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The Food and Drug Administration has proposed a new program to facilitate the construction and operation of new U.S. drug-manufacturing facilities that will strengthen domestic biopharmaceutical supply chains and accelerate the delivery of innovative medications to patients, the NAM told the agency recently.

What’s going on: “[T]he proposed PreCheck program … will provide the opportunity for early engagement and communication between manufacturers and the agency, which, in return, should allow for smoother processes and quicker timelines, both of which are critical for making new facilities operational,” the NAM told the FDA late last month in response to a request for comments.

• The FDA proposed the PreCheck program in August to shore up U.S. pharmaceutical production “by increasing regulatory predictability and facilitating the construction of manufacturing sites” in the country.
• The initiative would enable manufacturers to receive technical advice and facility evaluations from the FDA earlier in the building process.

Why it’s important: Biopharmaceutical manufacturers are economic engines, the NAM said, accounting for over $350 billion annually in value-added output to the American economy. Speeding facility construction via policies like the proposed PreCheck program could support further domestic biopharmaceutical investment.

Committed and ready: Biopharmaceutical manufacturers have demonstrated their commitment to investing in domestic drug manufacturing, with sizable recent announcements from Johnson & Johnson, AstraZeneca, Lilly, Novartis, Merck, Amgen, Genentech and Roche.

What should be done: To best help manufacturers see the benefits of the PreCheck program, the FDA should:

• Maintain the same inspector and review teams throughout facility review to create a smother process;
• Provide a liaison for manufacturers to ensure there is a consistent point of contact at the agency;
• Decouple facility inspections from drug approval submissions, which would allow for earlier inspections;
• Review drug master files when they are submitted, which would allow questions to be answered earlier and prevent future time delays;
• Allocate appropriate resources to the program “to prevent a reduction of resources for existing programs,” while actualizing time savings of the PreCheck program; and
• Broaden the program’s scope to include domestic facility expansions, which would accelerate domestic onshoring.

The biggest challenge: For programs like PreCheck to have their maximum intended impact, manufacturers also need policymakers to reform the broken U.S. permitting system.

• “The long timelines associated with permitting processes at the federal, state and local levels and the lack of coordination amongst them create burdensome delays,” the NAM told the FDA. “[I]t would be beneficial for FDA to push for collaboration with the appropriate agencies and entities to reduce onerous delays.”
• Last month the NAM released a policy roadmap outlining solutions to modernize the current permitting system to streamline the process and create regulatory certainty.