Leaked MAHA draft signposts US health reform under Trump

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A leaked version of the Make America Healthy Again (MAHA) programme for the Trump administration – if genuine – has plenty for the pharma industry to stew over.

Along with plenty of initiatives in areas like food and exposure to chemicals like pesticides, the document (PDF), acquired by Politico, reiterates a lot of MAHA projects that have already been drip-fed in recent months – such as investigations into the root causes of autism and vaccine injuries and 'over-medicalisation' of children.

However, it also points to upcoming scrutiny of direct-to-consumer (DTC) medicine advertising, reform of user-fee programmes, cutting red tape for drug development programmes, creating a real-world data platform, and loosening access to government data for research purposes.

More details have also emerged on changes to agencies governed by the Department of Health and Human Services (HHS), including the creation of the Administration for a Healthy America (AHA) – tasked with overseeing the government's efforts to tackle chronic diseases – and new NIH offices to 'prioritise' research programmes and look into technologies that can reduce the need for animal testing in R&D.

Some of the highlights from a pharma industry perspective include:

  • An NIH programme to link data from insurance claims, electronic health records, and wearables into a unified data platform that can be used to study chronic diseases;
  • Expanded use of non-animal methods (NAMs) like organoids and computer simulations, alongside real-world data, to reduce animal testing and "enable earlier, more predictive insights into chronic disease mechanisms;"
  • An investigation into prescribing patterns for mental health indications;
  • Research into the use of AI to assist in chronic disease care;
  • Increased oversight of DTC pharma advertising, including by social media influencers and DTC telehealth companies, to stamp out deceptive promotion;
  • A push to make sure that federal agency user-fee processes and research grants are transparent, efficient, and protected from conflicts of interest; and
  • Eliminating "regulatory burdens" on industry at the FDA, for example, by discarding animal testing requirements, introducing risk-based exemptions for some phase 1 trials, and speeding up access to personal health and digital health tools.

A finalised version of the MAHA report is expected to be published in the next few weeks, according to media reports.

The first, revealed in May, highlighted poor diets, environmental toxins, unhealthy lifestyles and too much reliance on pharmaceuticals as the drivers of an increase in chronic diseases in the last few decades.