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Why are FDA Inspections So Ineffective and Disappointing?

Are you losing faith in the FDA? Kaiser Health News reports on a scandal about FDA inspections and tainted medicine. How long has this been happening?
Why are FDA Inspections So Ineffective and Disappointing?
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People are preoccupied with the pandemic with good reason. We are hurtling towards 400,000 deaths in the US. Hospitals in many regions are overwhelmed. It’s hardly any wonder that people are not paying a lot of attention to the quality of their medicines during this crazy time. We worry about the shipment and storage of COVID vaccines because of stringent temperature requirements. But what about regular medicines? Without routine FDA inspections abroad, can we trust the quality of imported drugs?

FDA Inspections Suspended:

Has the pandemic affected the quality of your diabetes medicine, blood pressure pills or antidepressant? We cannot answer that question. The Food and Drug Administration suspended inspections of both domestic and foreign drug manufacturing in March, 2020. 

In normal times, the FDA inspects pharmaceutical facilities on a regular basis. It does this because not infrequently the agency has discovered lax standards or outright fraud.

Inspections are necessary to ensure good manufacturing processes are being followed. In addition to visiting plants, inspectors pore over company records to make sure nothing is amiss. 

Last spring the agency determined that COVID-19 posed a greater risk to inspectors traveling and visiting in person than the risk to consumers who might get substandard drugs. More recently, the FDA updated the Senate Committee on Health, Education, Labor, and Pensions about its response (Sept. 23, 2020).

Although routine inspections are still on hold, the FDA resumed priority inspections in the US in July. The agency has also continued “mission critical inspections.”

What Does Mission Critical Mean for You?

Most of the medications that Americans now take come from other countries. Few are considered “mission critical.” That means most drugs coming into the country recently have been made without direct FDA oversight. Because inspectors can’t travel safely, they are relying on company-supplied records.

Why is the lack of FDA inspections a problem? We know from investigating the FDA’s approval process ourselves the honor system does not work. There have been problems with records in the past.

Bottle of Lies!

Katherine Eban, an award-winning investigative journalist, is author of Bottle of Lies. In it, she documents many examples of deceit, falsification of documents and even outright fraud.

Even when the FDA was inspecting plants in person, the agency frequently notified foreign firms well in advance of the visit. This allowed companies to clean up before the inspectors arrived.

When we asked Ms. Eban about the effects of the pandemic on FDA inspections, she wrote:

“SARS-CoV-2 has not only exposed the perils of our dependence on a foreign pharmaceutical supply, but with the FDA shutting down inspections of foreign plants, the agency is flying blind, and must accept the word of drug makers that their plants are operating safely. This puts all U.S. consumers at risk of getting drugs that may be impure, contain particulate matter or that may not be bioequivalent. Even in the best of circumstances, the honor system is no way to regulate a drug supply.”

The FDA in the Best of Times:

I have been tough on the FDA, I admit it. Several years ago I discovered deep flaws in the agency’s generic drug approval process. You can read about them at this link

I have criticized the Food and Drug Administration for being slow to discover and report serious adverse drug reactions. The horrific prescription drug ads on television drive me crazy and I have been vocal about the FDA’s lax oversight of such commercials. I am especially dismayed by FDA inspections that have allowed serious problems to slip through the cracks. Equally disappointing is the FDA’s lack of transparency!

Readers Continue to Complain:

Well before the pandemic started, readers of this column were reporting generic drug problems.

One person told us:

“I had been on Celebrex [for pain control] for ten years before it became generic celecoxib. My first few refills worked fine, and then my pharmacy switched to a different manufacturer. Within a few days the difference was remarkable. It was like taking nothing at all.

“After trying it for two weeks, I went back to the pharmacy and discussed it with the pharmacist. He ordered it from the original manufacturer and things have been fine since then.”

Other readers are concerned about contamination:

“I have been taking metformin for diabetes for two decades. News of contamination is very disturbing. Despite all of the checks and balances that are supposed to protect people, manufacturers have found ways to produce and sell defective or damaging products around the world. What happens to people who need life-saving medications and have no way to avoid bad products?”

Sadly, many batches of metformin have been contaminated with the nitrosamine NDMA. You can read about the latest recalls at this link. Until the pandemic is controlled and FDA inspectors can once again visit foreign drug plants, consumers will be at risk.

Kaiser Health News Blows the Whistle on the FDA!

The Food and Drug Administration brags that:

“The U.S. drug supply chain remains one of the safest in the world.”

If that’s true, we really fear for other countries.

Kaiser Health News (KHN) investigated the FDA’s history of inspections and recalls.

The article by Sidney Lupkin was titled

“Tainted Drugs: When Medicine Makes Patients Sicker.”

“Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles and vials that have entered the U.S. drug supply and made their way to patients’ medicine cabinets, hospital supply closets and IV drips.”

The KHN investigation noted that the tainted products were problematical for a variety of reasons. Some contained too much or too little of the active pharmaceutical ingredient (API). Others were contaminated with bacteria, mold or foreign objects like glass.

Foreign OR Domestic Screw-Ups?

We have long worried about foreign drug manufacturing plants. That’s because the FDA has limited ability to inspect these facilities and detect problems that could lead to drug contamination. The agency must alert foreign drug makers well in advance of an inspection, blunting the effectiveness of this approach.

The KHN report suggests that even in the US, where FDA inspectors show up unannounced, inspections may not find all the problems that they should. Within a year of passing inspection, 65 drug manufacturing facilities had to recall almost 300 products.

FDA Inspections & Scary Stories!

