Supply chain
Some observers see risks to becoming over-reliant on local facilities, noting the potential need for trade partners if domestic production is disrupted.
While trade groups hail the executive order as a national health security opportunity, analysts warn that production costs could go up in the near term.
Among the problems cited were cat hair, bacterial contamination and instrument defects.
President Donald Trump first threatened pharma tariffs in February and recently said they were imminent. Johnson & Johnson’s new investment adds to a $55 billion pledge made by the company in March.
The voluntary pauses follow two patient deaths associated with the Duchenne muscular dystrophy gene therapy.
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.
Analysts acknowledged the long-term manufacturing deal could dull Viking’s takeout prospects but hailed it as a smart move to ensure supply.
The move comes after President Donald Trump warned Big Pharma leaders that he would impose tariffs on them if they refuse to reshore their manufacturing operations.
Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers.
Compounding pharmacies aren’t the only makers of off-brand versions of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. The situation is causing the FDA regulatory headaches and, more seriously, posing potential risks to the public.
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