The People's Perspective on Medicine

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!

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!

Finally an article that echoes my sentiments. When I did take meds I got permission to take brands but have no longer used anything for a long time. All meds are harmful with side effects but generics are worse. No one should profit financially from health care or education, which should be provided by government in a useful non-corrupt fashion.

I have had a few interesting experiences with generics. Some work, and some don’t! Have used Valium for years and was sent a generic by error, but decided to try it. I became a zombie! Three others I tried didn’t work at all, so I only use brand name. I tried 3 Ambien substitutes and found 1 that worked quite well. Toprol XL worked very well, (had maybe 2 or 3 episodes of A-Fib in a month), but with metatoprolol I had 7 episodes in 2 weeks! Just recently I was given a different generic of tramadol, which didn’t work at all. My Dr. has been very good about giving me a tiny prescription for the generics my pharmacy carries so that I can experiment .

I am a long time pharmacist with the majority of my career spent at the VA (>30 years). I just finished “Bottle of Lies”. I am embarrassed to not have known more of the details regarding the generic drug scandal(s). I am going to give an in-service to our clinic (9 providers) on this travesty. The issue of adulterated and/or non-equivalent meds is a terrifying concern to me. We have little control over what brands our patients get at the VA but all pharmacists, providers and nurses can do a better job of monitoring and raising Cain when issues like this arise. Patients all over the world deserve better than we are getting. Thanks to Peoples Pharmacy and Katherine Eban for their diligence.

Oddly enough, I do better on bupropion than on Wellbutrin.

Reference to Warfarin rather than Coumadin: I have been receiving Warfarin from my mail order pharmacy rather than Coumadin and, yes, my reading can and does vary from 2.1 to 3.5 in a week’s time. I am so very careful taking prescribed dosage, and my range should be 2.5 to 3.5 which it hardly ever is so I am running to the lab just about one a week.

Pharmacy will always send generic rather than the real thing so what can a patient do? Yes, health care is definitely a profit-driven business and no longer is patient concern and/or care their primary task. If one gets referred to a specialist–who do we see after and following first brief visit but the specialist’s assistant or PA. I am unhappy, to say the least.

Greetings. I took the generic of Valsartan from the now banned Zhejiang Huahai Pharmaceutical Co., Ltd. for several years. I took it because that’s what my pharmacy stocked. And this was a major chain. I trusted them. This was my first mistake.

Since that time, I have become a reluctant expert in Indian and Chinese generics, thanks in part to People’s Pharmacy, Katherine Eban, and my own research. What I have found is shocking. I was prescribed a replacement – irbesartan, and went to pick it up and found it was also made by Zhejiang Huahai. Yep, after all the news was out, including the ban on imports, several major pharmacy chains were selling their remaining supply from this company. The Irbesartan was recalled about a month or two later. Shocker. But I was aware it was made by them only after insisting to see the supplier’s bottle with the manufacturer on it. I refused it.

I have tried to find the “cleanest” generic out there for an ARB, but they keep getting recalled. I have called the FDA and spoken to their pharmacists. I have asked why one year later they still haven’t finished testing these drugs for “impurities.” I have learned that there are now five (5) known impurities in the ARBs, including the latest discovered by none other than Valisure – the online pharmacy that tests medication before selling it to consumers (what a novel concept huh?). They have found a new chemical called DMF or dimethylformamide (also a carcinogen) in valsartan. Apparently from cheap solvents. Valisure filed a Citizen Petition with the FDA you can find here: https://www.regulations.gov/document?D=FDA-2019-P-2869-0001

Good for them. Unfortunately, the FDA’s “safe” ARB listing doesn’t take this DMF contamination into account. See the article here : https://www.bloomberg.com/news/articles/2019-06-18/fourth-carcinogen-discovered-in-heart-pills-used-by-millions

The drugmakers questioned about this said, “they don’t have complete visibility into their supply chain” Shocker. One also said the DMF was likely caused by the testing/analysis! Now that’s a good one.

My god, folks. We’re in trouble here. I agree with this article. Doctors don’t seem to be concerned about this. Or, they are concerned, but aren’t taking action. It baffles me. I read in the article I included above that Cleveland Clinic has pushed the American Medical Association to assess whether more needs to be done to protect the U.S. drug supply.

Hey AMA, let me save you the time and effort. The answer is “YES!” Get on it and make a difference by getting out ahead of this. I predict it will get worse before it gets better. Please everyone, learn how to research your drug manufacturers. Read their FDA warning letters. Ask yourself whether your pharmacy is working for you, or for your insurance company. Do it like your life depends on it. A disclaimer – I have nothing to do with Valisure except that I have now become a loyal customer! Thanks People’s Pharmacy for mentioning them.

