Chair DeLauro Statement at FDA’s Foreign Drug Inspections Program Hearing
House Appropriations Committee Chair and Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee Chair Rosa DeLauro (CT-03), delivered the following remarks at the Subcommittee's oversight hearing on the FDA’s Foreign Drug Inspections Program.
"When most Americans take a pill out of the medicine cabinet they may not think twice about where the ingredients in it came from. But as foreign manufacturing of drugs has grown considerably in recent years, it is now estimated that around 80% of all drug ingredients come from foreign countries. Unfortunately, the Food and Drug Administration’s (FDA) foreign drug inspections program has failed to keep up.
As our witness will be testifying today, GAO has studied FDA’s oversight of the global pharmaceutical supply chain since 1998 and the results are not good. GAO has included the FDA on its high-risk series since 2009.
One of the main problems is that FDA gives foreign drug manufacturers, but not American ones, advanced notice of inspections. The twelve weeks of advanced notice has allowed foreign manufacturers to fabricate or shred data, use hidden laboratories, or secretly repeat tests before the FDA inspectors arrived.
By contrast, in unannounced inspections, investigators have found issues the plants were unable to hide: important manufacturing records tossed in a trash bin, bird and insect infestations, even human urine puddled on the floor. Clearly, that is not a safe or sterile manufacturing area.
These shoddy practices result in drugs with unapproved ingredients, toxic impurities, and dangerous particulates making their way into American medicine cabinets. In 2007 and 2008, hundreds of Americans died from contaminated heparin, an anticoagulant drug manufactured overseas. In 2018 and 2019 dozens of blood-pressure and anti-ulcer drugs were recalled because they contained more than 200 times the acceptable limit of a known carcinogen.
But now, because of the pandemic, the FDA has stopped nearly all overseas inspections. Unfortunately, this means the FDA’s work to prevent potentially tainted drugs from entering the US is even more difficult.
The GAO report was stunning. And that even so that the FDA uses alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused. And the tools rely on inspections conducted by foreign regulators and requesting and reviewing records and other information and sampling and testing drugs, FDA has determined that inspections conducted by certain European regulators are equivalent to and can be substituted for an FDA inspection. That is wrong because other tools provide useful information but are not equivalent to what rate of inspection we deal with at the FDA. And we also know that the GAO reported from 2016 to 2018 both foreign and domestic inspections decrease.
Today we are taking a closer look at how FDA’s inspections have been impacted by this pandemic, and critically how we can ensure the FDA has the resources it needs to restart and improve its foreign drug inspections program.
Americans trust and rely on these medicines to take care of themselves and their families. Many are sick and vulnerable and many more are elderly. They should not have to fear whether the drugs they take could make their symptoms worse, or even kill them. They should be able to trust that unsafe drugs will never get into their medicine cabinets in the first place."