The People's Perspective on Medicine

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?

We have been tough on the FDA, we admit it. We have questioned the agency’s generic drug approval process. We have criticized the Food and Drug Administration for being slow to discover and report serious adverse drug reactions. We have chastised the organization for permitting so many horrible drug ads on television. We are especially dismayed by FDA inspections that have allowed serious problems to slip through the cracks. We are also disgusted with the FDA’s lack of transparency!

Kaiser Health News Blows the Whistle!

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) recently 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.”

Carcinogens in Blood Pressure Meds?

Last July 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 July we have seen 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.

The People’s Pharmacy Perspective:

We have lost confidence in the FDA’s ability to ensure drug quality and safety. You have heard a lot about redactions of late. We have seen too many redactions in FDA reports. 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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I recently read an article titled…“FDA: Level of young people addicted to vaping may require drug therapies”. Now if THAT doesn’t convince you (not to mention the decades of other blatant evidence) that Big Pharma is calling the shots, I doubt anything will.

When it comes to food and drug safety, un-regulated and/or poorly regulated capitalism is a prescription for guaranteed disaster.

The horrendous opioid addition crisis in the USA is perhaps the most glaring example of the madness of applying “laissez faire-like economic theory” to food and drug production & distribution — but as this article shows, there are plenty of additional examples, as well.

The corruption of our drug safety regulations & procedures is, at root, A POLITICAL MATTER, and it directly reflects the corruption of our political-electoral processes.
Corporations can now indirectly infuse political campaigns, via IRS 501 (C) {4]’s known as “….charitable/educational institutions…”, with unlimited amounts of dark (untreaceable) money to help get pro-corporate candidates elected —- a process which changing democratic government into plutocratic, pro-corporatist government .
So, if we want a more consumer-protective FDA, we’ll first have to make basic reforms in how we elect our congressional lawmakers…!!!

This is an alarming condemnation of a major part of our government that needs to be fixed. The investigations have been done and the evidence presented, but no action has been followed up to clean out the incompetence in the bureaucracy running the FDA. The Peoples Pharmacy is not a political action organization but is a constant and reliable source of medical information to educate everyone that will listen. When there is a flagrant violation of the purpose of a federal agency so dangerous to the populations health as detailed in the reports from Kaiser Health and Peoples Pharmacy, it is time for the media and congress to get involved. The FDA’s malfeasance is as dangerous to us as that of the cigarette companies and should result in the criminal prosecution of the leadership of the FDA.
Drive carefully,
Monty

The best idea is partnering with Consumer Reports and starting some serious letter writing to Congress!

I agree 100%. Consumer Reports is excellent in this regard, and they have much greater political reach than People’s Pharmacy, wonderful as they are. Most everyone will at one time or another be taking these drugs, so the constituency for change is very large.

👍

Dear Joe Graedon; I just discovered your website recently and find it very informative, thus providing information that is long overdue. I strongly feel that mainstream medicine has lost it’s soul, for it has been taken over by corporations namely; Big Pharma. However I really appreciate the opportunity to be able to share some of my thoughts on the topic of corruption regarding the FDA and it’s lack of due diligence. On this matter I observed CDC statistics of deaths caused by influenza, in regards to promoting flu shots, being quoted on the People’s Pharmacy program. On that note, if I may, I would like to suggest , for future program subject matter, to inviting Dr. Brownstein, a holistic practioner from the state of oMichigan on one of the People’s Pharmacy Radio talk shows on subjects such as: CDC coverups on promoting vaccine for flu shots, /CDC whistleblower etc., plus many more health topics that could be brought up for discussion. I personally feel he is a shining star in the world of health and corruption around in cdc/fda circles. All the information on these matters can be found on Dr.Brownstein.com. Thank you. Your sincerely; Leonard.

Safety is the most basic of needs, and needs to be the highest priority. This includes foods, drugs and other chemicals we come in contact with and breathe in our air. It is time to unite and demand that the FDA, and EPA be fully funded and monitored.

While reading this article, I thought about sending a link to my doctor. When I reached the end of the article, I saw that the next item is your book, “Top Screwups Doctors Make and How to Avoid Them.” That might be a reason people don’t want to share this site with their doctors – screwups doctors make. It sounds so scandalous. Perhaps changing the title to Common Medical Mistakes and How to Avoid Them would sound a little calmer and more serious. These are serious problems that need to be brought to everyone’s attention, and you are right about getting people to complain to their representatives and senators being an important step. I appreciate the research and reporting you do, pulling all of this together in one place. Perhaps with so many new people in Congress, we can get them to take this seriously and push for change.

