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FDA’s Final Rule on Combination Products

Combination drugs continue to grow in popularity as novel alternatives and advances in biotechnology, pharmaceuticals and medical devices.  The market continues to see combination products like pre-filled syringes, drug patches and drug-coated devices as well as a host of other innovative drug and drug delivery combinations. This trend is of course bringing about an increased number of submissions for the U.S. Food and Drug Administration (FDA) and a desire from manufacturers to clearly understand requirements for compliance.

In September of 2009, FDA issued a proposed rule concerning current good manufacturing practice (cGMP) requirements for combination products.  The rule is really quite simple for companies that are manufacturing and packaging products separately – they follow their individual cGMP requirements.  It is the single-entity and/or co-packaged products that have posed the greater challenge.

At the beginning of 2013, FDA issued a final rule on cGMP requirements, attempting to add clarity on how these products can demonstrate compliance, while ideally streamlining the approach and reducing duplication of effort for the manufacturers/ packagers.  This final rule states that the combination product can either separately meet each of their own cGMP requirements or meet one of two guidelines they lay out in the rule.  (Click here to read details of the guidelines.)

FDA estimates that approximately 300 companies will be impacted.  Companies  currently operating in the combination product space will need to assess their compliance with this rule, although most view this as just a codification of current practices.  Although no new cGMP requirements are specifically proposed, some companies may choose to streamline or modify current practices and their associated SOPs to benefit from the clarifications of this final rule.  Those companies that are engaging in acquisitions and partnerships to enter the combination product space will need to count the costs of compliance and managing multiple quality systems.

The rule will take effect July 22, 2013.

Click here to read the Federal Register notice.

Tags: Strategy & Compliance