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Why Aren’t Docs Outraged by Inadequate Generic Drug Approval?

The FDA says that generic drugs are equal to brand name medicines. A new book, Bottle of Lies, reveals that generic drug approval and monitoring is flawed!
FDA Approved words on an orange pill or medicine bottle with long shadow

Doctors, pharmacists and nurses are directly responsible for patient care. They prescribe, dispense and oversee treatment. Why aren’t they more concerned about generic drug quality? We are confounded by the seeming indifference of health professionals to patients’ complaints about generic drug quality. Now, a new book, Bottle of Lies, confirms that there are huge gaps in FDA’s generic drug approval and monitoring process.

Why Aren’t Physicians and Pharmacists More Like Pilots?

When two separate Boeing 737 Max 8 airplanes crashed within several months of each other, the world took notice. Foreign regulators grounded this aircraft almost immediately. Pilots were outspoken in their criticism of the process that had allowed such a plane in the air.

Over the last year, manufacturers have recalled tens of millions of blood pressure pills. That’s because drugs like losartan, valsartan and irbesartan were found to be contaminated with carcinogens. The Chinese and Indian manufacturers had apparently been producing substandard products for years.

We have not heard an outcry from American health professionals. Doctors, nurses and pharmacists are responsible for their patients’ safety just as pilots are responsible for their passengers’ safety. Yet providers have not demanded changes in the way the Food and Drug Administration oversees the generic drug approval and monitoring process.

FDA’s Definition of Generic Drugs

For years, the FDA maintained that:

“A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.” in Applied Health Economics and Health Policy, June 20, 2015.  The same description is found on Medscape: “‘Generic Equivalent’: What Does That Really Mean?” (Oct. 2, 2017)

We pointed out to the FDA that the Oxford Dictionary defines the word identical as:

“adj. 1 agreeing in every detail. 2 one and the same.”

The Merriam-Webster Dictionary offers much the same definition:

“1: being the same 2: having such close resemblance as to be essentially the same.”

FDA Generic Drug Approval: Not Really Identical!

In truth, generic drugs are far from identical to their brand name counterparts. For one thing, brand name manufacturers do not hand over the recipe for making their medications. Generic drug companies have to reverse engineer products they want to copy. They often use different “excipients.” Those are the fillers, binders and coloring agents that hold the active pharmaceutical ingredient (API) together in the pills or capsules.

The formulation itself has to be recreated from scratch. When it comes to timed-release tablets, the generic manufacturer often has to develop a whole new technology. 

The Food and Drug Administration has dropped the word “identical” from its current definition. Now the FDA defines a generic drug this way:

“A drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.”

In our opinion, “comparable” is not the same thing as “identical.” Since we put up such a fuss about the word identical, the FDA also uses this hard-to-understand definition (CFR – Code of Federal Regulations Title 21, April 1, 2018):

“Bioequivalence is the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.”

We think this definition muddies the waters significantly. We find the phrase “absence of a significant difference in the rate and extent…” gives the FDA a tremendous amount of leeway. We think this newer definition is way too ambiguous.

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FDA’s Position: Be Happy, Don’t Worry!

Several years ago, we alerted the FDA to a large number of complaints about Budeprion XL 300, a branded generic form of the antidepressant Wellbutrin XL 300 (bupropion). Initially the FDA was skeptical. Officials insisted that any problems with Budeprion XL 300 were probably caused by psychosomatic factors. In other words, they were all in patients’ heads. Nothing to worry about.

We did not stop speaking up for patients, however. Eventually the agency decided to investigate. Independent testing showed that Budeprion XL 300 was not actually equivalent to brand name Wellbutrin XL 300. Other generic forms of bupropion also failed the tests.

Wellbutrin vs Budeprion Graphs

Read about this scandal at this link and see the so-called bioequivalence curves. You will find that the graphic comparing generic Budeprion 150 to Wellbutrin 150 shocking. The FDA still says these drugs are bioequivalent. This is not the same rate of absorption!

Do Physicians and Pharmacists Understand the Generic Drug Approval Process? 

Most health professionals have no idea how the FDA’s generic drug approval system works. They just assume that the FDA knows what it is doing. But take a look at the graphs below and tell us that these drugs have the same rate of absorption. 

Budeprion 150 versus Wellbutrin XL 150 bioequivalence curves

Note that the horizontal x-axis at the bottom is hours. Clearly, the generic Budeprion is absorbed into the body a lot faster than the brand name Wellbutrin. The generic peaks in less than 2 hours. The brand doesn’t peak until nearly 6 hours. Not identical!

