The Republican-controlled House Energy & Commerce Subcommittee on Health on July 16 held a hearing to examine three compounding legislative proposals, namely the Senate Health, Education, Labor, & Pensions (HELP) Committee bill (S. 959), a bill introduced by former House Democrat Sen. Ed Markey (D-MA) (H.R. 2186), and a discussion draft put forward by Rep. Morgan Griffith (R-VA). Unlike the two bills sponsored by Democrats, Griffith’s draft proposal contained no new authorities for FDA.
“We are not trying to take anything away from the current FDA authority,” Griffith said deep into the nearly 3-hour hearing. “We are trying to clarify without going too far.”
Materials for the July 16 hearing, Reforming the Drug Compounding Regulatory Framework, were posted on the House Energy & Commerce website. These materials include S. 959, H.R. 2186, Griffith’s discussion draft, and written testimony from the witnesses’ organizations, including FDA on the first panel and the National Community Pharmacists Association (NCPA), American Society of Health-System Pharmacists (ASHP), Pharmaceutical Research and Manufacturers of America (PhRMA), Generic Pharmaceutical Association, Pew Charitable Trust, International Academy of Compounding Pharmacists (IACP), and National Association of Boards of Pharmacy (NABP) on the second panel.
At issue in the drive by Congress to address the regulatory gray area occupied by the evolving compounding industry is section 503A of the Federal Food, Drug, and Cosmetic Act, which was added to the law in 1997. Section 503A exempts compounded drugs from three of the law’s provisions, including the premarket approval for new drugs, the requirement that a drug be made in compliance with current Good Manufacturing Practice (cGMP) standards, and the requirement that the drug bear adequate directions for use, provided certain conditions are met, according to FDA’s written testimony. Subsequent court decisions have “amplified the perceived limitations and ambiguity associated with FDA’s enforcement authority over compounding pharmacies.”
Griffith’s discussion draft would amend section 503A to clarify that the following conditions in general must be met: identified patient and receipt of prescription; timing and specificity of prescription or purchase order, including submission of a patient-specific valid prescription order to the pharmacist or physician not later than 7 days after the drug product is administered; compounding in compliance with U.S. Pharmacopeia standards; compounding using bulk drug substances and other ingredients in compliance with applicable monographs, with exceptions; drug products that do not appear on a “do not compound” list; drug products that are not essentially a copy of a commercially available drug product; drug products not presenting demonstrable difficulties for compounding; and a volume limitation yet to be determined.
In addition, Griffith’s bill would require a system for improved communication between FDA and state boards of pharmacy related to actions taken about compounding pharmacies or concerns that a compounding pharmacy may be acting illegally as a manufacturer, developed in consultation with NABP; FDA to review submissions from state boards of pharmacy and follow up with inspections of pharmacies in violation of the law not later than 60 days after receiving a submission, where an inspection may be in coordination with the relevant state board of pharmacy; an advisory committee on compounding including representatives from NABP, the U.S. Pharmacopeia, pharmacy organizations, physician organizations, consumer organizations, and others; updating lists at least once a year; and a review of FDA regulations on the possibility of adverse event reporting by compounding pharmacies.
At the beginning of the hearing, Griffith indicated that he wanted to draw a line between compounders and manufacturers with respective state and FDA oversight. He pressed the first witness, FDA’s Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research, for a number to nail down at what volume a compounding pharmacy can be classified as a manufacturer. “We’re never going to get it perfect. But let’s get it 80 to 90 yards down the field,” Griffith said.
Griffith also pressed for a number on the shelf life of compounded drugs. “I know this is difficult,” he added. “But sometimes we have to pull the trigger and figure out what the numbers are.”
In an opening statement, Rep. Henry Waxman (D-CA) supported FDA’s repeated arguments for new authorities over a new class of nontraditional compounders that doesn’t fit neatly within the “binary structure” of compounders and manufacturers under current law. He said that the agency needs strong records inspection authority, compounders to register, reporting of adverse events, and “a steady stream of resources.”
