Compounding hearing: FDA seeks more authority

Republicans not so sure new legislation needed; Democrats’ request for IACP testimony rejected by Republicans

At an April 16 hearing held by the House Energy & Commerce Subcommittee on Oversight and Investigations, FDA Commissioner Margaret A. Hamburg, MD, repeatedly argued for new legislative authority over the highest-risk compounding pharmacies, even as questions posed by the Republican majority conveyed skepticism about the need for new legislation.

The 3-hour investigative hearing, A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented, featured testimony under oath primarily by one witness—Hamburg—as well as a lawyer at FDA. Throughout the hearing, Hamburg often responded that she could not answer questions because of the ongoing criminal investigation.

Hamburg’s introductory testimony barely dipped into her written testimony, which referred to the 1997 law that added section 503A to the Food, Drug, and Cosmetic Act, and to subsequent conflicting court decisions interpreting the law differently for different parts of the country.

The hearing was the House subcommittee’s second hearing on the fungal meningitis outbreak—linked to the now-closed New England Compounding Center (NECC)—in which 53 people have died and more than 700 people have fallen ill, according to CDC. The House subcommittee’s first hearing was held November 14, 2012, the day before a Senate Health, Education, Labor, & Pensions Committee hearing on the tragedy.

Pushback by industry

At times, Republican members of the subcommittee addressed Hamburg in raised voices and asked for “yes or no” answers to their questions, especially questions concerning why it took FDA so long to respond to years of accumulating complaints about NECC and its sister company, Ameridose. Meanwhile,  Democratic members brought up pushback by the compounding industry, specifically the International Academy of Compounding Pharmacists (IACP).

Before the hearing, Democratic Reps. Henry A. Waxman (D-CA), Diana DeGette (D-CO), John D. Dingell (D-MI), and Edward J. Markey (D-MA) had sent an April 11 letter to subcommittee Chair Tim Murphy (R-PA) urging him to invite the IACP head to testify. The majority rejected the request.

Wrote the Democrats in their letter: “Internal IACP documents provided to the Committee reveal that for almost two decades, the organization lobbied aggressively and successfully to restrict FDA authority over compounding pharmacies, even when top IACP leaders were aware of significant public health risks from compounding.”

During the hearing, Dingell referred to “the trade association for these people” and added, “Let’s haul the right people in. Let’s get the right kind of legislation drafted. Let’s get the proper testimony. And let’s move forward.”

New legislation needed?

Starting the second round of questions, Murphy said: “We are talking about new legislation. I, for one, am not yet convinced that FDA has taken steps to clean up its own house.” He later told Hamburg: “You have said repeatedly that you don’t have the authority to have stronger oversight. My concern remains that where you do have authority you haven’t used it—except for the recent flurry of well-publicized inspections.”

“We weren’t as aggressive as we could have been,” Hamburg said in a subsequent exchange. “I regret that.” She added: “The uncertainty and ambiguity in the law and the patchwork of application of this law was making it harder for us to do our job.”

Waxman cited conflicting court decisions on the law. “It’s hard for any reasonable person not to conclude that you need a stronger, clear law to give you authority.” If FDA had acted sooner, the compounding industry would have alerted all its members, aggressively pursued pushback in the public and on Capitol Hill, and maybe sued the agency to go back to court; and FDA would have faced Congress, too, he said. “It’s easy to blame FDA, but in the real world, it would have been very hard to do this.”

Subcommittee Vice Chair Michael C. Burgess, MD, (R-TX) closed out the hearing. “It does seem at the agency [that] the emphasis was on policy and not on protecting the patient.” FDA’s mission is to protect the patient, he said. “The policy will always work itself out.” 

“Patients and public health have to be our first priority,” Hamburg replied. “If you give us additional authority that we feel we need to do the best possible job for the American people, we will use it.”

New legislation takes “a lot of time,” especially given the “current political environment,” Burgess responded. “Don’t blame your tools. Do your work.” 

Hamburg then said: “We need new tools.”