What About OTHER Problems with Generic Drug Approval?

A new book by Katherine Eban reveals that there are huge problems with both the manufacture and regulation of many generic drugs. In her book, Bottle of Lies, Ms. Eban documents cases of fraud, shoddy manufacturing practices and regulatory failures. This book should be required reading for all health professionals.

One of the critiques of the Federal Aviation Administration (FAA) is that it relies too heavily on the manufacturers’ testing and certification. The same might be said for the FDA. The agency depends almost completely on test results supplied by drug makers.

If the data are manipulated, the FDA might have difficulty detecting that the medications are substandard. This may mean that some generic drugs are ineffective or unsafe.

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Pilots Are Speaking Out! Where are the Physicians and Pharmacists?

Pilots have spoken up about their dismay with FAA’s handling of the Boeing 737 Max 8 crisis. One pilots’ union, the European Cockpit Association, declared that it was “extremely worrying” that “the manufacturer and the authorities are difficult to distinguish” in the FAA’s certification system.

The union president continued:

“What has been revealed is an oversight and regulatory setup that leaves pilots’ trust and confidence severely undermined.”

Safe and effective drugs, like safe and effective airplanes, require regulatory oversight independent of the manufacturers. Why haven’t physicians and pharmacists noticed problems with the quality of the drugs they prescribe and dispense every day? Why aren’t they as outraged as the pilots who are calling for changes in the way the FAA regulates airplanes?

The FDA often says it can’t change its procedures without legislative direction. Perhaps prescribers and dispensers (doctors and pharmacists) should be asking their senators and representatives to read Bottle of Lies. They should also read it themselves! 

If you would like to listen to our free interview with Katherine Eban about the generic drug approval and monitoring process, here is a link to our radio show. Click on the green arrow above Katherine’s photo for streaming audio. You can also download the free mp3 file at the this link if you select that option or you could purchase a CD to give to your busy health professional. 

Share Your Thoughts:

Why do you think health professionals have remained silent about this scandal? Have you had personal experience with the generic drug approval or monitoring process? We would love to get your perspective in the comment section.

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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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Citations
  • Shah US. Regulatory strategies and lessons in the development of biosimilars. In: Pharmaceutical sciences encyclopedia. Wiley; 2010. doi:10.1002/9780470571224.pse511.
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As a family physician, I am embarrassed to say that I did not understand the scope of the problem until patients brought it to my attention! I have looked into it further and have found out the shocking truth:the FDA is in the hands of the pharmaceutical industry. I have suspected this for a long time as the FDA has changed dramatically over the 30+ years I have been in practice.I admit to feeling somewhat powerless, in the sense that I am very busy and preoccupied with daily care of patients. That said, we as a profession could be lobbying congress, and complaining to the FDA. Introducing this topic at our professional meetings will be a start.

I took anastrozole, the generic form of arimidex, with minimal side effects for four years. During the fifth year, I switched to our local independent pharmacy for refills, trusting that all drug manufacturers who sold in the U.S. had been screened by the FDA and were safe, and that generic drugs were identical to the original.

But after a few months on the independent pharmacist’s generic, I began to suffer significant side effects: hair loss, upset stomach, hot flashes, joint pain, and stiffness. My quality of life was seriously affected by limited mobility and flexibility, not to mention painful. I mentioned it to my general physician and was told to report it to the pharmacist. The pharmacist told me to report it to the distributor. Then I learned about your research into generic and drugs and learned to research the manufacturer. My Rx was made in India.

A friend, who has testified before Congress about the problem with inadequate FDA oversight and inferior drugs, advised that independent pharmacists are driven by lowest cost because they don’t have the economies of scale that the large chain stores, and other large companies have. When I switched to one of them, sure enough, my new Rx was manufactured in the U.S. Ultimately, with my oncologist’s approval, I stopped taking the drug. The side effects began to diminish after two weeks and now are nearly gone. But a significant loss of bone mass in my spine occurred during the last two years. Time will tell what calcium supplements might do.

I am shocked and outraged at the FDA’s failure to do what a nation of people are expecting – and depending on – it to do. I will follow up with my members of Congress.

I take brand name Nuvigil at a high cost $800-1000/month @ first of yea, $80-100 later. It’s almost impossible to get. I was told that they aren’t selling enough to make it worthwhile. A terrible reason. Generic does not work.

I have very high blood pressure. I have tried many different kinds of hbp medicine. I get so many side effects from each kind. Depression, headaches, pain. I have no problem with my health until I take medicine. I just pray God will protect me from heart attack or stroke or any other health problem from hbp. I just turned 74, and He has for 14 years.,I take only supplements and do lifestyle changes for my health.

