Drugs

FDA Praised for Supply Chain Enforcement Delay

The Biotechnology Innovation Organization (BIO) says its members appreciate an FDA compliance policy statement on product identifier requirements under the Drug Supply Chain Security Act that postpones enforcement of the requirements for one year until 11/2018. The association says the agency “provided sufficient notice to stakeholders to plan for and prepare to be compliant with the new requirements.”

BIO also comments that it is critical for FDA to issue its promised guidance on the grandfathering product provisions as soon as possible so that stakeholders understand the relationship of enforcement discretion and grandfathering. And it asks that the agency align the compliance dates of grandfathering to the manufacturer’s enforcement discretion end date of 11/27/18. “We specifically ask that the grandfathering guidance align to the current industry understanding that any product that is packaged prior to 11/27/18 is grandfathered from the serialization product identifier requirements,” it says.

In its comments, Pharmaceutical Research and Manufacturers of America (PhRMA) also commends FDA for exercising enforcement discretion and not taking action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced into commerce before 11/26/2018. PhRMA asks that FDA clarify that the date that a product “is intended to be introduced in a transaction into commerce” and thus not require a product identifier is aligned with the packaging date, even if that date falls within the period of enforcement discretion. And it wants the agency to clarify that for grandfathering purposes, a product that is packaged during the enforcement discretion period is also grandfathered.

The International Society for Pharmaceutical Engineering says it also supports the one-year enforcement delay for affixing or imprinting a product identifier and consideration of a further two-year delay after 11/27/18 for repackagers to engage only in transactions involving products that bear a product identifier and a commensurate delay in the parallel requirements for wholesale distributor compliance.

In its letter, AmerisourceBergen says that while it supports the delay for manufacturers, it cautions that FDA may need to move other compliance dates in the future and it may seek further enforcement discretion from the agency at a later time.

Specific, line-by-line comments were submitted by Apotex and Gilead.

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