A House Energy and Commerce Committee meeting about the meningitis outbreak ended on a bitter note Wednesday, with lawmakers asking the FDA what regulatory changes, if any, would give it proper authority, and others arguing the agency failed to exercise powers it already has.
Push to beat the clock
The meeting, headed by the subcommittee on oversight and investigations, followed the deaths of 32 people killed by contaminated versions of methypredinsolone that were made by the New England Compounding Center (NECC). The session lasted just under four hours Wednesday, with lawmakers also clashing over whether it would be possible to grind out effective legislation before the New Year rings out the 112th Congress and brings in the 113th, forcing discussions to start from scratch.
Ranking member Henry Waxman (D-Calif.) pushed the clock issue, telling members that time will give interest groups room to “get up and try to stop regulations,” and anticipated the pleas against compounding pharmacy oversight with claims that “we really don't need the FDA to look at these compounders” and to allow state oversight to handle things.
In addition to killing patients in 19 states and sickening 438, the same drug, made by the same company, was linked to meningitis-like symptoms in the 2000s. Both the FDA and the Massachusetts Board of Pharmacy had identified a series of violations at the NECC locations over the course of 10 years, but the center continued to operate.
Those facts played into the title of the meeting, “The Fungal Meningitis Outbreak: Could it have been prevented?”
Regulatory shortfalls highlighted
Commissioner Margaret Hamburg proposed creating two compounding classifications -- traditional and large scale, with the traditional compounders falling under state regulations and the large-scale compounders who are more like manufacturers to come under FDA authority. A back-and-forth between Hamburg and Rep. John Dingell (D-Mich.) tried to highlight the limited authority Hamburg asserted her agency had when it comes to compounders.
This Q&A indicated that putting large-scale compounders under the same scrutiny as drug manufacturers would mean the FDA would be able to require compounders to report adverse events, give the FDA that authority to review company records without having to use subpoenas and to require good manufacturing practices, among other measures.
Although the impact has been nationwide, and despite the FDA's clear oversight of drug manufacturers, its authority over compounders has been fuzzy, in that the most traditional definition of a compounded medication is a drug that is made for an individual patient, meaning a small-scale operation that makes customized medications with a limited geographic range. The FDA does not regulate such businesses, nor are they required to register with the FDA.
The NECC qualifies as a compounder in name, but its actual business model was at a far larger scale than that of a traditional compounding facility. This difference presents a blind spot, and Hamburg told lawmakers that the agency did not have full power over the compounder because current laws create a gray area that allow the business label -- compounder vs. manufacturer -- to determine its scope.
State agencies currently regulate compounders, but the seeming intersection between the FDA and Massachusetts were a flashpoint throughout the proceedings, because the FDA had issued a warning letter to the NECC in 2006 that threatened the compounder for noncompliance. Committee Chairman Clifford Stearns (R-Fla.) asked how the FDA could issue such a letter if it lacked the authority to follow through. This trope was repeated and countered by various lawmakers, without resolution.
Several Congressmen picked at the perceived divide between compounders of scale and drug manufacturers, and pressed Hamburg how her agency could not see that a large-scale manufacturer was operating like a drug manufacturer. “If all you need is a cloak of invisibility of saying, ‘I'm a compounding pharmacist'...that's nonsense. No one believes that's the way it should be,” said Rep. Michael Burgess (R-Tex).
“We need a strong, clear appropriate legislation. We cannot have a crazy quilt where different parts of the country,” have different rules, Hamburg told the committee.
The agency was also criticized for failing to turn over emails committee members requested last month. Hamburg said the emails were coming, but the same people who would handle the emails are the ones handling the NECC fallout, displeasing several lawmakers, including Burgess who threatened to issue a subpoena to get them. “Give us the stuff,” he said, adding that seeing the correspondence will allow them to understand the shortcomings of the current legislation.
NECC President/Co-Owner and Director of Pharmacy Barry Cadden pled the fifth to all of the committee's questions.
Congressmen also heard from a victim's family. “We have lived a nightmare,” recently widowed Joyce Lovelace told the committee members before proceedings kicked off. “We will be living this nightmare for ages to come...it was such a useless thing that happened to my husband.
“We are angry. We are heartbroken. We're devastated. And I'm here begging you to do something about the matter,” Lovelace added. She found out her 78-year-old husband's death was linked to the contaminated drug from news reports. Her doctors initially said he died of a stroke.