Documents show that thanks to regulatory tunnel vision and sweeping assumptions, the FDA created a worse problem than what it set out to solve.

Did the U.S. Food and Drug Administration cause the infant formula shortage? FDA inspection records show how the agency may have had its finger on the scale in deciding to shut down the Abbott Labs plant in Sturgis, Michigan, causing the major supply chain crisis for families across the country. These exclusive documents show widely varied differences in how the FDA handled inspections at Abbott compared to similar violations at a competitor.

During a congressional hearing on May 18, neither Democrats nor Republicans questioned the agency’s judgment in its February order shutting down an Abbott Labs plant in Michigan, which had been producing 35 percent of the nation’s supply of formula for infants, including a majority of the country’s specialty formulas for children with digestive ailments.

Rather, the panel and the media have focused on an anonymous whistleblower — a disgruntled former employee of the plant who was terminated by Abbott in August 2020 – and the timing of when FDA investigated the whistleblower’s allegations.

The Wall Street Journal reports that the ex-employee first complained in February 2021 to the U.S. Occupational Safety and Health Administration (OSHA), and cited “a host of problems at the company’s Sturgis plant…”

The employee also had filed a discrimination complaint with the Michigan OSHA. Abbott and FDA...

Read Full Story: https://thefederalist.com/2022/06/15/did-the-fdas-regulatory-red-tape-cause-t...