New Report Shows FDA Inspected Just 6% of Drug Manufacturers
By some estimates, well over half of America’s generic drug supply comes from overseas. Europe is a top source of branded drugs. India and, increasingly, China are top sources of generic drugs. In the U.S., labs are inspected by the Food & Drug Administration more frequently. They can drop in unannounced. Not so for FDA inspections in India, for example. They have to set an appointment. And now, short-handed and still not on full footing post-pandemic, they are not up to par with overseas inspections of the foreign labs that dominate America’s generic drug supply.
On April 19, non-profit investigative news publisher ProPublica said that FDA inspection data as of April first shows that FDA inspections of overseas labs, mainly those in India and China, have “dropped precipitously” despite a rash of import bans and Warning Letters sent to the few labs that the FDA did inspect.
This means the U.S. drug supply is at risk of tainted medication, uninspected for American quality. The quality of critical drugs, whether it is amoxicillin or blood pressure medication used daily by millions, is at the mercy of foreign companies with almost no FDA oversight,
In fiscal year 2019, the year before the COVID-19 pandemic limited travel and movement, the FDA inspected only 37% of the roughly 2,500 overseas pharmaceutical manufacturers that are allowed to sell drugs to U.S. medical patients. Obviously 2020 inspections were non-existent. Medication kept flowing in any way.
Worse yet, the FDA only inspected 6% of around 2,800 labs last year, according to the Pro Publica report. There is no improvement in sight, despite ongoing voluntary recalls by companies like Aurobindo of India, and questionable allowances by the FDA for drugs to come into the country even in instances when the lab was written up after a lackluster inspection.
In February, for example, Glenmark Pharmaceuticals said the FDA gave it an exception to export an anti-microbial drug called Atovaquone from its India facility, which was under an import alert. Import alerts inform the FDA's field staff and the public that the agency has enough evidence to allow for import bans.
In a regulatory filing, Glenmark said that they were granted access to the U.S. market for its Atovaquone drug because of “potential drug shortage expectations”. The exception granted the multinational drug maker to supply Atovaquone Oral Suspension USP 750mg/5ml to the U.S. market regardless of the import alert.
Indian labs have been in the news lately, and not for good news.
Contaminated eye drops made in India led to blindness in a small number of users. Sadly, the FDA inspected only 3% of Indian eye drop labs in 2022 — which was even less than it did in 2019, when only 45% of plants were looked at, according to ProPublica.
The FDA, which is tasked with ensuring the safety and efficacy of both prescription and over-the-counter drugs, has acknowledged that limited resources make it impossible to inspect every plant, whether in the U.S. or not, that makes drugs or their ingredients. But the agency has been slow to make improvements. It would be much easier if more of those critical drugs were made in the U.S., where location alone makes it much easier to inspect.
The FDA affirmed the necessity and importance of in-person inspections in its latest annual report on pharmaceutical quality, saying, “In the absence of inspections, many of these situations” that could result in defective products, “and possible public harm, could have gone undetected.”
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.