The company defends its plan as a strategy to stave off shortages. However its personal evaluation has proven that shortages are pushed by razor-thin revenue margins and subpar manufacturing practices — not by security requirements. Decreasing the bar gained’t resolve these points.
It’s going to, nonetheless, drive accountable producers out of the market and put fragile infants in danger.
And the implications prolong far past neonatal care. If regulators are prepared to compromise protections right here, what’s to stop comparable strikes elsewhere? The genius of Hatch- Waxman was its readability: generics needed to match model medication in security and efficacy. As soon as that line is blurred, belief begins to unravel. Physicians develop reluctant to prescribe, sufferers hesitate to modify, and costsclimb for all.
