For years, the most critical link in our drug supply chain — the upstream chemistry — has been invisible to our own regulators. A medicine finished in Europe is not necessarily a European medicine, and this rule finally begins to expose that fiction.
Sen. Kirsten Gillibrand (D-NY) has become one of the Democratic Party’s leading voices raising concerns about the pharmaceutical industry’s growing ties to China.
Lawmakers from member states of the European Union agreed to measures last week to stop drug shortages and fix chronic Asian dependencies for critical medicines, this time spurred by worries over the antibiotics supply chain.
Without secure upstream API and 6-APA production, the United States does not have true antibiotic supply security. With the right policy framework and close coordination with European partners, we can rebuild domestic capacity, strengthen allied production, and secure essential medicines for the long term.
China holds a rapidly expanding position in the global biologics and biosimilars market, driven by heavy government support, regulatory reforms, and massive investments in biotech hubs like Shanghai and Suzhou.
CPA welcomes new proposals from the Food and Drug Administration (FDA) aimed at rebuilding domestic generic drug manufacturing, strengthening oversight of foreign pharmaceutical production, and improving supply chain transparency.
Today’s action is a meaningful step toward restoring America’s ability to produce critical pharmaceuticals and APIs.
America’s healthcare system cannot remain dependent on fragile and subsidized foreign supply chains for generic pharmaceuticals and other critical countermeasures that are fundamental to patient care.
Everyone agrees, in particular that reliance on China for key ingredients used to make medicines is risky; and everyone agrees that further up market – in advanced biotech – China is becoming an unmatched rival that could easily shrink America’s role in drug innovation.
It’s the second month in a row now that the U.S. Senate Special Committee on Aging has taken up the question of our woeful generics supply chain. This time, however, Ranking Member Kirsten Gillibrand (D-NY), started the hearing off by touching on a key topic in pharmaceuticals: the cost equation can no longer override the quality equation.
