In my last appearance before this Subcommittee, I presented a framework that could serve as a basis for the development of a risk-based program to better protect the public health, improve accountability, and provide more appropriate and stronger tools for overseeing this evolving industry. We have since met with over 50 stakeholder groups, including pharmacy, medical, hospital, payer, and consumer groups, and State regulators, to help further our understanding and inform our framework. Today, I will first provide background on FDA’s current legal authority over compounded drugs, then provide additional details about the framework and suggest specific actions that Congress can take to help us better do our job and prevent future tragedies like this one.
FDA’s Legal Authority over Compounded Drugs
FDA regards traditional pharmacy compounding as the combining or altering of ingredients by a licensed pharmacist, in response to a licensed practitioner’s prescription for an individual patient, which produces a medication tailored to that patient’s special medical needs. In its simplest form, traditional compounding may involve reformulating a drug, for example, by removing a dye or preservative in response to a patient allergy. It may also involve making an alternative dosage form such as a suspension or suppository for a child or elderly patient who has difficulty swallowing a tablet. FDA believes that pharmacists engaging in traditional compounding provide a valuable medical service that is an important component of our health care system. However, by the early 1990s, some pharmacies had begun producing drugs beyond what had historically been done within traditional compounding.
After receiving reports of adverse events associated with compounded medications, FDA became concerned about the lack of a policy statement on what constituted appropriate pharmacy compounding. In March 1992, the Agency issued a Compliance Policy Guide (CPG), section 7132.16 (later renumbered as 460.200) to delineate FDA’s enforcement policy on pharmacy compounding. It described certain factors that the Agency would consider in its regulatory approach to pharmacies that were producing drugs.
The compounding industry objected to this approach and several bills were introduced, some with significant support, to limit the Agency’s oversight of compounding. In November 1997, S. 830, the Food and Drug Administration Modernization Act of 1997 (FDAMA), was signed into law as Public Law 105-115. FDAMA added Section 503A to the FD&C Act, to address FDA’s authority over compounded drugs. Section 503A exempts compounded drugs from three critical provisions of the FD&C Act: the premarket approval requirement 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. These provisions were the subject of subsequent court challenges, which have produced conflicting case law and amplified the perceived gaps and ambiguity associated with FDA’s enforcement authority over compounding pharmacies. In 2002, immediately after a Supreme Court ruling that invalidated the advertising provisions of Section 503A, FDA issued a revised compliance policy guide on compounding human drugs. Several additional legal challenges and court decisions then followed. More recently, FDA made significant progress toward issuing another CPG. In fact, FDA was on track to publish a revised draft CPG in the fall of 2012, but the fungal meningitis outbreak intervened and we are now reevaluating the draft. It is important to note, however, that a CPG is not binding on industry and updating the CPG would not alleviate all issues with Section 503A.