Is your drug safe?

A lack of of FDA inspections abroad may result in unsafe drugs for patients.

60% of the drugs sold on the American market are coming from foreign countries and 80% of their ingredients are also coming from abroad manufacturing facilities.

As a result the FDA send inspectors abroad to make sure drugs are manufactured in a safe environment. In 2018, 57% of the FDA drug inspections occurred in foreign countries mostly China and India.

Since 2016 the number of inspections has been declining because the FDA hasn’t been able to find qualified investigators or hasn’t dedicated enough time to look for them. Additionally, investigations in India and China have been found particularly challenging with the FDA being unable to conduct unannounced inspections. Announced inspections give time to manufacturers to clean the facilities or “rearrange” their papers to pass the inspection.

In some cases even though the inspection was announced, inspectors found significant problems mostly related to equipment flaws and cleaning problems. Such problems can lead to cross-contamination between drug products or to alteration of the drug products.  In 2008, 81 people died and 785 suffered severe injuries after using a tainted batch of Heparin, a blood thinner, coming from a Chinese factory that had never been inspected.

Additionally, according to a recent article in Fair Warning, the FDA has a history of softening its own negative inspection findings and downgrading sanctions against pharmaceuticals.

This raises the concern that the FDA is after all not that concerned as to what is going on in pharmaceutical manufacturing facilities abroad.