PhRMA, AAM Seek Tweaks to FDA’s Verification Guidance

Regulatory NewsRegulatory News | 05 February 2019 |  By 

Pharmaceutical and generic drug industry groups are seeking changes to US Food and Drug Administration (FDA) draft guidance on the verification systems that can determine, quarantine and investigate suspect or illegitimate products.

The 11-page draft, released last October, lays out how FDA recommends that trading partners submit cleared product notifications (ie. that a product is not illegitimate) and the statutory requirements for verification, including verification of saleable returns, at the package level for product identifiers on packages and homogenous cases intended to be introduced into commerce.

Both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Association for Accessible Medicines (AAM) took issue with a provision in the draft that requires manufacturers and repackagers to have systems in place to respond to requests for verification from trading partners within 24 hours of receipt of a request.

“In certain circumstances, however, ensuring accurate responses may not be feasible within a 24-hour timeline (e.g., when the request for verification is received on a holiday weekend),” PhRMA notes, suggesting that FDA clarify when certain circumstances arise that would allow for flexibility and a longer time period.

AAM also notes that some contract manufacturers may have facilities located outside the US, meaning it may be necessary to allocate more than 24 hours for certain requests.

“AAM member companies believe the imposed 24-hour response requirement would present a challenge taking into account adequate time necessary to provide notice to and receive a response from FDA. As such, AAM would like for FDA to consider instituting an expedited communication method” that could be in the form of an email address “to provide quick responses and respond to stakeholders for queries similar to requests for additional time due to local customs, time differences, etc. as needed,” AAM said.

The generic drug association also raised questions with sections of the guidance on enhanced verification and the scope of data integrity rules.

PhRMA, meanwhile, takes issue with a requirement in the draft that requires companies to retain samples of illegitimate product.

“PhRMA is concerned by this requirement as many companies do not have a system for storing (either short-term or long-term) samples of illegitimate product or for recording chain of custody for such samples,” the lobbying group said. “Maintaining these samples in perpetuity would be a resource burden to industry. PhRMA recommends that FDA update the Draft Guidance to explicitly state that 1) this requirement applies only to confirmed illegitimate product (as opposed to suspected illegitimate product), and 2) that samples of illegitimate product must be retained only until the investigation has been completed (in other words, the end-date for sample retention is the same as the end-date of the investigation).”



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