REPORTING: Trump vs. Pharma?

1. The 15% Tariff: A Modest Jolt Or Deeper Disruption? 9/12/2025

   Regarding the U.S. / E.U. “agreement” to a blanket 15% tariff on pharmaceuticals entering the former from the latter, Chief Editor Louis Garguilo zeroes in on potential effects of outsourcing active pharmaceutical ingredients (APIs). A 2025 analysis indicates 43% of branded pharmaceutical APIs used in U.S. prescriptions come from the E.U. Learn more about our predicament from a case study and closer look.

2. What FDA's Complete Response Letters (CRL) Say About Outsourcing 9/2/2025

   The FDA embraced "radical transparency” by publishing over 200 complete response letters (CRLs) for drug and biologics applications submitted between 2020 and 2024. Hooray for the FDA; good for drug developers hard at work today. Good for developers, writes Chief Editor Louis Garguilo, because he can identify patterns to help us outsource better.

3. The FDA Was Darned Near Perfect, Right? 7/11/2025

   Let's return to minutes before Donald Trump became president in January, to a time when the FDA was near perfect. That’s what one would assume today listening to those up in arms over the agency. Of course, the reality was quite different. Chief Editor Louis Garguilo helps regain perspective.

4. Why CDMOs Are Leaving Small Molecules Behind 7/7/2025

   It’s rare when a CDMO’s restructuring leads to thoughts about national health policy. But as Chief Editor Louis Garguilo wrote his recent editorial on Lonza’s decision to focus heavily on biologics, it brought to mind a government policy that may have contributed to the company’s restructuring. No, it's not tariffs.

5. Tariffs On Toys … And API? Biopharma As The Next Battleground 6/3/2025

   Outsourcing drug development and manufacturing is an attempt at purposeful action in a web of interdependent contingencies. The contingency top-of-mind today is President Trump’s tariff strategy, and global "negotiations" that have ushered in a supply-chain disquietude.

6. Evolve Or Fade Away? Biotech's Outsourcing Moment In Trump's Tariff Tangle 5/22/2025

   Ali Pashazadeh is "a deep thinker" that our Chief Editor visits with annually. Recently, he asked Pashazadeh to help us think through the evolving policies of the new U.S. presidential administration and the tariff turbulence, as they relate to a biotech's development and manufacturing outsourcing.

7. Lilly's CEO Building On The Trump Agenda 5/12/2025

   “We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Eli Lilly CEO David Ricks recently said, announcing — in Washington, DC — plans to invest $27 billion to build four new manufacturing plants in the U.S.

8. Tariffs Won't Stop Drug-Candidate Licensing From China Biotechs 4/23/2025

   According to Global Data, the total deal value of U.S. licensing of innovator drug candidates from Chinese biopharma companies has surged since 2020. This is an area way upstream of the current tariff focus on manufacturing. But how this R&D trend and those tariffs play out will impact your U.S.-based CDMOs.

9. CDMOs Bet Big On Asia Expansion. Can Trump Reverse The Tide? 2/20/2025

   Facility investments by CDMOs continue to be magnetized to Asia. Recent examples abound. Chief Editor Louis Garguilo details some of those, and discusses whether, for example, a President Trump-intensified focus on increasing manufacturing in the U.S. can change this. Will your outsourcing in 2025 change direction? The answer may surprise you.

10. What If The Trump Tariff Strategy Works? 4/8/2025

    Doom and gloom in the drug development and manufacturing supply chain.  Predictions of disruptions and displacements. The Trump tariff ploy will fail, and costs/prices will skyrocket. But have you considered this “risk”? The tariff tantrum lowers national export/import duties for the entire globe.