PhRMA concerned proposed FDA rule could delay excipient import

in-Pharma Technologist has reported that the Pharmaceutical Research and Manufacturers of America (PhRMA) has expressed its concern that the full implementation of a proposed rule could lead to manufacturing delays.

The proposed regulation will authorise FDA to destroy a drug valued at $2500 or less that has been refused admission into the US, only if they have provided the owner or consignee with written notice and an opportunity to present testimony to the agency prior to destruction.

There is also concern regarding the estimate of how many drugs will be destroyed — PhRMA believes FDA's estimate of 12,100 is somewhat conservative and, therefore, says more research is required.

To destroy or not to destroy, that is a question to which PhRMA also seeks further clarity in its quest to understand the criteria that will determine whether a refused drug will be destroyed or exported. FedEx is particularly interested in the export element of the proposed rule, fearing it may have a negative economic impact on carriers.

Although PhRMA and FedEx generally support the proposed rule, they highlight the need for further data and clarity before the rule is implemented.