Locator: 48856BIGPHARMA.
This initiative was long overdue. Long overdue. Amazing. President Trump has been in office about seven months.
It would be fun to discuss how I see these things develop. I noticed it when part of the USAF intelligence team working strategic issues. but the discussion would fall on deaf ears. LOL. This, by the way, separates the highly successful companies from the less successful companies, all things being equal.
The White House expects government policy makers to work on "Trump time": get things done as fast as possible without screwing things up.
AI Overview
Key pharmaceutical initiatives as of August 14, 2025:
Today, August 14, 2025, sees several important initiatives in the pharmaceutical space across different sectors:
1. Drug price reduction and domestic manufacturing
- Executive Orders: President Donald J. Trump has signed Executive Orders aimed at reducing drug prices for Americans and taxpayers.
- The orders aim to bring US prescription drug prices in line with those of other developed nations.
- Actions include ensuring foreign countries are not undercutting market prices and establishing price targets for manufacturers.
- The Secretary of Health and Human Services is also instructed to explore mechanisms for direct drug purchases from manufacturers at "Most-Favored-Nation" prices.
- FDA PreCheck Program: The FDA has launched the "FDA PreCheck" program to streamline the review process for new domestic pharmaceutical manufacturing facilities, aiming to boost US drug production and reduce reliance on foreign sources.
- This program involves early engagement and feedback between manufacturers and the FDA during facility design, construction, and pre-production.
2. Supply chain resilience and strategic reserves
- Strategic Active Pharmaceutical Ingredient Reserve (SAPIR™): Phlow Corp. has lauded an Executive Order focused on operationalizing the Strategic Active Pharmaceutical Ingredient Reserve (SAPIR™).
- SAPIR is a national initiative to strengthen the pharmaceutical supply chain and ensure access to essential medicines during emergencies.
- Phlow has been collaborating with the government since 2020 on the development of SAPIR, aiming to address the country's dependence on foreign sources for essential medicine ingredients.
- Domestic Manufacturing Showcase: On Demand Pharmaceuticals hosted HHS officials to showcase their domestic pharmaceutical manufacturing capabilities, including a virtual demonstration of real-time formulation of an essential medicine, highlighting their distributed Quality Management System and agile production at the point of care.
3. Orphan drug designation in the EU
- Sanofi's Rilzabrutinib: The European Medicines Agency (EMA) has granted orphan designation to Sanofi's rilzabrutinib for IgG4-related disease (IgG4-RD). This designation is for treatments of rare conditions affecting a small number of people in the EU. This decision follows positive Phase 2 study results.
4. Addressing challenges in the pharmaceutical industry
- PBM Reform: Legislation like the PBM Reform Act is being pursued to increase transparency and accountability in the Pharmacy Benefit Manager (PBM) industry.
- Expanding Pharmacist Roles: States are broadening the scope of practice for pharmacists, such as allowing them to provide HIV prevention medications and dispense hormonal contraceptives.
- Managing Complex Diseases: There is continued focus on improving diagnosis and treatment for complex diseases like Alzheimer's.
- Targeted Medication Safety: Efforts are being made to improve medication safety practices.
- Addressing Youth Substance Use: A CDC campaign is addressing youth substance use and mental health.
This
summary provides a snapshot of key initiatives and developments as of
today, August 14, 2025. The pharmaceutical landscape is constantly
evolving with ongoing research, development, and policy changes.
