US Food and Drug Administration (FDA) Commissioner Margaret Hamburg was faced with skeptical and at times angry questioning by legislators at a hearing regarding a recent outbreak of fungal meningitis that has killed dozens and made hundreds ill.
In her prepared testimony, Hamburg said the crisis had been caused by a confusing patchwork of regulation in which FDA theoretically had authority over some, but not all, compounding operations, but was consistently operating in legally murky waters. Hamburg also called on the legislators, members of the House Energy and Commerce Committee, to support a new approach under which FDA would have explicit authority to regulate so-called "non-traditional compounders."
[To read more about Hamburg's plan, please see Regulatory Focus' 14 November 2012 story, "Hamburg Calls for New Regulatory Authority in Wake of Compounding Scandal."]
A Cold Reception for Hamburg
But if Hamburg was expecting a warm or even sympathetic reception from legislators, she was quickly disabused of those notions. The previous witness, Barry Cadden, owner of the New England Compounding Center-the facility blamed for the outbreak-informed the committee shortly before being sworn in for testimony that he would be exercising his Fifth Amendment rights not to make any statements that could be self-incriminating to the committee. Cadden remained on the stand for just a few minutes. The previous witness, Joyce Lovelace, is the widow of a federal judge who died after being injected with a compounded drug manufactured by NECC.
The remaining two witnesses, Hamburg and Dr. Lauren Smith, who assumed control of the Massachusetts Department of Public Health just three weeks ago, were left to face the brunt of the legislators' anger, the majority of which fell on Hamburg.
A frequent question asked of Hamburg related to FDA's 2002 inspection of NECC's facility and inspections made of the facility thereafter.
"I was stunned and angered to learn that an inspection of the NECC by the FDA and the Mass Board over 10 years ago identified contamination in the very same drug at issue in the current outbreak," said committee chairman Fred Upton (R-MI). "The reason for that inspection? Patients had been hospitalized with meningitis-like symptoms."
"This is simply inexcusable," he added. "After observing multiple violations of the Food, Drug, and Cosmetic Act leading up to FDA's 2006 Warning Letter, why did the agency fail to conduct a single follow-up inspection?"
A Failure to Lead?
Throughout the hearing, Hamburg struggled to explain FDA's actions, at times earning legislators' ire as they pressed her for both details and simply answers.
"There is an enormous lack of clarity, and we should seize this opportunity to address it," Hamburg said.
In a memorable exchange, Rep. Tim Murphy (R-PA) launched into a scathing rebuke of Hamburg, accusing her of a failure of leadership. (@2:33:00)
"I'm sorry I can't just give you a yes-or-no answer, but this is a very complex issue," Hamburg said, referring to whether the agency had a definition of pharmaceutical compounding in relation to the definition of pharmaceutical manufacturing.
"Ma'am, that's not complex," snapped Griffin. "Complex is the lives of the 32 victims …. What you have to do is easy, ma'am. Leadership is easy if you're willing to accept it, and you are not."
"Go look in the eyes of the victims and try to comfort them with that," he added, referring to Hamburg's answer over definitional complexity.
Numerous other congressmen expressed their skepticism about FDA's authority as well, noting that FDA has at various times asserted the authority necessary to inspect compounding pharmacies. Rep. Morgan Griffith (R-VA) said he was confused in particular by how FDA had the authority to raid NECC earlier in the month to seize records and materials, but didn't have the authority to inspect even after it was aware that the pharmacy was engaging in activities that met the definition of manufacturing.
Even members of the committee who are normally sympathetic to FDA-Henry Waxman (D-CA) and Diana DeGette (D-CO)-seemed frustrated with Hamburg's responses, at times formulating their own responses on behalf the commissioner and explaining the complexities of compounding law to their colleagues.
"Next time, let DeGette prepare Hamburg's testimony," quipped healthcare legal expert Kevin Outterson of Boston University Law School on Twitter. "Very clear [explanation of compounding law]."
Is Congress to Blame?
But if legislators were quick to blame Hamburg, some reports indicate Congress may be as much to blame as any state or federal agency. The New York Times on 13 November filed a report noting close ties between compounding pharmacies and federal legislators, noting the ties "have helped drug compounders avoid tighter rules."
"Over the years, industry friends like Tom DeLay, the former House Republican leader from Texas, have come to its defense," the Times noted. "Even Senator Edward M. Kennedy, regarded as the strongest health care advocate in Congress in recent times, dropped efforts to impose new safeguards."
The industry, though low in lobbying resources, persuaded many legislators that it was a low-cost alternative to non-compounded drug products, and thus should be exempted from tighter regulations.
But if those arguments worked in the past, they may now fall on deaf ears. "If history is a guide," observed the Times, "it often takes a disaster to get real change in the law."