She writes, “Concerns about quality control and data integrity have focused on numerous companies in India and China, where more and more drugs and active ingredients used in medicine for the U.S are being made. But the interviews and documents suggest that those concerns aren’t limited to overseas factories. And the issues surrounding them are twofold: a drop-off in inspections in many places and, in some cases, the softening of penalties when problems are found.”
Inspections alone aren’t enough to ensure the safety of the U.S drug supply, it is unfortunately one of the few concrete tools at the FDA’s disposal. The concern to lawmakers is that the FDA is focusing on drug approvals above enforcement.
She goes on to state, “To patients in the U.S., the origin of their drugs shouldn’t make a difference. Whether treatments are made in West Virginia or Mumbai, they’re supposed to meet FDA standards for safety and efficacy. But as the industry has become increasingly global and desire for lower drug prices continues to grow, signs are indicating that U.S.-made drugs aren’t immune from the same forces that have led to corner cutting overseas.”
The FDA inspection rates have been decreasing in recent fiscal years. With less inspections, the FDA relies on manufacturing companies to use the honor system to ensure the quality of its drugs are being maintained. “If manufacturers are omitting data that show quality testing failed, that information might not get to the FDA.”
To read the full article, click here: https://www.bloomberg.com/news/features/2019-01-29/america-s-love-affair-with-cheap-drugs-has-a-hidden-cost