Without admitting that there is a problem with generic drugs, theĀ  U.S. Food and Drug Administration has just announced that it is initiating a $20 million testing program. The FDA’s new Office of Pharmaceutical Quality will scrutinize generic drugs, over-the-counter medications and brand name products in an effort to improve quality.

This is an incredible about-face by the FDA and a huge victory for patients. It is also a testimony to the thousands of stories people have shared on this and other web sites about their problems with generic drugs. In particular, the FDA admits that the new testing program evolved in part from the discovery that a generic version of Wellbutrin XL 300 (Budeprion XL 300 from Teva) was not bioequivalent to the brand name. That was a direct result of hundreds of patient reports on this website.

The FDA still states on its website that:

“All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product.”

That may seem reassuring, but it is quite clear that the FDA has not had the resources to regularly monitor manufacturing abroad. Serious flaws in foreign pharmaceutical plants have come to light in recent years. India now supplies 40% of over-the-counter and generic medications sold in the U.S. The FDA inspected 160 Indian drug plants in 2013 out of the 500 that are registered to export medicines to the U.S. That might not seem like many, but it is three times more than were inspected in 2009.

FDA Commissioner Margaret Hamburg, MD, is just back from a trip to India where she was presumably trying to improve quality standards. Improvement is essential. The FDA recently banned all exports from Ranbaxy, the largest drug company in India, because of concerns about faulty data and flaws in manufacturing. Another large Indian company, Wockhardt, also came under fire in recent months because of serious violations. It too has had drugs banned from the U.S. market.

Sadly, the top drug regulator in India seems to have undermined Commissioner Hamburg’s trip. Even before the ink was dry on a statement of cooperation between India and the U.S., the top Indian drug regulator was quoted:

“If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country. Our priority is to make medicines available and affordable to all.” He also went on to say, “We don’t recognize and are not bound by what the US is doing and is inspecting…the FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.”

Things may be even worse in China. Only 78 inspections were carried out there last year. An effort to increase the number of inspectors on the ground in China has been blocked by Chinese authorities. Even though the FDA has new staffers ready to start inspections, visas for these people have been denied. There is also a problem with surprise inspections, which are not feasible in China. If manufacturers have to be informed in advance that FDA inspectors will be coming, the value of the inspections is questionable.

That is why we are so excited about the FDA’s new Office of Pharmaceutical Quality and the new testing program. Initially, about a dozen academic centers, including Duke University, University of North Carolina, University of Michigan, University of Maryland, Johns Hopkins University and Brigham & Women’s Hospital in Boston, will be involved in generic drug testing. These institutions will be examining the very medications that visitors to this website have been complaining about, including ADHD drugs, anti-seizure medicines, heart drugs, immunosuppressants and antidepressants.

If independent generic drug quality assessments are carried out by academic researchers, it will go a long way towards improving the current honor system that the FDA has relied upon for decades. Once generic manufacturers realize that their products will actually be tested they may clean up their act. Ultimately, this new program could go a long way toward reestablishing trust in generic medications.

To see why we are in desperate need of a verification system, here are some reports from visitors to this website.

“I am a recently retired family doctor of 35 years. This problem goes back at least 20 years. It was and still is most noticeable in psychiatric drugs which I used a lot in my clinic.

“Patients often found that when the pharmacy would change generic manufacturers they would lose control and as soon as they went back to the original drug maker they felt better within days. One person was on buproprion (Wellbutrin) and 3 different generics didn’t work and within 3 days she could tell a MAJOR improvement back on the brand.

“In the last few years prices of very inexpensive generics that have been available for many years have suddenly gone up 3-10 times the previous price, often over a few months. Many prices are only slightly less than the brand name.” Dr. E.W.L.


“I suffer from Obsessive Compulsive Disorder and had taken Zoloft for 5 years with excellent symptom relief. Within a week of switching to the generic sertraline, my symptoms returned full force.

“At first I had no idea what was happening, but then I started thinking that maybe it was the switch to the generic. I returned to brand name Zoloft and my symptoms stopped within a few days.

“My insurance company refused to pay for the brand name Zoloft even after my doctor told them it was medically necessary. I tried the generic several more times with the same results each time.

“I now must pay over $200 a month for my brand name Zoloft because insurance won’t cover it. If I want a normal life, I have no choice.” C.K.


“I was using Cardizem HCI 300mg. The prescription for name brand is no longer paid for. After trying a generic from a major discount store, it failed to control blood pressure, and I ended up in the hospital with A-fib.

“After checking around I found the generic version was in fact made in India. I did research and found a generic called Cartia XT by Watson produced in California; it actually works better than Cardizem. Do you homework when looking for generics.” R.J.W.


“Several years ago my husband was prescribed Norvasc for slightly elevated systolic blood pressure. The pharmacy filled the prescription with a generic form (amlodipine). Nothing happened. It did not work.

“One month later I had the doctor send a new prescription calling for the original Norvasc. It works. It is quite expensive, though.” P.L.S.


“I have used brand name Valium for decades on an as needed basis. No problems.

