The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.

As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.

And truly it gets worse every year…

  *He and his colleagues had also been engaged in a decades-long debate with a sprawling community of watchdogs — mostly doctors, lawyers and scientists from outside the agency — who were often broadly supportive of the agency’s mission but who fought with officials like Califf, sometimes bitterly, over the specifics: How should the F.D.A. be financed? What kind of evidence should new drugs and medical devices require? How should regulators weigh the concerns of industry against the needs of doctors, patients and consumers?*