The debut episode of Supply Chain Signal, featuring pharmaceutical supply chain expert Thanigavelan Jambulingam, PhD, examines three regulatory developments reshaping how pharma companies plan, price, and build for the US market, and what they mean for pharma.
The FDA recently named the first cohort of its PreCheck Pilot Program, selecting seven manufacturers from a pool of more than eighty applicants. Established under a May 2025 executive order aimed at strengthening domestic drug manufacturing, PreCheck is designed to move FDA scrutiny earlier in the facility-readiness process, surfacing potential issues before they become deficiencies that delay or block application approval. The selected projects span small-molecule sterile fill, large-scale biologics, and cell and gene therapy. Jambulingam breaks down whether a regulatory incentive like PreCheck does more to drive reshoring than tariff pressure has, whether an accelerated approval pathway actually translates into new domestic manufacturing capacity, and what it would take to expand the program beyond a seven-company pilot.
The conversation then turns to trade policy's growing role in drug pricing disputes. In June, the Office of the US Trade Representative opened a Section 301 investigation into Germany over pricing practices the USTR says force the US to shoulder a disproportionate share of global pharmaceutical R&D costs. The timing coincides with sweeping German cost-containment legislation, passed by parliament this week, that raises mandatory industry discounts to statutory insurance funds, prompting several drugmakers to warn they may delay or withdraw new medicines from the German market. Jambulingam assess whether this marks a broader shift toward trade law as Washington's primary lever for resolving international drug pricing disputes.
Rounding out the episode is CMS's proposal to convert the Medicare Drug Price Negotiation Program from annual guidance into a permanent regulation beginning with the 2029 negotiation cycle, covering up to twenty drugs per cycle across Part B and Part D. The proposed rule would also narrow a policy some manufacturers have used to prevent reformulated products from being aggregated with the original product for selection purposes, closing a pathway some companies have relied on to avoid negotiation eligibility, a change with particular implications for combination products in cardiovascular, renal, metabolic, and obesity categories. The episode closes with Jambulingam's take on whether codifying the program into permanent rule will meaningfully change manufacturer behavior, and a breakdown on how all three topics relate.
Stay tuned for next month’s installment of Supply Chain Signal.