“Last year I was sent a generic and decided to try it. Within 20 minutes a friend looked at me over the card table and asked if I was all right. I felt totally out of it and could hardly focus. I have destroyed the bottle, and don’t know the manufacturer.

“6 or 8 years ago I was on Toprol XL for A-fib. I could use 25mg, which I did once or twice every 2 weeks, and that seemed to work fine. But when I was sent the generic metoprolol for Toprol XL I went into A-fib 7 or 8 times in a 2 week period. That was the end of that!” S.D.


“My Wellbutrin XL 300mg was changed to bupropion and within 3 months my family was concerned. I was showing traits of when I first broke down. I called my doctor, went in, took the bottle with me. She cancelled that immediately and put me back on Wellbutrin and told me to always make sure every doctor put “DAW” (dispense as written) on further prescriptions.

“Within a few weeks I was doing fine. Since then I question every generic as there is not enough info as to where it is made, what country made it, what was in it, etc. Why should we depend on foreign countries to take care of our basic medical needs when they are not as developed as this country is. That is turning our lives over to questionable facilities.” Carol


“I have tried to go generic for Keppra (levetiracetam), an epilepsy drug. I have been on Keppra without a problem for eight years . But I am jobless and Keppra costs thousands a year. To save money I have tried two generics. Neither works. Both cause itching, burning, and lethargy.” L.C.


“My daughter started having grand mal seizures at 10 years old in her sleep. Despite many tests, they could never find the cause of her condition. At first she was only having a few seizures in her sleep lasting between 20-60 seconds. When she was around 13 the seizures were happening more frequently, about once a month instead of a few times a year.

“At this time I decided to put her on meds. They started her on Keppra 500 mg twice a day. No seizures for 25 mos., not one. We thought we were in the clear. Then the generic came out and the insurance company will only pay for the generic because of course it all comes down to money.

“The pharmacy informed me there is no difference between the generic and the brand and just switched her without even notifying or asking the doctor. Since then she has been having relapse seizures. Every month the pills are different shapes, sizes, and colors. My neurologist informed me there are 28 different companies that manufacture this drug and none of them can be 100% identical. The doctor is very adamant about the generics being responsible and he is outraged by this. He has many patients experiencing the exact same thing with the generic form of Keppra.

“He wrote a letter to my insurance company demanding she be on the brand. I don’t know how they approve drugs that don’t work with something like this.

“I have switched my daughter back to the brand and I am paying for it. I will never put her back on the generic.” E.P.


Share your own experience with generic medications below. Let us know what you think about the FDA’s new generic testing program. We will let the FDA know what you think of their new program.

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  1. Scribe
    Reply

    Generic drugs that are not effective and/or cause unwanted side effects are a punishment for anyone who is ill. We can usually tell the difference when we don’t know we’ve been switched to a generic.
    Twice now within the space of a few months those who cannot afford the brand name anti-depressants Wellbutrin and Cymbalta (the latter also used for anxiety, as well as pain relief from fibromyalgia) have been compelled to experience a return of symptoms and intolerable side effects as the generics fail to deliver. The downward spiral is heartbreaking.
    In February the patent for Cymbalta ran out. The generic substitute Duloxetine looks exactly like the brand capsules; same colors, same size. Only the writing on them is different. Symptoms while taking the generic were a fuzzy feeling in the head, insomnia for periods lasting more than 48 hours, pain, feeling flat and remote as positive emotions disappeared, and the resurgence of purely depressing and anxiety provoking thoughts. Theorizing that a different delivery system might require a change in time of administration, experiments ensued. But the drug simply didn’t work and the Brand had to be purchased to feel normal again. This is not acceptable. What to do with 168 useless, though not inexpensive generic capsules? Into the closet they go with all the other containers of unusable generics.
    Who, specifically, is making a lot of money on products that are not what they claim to be?
    The problem isn’t limited to brand vs. generic.
    It’s generic vs. generic, too, as in the case of Bupropion 300 XL, brand name Wellbutrin. After several years of heated debate in which there were hints that the contentions of complainants might be attributable to their ‘conditions’, the FDA finally asked the drug companies to retest their products. It was determined that some of the generics lacked bioequivalence. Consumers, who had known immediately, were again forced to jump from one generic to the other in search of relief, just as they had in 1999 when the original patent expired.
    Watson decided to pull their effective 150 XL at the same time they voluntarily pulled the 300 XL that lacked bioequivalence. Having merged with Actavis, Watson probably decided it was cost effective to continue producing the Actavis generic and cut their losses with the Watson formula.
    Watson or Actavis, whatever you call yourselves now, how could you do this? The 300 XL had never been proved effective; its acceptance was based on the “proven” efficacy of the 150 XL. (What’s going on with the FDA?) The Par generic that has been substituted for the Watson 150 XL generic isn’t working. In warehouses somewhere thousands of effective bupropion 150 XL tablets will probably be sold off to the global market along with the ‘inferior’ 300 XLs.
    Must they always capitalize on the misery of their customers for the sake of the bottom line? What exactly do pharmaceutical companies do to “give back” here in the United States?

