Each week we highlight five things affecting the life sciences industry. Here’s the latest.
New FDA commissioner will review layoffs
- Marty Makary, the presumptive nominee for U.S. Food and Drug Administration commissioner, pledged to independently assess agency staffing but did not commit to reversing recent layoffs, per BioPharma Dive.
- Lawmakers and industry leaders expressed concerns that layoffs, particularly among probationary employees and artificial intelligence specialists, could disrupt drug and device approvals.
Status of U.S. pharmaceutical investment in Ireland uncertain amid potential changes in policy
- As Irish politicians visit Washington to celebrate St. Patrick’s Day, a major topic of discussion will be pharmaceutical exports to the U.S., which surged 42% to $50 billion last year. The Trump administration has signaled potential tariffs on pharmaceuticals, which could reduce Ireland’s pharmaceutical output by 12%, threatening both industry growth and tax revenues, according to The Wall Street Journal.
- Many U.S. pharmaceutical companies benefit from Ireland’s favorable tax policies, reducing their U.S. tax liabilities while boosting Ireland’s corporate tax revenues. Trump’s past tax reforms unintentionally incentivized further offshoring to Ireland, but future U.S. tax changes or tariffs could pressure companies to shift more profits back to the U.S.
Research organization highlights areas of concern regarding AI in health care and life sciences
- MedTech Dive reports that Emergency Care Research Institute (ECRI), an independent health care research nonprofit organization, ranked insufficient AI governance as the second biggest patient safety threat. The organization noted that AI-driven medical errors could lead to misdiagnoses and improper treatments.
- Additionally, cybersecurity breaches could pose significant risks, delaying care and increasing complications. ECRI recommends stronger oversight and risk assessments for AI and connected medical devices.
Several factors contribute to discontinuation of GLP-1 drugs
- According to BioSpace, there are numerous side-effects associated with GLP-1 drugs such as gastrointestinal issues, that often lead to discontinuation of use. Drug developers are addressing this through the use of, combination therapies and secondary treatments.
- While side effects contribute to treatment cessation, other factors like cost, availability, physician switches and weight loss goal achievement play a role. Recent studies show only 15% of patients persist on GLP-1 drugs after two years
Merck opens $1 billion domestic manufacturing plant
- Merck & Co. opened a $1 billion vaccine manufacturing plant in Durham, N.C., as part of a broader effort to increase U.S. production, with plans to invest an additional $8 billion by 2028, per BioPharma Dive.
- This move aligns with ongoing reshoring pressures amid U.S. trade policies on pharmaceutical imports.
For more insights in life sciences, check out RSM’s industry outlook.
