At a hearing of the same committee five months ago, Hamburg argued that the FDA was hamstrung in its efforts to exert tighter control over compounders, which are generally regulated by state agencies.
“It is clear to me that we should have more aggressively (used our authority) in spite of (conflicting) statutes, a changing legal landscape and continuous challenges to our authority by the industry,” she said today.
She also warned lawmakers, however, that if Congress doesn't clarify and strengthen the FDA's authority over certain types of compounders, another NECC-type situation could happen.
Specifically, Hamburg asked for legislation that requires all compounders to register with the agency. In addition, she called for uniform quality standards to abide by and mandatory reporting of adverse events to the FDA. Currently, section 503(a) of the Food, Drugs and Cosmetics Act exempts compounders from certain regulations that apply to other drug manufacturers.
Hamburg said the authority the agency currently possesses is too limited and not enough to properly ensure the safety of some compounding pharmacy products. In particular, she said her biggest concern amongst such pharmacies is with those making what she called “high-risk, sterile” products that are often made in high volumes despite not having an individual prescription and sent out of state. Hamburg estimated about 3,000 compounding pharmacies engage in making sterile products.
She added that there have been several occasions where the FDA has been rebuffed by compounding pharmacies to conduct inspections, saying that the agency does not have such authority, and have sued to prevent access.
In response to questioning from one committee member, Hamburg said she agreed that the International Academy of Compounding Pharmacists, a trade association, has stepped in the way of inspections, adding that “the IACP has for many years questioned our authority.”
The IACP, which declined an invitation to testify, said in a statement that the FDA's recent round of inspections conducted at compounding pharmacies demonstrates “that the agency does indeed have the necessary authority and ability to determine if there are problems or questionable practices in those facilities.” The organization asserted in the statement that public health crises like the one tied to NECC could be averted by better communication between the FDA and state boards of pharmacy.
Some Republican members of the committee similarly wondered whether the FDA really needs additional regulatory authority.
“Before we get to the matter of additional authorities and new legislation, we have to ensure that the agency is going to be ready to implement them properly,” Committee Chairman Rep. Fred Upton (R-Mich.) said. He added that he was troubled by the agency given that district staff had pushed to reinspect NECC facilities or take enforcement actions, “but in most cases, it didn't happen. This is what concerns me the most.”
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