BIO Comments on FDA Draft Guidance: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
<p>BIO applauds the issuance by the Food and Drug Administration (FDA) of the Draft Guidance entitled, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” (Draft Guidance)1 The policies and recommendations set forth in the Draft Guidance, when finalized, represent critical steps forward in the effort to protect patients from biological products prepared under conditions that could result in their contamination or a lack of effectiveness.</p>
BIO applauds the issuance by the Food and Drug Administration (FDA) of the Draft Guidance entitled, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” (Draft Guidance)1 The policies and recommendations set forth in the Draft Guidance, when finalized, represent critical steps forward in the effort to protect patients from biological products prepared under conditions that could result in their contamination or a lack of effectiveness.
As BIO has noted in previous comments to FDA regarding compounding, we strongly believe that the drug compounding provisions of the Drug Quality and Security Act (DQSA) did not alter current law with regard to biologics and that therefore there is still no applicable exemption in the Food, Drug, and Cosmetic Act (FD&C Act) compounding provisions for entities that compound or repackage biological products. As such, BIO is pleased that FDA reiterated in its Draft Guidance that “[a] biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the [Public Health Service] PHS Act.” This means that such a product lacks the assurances of safety, purity, and potency provided by FDA licensure, which requires extensive studies and considerable analytical, preclinical, and clinical data as well as detailed information about the methods, equipment, and controls used to manufacture the product and ensure its quality. Moreover, once a biological product is removed from its approved container-closure system in the absence of appropriate manufacturing controls, it is “highly likely to affect the safety and/or effectiveness of the biological product.”
For this reason, the manipulation of licensed biological products should be limited to instances where medically necessary to meet the specific needs of individual patients and such manipulation is performed under conditions that will help to ensure the quality of the resulting product. We are also concerned with FDA’s stated policy of enforcement discretion, which we elaborate in detail in the section below.
