Industry Calls on FDA to Streamline Process of Providing Marketing Status Updates

Regulatory NewsRegulatory News | 03 April 2019 |  By 

Industry groups PhRMA and the Association for Accessible Medicines (AAM), as well as companies Pfizer and Teva Pharmaceuticals are calling on the US Food and Drug Administration (FDA) to tweak and clarify recently drafted guidance on marketing status updates.

The draft guidance from January helps sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they have to share with FDA on the marketing status of their products. The 5-page guidance identifies the required content for marketing status notifications, the recommended format for submitting these notifications to FDA and the required timelines for submission.

On the NDA side, PhRMA noted that sponsors are subject to “multiple and overlapping status notification requirements” and therefore recommends FDA to “take steps to streamline implementation of those submission requirements...PhRMA suggests that FDA consider adopting one notification procedure that can satisfy all the requirements.”

Similarly, on the generic side, AAM explains how the draft guidance “creates scenarios where a sponsor will be required to notify FDA with upwards of four separate types of submissions when providing market status of a product.”

AAM requests that FDA review the various regulations to streamline the submission processes and improve efficiencies where possible.

PhRMA also calls on FDA to provide more clarity on what it means when the draft guidance says it will consider a product deemed “withdrawn from sale” but without a notification from a sponsor. “We recommend that FDA clarify when the Agency would move a product to the Discontinued Drug Product section without a withdrawal notice from the sponsor,” PhRMA writes.

Teva, meanwhile, calls for more clarity from FDA when the draft references “the date on which the drug is expected to no longer be available for sale.”

“That date may be different, depending on interpretation. For example, it could be the date the manufacturer ceases to sell product to wholesalers/pharmacies. Or, it could be the last date that any dispensing pharmacy may have non-expired product available on its shelves. Teva’s longstanding practice has been to define the last date of sale according to the date of expiration of the last lot released for sale,” Teva says.

Further clarity is also sought by Pfizer on how potential errors might be corrected. The draft explains how FDA can move an NDA and/or ANDA holder’s (or holders’) drug products from the active section of the Orange Book to the discontinued section if certain marketing status notifications are not submitted.

“The Draft Guidance should also note when and how sponsors are notified of FDA decision to move products from the active section of the Orange Book to the discontinued section. It is unclear what process a sponsor should follow if they consider that there has been an error in FDA action, including whether a sponsor will be allowed an opportunity to confirm or correct status prior to the Agency’s action,” Pfizer writes.

And AAM also wants to tweak the draft so that sponsors can make status notifications earlier than “once marketing begins” to allow for Orange Book updates by the time marketing commences.

“Notification after marketing begins will result in a delay in updated Orange Book information reflecting when the drug is available for sale, which could affect how the product is viewed by important stakeholders in the marketplace, especially payers. AAM recommends that FDA allow sponsors, if they so choose, to provide notice 60 days prior to the planned launch date, ensuring adequate time for FDA to update the Orange Book listing to accurately reflect availability of a product on the actual launch date,” the group said.



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Tags: AAM, Pfizer, PhRMA, Teva

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