I would love to be able to talk to some of the richest donators to health improvements like Gates, Buffet, Bezos etc.and urge them to start an organization that focuses on natural and herbal cures for diseases. Hire scientists, lab workers and doctors who are not trying to make a bundle of money on sick people and who will focus on the cures that the Greater Being has already given us from herbs, food and vitamins etc.

As a former grad student in organic and biochemistry (MS) and being involved with development of drugs that were ‘farmed’ out to various pharmaceutical companies, I believe that we have the best medicine that “money can buy”. The ethics of the pharmaceutical companies are on a par with car salesman, politicians, chemical companies (I was also a research chemist for Dow.), and traveling medicine shows. Now this has extended to the FDA and the EPA; not a new thing and has been going on for many years. There is no way I believe the the best and safest drugs are available to the consumer. Many drugs should not even be on the market or should be extremely limited in scope. Is money changing hands? I will leave that up to you to decide.

I suspect that the FDA is caught between a rock and a hard place in that funding is limited, and the areas they are to monitor are huge and growing each year. Other agencies have the same problem.

However, having said that, when the FDA does come across an issue like those stated above why don’t they ban that company from the supply list? Also why aren’t their findings brought to the public’s/media’s attention in a big way? Why does it take internal medical sites like The People’s Pharmacy to highlight these problems? Maybe if the general public had this information there would be more pressure for the U.S. Gov to resolve these issues.

It’s been my observation that money talks, and big money out talks EVERYTHING! It takes money to get elected, and I’d wager everyone in Washington is heavily invested in the cash cow that is big pharma. Do you really think ANY of them will jeopardize the cash flow? Far easier and more lucrative to jeopardize the American people.

Perfect summary!

Certain people in Congress want to get rid of the FDA entirely and give it less money all the time. We need much more $ to give the inspectors more reason to be careful with their work and have less of it to inspect.

Once again this country seems to be all about profits. Is anything going to change? I doubt it. Until greed is eliminated from the human psyche or until penalties are so huge, nothing will change. Give me animals any day, most human beings are disappointing. I am on Losartan and will try to find an alternative.

I have complained to two big chain pharmacies about the generic Lortab. I have severe osteoporosis and RA. The tablets now distributed are like chalk. They fall apart and make me ill. My plea to get other generic brand falls on deaf ears. “That’s what the distributer sends,” they say. It’s a crime. I have no means to fight this.

Yes, you can fight. Try an independent pharmacy rather than the chains. Specify no drugs from China or India for your family. They can order a different generic for you from the distributor. Check each refill’s label for the company name, which may even be different each time, and do Google research to see where the company is that is manufacturing (not the marketing or corporate address, which might be in the U.S. That is a common ploy by China and India to throw pharmacies and customers off track). One of my RXs showed a company name on the pill bottle that was the marketer located in New Jersey. Further research turned up two other company names in China that were the real manufacturers. It’s tough staying on top of it, but your health depends on it. Bottom line: if a generic isn’t working, try another brand. And if a pill crumbles, return it to the pharmacist for replacement.

This is beyond sad. This is criminal.

Outstanding article with very useful links. I wonder whether you folks could work with Consumer Reports, because they use form letters to government representatives that readers can fill out and have added to those of others. We really need an organized lobbying of the Congress to make any progress. Also, perhaps the AMA could be enlisted, assuming they’re not in bed with the drug companies.

Is there a way to publish the European Medicines Agency reports, since our FDA is so ineffectual. Hello, Congress people! Get on the FDA’s back.

I’ve wondered for some time if FDA means “For dollars, anything!”

I don´t think there´s much difference between FDA and EMA (European Medical Agency).
Here is an article from an independant, French organisation – http://www.prescrire.org.
They have a free news letter in English and I have chosen one of their articles.
http://english.prescrire.org/en/81/168/55813/0/NewsDetails.aspx

Too much under-the-table money out there!

I have to weigh what I believe to be more problematic: my condition or the “cure.” That’s why I don’t take statins. In addition to my concerns about the efficacy of the drugs, I also have doubts about their purity, especially since you don’t know where it is manufactured. And even if you do know where it is coming from that doesn’t mean six months from know it isn’t coming from some other plant in some other country. Many of these drugs are coming from countries that aren’t necessarily our friends. Our government has failed to protect the public.

I think when you allow the fox to guard the hen house, this is what you get.
I think it comes down to people demanding that agencies that they pay for with their tax dollars do the job that they are suppose to.

There’s coruption only because we allow it.

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