PUBLIC QUALITY STANDARDS FOR BIOLOGIC PRODUCTS

To oppose federal or state legislation that would remove the requirement for biologic products to adhere to public quality standards; further,

To review and evaluate current public standards to ensure that they are relevant and appropriate to biologic products.

Rationale

ASHP has long recognized that application of quality standards (e.g., United States Pharmacopeia monographs or other applicable guidance) helps guarantee safe use of drugs. ASHP joined virtually all national pharmacy groups, including more than 30 state pharmacy associations, in opposing Congressional efforts to eliminate monographs for biologic medications in the 115th and 116th Congresses. The FDA advocates for voluntary standards for biologic products on the basis of reduced costs and improved access, but the agency does not provide data to justify that stance. The arguments against requiring monographs center on their potential use as a barrier to competition, because manufacturers could incorporate patentable characteristics relevant to the product’s safety and efficacy. However, removing monographs for one class of drugs could open the door to removal of standards for other drug classes and to laxer safety standards generally. There is evidence that the monographs do not dampen innovation, as new products continue to enter the market.