Opinion | Americans Need Generic Drugs. But Can They Trust Them? – NY Times – By May 2019
Technicians used initial hidden tests to get preliminary results, which then guided them as they tinkered with the test settings.
Then they retested in the plant’s official system to get the desired results showing that the drugs fell within specifications. Those drugs with altered test results could then be released to patients.
During his 27 months in India, of the 38 drug plants he inspected, Mr. Baker found fraudulent or deceptive data in 29 of them.
A new head of the F.D.A.’s India office, Altaf Lal, arrived in mid-2013. To tame the twin problems of company fraud and compromised investigators, Mr. Lal made a novel pitch to agency officials.
He proposed a pilot program to make all inspections in India either on short notice or unannounced. By December 2013, he had a green light. The results were instantaneous.
In January 2014, the F.D.A. was planning an unannounced inspection at a plant in northern India on a Monday. Fearing that plant officials had heard they were coming, Mr. Baker and his colleague went a day early, unannounced.
Dozens of workers hunched over documents, backdating them. On one desk, Mr. Baker found a notebook listing the documents the workers needed to fabricate in anticipation of the inspectors’ arrival.
the pilot program uncovered a long-running machinery dedicated not to producing perfect drugs but to producing perfect data.
At the vast majority of the unannounced inspections, the investigators found things the plants no longer had time to fix:
- Infestations of birds and insects.
- A pile of critical manufacturing records, tossed in a trash bin.
- An employee bathroom near a sterile manufacturing area in one plant lacked drainage piping, so urine puddled directly onto the floor.
Author: Katherine Eban is the author of the forthcoming “Bottle of Lies: The Inside Story of the Generic Drug Boom,” from which this essay is adapted.
China and other overseas manufactures supply most of the active ingredients in prescription and over-the-counter drugs and less than 20 percent of these overseas facilities got inspected last year.
A News 4 Investigates review of Food and Drug Administration documents paint a concerning picture of overseas drug manufacturing facilities that lack the quality control necessary to ensure the drugs that ultimately get shipped to the United States are pure, safe and effective.
The FDA documents detail bizarre attempts of foreign companies to sidestep their inspections, which are often announced ahead of time, unlike the process for U.S. facilities.
For example, a manufacturer in India faked an employee strike to delay an inspection. When the inspector did arrive, he was forced to conduct his work in the dark with a flashlight.
…most of the U.S. producers were driven out by China, who dumped “a whole lot of it on the global market at a really low price.”
As a result, medicines like antibiotics, aspirin, penicillin – even Vitamin C – are made overseas. Generics drugs – birth control, antidepressants, and medicines for Alzheimer’s and Parkinson’s disease – are also being made more often overseas.
Challenges faced by FDA
One of the problems, experts said, is that the FDA typically informs overseas plants of when they want to inspect.
“It’s incumbent on Congress to exercise its oversight responsibility and to get the Food and Drug Administration to more aggressively monitor that activity by actually going into these plants and confirming what is being done,” Higgins said
David Light, the CEO and founder of the online pharmacy Valisure, said they have an analytical laboratory to test the quality of every drug it purchases.
Light said about 10 percent of the batches tested end up failing. Most come from China and India. Sometimes, the dosage is off or the batch is contaminated. They have even found batches contaminated with industrial solvents.
Light said what most people do not realize is there are about three drug recalls per day, and 100 recalls per year with the risk of death.
“And also it’s important to understand that the FDA does as good of a job as it can, but this is a $2-trillion global chain that’s incredibly complicated. And the FDA, for the most part, doesn’t do chemical testing.”
One of the problems, Light said, is that drug manufacturers self-report their analytical testing of the drugs to the FDA, which has already said it does not have the resources to review all of these reports.
“We can’t just rely on the industry in a self-reported fashion. It’s not even just overseas. We’ve seen problems of American manufactures that have been cited by the FDA.”