Government Accounting Office Questions Ability of FDA to Inspect Drugs from Overseas Manufacturers

The Food and Drug Administration (FDA) has the responsibility for monitoring drugs, medical devices, dietary supplements, food, cosmetics, and other products. FDA oversight is based primarily on the Food, Drug, and Cosmetic Act. The oversight is not limited to American production of drugs and other products. FDA oversight also extends to which products can be imported into the United States and under what conditions.

FairWarning reported that Government Accountability Office is now concerned, as a result of their own report that the FDA’s monitoring of foreign drug makers is not effective at unveiling unsafe practices. FairWarning states that, “According to the FDA, roughly 40 percent of finished drugs and 80 percent of active drug ingredients are made overseas.” Foreign production of drugs often means little control and little knowledge about the manufacturing process.

The findings from the GAO report

The GAO report raised the following concerns:

• FDA inspections have been decreasing since 2016
• The inspections that do occur have problems due to:
  • A lack of translators which means that FDA must rely on the drug manufacturer’s translator which raises credibility concerns
  • Advance notice is required for foreign inspections which gives the manufacturers months to prepare for the inspection – when unannounced inspections usually find more problems and help prevent manufacturers from deceptive practices

FDA official, Janet Woodcock, stated that while unannounced visits might be better, they were often “inefficient” due to the large operations of most drug manufacturers. She states that many problems have been found even though inspections are announced.

Examples of problems with foreign investigations

FDA does send FDA warning letters when it believes a company is violating FDA rules and regulations. The warning letters can be sent as a result of a physical inspection. Warning letters can also be sent as a result of improper claims made on company websites and promotional materials. New drugs, in particular, normally require rigorous scientific testing before the FDA will approve them. Older drugs still must be made according to proper FDA protocols and industry standards.

A few of the warning letters reported by FairWarning include:

• One FDA warning letter informed an Indian manufacturer that it had founded “bags of documents awaiting shredding and a binder full of records dated seven days before the inspection.”
• A 2018 inspection of another Indian company, B. Jain Pharmaceuticals, found “numerous flying insect in a raw material storage room, and the ceiling of the quarantine room stained with what appeared to be mold.” This caused an FDA warning letter to be sent.
• An October 2018 FDA warning letter found that another Indian company, Centurion Laboratories, had “visible product build-up” in a room that had been marked as “cleaned,” as well as a damaged air filter full of holes. Centurion chalked these deficiencies up to “a shortage in manpower related to a nine-day dancing festival and government holiday.” Drugs produced in this fashion may be considered “adulterated.”

Part of the problem for FDA officials is finding the right balance between conducting more inspections so drugs are determined to be safe with making sure there are enough drugs, especially generic drugs, at reasonable prices for various health disorders.

Manufacturers of drug products owe a duty of care to the consumers who use those products. Generally, if drugs are defective and the defects cause death or injuries, the manufacturers can be held accountable. Defective drugs can cause pain, infections, bleeding, tissue and organ damage, allergic reactions, and other serious medical problems.

At Cunningham & Mears, our Oklahoma City product liability lawyers work with drug safety professionals to help verify that that the drugs you or a loved one took were defective. We work with your physicians to fully understand how the drugs have changed your life. For help with any medical product liability claim call us at 405.212.9234 or complete our contact form to schedule an appointment with one of our seasoned attorneys.