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Meningitis Focus Shifts to Oversight

- Wall Street Journal

10/08/2012 - As many as 13,000 patients may have been exposed to fungal meningitis from tainted spinal steroid injections, authorities said Monday, as some lawmakers called for bringing certain specialized pharmacies under greater regulatory scrutiny.

The oversight of compounding pharmacies, which create customized versions of medicines, is gaining greater attention as the death and illness tolls in the outbreak continue to rise. On Monday, the Centers for Disease Control and Prevention said eight people had died and 105 people in nine states had been sickened by fungal meningitis, a rare but potentially deadly inflammation to the brain or central nervous system.

State regulators, federal agencies and the pharmacy industry all share some responsibility for monitoring compounding pharmacies like the New England Compounding Center, the Massachusetts facility that shipped the contaminated steroid tied to the meningitis outbreak. But health officials and lawmakers say these facilities essentially slide through the cracks because no one entity has full responsibility for overseeing them.

"Compounding pharmacies currently fall into a regulatory black hole," Rep. Ed Markey (D., Mass.) wrote in a letter to Margaret Hamburg, Food and Drug Administration commissioner, on Monday.

Sen. Richard Blumenthal (D., Conn.), called for the FDA's oversight authority of the facilities to be extended if necessary, saying that compounding pharmacies' "relative immunity from standards of safety and effectiveness seems anomalous and unacceptable." Mr. Blumenthal is on the Senate committee that oversees how much jurisdiction the FDA has.

If the FDA had full oversight of these pharmacies, it could treat their compounds as new drugs and require the pharmacies to submit clinical trials before the drugs are allowed on the market. It also would have more powers to inspect facilities.

Three lots of potentially contaminated steroid injections were sent by New England Compounding Center to 75 health facilities in 23 states from July to September, according to state and federal officials. But oversight of the facility, which specializes in assembling spinal steroid injections made from a powder and solution mixture, falls with the state and not the FDA. That is because NECC is considered a pharmacy and not a manufacturer. A spokesman for NECC declined to comment, and a spokesman for the Massachusetts Department of Public Health didn't reply to a request for comment.

"From what we can tell so far, it seems that the majority [of patients] are not ill," said Benjamin Park, a CDC medical officer. Whether a patient ends up getting sick depends on the amount of the contaminated steroid vial they are exposed to and their immune system, one health expert said.

There are about 3,000 compounding pharmacies, and drugs made by the facilities represent as much as 3% of the roughly $300 billion in prescription drugs sold in the U.S. each year, according to the International Academy of Compounding Pharmacists, an industry group.

The FDA has pushed in recent years to increase its regulatory authority over compounding pharmacies. But it has been stymied by, among other factors, a 2002 Supreme Court decision. In the majority opinion, written by Justice Sandra Day O'Connor, the court struck down as unconstitutional the portion of a 1997 law setting out how the FDA would decide which compounding pharmacies it would regulate. The FDA had pushed for the 1997 legislation, according to agency officials.

Another piece of guidance from the FDA said it "should seriously consider enforcement action" if the "nature and scope" of a pharmacy's activities are more like a drug manufacturer than a drugstore. But it hasn't gone back to Congress to codify its regulatory standards and has supervised compounding pharmacies only fitfully, current and former agency officials said. The FDA declined to comment.

"This method of taking enforcement cases from time to time hasn't really worked," said Mary Pendergast, a former FDA lawyer.

The compounding pharmacy industry has created safety standards meant to reduce the risk of tainted products. In 2004, United States Pharmacopeia, an industry-backed nonprofit, established safe-practice guidelines for compounding pharmacies.

But the industry is required only in 17 states to follow the guidelines, according to a survey conducted this year by Pharmacy Purchasing & Products, a trade publication. Researchers found that compounding pharmacies in states that required the guidelines reported higher levels of compliance.

"This is yet another preventable event that's harmed way too many people," said Eric Kastango, one of the researchers from the PP&P survey who also helps update the guidelines.

Part of the struggles with maintaining oversight of the compounding-pharmacy industry is that there are few avenues for quality control of the product—except when tainted products sicken or kill people, health officials and pharmacy experts said.

There are no legal requirements that compounding pharmacies test each batch of injectable steroids or record where they go, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy. "It's something the good pharmacies do and the other pharmacies don't," he said.

States cite several reasons why they don't require compounding pharmacies to adhere to the industry-created guidelines. The higher costs and the need to conduct more frequent monitoring and sampling of the work areas are the most commonly cited reasons by compounding pharmacies for not complying, said Kate Douglass, president of Performance Strategies LLC, which consults sterile compounding pharmacies on safety issues.

"The amount of compounding pharmacies that are aware of the guidelines grows every day," Ms. Douglass said. She consults compounding pharmacies on safe practices but believes very few are fully compliant.

Joe Alessandrini, assistant vice president of Clinical Services at South Jersey Healthcare, which had 124 patients at two hospitals receive the recalled steroid injections, said the health system started buying the steroid injections from the NECC about eight years ago after being frustrated by shortages of brand-name steroids from drug manufacturers.

He said the health system and state officials have contacted all of the patients, including making home visits to some who didn't have telephones. So far, 87 patients have visited a special clinic that was set up to screen patients concerned they might be sick, and 13 have been referred for additional testing. No illnesses have been reported.

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