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FDA Pilot Program Will Speed Imports With Secure Supply Chains

This article was originally published in The Tan Sheet

FDA is planning to test a program to speed entry into the U.S. of drugs that flow through a strong supply chain.

The Secure Supply Chain Pilot Program would apply to specific finished drug products and active pharmaceutical ingredients. The goal is to increase substantially the rate of participating products entering the country without human review or examination at point of entry.

This would allow FDA “to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant” with U.S. regulations, the agency explained in response to questions from House Energy and Commerce Committee Oversight and Investigations Subcommittee Chairman Cliff Stearns, R-Fla., and other members.

The subcommittee submitted the questions to Commissioner Margaret Hamburg during an April hearing where she reported on implementation of the PREDICT system – Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting – to identify high-risk imports for possible inspection (Also see "PREDICT Helps FDA Answer Appropriators' Call To Facilitate Imports" - Pink Sheet, 6 Jun, 2011.).

The full committee has discussed legislation to enhance FDA’s drug import oversight since 2007. With the Prescription Drug User Fee Act up for renewal in 2012, Congress could include import safety provisions in the reauthorization bill (Also see "What’s In A PDUFA Reauthorization? Maybe These Issues…" - Pink Sheet, 11 Jul, 2011.).

Committee leaders in both the House and Senate plan to complete action on PDUFA V during the first half of 2012. Supply chain provisions included in the bill likely will be targeted and relatively noncontroversial.

Quick Entry Essential To Program Success

While waiting for Congress to act, FDA is moving ahead with SSCPP, which the agency envisions as a two-year program with 100 participants. While participating products will not receive human reviews at the border at the same rate as other imports, they will be subject to full electronic assessments.

The agency has not indicated how limited human interaction with SSCPP shipments will be, or how much time will be gained at the border.

In comments on the pilot proposed in 2009, Pfizer cautioned FDA to ensure the program delivers faster entry for importers or it will wilt for lack of participation.

The benefit for importers is “increased predictability and reduced clearance time,” as evidenced by “actual improvements in cycle time across the spectrum of ports and products,” the firm stated.

“If improvement is not significant, it is unlikely that participants would go forward with additional products should the pilot continue.”

Participation Requirements

Because specific products or APIs, rather than firms, will participate in the program, an applicant must hold the new drug application or an ANDA, or be the foreign manufacturer of the drug or API.

Shipments of APIs must be used to make FDA-approved drugs. Recipients of a drug in its finished dosage form must be identified in the NDA or ANDA.

The foreign drug manufacturers and U.S. establishments receiving the drugs must be FDA-registered and comply with good manufacturing practices.

Applicants must maintain records to document the product’s movement through a secure supply chain, from the manufacturing site to its receipt by the ultimate consignee.

Participation in Customs and Border Protection’s Customs-Trade Partnership Against Terrorism program is a prerequisite for SSCPP (Also see "FDA Could Beef Up Food Safety Enforcement Through Inter-Agency Center" - Pink Sheet, 21 Dec, 2009.).

Planning For Recalls

Should FDA have concerns about an applicant’s supply chain or a shipment, the applicant must have a plan in place for making corrections or recalling the product. Currently FDA cannot mandate recalls of a drug, but only request a recall, issue warnings or make a case to seize a product.

Hamburg cited the need for mandatory drug recall authority during the April hearing. Stearns, in his written questions, asked about manufacturers’ cooperation with recall requests.

The responsiveness of firms “is highly variable, often resulting in extensive delays that increase consumer and patient exposure to unsafe products,” FDA said.

Mandatory recall authority would allow the agency to “more efficiently utilize available resources,” the agency added, noting that it already has such authority for devices, biologics and foods.

In response to other questions, FDA said field staff are testing mobile analytical tools for increasing operation capabilities and providing viable detection outcomes. The tools’ functions include identifying potentially counterfeit products and detecting heavy metals, with results available within minutes.

The agency also is developing guidance for field staff on interdicting imported products to reflect the risk-based enhancements of the PREDICT system and is participating in a Border Interagency Executive Council on initiatives related to information sharing, document imaging and partnership programs.

[Editor's note: This article was provided by "The Pink Sheet," Elsevier Business Intelligence's source for pharmaceutical and biotech industry news. Register for a 30-day risk free trial.]

By Cathy Dombrowski

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