Washington Report

New FDA Policies Shape Pharma Development and Production - continued

Concerns about compounding Another manufacturing quality issue that surfaced in recent weeks involves large pharmacy compounding operations accused of producing and marketing low-quality drugs on a commercial scale. A coalition of patients and healthcare providers that deal with respiratory problems recently filed a petition requesting that FDA develop labeling rules for compounded drugs that treat asthma and other respiratory conditions, an action that focuses attention on FDA’s long-term difficulties in imposing standards on compounding activities. The patient group claims that the lack of FDA regulation is encouraging a growing number of pharmacy businesses to mass produce aqueous-based drugs for inhalation without approved labeling, instructions for use, or warnings. Petitioners claim that these unregulated products often fail to meet FDA sterility standards and expose vulnerable patients to infection. FDA has a checkered history of trying to impose rules and standards on drug compounding. Historically, most drugs were compounded by pharmacists, and current policies permit pharmacy compounding to fit the needs of individual patients unable to use standard marketed drugs. Pharma companies have long sought to limit the activities of large compounders that operate similarly to manufacturers, but don’t fall under GMPs or FDA quality standards. A provision in the 1997 Prescription Drug User Fee Act aimed to clarify FDA regulatory authority over compounding, but pharmacists objected, and new FDA rules were struck down by a 2002 Supreme Court decision. Since then, FDA efforts to regulate compounders have moved off the front burner, despite continued congressional pressure on the agency to act. At the recent USP convention, members approved a resolution supporting increased pharmacopeia efforts to develop more monographs for compounded drugs, partly to fill the regulatory gap created by the Supreme Court ruling. USP committees recently have written general chapters on compounding procedures and processes for sterile and nonsterile pharmaceuticals and have identified some 1000 compounded preparations that warrant monographs providing standards for analysis. Congress has encouraged FDA to partner with USP to update monographs and chapters on good compounding standards, but FDA officials claim a lack of funds to support such an extensive undertaking. Agency leaders object, moreover, that compiling more monographs for compounded drugs will do little to improve product quality without some way to enforce compliance with standards and that it has no way to monitor thousands of compounders. The agency notes that it has sent warning letters to large compounding operations and is revising a draft pharmacy compounding compliance policy guide. This new petition challenging compounded respiratory medicines could move such efforts up the priority list. (continued)