In the past I tried the generic form of Welbutrin XL 300 twice, probably 4-5 years apart. The generic was useless. Less expensive, but ineffective. The second time (2016) I tapered myself off because the price for brand name was exorbitant. I miss it, but …

Recently, I was taking Losartan. The last refill was from a different pharmaceutical, which increased my alarm regarding taking this generic. When I went to the FDA website and saw the pages and pages of recalls, I did not hesitate to request an Rx for the brand name Cozaar from my cardiologist. My new Rx for Cozaar is waiting to be picked up today at my pharmacy. The NP at my doctor’s who responded to my e-mail request noted that the pharmacy must notify me if that Losartan has been recalled. I choose not to wait to see if there is bad news. As I emailed her back, I said cancer is deadly. Did she need a reminder?

I’m also paying the cost for brand name Crestor rather than the generic which my insurance will cover, but not the brand name. Crestor plus Cozaar makes my meds very expensive. But safer. I hope!

It seems to be a very expensive, discouraging, and (maybe) dangerous world of meds we live in these days.

Just finished reading Eban’s book and am horrified. I had previously heard her speak after she wrote “Dangerous Doses” and was horrified about counterfeit drugs.too. I questioned my dr regarding some of my generic medications, and he said he mostly prescribes generics and has never heard of any problems. I’m still concerned! Several of my and my husband’s drugs are manufacured in India, although not by the company Eban focuses on in her book. My opinion of the FDA has plummeted and am now worried that I may be taking drugs that are actually bad for my health.

Totally agree with Linda and so many other comments here! Does this tell you something about how the inadequate, incompetent, messed up medical system in this greedy, FOR-profit, drug company- controlled country has steadily gone “down the bedpan”? How sad to have once had the best medical care system that has now gone to profits, hugh corporate salaries/benefits and politicians who do NOTHING to make it more accessible, affordable, reliable and better for everyone, not just the wealthy who can afford to pay more out of pocket for better care and hospitals. This is sinful, America!

My aunt, hospitalized could not be diagnosed, due to being on 23 prescribed, generic drugs! received by mail, cheap… unless you figure in the cost to her life.

At 83, among other drugs… estrogen, PPI, 150mg levothyroxine, fentanyl patch.. several BP drugs. She was so weak, she couldn’t lift her hand to her mouth…She is still trying to recover.

A 91 year old friend was on 15 prescriptions (3 blood thinners)… all generics… liver ruptured, bled into his stomach..

I tried generic Syntoroid; it didn’t work… medicare/Aetna..refuses to pay for name brand! I pay full price, filed a complaint with Medicare, still waiting to hear.

When I asked my aunt why she was on so many drugs…she said she trusted her doctors…

Well, why aren’t they? Are they getting paid by the pharmaceutical companies? Or is there something going on with the insurance companies? How are doctors benefitting from not being outraged?

Personal experience noted over 19 years. Have tried several times to substitute Warfarin for Coumadin. Prices keep increasing for Coumadin-ridiculous considering its age on the market. Warfarin does NOT hold true. INR can vary from 2.5 to 3.4 in 2 week period-and I am extremely careful of the proper dosage.

Starting to have a similar question about the generic Lasix.

Co-opted by the medical industrial complex with regular hours and good salaries?

Indoctrinated in medical schools to believe in the business model in which patients are secondary to profits and collateral damage is an accepted part of the assembly line nature of medicine? The fragmented nature of having a primary care doctor who refers you to a specialist for every different part of your body–under the guise of “team health care”? The increasing reliance on nurses and physician assistants for routine health care and the attendant possibilities of misdiagnoses?

Surgical procedures rushed through in order to fill quotas? Those of us who remember when “health care” was patient-centered are dying out. The business model of health care ensures profits, Medicare/Medicaid fraud, a top down system in which decisions are made by bean counters rather than medical professionals–and the subsequent burnout of medical professionals who thought patient health was the primary goal of a health care system.

Even the generics are different. When my pharmacy switches my generics one for another, I have trouble. Most recently they switched amitriptyline made by Sandoz to amitriptyline made by Zydus. I immediately began having nightmares, depression issues, and more fibromyalgia pain on the Zydus brand. My doctor is still working with me to try to sort this out since I have been told locally there is no Sandoz brand available at any pharmacy. I also have been told there is no longer a brand name of this drug (Elavil) available, or I would take that.

This is not the first time this has happened and it is particularly troublesome with mood-altering drugs. I can’t help but wonder how many people have died or harmed themselves because of a generic drug switch and no one figured it out. This is life or death and the federal government should be ashamed that it has allowed this to happen.

Why not ask doctors and pharmacists if they take generics or if they only take brand? The answer will tell you everything you need to know!

Most health care workers are overworked and simply don’t have the time or energy to invest in what is sure to become a very contentious issue where government regulations and big money are involved. During 30 years of retail practice in corporate chain store practice, I had little if any energy left to fight additional battles outside of the practice of hands on pharmacy. I believe health care practitioners certainly are concerned, but more than likely are deterred by the inertia of the system and a nagging doubt thay “you can’t fight city hall” (or more specifically, big government and big business).

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