House Democrats are calling for a federal investigation and subsequent hearings on a recent fungal meningitis outbreak that has caused 11 deaths in four states
Reps. Henry Waxman (D-Calif.), Frank Pallone (D-N.J.) and Diana DeGette (D-Colo.), the ranking members, respectively, on the Energy and Commerce Committee, health subcommittee and oversight and investigations subcommittee, sent a letter Tuesday (PDF)
—in the middle of a seven-week-long congressional recess—to Reps. Fred Upton (R-Mich.), Joe Pitts (R-Pa.) and Cliff Stearns (R-Fla.), the chairmen of those panels, requesting an investigation into the outbreak caused by a contaminated, injectable steroid made by Framingham, Mass.-based New England Compounding Center, a pharmacy compounding facility.
The letter acknowledged that “compounding pharmacies can serve an important public health function” by adjusting medications to suit patient needs. It also highlighted the Food and Drug Administration Modernization Act of 1997, which included provisions to regulate the practice of pharmacy compounding. Congress intended, the lawmakers wrote, for pharmacy compounding to be confined to limited instances and did not intend for a compounding pharmacy to act as a small drugmaker.
“Yet it appears that is exactly what NECC did: it appears it was able to essentially operate as a manufacturer, producing large quantities of the drug, shipping it to hundreds of pain clinics in dozens of states, and even flying in sales representatives to potential customers, all with no oversight from FDA,” according to the letter.
Waxman, Pallone and DeGette said the FDA is not the only regulatory body responsible for overseeing the situation because states mostly regulate the practice of pharmacy. The investigation should seek the answers to a host of questions, including whether the FDA knew that the NECC manufactured and shipped more than 17,000 vials of the steroid to 23 states, what state laws governed NECC's activities and whether NECC served a legitimate medical need.
Meanwhile, Rep. Rosa DeLauro (D-Conn.)—ranking member on the House Appropriations subcommittee that funds the FDA—announced Tuesday that she will introduce legislation that would bolster the FDA's authority
to ensure the safety of drugs from compounding pharmacies. In a letter to HHS Secretary Kathleen Sebelius, DeLauro asked what HHS is doing to reach out to healthcare providers and patients to make sure large patient populations are quickly notified that their health could be at risk. The Connecticut Democrat also asked how HHS ensures the safety and efficacy of compounded drugs prescribed for patients in the Medicare program, and how the department makes certain that Medicare reimbursement does not “inadvertently incentivize the use of compounded drugs”?
In the upper chamber, Sen. Richard Blumenthal (D-Conn.) sent a letter this week to FDA Commissioner Margaret Hamburg
stating, “Stricter scrutiny by the FDA could help prevent contamination of medicines—apparently the cause of this 23-state crisis—produced by such compounding pharmacies.”
According to the Centers for Disease Control and Prevention, the potentially contaminated injections were given starting on May 21, and the form of meningitis is not contagious.
On Oct. 6, NECC
announced a nationwide voluntary recall of all products that were distributed from the company's Framingham facility. NECC said that it would notify all its customers by fax, and that “clinics, hospitals and other healthcare providers that have product which is being recalled should stop using the product immediately, retain and secure the product” and follow the instructions included in the company's notice.