GOP lawmakers fault FDA for fatal drug compounding incident

A House panel says the agency didn’t do enough to prevent a meningitis outbreak linked to compounded medications. The FDA says it needs more regulatory authority.

By — Posted April 29, 2013

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An investigation by congressional Republicans suggesting that the Food and Drug Administration missed opportunities to prevent a deadly meningitis outbreak cast a new spotlight on the pharmacy compounding industry and how closely it should be regulated. The industry’s trade group said it was willing to work with the FDA to strengthen state regulations on compounding, but some health care professionals believe these facilities need federal oversight.

Pharmacy compounding refers to a process under which licensed pharmacists work with ingredients to create a tailor-made drug for an individual patient. According to the FDA, this practice, “if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication.”

But something went wrong in 2012 when contamination of an injectible steroid at the New England Compounding Center in Framingham, Mass., resulted in a fungal meningitis outbreak that sickened more than 700 people across the nation, killing 53. The Centers for Disease Control and Prevention had reported the presence of Exserohilum rostratum in sealed, 80 mg/mL vials of preservative-free methylprednisolone acetate produced by NECC, which suspended production soon after the outbreak.

At its Interim Meeting in November 2012, the American Medical Association House of Delegates responded to the events by approving policy for organized medicine to monitor the investigations of these pharmacies and advocate for new regulations that would ensure patient safety.

Republican lawmakers also decided that the event warranted further investigation. On April 16, the majority staff of the House Energy and Commerce Committee released a report concluding that the agency didn’t take appropriate actions against NECC and its sister company, Ameridose, after an initial warning letter in 2006, despite numerous complaints from health care professionals, patients and others that the facilities were engaging in unsafe practices.

Inspections and related enforcement measures had been considered during the past six years, but “they were repeatedly delayed and ultimately canceled,” the report stated. The findings also said the FDA failed to alert the state of Massachusetts routinely about safety issues related to NECC and Ameridose products.

More scrutiny sought

The Energy and Commerce oversight and investigations panel sought further answers from FDA Commissioner Margaret Hamburg, MD, at an April 16 hearing.

In her testimony, Dr. Hamburg acknowledged that the compounding industry was evolving and required more oversight. Too many deaths and injuries have resulted from unsafe practices at these facilities, she said. “However, the current legal framework does not provide the FDA with the tools needed to identify and adequately regulate these pharmacies to prevent product contamination.”

The FDA needs a system “that requires these compounding facilities to register with us so we know who they are,” she said.

Republicans on the panel remained skeptical about the FDA’s handling of the Massachusetts facilities. It’s unclear why the agency never inspected NECC or Ameridose but had inspected other compounding facilities after the outbreak, said Rep. Bill Johnson (R, Ohio). “What causes you enough alarm to want to go inspect? If event reports that say public health is in danger and that lives are in danger … if that’s not enough, I’d like to be able to understand that.”

State pharmacy boards currently regulate the quality and safety of compounding pharmacies. Although thousands of pharmacies specialize in compounding, only a handful have been accredited.

David Ball, a spokesman for the International Academy of Compounding Pharmacists, said the approximately 30 inspections the FDA recently conducted shows that the agency already has adequate authority to look into questionable practices or problems.

The events discussed at the hearing revealed that the FDA failed to take prompt action, Ball said. But to prevent similar incidents as the meningitis outbreak, “the State Boards of Pharmacy that regulate compounding need to have open communication with the FDA. IACP has recommended and continues to advocate for changes and improvements to the state regulation of compounding pharmacies.”

Doctors debate federal monitoring

Other observers aren’t convinced that state regulation is the answer. “Every state is different,” said Timothy Deer, MD, an anesthesiologist and a member of the board of directors of the American Academy of Pain Medicine. “You may see some states that are more relaxed than other states. So I think accrediting should be mandatory and monitored by the federal government, and that would certainly improve safety.”

Accrediting is voluntary now, Dr. Deer added. In his view, any compounding pharmacy that makes a drug that’s injected, taken orally or infused should require accreditation.

Michael Schafer, MD, communications Cabinet chair at the American Academy of Orthopaedic Surgeons, said it should be up to the FDA to determine what changes should be made regarding the regulation of compounding pharmacies. “We have been proactively educating and updating our members on this issue since the initial reports of concern came to our attention,” he said. “Any time patients are at risk from a medical product or procedure, we certainly have to determine if there is more we can do to mitigate risks.”

In a health alert issued March 4, the Centers for Disease Control and Prevention advised physicians to remain aware of any signs and symptoms indicative of meningitis after the Massachusetts outbreak. Although the outbreak first was reported in September 2012, the CDC cautioned that the infection had a prolonged incubation period.

None of the patients in Dr. Deer’s practice uses compounded steroids, and they weren’t at risk during the meningitis outbreak. If a physician does have patients at risk, the patients should be contacted and informed on what the signs are for this infection, he advised. Collaboration with other physicians also is crucial, he said. “If it’s an infectious risk like this was, I think it’s important to reach out to the infectious disease doctors who have more expertise than the anesthesiologist doing the injection would have, and get their input.”

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Multiple incidents tied to compounded products

Food and Drug Administration Commissioner Margaret Hamburg, MD, said at an April 16 House committee hearing that the agency planned to be more aggressive about monitoring compounding facilities, but that it needed more regulatory authority over this industry. In her testimony, Dr. Hamburg outlined several incidents during the past decade in which compounded products led to serious injuries or deaths.

  • 2012: Fungal meningitis outbreak associated with a contaminated injectable steroid distributed by the New England Compounding Center results in about 700 illnesses, with more than 50 deaths.
  • 2012: Contaminated sterile ophthalmic drugs cause fungal eye infections in 43 patients.
  • 2011: Nineteen bacterial infections, including nine deaths, result from contaminated total parenteral nutrition products.
  • 2007: Texas compounder sells colchicine that is 640% the labeled strength, resulting in three people dying from organ failure.
  • 2005: Five cases of severe system inflammatory infections, three of which result in death, are caused by contaminated cardioplegia solution.
  • 2001: Three patients die and others receive medical care or are hospitalized after injections of a contaminated steroid solution.

Source: Testimony of Margaret Hamburg, MD, Food and Drug Administration commissioner, before the House Energy and Commerce oversight and investigations subcommittee, April 16 (link)

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