Revamping US pharma manufacturing: Trump’s executive order faces industry doubts

GlobalData Healthcare

Fri, May 16, 2025, 7:18 AM 3 min read

US President Donald Trump has issued an enforcement bid aimed astatine easing regulatory challenges for home pharmaceutical producers portion imposing stricter conditions connected overseas manufacturers. The enforcement order, signed connected 5 May 2025, instructs the US Food and Drug Administration (FDA) to expedite the support process for home pharmaceutical manufacturing facilities. Despite these efforts, skepticism remains wrong the pharmaceutical manufacture regarding the imaginable interaction of the enforcement order.

The bid besides mandates the FDA to summation fees and inspections for overseas manufacturing plants. However, it lacks circumstantial details and objectives, leaving it unclear whether the directive applies to each FDA inspections oregon is constricted to caller facilities, accumulation lines oregon products. It volition beryllium up to national agencies to make circumstantial regulations.

To enactment home manufacturers, Trump has called connected the FDA to destruct "duplicative and unnecessary requirements," streamline the reappraisal process and supply aboriginal assistance earlier facilities go operational.

FDA commissioner Dr Marty Makary has expressed his enactment for the enforcement bid and is acceptable to instrumentality its directives. During the signing ceremonial astatine the White House, helium criticised the existent inspection system, noting that US pharmaceutical manufacturers look rigorous inspections portion overseas sites often person leniency with scheduled visits. He stated that the FDA plans to displacement from announced inspections to astonishment visits for overseas cause manufacturing facilities.

Recent occupation losses astatine the FDA person impacted the Office of Inspections and Investigations. Although inspectors themselves were not laid off, the simplification successful administrative unit has raised alarms astir imaginable delays and disruptions successful the inspection process.

Makary indicates that the FDA plans to shorten the duration of aboriginal inspections. "We’re besides not going to person our inspectors hanging retired for 3 to 4 weeks," helium stated. "We’re going to streamline the process, allowing america to behaviour much inspections with the aforesaid resources."

Danish pharma shaper Novo Nordisk's main fiscal officer, Karsten Munk Knudsen, expressed doubts connected 7 May astir whether the enforcement bid would importantly change timelines for pharmaceutical works approvals. In an interview, helium noted that it typically takes years for a pharmaceutical institution to conception a mill that complies with the stringent prime protocols acceptable and enforced by the FDA.

Due to the looming menace of tariffs connected pharmaceuticals successful the adjacent mates of weeks, companies specified arsenic Novartis (based successful Cambridge successful the US authorities of Massachusetts), AstraZeneca (based successful Cambridge, United Kingdom), Eli Lilly (based successful Indianapolis, Indiana), and Roche (based successful Basel, Switzerland) person announced investments to grow their US manufacturing efforts. In June 2024, Novo Nordisk announced a $4.1 cardinal concern successful US manufacturing.