In this episode, host Duane Schulthess sits down with Steve Usdin, Senior Washington Editor at BioCentury Publications since 1993 and one of the most cited experts on FDA regulation, Medicare policy and the political forces driving biopharma innovation, to explore the major forces reshaping U.S. life sciences: looming Section 232 tariff probes, the unintended “small-molecule penalty” baked into the Inflation Reduction Act, deep NIH/FDA budget cuts, post-COVID science skepticism, and China’s surge in clinical filings, and what these policy shifts mean for innovation, patient access and America’s competitive edge.

Recorded April 8th, 2025

Key Topics:
Tariffs & Trade Policy: Section 232 investigations threaten pharma-specific levies that drive up interest rates, deter capital raises, and expose domestic and allied supply chains to greater disruption.
Inflation Reduction Act (IRA) Impacts: A nine-year exclusivity window for small molecules versus thirteen for biologics creates a “pill penalty,” chilling R&D in age-related and chronic disease; debates around the EPIC Act and expanded orphan-drug carve-outs aim to recalibrate incentives.
Regulatory Uncertainty: Arbitrary NIH and FDA budget cuts, coupled with an HHS leadership shake-up, are stalling translational science, jeopardizing advanced biomanufacturing efforts, and eroding long-term policy stability.
Science & Public Trust: COVID-era vaccine mandates and missteps have fueled anti-science sentiment and mRNA platform skepticism, complicating future therapeutic innovation and public-health communication.
Global Competition & Talent: China’s record number of IND filings, restrictive H-1B visa policies, and repatriation of PhD talent threaten U.S. biotech preeminence unless immigration and research-funding policies pivot to attract and retain innovators.

In this episode, host Duane Schulthess sits down with Steve Usdin, Senior Washington Editor at BioCentury Publications since 1993 and one of the most cited experts on FDA regulation, Medicare policy and the political forces driving biopharma innovation, to explore the major forces reshaping U.S. life sciences: looming Section 232 tariff probes, the unintended &ldquo;small-molecule penalty&rdquo; baked into the Inflation Reduction Act, deep NIH/FDA budget cuts, post-COVID science skepticism, and China&rsquo;s surge in clinical filings, and what these policy shifts mean for innovation, patient access and America&rsquo;s competitive edge.
Recorded April 8th, 2025
Key Topics:
<ul>
<li>Tariffs &amp; Trade Policy: Section 232 investigations threaten pharma-specific levies that drive up interest rates, deter capital raises, and expose domestic and allied supply chains to greater disruption.</li>
<li>Inflation Reduction Act (IRA) Impacts: A nine-year exclusivity window for small molecules versus thirteen for biologics creates a &ldquo;pill penalty,&rdquo; chilling R&amp;D in age-related and chronic disease; debates around the EPIC Act and expanded orphan-drug carve-outs aim to recalibrate incentives.</li>
<li>Regulatory Uncertainty: Arbitrary NIH and FDA budget cuts, coupled with an HHS leadership shake-up, are stalling translational science, jeopardizing advanced biomanufacturing efforts, and eroding long-term policy stability.</li>
<li>Science &amp; Public Trust: COVID-era vaccine mandates and missteps have fueled anti-science sentiment and mRNA platform skepticism, complicating future therapeutic innovation and public-health communication.</li>
<li>Global Competition &amp; Talent: China&rsquo;s record number of IND filings, restrictive H-1B visa policies, and repatriation of PhD talent threaten U.S. biotech preeminence unless immigration and research-funding policies pivot to attract and retain innovators.</li>
</ul>

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess, Managing Director of Vital Tran…

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