may lack sufficient controls-equipment, training, testing, or facilities-to ensure product quality or to compound complex products such as sterile or modified release drugs."

Particularly when compounding pharmacies begin to engage in large-scale operations mirroring those of their non-compounding counterparts, tensions begin to emerge in the regulations, added Galson. In the case of the meningitis outbreak, New England Compounding Center shipped more than 17,500 vials of the steroid-hardly a small amount.

Though FDA in theory is able to regulate compounders who produce product in bulk or enter products into interstate commerce, this authority has recently been under attack in the courts, explains The New York Times. In a case involving Franck's Pharmacy-the same company whose products were involved in the May 2012 recall-a judge ruled FDA could "not assume it had authority to regulate compounding pharmacies."

FDA, too, has sometimes used compounding regulations to its own advantage. In a long-running court battle with KV Pharmaceuticals, the manufacturer of a controversial pre-term birth drug known as Makena, FDA contended that compounding pharmacies would be allowed to manufacture copies of Makena as long as they did so on a small scale and in accordance to quality guidelines. KV subsequently sued FDA, contending that the agency's actions violated its marketing exclusivity for the drug, but a judge threw out its challenge on unrelated grounds.

It remains to be seen if the crisis will lead to new calls for bolstered FDA authority or if reforms will be conducted at the state level, where many compounders are now regulated.

Read more:

NY Times - News Analysis - A Question of Oversight on Compounding Pharmacies

Pharmalot - FDA & Compounders: More Oversight Needed?

NPR - Spinal Injections May Be Source Of Rare Meningitis

AP - New England Compounding Center: Avoid Drugs From Company Tied To Meningitis, FDA Says

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