This past January, the National Academy for State Health Policy, which has worked in the past with the John and Laura Arnold Foundation, praised the state of Vermont’s plan for drug importation. Another scholar supported by the Arnolds, Aaron Kesselheim from Brigham and Women’s Hospital and Harvard Medical School, also has called for limited importation of generic drugs.
This blog has discussed the risks associated with drug importation several times, including here and here.
Two reports released over the last week have increased our anxiety. Even when the FDA is looking over the shoulder of manufacturers abroad, medicines are not as safe.
First, as Politico Pro (subscription required) reported last Friday, a draft report from the U.S.-China Economic and Security Review Commission “raises alarm about the safety and reliability of pharmaceutical imports from China and urges Congress and the administration to take action to protect the public.”
The report says China’s pharmaceutical industry is “not effectively regulated” and that puts American consumers and members of the U.S. military at “risk of exposure to contaminated and dangerous medicines” because the United States manufactures only 20 percent of the active pharmaceutical ingredients used in domestic pharmaceutical production. The commission’s draft study notes that “over the past decade, the U.S. market has been rocked by high-profile recalls of Chinese drug products, such as U.S. FDA’s recall of contaminated heparin, a blood thinner commonly used in U.S. hospitals, which has been linked to more than 200 deaths in the United States.”
The second report comes from STAT News. Through an analysis of Food and Drug Administration (FDA) records, investigative reporter Katherine Eban found data falsification is an enormous problem at foreign drug manufacturing plants, particularly at, you guessed it, facilities in China and India.
Eban conducted her analysis with the data analytics company FDAzilla. Michael de la Torre, CEO of FDAzilla’s parent company, said his researchers found, “While the U.S. and Europe are not immune to serious data integrity violations, China and India are at least twice as likely to have these issues.”
The disparity occurs in part, Eban said, because the FDA does not conduct inspections abroad the same way it does in the United States. “In the United States, FDA investigators show up unannounced for inspections,” Eban wrote. “But abroad, the agency has chosen to pre-announce its inspections, a system that gives plants time to clean up any evidence of unsanitary conditions, wrongdoing, or data manipulation.”
That’s not all. Not only are there more data violations abroad, the nature of the wrongdoing is more severe, Eban says. She explains, for example, that a January 2019 FDA inspection at a plant in India found “the manufacturing plant had faked the data in its batch production records to justify the release to market of its diabetes drug glimepiride” even though “raw testing data showed that the drug did not meet quality standards and therefore should not have been released to patients.”
What does this mean for patients? Eban explained, “While data integrity violations may sound minor and technical, for patients they can mean the difference between a safe, effective generic drug that functions just like the brand and a drug that is not equivalent to the brand, or that may contain toxic impurities or foreign particulate matter.”
In short, Eban concludes, it is the “difference between life and death.”