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  • snitzoid

Is the FDA ret--ded? No I am not using the R word.

Want to know why we didn't stop the Opioid epidemic before it started? Because the FDA allowed Purdue Pharma to start selling OxyContin for chronic pain without any testing or clinical trials. It was designed to be used only for short-term (aka a few days) post-surgical pain.

The FDA, while delaying the approval of actual good drugs that work, decided to let Purdue have a "pass". Oh well!

Here's a great that chronicles the whole bloody mess.

The FDA’s Baby Formula Whitewash

An agency report blames its failures on—wait for it—lack of money.

By The Editorial BoardFollow

Sept. 21, 2022 6:38 pm ET

The Food and Drug Administration on Tuesday took responsibility for this spring’s baby formula shortage. Alas, no. Instead the agency released a report whitewashing its failures and imploring Congress for more money.

Parents were left to scavenge supermarkets for baby formula after the shutdown of an Abbott Laboratories plant in Michigan linked to four infant illnesses. The FDA blames “unique circumstances, requiring the agency to address a relatively poorly understood pathogen.” But the bacteria Cronobacter that caused the illnesses isn’t novel.

The Centers for Disease Control and Prevention’s website has a section on Cronobacter that explains how the germ can contaminate powder formula in the home and processing facilities. FDA also says its “foods program had to balance considerations of product safety and product availability in a way it has never had to before,” but this also isn’t true.

Several infants became ill with Cronobacter in 2011, including one who died after consuming Mead Johnson’s Enfamil. An FDA investigation found no bacteria in Mead Johnson’s formula and cleared it to stay on the market. This time the FDA was late to investigate problems at Abbott’s Michigan plant and then didn’t ensure adequate formula supply when it shut down.

A whistleblower report to the agency last October described unsanitary conditions at the plant. The FDA report says the complaint was lost in its mail and that “inadequate processes and lack of clarity related to whistleblower complaints may have delayed” its response. Investigators didn’t start to inspect the Abbott plant until late January.

After inspectors identified Cronobacter on some surfaces, Abbott shut down the plant and initiated a recall in mid-February. Abbott says its own investigation found that its product didn’t cause the illnesses, and the FDA hasn’t shown otherwise.

The FDA could have then eased formula labeling and ingredient requirements so more product could be imported. Some 98% of U.S. formula is manufactured domestically. But FDA didn’t start to allow more imports until mid-May when shelves were already bare.

The report says the FDA did not “have the authority, expertise, or resources to manage supply chain issues and shortages of critical food product,” nor “sufficient staffing, training, equipment, and regulatory authorities” to fulfill its mission. “Simply put, if the FDA is expected to do more, it needs more,” the report’s author Steven Solomon says.

Regulatory agencies always ask Congress for more money to fix failures caused by their own bureaucratic breakdowns. But the FDA still hasn’t learned its lesson and has been slow to approve foreign formula, 13 GOP Senators led by Kansas’s Roger Marshall said in a letter Tuesday to Commissioner Robert Califf.

Abbott Nutrition, Mead Johnson, and Perrigo control more than 80% of the U.S. market, and “any disruption in an oligopoly will undoubtedly lead to supply chain shortages,” the Senators noted. Yet the “FDA has still not indicated any attempt to review or prioritize increasing domestic production through competition.” The last application granted by the FDA was on Aug. 10.

With Abbott’s Michigan plant restarting, perhaps the FDA figures foreign formula won’t be needed. But shortages are sure to happen the next time there’s a problem at a domestic factory. Regulators who don’t learn from their mistakes are doomed to repeat them—and then ask for more money again.

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