Hearing(:) a lot of nonsense

The House Committee on Oversight and Reform held a wide-ranging hearing Wednesday, “Restoring Trust in the FDA: Rooting Out Illicit Products,” and among the topics it considered was illicit imports of substances purportedly intended to be used in compounded drugs. Watch it here.

Unfortunately, the committee invited the pharma-funded “Partnership for Safe Medicines” to testify, and PSM brought with it unsubstantiated claims that counterfeit API was “likely” being used in compounded drugs dispensed to patients.

(At one point, PSM’s executive director tried to claim that his organization wasn’t funded by pharmaceutical companies, leading one congressman to submit for the record articles that showing PSM was indeed largely funded by drugmakers.)

APC addressed the PSM testimony in a letter to the committee chairman and pulled no punches. 

“Not a shred of evidence is presented to show that any state-licensed pharmacy used these substances,” we wrote.

“The idea that these personalized therapies are "knockoffs" — as PSM alleges — is both misleading and offensive. These are not counterfeit drugs. They are not illegally manufactured. And, importantly, there is no evidence in the report that legitimate compounding pharmacies are importing or using unregistered substances.”

The PSM wasn’t the only one testifying on behalf of the pharma industry. Former FDA Commissioner David Kessler also spoke … and also played fast and loose with the facts, implying that compounding pharmacies source their ingredients from random, unregulated overseas manufacturers. He should know better — that compounders source their ingredients from highly regulated FDA-registered, U.S.-based wholesalers, not directly from manufacturers.