FDA on hot seat over spinal meningitis outbreak

Last fall, the New England Compounding Center (NECC) in Massachusetts made thousands of tainted vials that killed 50 people and sickened more with the deadly spinal meningitis virus.

The House Energy and Commerce Subcommittee on Oversight will hear from Food and Drug Administration (FDA) Commissioner Margaret Hamburg on April 16 to examine whether the agency has the tools it needs to regulate the growing industry.

“The evidence so far demonstrates the NECC should have been shut down long before 50 people tragically lost their lives from contaminated injections,” said Rep. Tim Murphy (R-Pa.), the chairman of the subcommittee that will hold the hearing. “With many more still sick, we will continue investigating the breakdown at the FDA so a public health disaster like this one never happens again.”

More than 700 individuals have been sickened from the NECC contamination, and various other safety issues were found at compounding pharmacies in at least six other states, not including another in Massachusetts that prompted recalls of products.

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These types of facilities create custom prescriptions for individuals, such as turning a FDA-approved drug usually taken in pill-form into a liquid or adding flavoring to a child’s medicine to make it more palatable. But they are not bound by many federal regulations, and instead states are supposed to oversee them.

There have been 44 federal investigations into compounding pharmacies nationwide since January. The FDA has released 31 reports that claim a host of violations.

Officials from the FDA have acknowledged the gray area surrounding specialty pharmacy rules but also say there’s more they could have done to prevent deaths and illness stemming from tainted medications.

The regulator has been able to step in at compounding pharmacies suspected to be producing products en masse or ones that consumers have complained about. Still, officials say their ability to unilaterally act on inspecting the estimated 28,000 pharmacies is limited, at best.

“This is no way to regulate an industry,” said Janet Woodcock, the leader of the FDA’s Center for Drug Evaluation and Research (CDER). “Sure, we could have gone out and done more inspections like this and battled each one in court. But there’s 28,000 compounding pharmacies of any type and we don’t know who’s who, because they don’t send us anything or tell us.”

Woodcock and Howard Sklamberg, the head of CDER's Office of Compliance, spoke to the publication Pharmalot on Tuesday about the rising number of investigations and the curtailed authority to oversee the products.

“How would we regulate that industry when we go there and have to get a warrant from a judge to walk in the door? You could say we could battle in court and get in the firm,” Woodcock continued, but what about the other 27,999? We have to have a scheme — these firms we regulate or we don’t.”

In the midst of the public outcry last month, a pharmacy trade group pushed back against calls to give the FDA more power.

The head of the National Community Pharmacists Association (NCPA) said there are already enough state-level rules governing the business and argued that NECC acted as a “rogue entity.”

“As a country, we must strike the right balance to go after rogue entities like NECC while preserving patients’ access to the safe and essential compounded medications that their physicians prescribe,” said B. Douglas Hoey, the chief executive of the NCPA, pledging that the organization would “continue to work with health officials” on the issue.

“The FDA owes the American public the peace of mind that it will do all it can to protect the integrity of the nation's drug supply chain, and the goal of our investigation is to ensure that happens,” Murphy said.