The doctors insist we keep trying untill I find a BP med my body can tolerate. When I read and study that some of these medicines are made overseas and in horrible conditions,I refuse to put them in my body. People need to read and study for themselves because the local pharmacy or the doctor may not know the truth about the medicines they are taking and where they are being made. I thank Peoples Pharmacy for giving us the latest health information and being honest with us.

My doctor agrees completely and advises us not to take generics. However, many medications are only available as generic because the brand is no longer being manufactured! However, the brand company has sold the drug name to the generic company so that consumers will not even be aware they are taking a generic.

I advise everyone to look up the drugs they take and make sure they are made by the brand company reguardless of the name on the bottle. Many cardiologists only prescribe brand because the problems with generics is that they don’t work and for cardiac patients that can mean death.
Thankfully, my doctor understands but I have been fired by some physcians for refusing to take medications they prescribe!

I believe my mother is still alive at 96 mainly because I have stopped her from taking medications and control the few she takes. I have spent two years getting her off PPIs.

A number of year ago my prescription for Zoloft was changed over to a generic sertraline and simultaneously became ineffective. In response, my PCP began adding other drugs to the generic sertraline to try to achieve a response. After several attempts at different add-ons, I was prescribed generic Budeprion XL 300 and three days later I suffered a gran mal seizure due to serotonin syndrome. I quit all Rxs for depression at that time and have suffered through major depression since that time — which is marginally better than dealing with potentially life-threatening side effects of these generic drugs being dispensed by folks who are not paying sufficient attention to the problems these drugs present to their patients. I’m not willing to be their guinea pig!

I am a clinical pharmacist and midway through the book “Bottle of Lies.” I am outraged, disgusted, and now mistrustful of our regulatory agencies to keep all of us safe. I trusted that our drug supply was safe. I believed (evidentially wrongly) that the area under the curve was a true and accurate measure of bioavailability. I never imagined that any entity would completely fake the data.

But in the past couple of years there have been so many recalls, that I began to question how this could happen. And yet, our supposed protector, the FDA, has looked the other way, has wimped out and have not done the right thing. I am furious about their cowardice. Recently the governor of my state, Florida, has OK’d the import of drugs from Canada. I do not believe that their drugs are any safer than ours are. Both are at high risk.

I am telling every health professional that I talk to to read this book. I am seeing my husband’s endocrinologist tomorrow and I am going to tell him. The metallic particulate in insulin might get his attention.

I am writing Governor DeSantis, President Trump and Senator Charles Grassley. I am also going to contact top level Pharmacy Quality people at our large national pharmacy chain and inform them that they need to read this book ASAP.

I will never take another drug that is not manufactured in the USA. The larger question is how to track down where the raw ingredients came from, even if the drugs were manufactured i the USA. I guess I’ll pay cash for brand name drugs because I am certain that my insurance company is going to make it impossible to get brand name drugs and will not pay for them.

I think your analogy with the pilots is flawed. The pilots’ lives are at stake if a plane goes down so they have a much greater reason for caution. No health professional puts their own life on the line. The history of business in this country is rife with examples of those at the top not caring about those at the bottom.

All I get from this is it doesn’t appear as though we have any hope. The medication I get is wildly variant in its effectiveness, and it’s the only relief I ever get. I would love to know how to approach my doctor but it might already be too late. Does anyone have any ideas on how to survive and get the care we need??

I feel terrified. Helpless and terrified.

I am convinced that most people fail to look at and truly understand the “big picture” of how things interface with each other (or don’t) and affect outcomes. Why? Look at the way we go through life anymore. We live in a “not my concern” blinder society where individuals too often expect others to assume or fix health and life issues that in reality are their own responsibility. The media constantly bombards people with advertising, creating false security/pseudo-truths. Companies like big pharmaceuticals stand to gain billions $$$$ and want to keep the gravy train coming so only tell part of the truth, ignore/downplay negative issues, rush new drugs or knowingly stall until forced to deal with problems. Follow the “money” as the saying goes.

The best thing people can do is QUESTION – look for the patterns, research, advocate, demand change/accountability, and take responsibility for their own health and well-being with their providers instead of relying on others to do it or putting blind faith in the healthcare system to fix. I worked in direct healthcare for many years and have painfully watched our healthcare system become more and more convoluted and dictated to in the name of profit – at the expense of us, the consumer.

Where will our road take us in the next decade? Not a good place if we don’t step up and take charge. Our health status is our own responsibility to ensure. The healthcare system is only there to help along the way!

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