The Coalition to Close the De Minimis Loophole launched today, representing thousands of voices, from the families of victims of fentanyl fatalities and nonprofit and nonpartisan organizations to labor unions, domestic law enforcement associations, domestic manufacturers, and business associations.
America’s largest generic drug supplier, Aurobindo, is riddled with safety and quality issues, including ties to overseas suppliers with links to China’s military.
Roughly 40 congressional staff members had a chance to meet with and hear from industry leaders as diverse as Florida farmers to multinational corporations in the renewable energy space about the trials and tribulations of competing with emerging markets that play by different rules. And often break existing ones.
Coalition vice presidents explain the FDAs shortcomings and why U.S. medicines are often in short supply in a new American Affairs Journal article.
The expert witness testimony made it clear that U.S. labs were treated differently than foreign ones, and despite increases in hiring at the FDA over the years, lawmakers have a lot to be concerned about when it comes to the FDA conducting proper oversight of foreign manufacturing facilities.
According to expert testimony given by the witnesses, the crisis is being fueled by poor manufacturing practices that have led to recalls by foreign drug manufacturers, and the race to the bottom on generic drug prices that make it impossible for American generic drug makers to compete with subsidized competitors in India and China.
CPA’s report exposes that “Aurobindo does business with at least four suppliers that have ties to organizations under US sanctions for their connections to China’s military industry.”
The Active Pharmaceutical Ingredient Innovation Center (APIIC), a consortium of biotechnology industry, policy and academic leaders, said in a whitepaper released to the media on Jan. 24, that reshoring the manufacture of essential, life-saving pharmaceuticals was urgently needed.
This week’s Senate Banking Committee hearing on fentanyl was high on celebrity, short on solutions.
In Senate hearing: imported generic drugs facing consistent drug shortages need a government incentive program to help labs make life-saving commodity drugs domestically.