Over the last decade or so we have been tracking FDA inspections. What we discovered is troubling, to say the least. It is also amazing how fast these scandals disappear without a trace.

We do not understand why health professionals, patients and politicians have lost their sense of outrage. Too many people, it seems, have the attention span of gnats. Shortly after a story breaks, everyone loses interest. It’s on to the next news cycle and business as usual.

The Ranbaxy Debacle:

Investigative reporter Katherine Eban described in detail a case of fraud at Ranbaxy Laboratories in India in her May 15, 2013, article in Fortune titled “Dirty Medicine.”

A whistleblower at the company described

“…how the company fabricated and falsified data to win FDA approvals…”

Eventually Ranbaxy pleaded guilty and paid

“…$500 million in fines, forfeitures and penalties—the most ever levied against a generic-drug company.”

What is extraordinary about this scandal is that the FDA inspected one of the Ranbaxy facilities in 2004. This was around the time the whistleblower was discovering serious problems. The FDA apparently gave the company a green light to keep manufacturing and allowed ongoing generic drug export to the U.S.

Here’s the kicker. In her Fortune article Katherine Eban noted that:

“…the company’s misconduct continued well into 2009 even after the FDA restricted the company’s activities.”

“For all the actions taken by federal authorities, there is a deeply troubling aspect to the government’s role in the saga of Ranbaxy. Even as ever more details of the company’s long-running misconduct emerged, drug regulators permitted Ranbaxy to keep on selling many of its products.”

Cetero and FDA Inspections: The Big Ooops!

Lest you think FDA inspections abroad are the only problem, let us share this story about a Houston testing laboratory. Cetero Research analyzed data for brand name and generic drug companies.

The FDA sent inspectors to the lab on numerous occasions and did not uncover serious flaws. The data from Cetero was used to approve numerous generic drug products for sale in the U.S. But a whistleblower at the company reported that some of the scientists there were falsifying data.

The FDA eventually determined that drug tests done at Cetero between 2005 and 2010 were untrustworthy. ProPublica (April 15, 2013) issued an investigative report that was mind blowing  :

“FDA Let Drugs Approved on Fraudulent Research Stay on the Market”

We summarized this scandal at this link:

“FDA Silent on Generic Drug Fraud”

The bottom line is that the agency 1) did not uncover the fraud during its FDA inspections and 2) did not notify the American public which drugs were under suspicion or suspend sale of the questionable products. This is another egregious case of FDA’s lack of transparency.

There are many other examples of fraud and drug contamination. We will not bore you with additional examples. It often takes a story to bring home these abstract problems and make them meaningful.

When FDA Inspections Fail There Is Human Tragedy:

The KHN investigative piece (January 4, 2019) about tainted drugs gets personal with this tragic story.  It involves an over-the-counter stool softener (docusate). Staff at a Texas hospital noticed an increase in an unusual infection called Burkholderia cepacia. This bacterium is found in soil and has no place in medicines. A six-month investigation traced it to docusate made at a plant in Florida.

The KHN report highlights the case of a toddler treated with contaminated docusate. B cepacia showed up in his respiratory tract and led to “serious and dangerous life-threatening injuries,” according to a lawsuit his parents filed. Years later he is still on a ventilator. The same OTC medication has affected 63 individuals in a dozen states according to KHN.

FDA Inspections: No Guarantee!

How could a contaminated OTC drug get to consumers? Unfortunately, it’s easier than you might think. The FDA is supposed to carefully inspect all drug manufacturing facilities on a regular basis.

But the KHN report notes:

“Inspectors miss serious hazards. Drugmakers fail to meet standards even after the FDA has taken enforcement action. Hundreds of plants haven’t been inspected for years, if ever.”

We fear that the suspension of routine unannounced inspections because of the COVID pandemic will make this dismal track record even worse.

Carcinogens in Blood Pressure Meds?

Over two years ago the European Medicines Agency (EMA) announced a recall of a popular blood pressure drug, valsartan. The Chinese company, Zhejiang HuaHai Pharmaceutical company in Linhai, China, had changed its manufacturing process. The result was contamination with a probable carcinogen, NDMA (N-nitrosodimethylamine). As far as we can tell, the contamination had been going on for years.

The FDA eventually issued its own recall. Since then there have been a shocking number of additional recalls. Not only valsartan, but also irbesartan and losartan and several combination medications have been caught up in the ongoing contamination controversy. You can read about these disasters at this link.

In one case, the active pharmaceutical ingredient losartan was made in China by Zhejiang HuaHai. The drug was shipped to the Lek Pharmaceutical company in Ljubljana, Slovenia, where it was formulated into pills for Sandoz. The FDA announced in November, 2018, that these pills were recalled because they contained NDEA (N-nitrosodiethylamine), another probable carcinogen.

There have also been recalls of the popular heartburn medicine ranitidine (Zantac) and the diabetes drug metformin. All involved nitrosamine contamination. We anticipate more such recalls in the years ahead.

The People’s Pharmacy Perspective:

We have lost confidence in the FDA’s ability to ensure drug quality and safety. The KHN report is very scary. Sadly, it does not surprise us.

If you would like to learn more about our own investigation into how the FDA oversees generic drugs, you will find details in our book, Top Screwups. We wish  health professionals would read the KHN investigation into FDA inspections and get mad!

We would hope that the outrage would last more than a nanosecond. Perhaps if patients, physicians and pharmacists told their politicians that enough is enough, there would be legislative action to ensure the agency is well funded and encouraged to become more proactive in protecting the public. A little more transparency would also be helpful.

Share your own thoughts about this topic in the comment section below.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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