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The report details the administration’s potential plans for a variety of issues that will directly impact pharma.
The alleged document reveals the administration's strategy for a variety of health-related issues.
A potentially leaked draft of the MAHA Commision's report to the Trump administration on children’s health may shed some light on HHS’ strategy in the coming years.
Politico published an alleged draft copy of the report1 that the news outlet says was leaked to it by anonymous sources. According to the report, the White House has been showing the draft to industry representatives before publicly releasing the report.
Politico also reports that the White House said, “Until officially released by the White House and MAHA Commission ... any documents purporting to be the second MAHA Report should be disregarded as speculative literature.”
The report details strategy for a wide variety of issues related to childhood health, with only several of the sections relating to the pharmaceutical industry. Significant sections of the report detail the impact of food, exercise, and proper sleep on children’s health. However, pharma related issues such as vaccines are also addressed.
The report also states the administration’s stance on DTC pharma advertising, saying, “FDA, HHS, The Federal Trade Commission (FTC), and DOJ will increase oversight and enforcement under current authorities for violations of DTC prescription drug advertising laws by prioritizing the most egregious violations including by social media influencers and DTC telehealth companies and demonstrating harm from current practices (including dissemination of risk information and quality of life through misleading and deceptive advertising on social media and digital platforms). The United States is one of two countries in the world which allow the pharmaceutical industry to market directly to consumers. “
Members of the administration previously discussed their desire to completely ban DTC advertising.
The draft also discusses NIH and FDA investigating the use of repurposed drugs and looking for opportunities to use existing drugs to treat chronic diseases. Another section discusses plans to use AI and other advacned technologies to to "transform research and clinical trials on pediatric cancer."
When it comes to prescription drugs used to treat mental illnesses, the draft reads, “HHS (inclusive of ACF, SAMHSA, FDA, NIH, and CMS) will form a mental health diagnosis and prescription working group to evaluate prescription patterns for SSRIs, antipsychotics, stimulants, and other relevant drugs for children and evaluate the therapeutic harms and benefits of current diagnostic thresholds, overprescription trends, and evidence-based solutions that can be scaled-up to improve mental health, including through school-based interventions, diet, and foster care services. NIH will conduct research as appropriate. FDA will update labels for older, generic drugs to better reflect the latest science.”
Not surprisingly, there are also separate sections discussing autism and vaccine injury investigations. NIH will collaborate with CMS to study the root causes of autism using a platform that utilizes real-world data. Meanwhile, HHS will investigate vaccine injuries through “improved data collection and analysis.” A new vaccine injury research program will be created at the NIH Clinical Center.
The draft also discusses further use of AI, saying, “HHS will prioritize research into the appropriate integration of AI when to assist in chronic disease care through earlier diagnosis, personalized treatment plans, real-time monitoring, and predictive interventions that prevent hospitalizations, reduce costs, and reduce the burden of chronic disease.”
Another section describes potential plans to address “excessive open access payments to scientific journals” in relation to open access publishing.
According to Poltico’s reporting, the draft documents are dated August 6 and August 11.
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