FDA, pharmacy groups support Senate draft compounding legislation

Some disagreement on details at HELP Committee hearing


FDA and pharmacists testifying at the Senate Health, Education, Labor, & Pensions (HELP) Committee hearing today generally supported draft compounding legislation released by the committee on April 26.

With a goal of marking up a compounding bill before Memorial Day, the HELP Committee held the full committee hearing, Pharmaceutical Compounding: Proposed Legislative Solution, to refine the draft proposal with input from stakeholders including FDA and pharmacists representing the National Association of Boards of Pharmacy (NABP), The Pew Charitable Trusts, International Academy of Compounding Pharmacists (IACP), and American Society of Health-System Pharmacists (ASHP).

“From the general tone, I think we’re very, very close,” said Sen. Tom Harkin (D-IA), Chair of the HELP Committee, at the end of the 2-hour hearing.

The witness on the first panel was Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA. “We’re here because of an appalling tragedy,” Woodcock said, referring to the fungal meningitis outbreak linked to the New England Compounding Center that has resulted in at least 55 deaths and 741 illnesses in 20 states, according to the latest counts from CDC. “This bill is a huge step in the right direction.”

Woodcock sought clear authority to look at records particularly in the case of an outbreak and a delayed effective date of compounding legislation.

Asked by Sen. Al Franken (D-MN) whether mom-and-pop pharmacies would have to change their current practices, Woodcock replied, “No, the traditional pharmacy compounding will not substantively change. Period.”

The second panel’s witnesses were Carmen Catizone, MS, BSPharm, Executive Director, NABP; Allan Coukell, BScPharm, Director, Medical Programs, The Pew Charitable Trusts; David G. Miller, BSPharm, Executive Vice President and CEO, IACP; and Kasey K. Thompson, PharmD, Vice President, Office of Policy, Planning, and Communications, ASHP.

Catizone indicated that most provisions in the draft proposal “align well with the approach suggested by the states.” NABP supported FDA authority to “seize any and all records required for oversight of compounding manufacturers” but was “concerned that requirement could create a confusing situation” and called for “better communication”; and NABP believed that non–patient specific intrastate activities fall within the scope and authority of FDA because “the same risks happen with intrastate compounding as with interstate compounding.”

Coukell said he was pleased to support the draft legislation but urged the committee to allow FDA to access records and said some important areas of risk were not addressed by the proposal, including products produced within states.

Miller said, “I think we’re close. We’re not there yet, but we’re close.” His statement focused on what he called consistency, accountability, and patient protection. In the patient protection category, Miller was opposed to the exemption for hospital pharmacies.

Thompson called the draft proposal “thoughtful and well developed.” He supported the provision exempting health systems from being designated as compounding manufacturers; “hospitals and health systems are not engaged in the retail sale of compounded products but instead for the patients being cared for in their hospitals, health systems, and clinics.”

Harkin asked the four pharmacists whether the draft proposal drew a clear line for FDA and states. They each said “yes,” but Miller added, “With [better] definitions.” Harkin asked the pharmacists whether the draft proposal provided tools for FDA. They each agreed, but Coukell said, “Some tools, not all”; and Thompson said that he supported the user fees but was concerned about general funds for FDA.

Then Harkin zeroed in on areas of disagreement among the pharmacy groups. Noting that Miller had testified hospitals should not be exempt and Thompson had testified in support of the exemption, Harkin asked Catizone and Coukell to weigh in on whether hospital systems should be exempt.

Catizone and Coukell supported the exemption.

Sen. Lamar Alexander (R-TN) pursued the question of FDA access to records.

Catizone repeated that “allowing FDA access to records and giving them authority over state-regulated activities [would] cause confusion.” Miller said that FDA has “always had the ability to access records” and that IACP doesn’t “believe changes to a statute that’s worked for a long time are actually mandated.” Thompson said that “records should stay within the state. If FDA has cause, they shouldn’t be prohibited from accessing records.”

But Coukell said, “It’s hard to carry out responsibilities without ability to access those records.”

Toward the end of the hearing, Sen. Pat Roberts (R-KS), a veteran of previous attempts by Congress to regulate the compounding industry, told Miller, “I’m glad you’re on the stagecoach.”