The FDA last week introduced PreCheck, a new program designed to support construction of domestic pharmaceutical manufacturing facilities and reduce dependence on foreign drug production. However, the initiative is short on detail, according to Mike Varrone, counsel at global law firm Sidley, who worked at the agency for more than two decades.
“It seems like a good first step in promoting domestic manufacturing,” Varrone told Pharma Manufacturing. At the same time, he said it remains to be seen whether the program boosts U.S. drug production, as the regulator asserted in its announcement.
“There’s a lot that remains to be seen on the details,” according to Varrone, who advises clients on compliance, enforcement, and regulation issues. “I’m curious to see what FDA says during this public meeting that’s coming up — that may shed some more light on the details here about how they’re going to effectuate this.”
The agency is holding a public meeting on Sept. 30 at its White Oak Campus in Silver Spring, Maryland, including a presentation of the PreCheck draft framework as well as stakeholder discussions on “additional considerations to overcome current onshoring challenges relevant to FDA authority.”
Varrone pointed out that bolstering domestic manufacturing is a “longstanding” issue that predates the second Trump administration. The FDA’s PreCheck program takes a two-phase approach to help facilitate new U.S. drug manufacturing facilities.
The Facility Readiness Phase is meant to provide manufacturers with more frequent communication with the FDA at critical development stages — including facility design, construction, and pre-production — and “encourages companies to provide comprehensive facility-specific information through a Type V Drug Master File (DMF), such as site operations layout and description, Pharmaceutical Quality System elements, and Quality Management Maturity practices.”
According to Varrone, Type V DMFs will help enable the agency to make its determinations earlier in the process.
“It’s a two-way street,” he said. “FDA needs to communicate back to these companies, so they know whether they need to adjust — and they have time to do it on the front end, so they’re not in a situation where they’re delayed on the back end in trying to address any issues.”
PreCheck’s Application Submission Phase is designed to streamline development of the Chemistry, Manufacturing, and Controls (CMC) section of the application via pre-application meetings and early feedback.
Executive order gets ball rolling
FDA’s PreCheck was developed in response to President Trump’s executive order in May instructing the agency to expedite the approval process for U.S. pharmaceutical facilities. The order calls for reducing the amount of time it takes to approve domestic drug manufacturing plants by eliminating duplicative and unnecessary requirements, streamlining reviews, and working with manufacturers to provide early support before facilities come online.
Trump’s order notes that building new pharma manufacturing plants can take as long as five to 10 years, as manufacturers “must navigate myriad Federal, State, and local requirements ranging from building standards and zoning restrictions to environmental protocols that together diminish the certainty needed to generate investment for large manufacturing projects.”
The directive is designed to speed up timelines for building U.S. sites by reducing regulatory barriers to construction. However, data and analytics firm GlobalData contends that Trump’s order “has ignited a wave of skepticism within the industry regarding its potential effectiveness.”
Kathryn Kinch, GlobalData’s senior pharma product manager, said in a statement that critics are “raising eyebrows over the lack of clarity” surrounding the implementation of the order and as federal agencies including the FDA “scramble to develop actionable guidelines, the pharmaceutical sector watches closely.”
Ei Lilly CEO Dave Ricks complained in a recent interview with Fox Business about permit delays from the FDA and other challenges in building drug manufacturing plants in the U.S.
“They take time to build. We need to speed that up. That’s been a challenge,” Ricks said. “There’s always talk of permitting reform and getting clearance from the FDA faster. Those are things we could use some help with to speed these factories getting built.”
In February, Lilly announced a $27 billion investment to build four new U.S. pharmaceutical manufacturing sites — three for active pharmaceutical ingredients (APIs) and one to manufacture injectable products and devices.
According to the FDA, more than half of all drugs distributed domestically are manufactured overseas, and only 11% of API manufacturers for FDA-approved products are based in the U.S.
“Our gradual overreliance on foreign drug manufacturing has created national security risks,” FDA Commissioner Marty Makary said in a statement last week. “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America’s reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”
Varrone in a blog post last month advised that as the pharma industry navigates the complexities of onshoring foreign manufacturing operations, it is important to remain “vigilant” about key FDA regulatory and compliance considerations in this “evolving” policy landscape.
The decision to relocate manufacturing operations for FDA-approved drugs is “fraught with regulatory obligations” — including those administered by the agency — and “strategic considerations that must be thoroughly analyzed,” Varrone wrote.