But Health Subcommittee Vice Chairman and Rep. Michael C. Burgess, MD, (R-TX) called new authorities for FDA a “power grab” and asked who at FDA had been fired over the deadly fungal meningitis outbreak linked to the now-closed New England Compounding Center (NECC). “It doesn’t sound like a gap in the statute,” he said. “It sounds like an enforcement issue.”
Woodcock responded to a question from Waxman about the 7-day provision in Griffith’s discussion draft that FDA was “struggling to put some type of quantitative framework.” Woodcock told Rep. John D. Dingell (D-MI) that FDA proposed using interstate commerce as a proxy for risk. In a later exchange with Rep. Marsha Blackburn (R-TN) related to the volume limitation, Woodcock told her, “We have struggled with this and we have had a very difficult time coming up with a coherent scheme that would use volume.”
Rep. Kathy Castor (D-FL) asked Woodcock to weigh in on the three legislative proposals on the table. Woodcock preferred the Senate bill and said, “We feel that’s a good start.”
Soon the second panel of witnesses had their chance to provide 5-minute summaries of their written statements, followed by questioning from Members of Congress.
NCPA CEO B. Douglas Hoey, BSPharm, MBA, supported Griffith’s discussion draft as striking the “proper balance.” NCPA specifically supported its preservation of state board of pharmacy oversight of pharmacy compounding and preservation of office use and anticipatory compounding.
ASHP’s Kasey K. Thompson, PharmD, MS, Vice President of Policy, Planning, and Communications, said that the evolution of the compounding outsourcing industry has outpaced the law’s ability to keep up. He expressed concern that state boards of pharmacy may not have the capability to determine whether compounders have crossed the line into manufacturing. ASHP believed that FDA should regulate compounding outsourcers.
PhRMA’s Jeffrey Francer, JD, MPP, Assistant General Counsel, believed pharmaceutical manufacturers and nontraditional compounders should be regulated by FDA “using the same high safety standards” and that “in light of NECC, Congress should revisit FDA’s authority.” He said that a third class of nontraditional compounders was unnecessary.
David Gaugh, BSPharm, Senior Vice President for Sciences and Regulatory Affairs of the Generic Pharmaceutical Association, said that FDA should regulate large-scale sterile compounders to the same standards as apply to sterile manufacturers, specifically cGMPs and adverse event reporting requirements; and that FDA should have additional resources to conduct inspections of large-scale compounders and compounding manufacturers.
Allan Coukell, BScPharm, Senior Director of Drugs and Medical Devices at the Pew Charitable Trusts, called the current law inadequate and supported a third category that is neither traditional compounding nor drug manufacturing. He called for large-scale operations to be subject to cGMPs, said that expiration dates may serve as a distinguishing mechanism, and that compounded drugs should be clearly labeled as such.
IACP Executive Vice President and CEO David G. Miller, BSPharm, said that Griffith’s discussion draft was “the closest solution.” He said that NECC “fundamentally has uncovered a real gap in our laws,” and noted that during the day’s testimony he had heard “six different terms to define this thing that we are attempting to regulate.”
NABP Executive Director Carmen Catizone, MS, BSPharm, DPh, said that NABP supported the Senate HELP bill and supported the new category of compounding manufacturing falling under the purview of the FDA. “There are provisions in the House bills that could take us in the wrong direction and could lead to another NECC tragedy,” he said.
During the question-and-answer part of the hearing for the second panel, Griffith said, “I don’t believe that our bill would have allowed the NECC situation to have occurred.” As the second panel’s witnesses suggested ways to clarify section 503A—volume, expiration dates, interstate commerce, percentage of business—Griffith added, “We’re going to have to draw the line somewhere.”
Before the hearing adjourned, Rep. Renee Ellmers (R-NC) asked ASHP’s Thompson why state boards shouldn’t regulate nontraditional compounders. Thompson replied, “It comes down to resources and expertise.” He added, “Some version of cGMPs would be important.”