When you get on an airplane or an elevator you assume someone inspected the equipment. That is the implicit understanding between customers and companies. The goal is safety. But who inspects pharmaceutical manufacturers? It’s supposed to be the FDA. The agency is responsible for ensuring drug quality and safety. But ever since the start of the pandemic, FDA inspectors have been off the job in foreign countries where most of your medicines are made.
There is a Reason to Trust but Verify!
We love the old Russian proverb “Doveryay, no proveryay.” It has been loosely translated as “Trust but verify.” Ronald Reagan was fond of repeating this saying when negotiating with the Soviet Union.
Most of us intuitively get the meaning of this phrase. When we cash a check at the bank, we trust the teller to get it right, but we still count our money before we leave.
Drug Company Malfeasance:
We wish the FDA were as careful about verifying drug quality. Over the last decade or two, there have been repeated problems with pharmaceutical testing and manufacturing. We have been documenting contamination with carcinogens, corruption and falsification of documents for years.
For example, in 2013 investigative journalists at ProPublica reported on the FDA’s missteps.
A whistle blower at a large research laboratory tipped the agency off to fraudulent data manipulation. Over 100 drugs were involved, many of them generics. The fudging of data lasted from 2005 till 2009 and was characterized as egregious by the FDA investigators.
Since the agency could not trust the data for many of the medications that had been approved, it required retesting, but it did not tell physicians, pharmacists or the public which medications were under scrutiny. Most remain on the market and no list of affected drugs is available. We still do not know how the FDA verified drug quality for these frequently prescribed medications.
COVID-19 Has Halted Foreign Inspections:
The pandemic has only made matters worse. Because so many of our medications are now made in foreign countries, inspections are more important than ever. The FDA finds it challenging to inspect these plants even under the best of conditions. When COVID-19 began threatening world health, the FDA suspended on-site monitoring practices.
With the pandemic still killing people, the agency is:
“limiting unnecessary contact by only conducting prioritized domestic facility inspections and those that are deemed mission-critical.”
In practical terms, that likely means that the medicines you are now swallowing for blood pressure regulation, diabetes management, epilepsy regulation or cholesterol control were manufactured without much, if any, FDA oversight.
What’s Happening in India?
In case you have not been following the news, India is now in terrible shape. Hospitals are overwhelmed. Nearly 350,000 people tested positive last Sunday. We suspect that many more cases went undetected. Oxygen is in short supply and there are not enough hospital beds. That means people are dying at home and even in the street.
Where do you think a great many of our generic drugs come from? India! Here is just a partial list of Indian drug manufacturers:
Given how bad the pandemic is in India, it’s no wonder the FDA is not sending inspectors to that country. It has likely been more than a year since FDA inspections have been carried out there and it could be many more months before on-the-ground examinations resume. How is the FDA guaranteeing drug quality in India?
The GAO Inspects the FDA!
The Government Accountability Office (GAO) recently reported that FDA:
“has paused most inspections since March 2020.”
“FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections and will likely face a backlog of inspections in future years.”
The countries most affected are China and India.
In a typical year, the FDA would carry out at least 600 inspections of foreign manufacturing facilities. The GAO reports that “FDA conducted three foreign inspections in fiscal year 2020 following the pause” due to the pandemic.
Why did the GAO conduct its review of FDA inspections? The United States increasingly relies on foreign companies for the drugs Americans take. Three fourths of the active ingredient manufacturers are located outside our national boundaries.
The GAO report notes:
“FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced, and it conducts inspections of both foreign and domestic manufacturing establishments.
“GAO has had long-standing concerns about FDA’s ability to oversee the increasingly global pharmaceutical supply chain, an issue on our High Risk List since 2009.”
What is the FDA Doing About Drug Quality?
How is the FDA responding to worries about its lack of drug company inspections? The agency has just issued a new guidance for “voluntary remote interactive evaluations.” Essentially, these are video visits.
Anyone who has been meeting on Zoom during the pandemic knows that it’s better than nothing, but certainly not the same as being there in person. For remote evaluation, the facility must have adequate internet connection throughout to support livestreaming video and audio during the “walkthrough.” Inspectors may also need translators to help with communication during interviews.
Even in-person inspections don’t always reveal problems with quality control or outright fraud. To learn more about the shocking state of global drug manufacturing, you might want to listen to our free interview with Katherine Eban, author of Bottle of Lies: The Inside Story of the Generic Drug Boom. It is Show 1169: What Are the Problems with Generic Drugs at this link. Click on the arrow inside the green circle to hear Katherine Eban explain what she uncovered about drug quality problems. You can also read about our investigation of the FDA’s generic drug approval process in our book, Top Screwups. It is currently on sale for 30% off at this link when you check out.