The Drug Quality and Security Act (DQSA), recently passed into law in November, contains numerous provisions intended to regulate pharmaceutical.
The Drug Quality and Security Act (DQSA), recently passed into law in November, contains numerous provisions intended to regulate pharmaceutical products produced by so-called “compounding pharmacies.” Compounding pharmacies make custom versions of already-approved pharmaceuticals with the purpose of meeting unique patient needs. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, or to avoid a non-essential ingredient that the patient is allergic to.
In the early 1990’s, some pharmacies had begun producing drugs beyond what had historically been done within traditional compounding. In 1992, the FDA issued a Compliance Policy Guide 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 a 1996 House Commerce Committee hearing on FDA reform legislation, FDA Commissioner David Kessler testified that the compounding provision being considered by the Committee (to limit the Agency’s oversight) was likely to encourage large-scale manufacturing under the guise of pharmacy compounding, and could allow for potentially dangerous compounding of sterile products, leading to serious safety problems or death. The following year, the Food and Drug Administration Modernization Act of 1997 (FDAMA) was signed into law, and addressed the FDA’s authority over compounded drugs. The FDAMA exempts compounded drugs from three critical provisions of the 1938 Federal Food, Drug, and Cosmetic Act (FDCA): the premarket approval requirement for “new drugs”; the requirement that a drug be made in compliance with current good manufacturing practice (cGMP); and the requirement that the drug bear adequate directions for use, providing certain conditions are met. Further, the FDAMA allows the FDA to restrict the compounding of certain categories of drugs, limits the quantity of compounded drugs that a pharmacy could ship out of state, and contains restrictions on the advertising or promotion of the compounding of any particular drug. These provisions of the FDAMA were the subject of several subsequent court challenges, which have produced conflicting case law. As a result, pharmacy compounding over the last decade has fallen into a gray area between state and federal oversight.
After the 2012 deadly outbreak of fungal meningitis that was traced to several lots of a drug compounded by the New England Compounding Center, many saw a need for more federal regulations regarding compounding pharmacies. The result was the passage of the DQSA in November 2013, which granted the FDA more authority to regulate and monitor the manufacturing of compounded drugs. Required in this act, is the creation the Pharmacy Compounding Advisory Committee. This newly created advisory committee (adcom) will provide advice on scientific, technical, and medical issues concerning drug compounding. The FDA is currently accepting nominations for this newly created adcom and will likely see the first meeting of the Pharmacy Compounding Advisory Committee take place this year.
The creation of the Pharmacy Compounding Advisory Committee serves as a reminder that in the current environment of increasingly strict federal regulations, the creation of new FDA advisory committees will become an increasingly common event. Innovative Science Solutions (ISS) provides strategic support for sponsors participating in FDA Advisory Committee meetings. Navigating this increasingly complex regulatory environment appropriately (including meetings with newly created adcoms) is critical for a successful outcome. It is ISS’ experience that allows us to provide high quality insight into preparing for these issues and tackling them head on.
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