    • Wendy
      United States
      Reply

      Thank you for your comments regarding generic duloxotine (Cymbalta). I have been on Cymbalta for nine years with excellent results for generalized anxiety disorder. In effect, I credit it with making my life worth living. Approximately 6 months ago I started to experience insomnia, fatigue and increased anxiety. It took me several months to connect it with the change from brand to generic. As an RN I was skeptical to believe that it could make that much of a difference in how I felt. Like many others I am battling my insurer for coverage of the brand medication. I appreciate the People’s Pharmacy for providing a forum for discussing these issues and for advocating for consumers.

  2. Helen M
    Reply

    I would suggest stocking up on all the brand name you can find; that will give you time to try a generic here and there, just purchasing a few pills out of pocket. You will be able to question the pharmacist/s as to who makes the generic and where it comes from. A small pharmacy might be better for this than a chain pharmacy. It might be possible to find a well made generic by an American company.
    My husband uses fentanyl patches and insists on the Teva made ones, for various reasons. Teva is an Israeli company, and I would place far more trust in them than in an Indian or Chinese company. I remember when packages of medications bought over the net could be seized by customs and destroyed because we were told we could not trust any medication that did not originate in this country. Unfortunately it is all about greed and corruption reaching high into the FDA and the chain drugstores.

  3. Lida R.
    Reply

    I am a geriatric woman who has been taking the brand-name drug Klonopin for 28 years, since I contracted motor and sensory Peripheral Neuropathy in 1986. I take 3/4 mg. to 1 mg. daily, (0.5 mg. tablets which I cut in half), to stop body spasm, calf and foot spasm, esophageal spasms and nerve pain in all those areas.
    Recently, Roche-Genentech has stopped making brand-name Klonopin due, I am told, to the number of generic Clonzepam products on the market, which makes it not cost effective for them to keep producing the brand-name Klonopin, which sells for close to $260.00 per hundred, while the generic versions are much cheaper. I have called Roche-Genentech and their reps state that Klonopin may go back into production by October 2014, but they completely stopped production of their brand-name Valium last year too, so it seems unlikely.
    The problem if they stop making it, is that this drug is a habit forming, addictive drug, which has a very difficult, uncomfortable and long, drawn-out withdrawal period. I was told this when I first started taking Klonopin, but my Neurologist stated I’d have to be on the drug for the rest of my life, due to my neurological illness, and there was no generic version of course, at that time.
    I’ve tried many of the “generic” Clonzepam products and none of them work as effectively as the brand-name Klonopin, i.e., I go into severe withdrawal. I’ve searched the internet and find sites where many other brand-name Klonopin users are experiencing the same problem in attempting to switch over to a generic version of Clonazepam, i.e., horrendous, slow, withdrawal.
    One would think companies like Roche-Genentech would show some compassion for users of their brand-name drug, because of the terrible withdrawal symptoms they will almost certainly experience when switching to the generic equivalents, which many who have tried them state don’t work as well. As always, it’s only the bottom line in dollars these large companies seem to care about, and screw the patient!
    Frankly, I don’t know what I’m to do if this drug is withdrawn from the market?! Guess I’ll have to do myself in, as I don’t wish to live in a perpetual state of withdrawal…Sad state of affairs, and I know I’m not the only one…

  4. MM
    Reply

    It is more than about time! A decade or more ago, there was an investigative report in the paper (remember those) where the reporter went to various pharmacies throughout the US to get a generic version of a drug, and had them analyzed at an independent lab. What was found was that the actual active ingredient varied widely from not only different manufacturers, but from region to region. This was of course way before medicare part D, but seems like nothing has changed.
    I too have noticed differences in generic vs brand drugs. There are some generics that work better than others, but if I were a heart patient, I would not mess around with generics, and I know cardiologists who only will dispense brand name, because they don’t trust generics either, which of course is a problem because these stupid insurance plans do not like to pay for brand if they can get away with it, and they will! They don’t care if the doctor says the patient must have brand name! As usual, it’s all about the bottom line for them, screw the patient, get the money! I really do wish I lived in Canada, because this sort of thing just doesn’t happen there, from what I can gather.
    In my own case, I have to be on a few drugs for various problems, and the only drug I have to insist for brand name is percocet (a couple of my other drugs are compounded, and those I have to pay for, and that’s expensive). When the insurance company switched me to generic, it just doesn’t work like brand name; it takes two of the generic to even start to get an effect, while only one of the brand name took care of everything!
    The doctor (who is certified as a doctor who just treats pain patients) insisted I get the brand name, but the insurance company refused, so I’m stuck with generic. I cannot afford to pay for brand name, and I don’t know what to do exactly, and recently, the pharmacy switched the generic, and this generic really does not work well at all, worse than the other one!
    This pharmacy I found had the best generic percocet, and I traveled one hour one way to get it, and now they switched it. I have to find out why, I really like this pharmacy, they will give me the details, and then I have to find out the manufacturer of the previous generic. People who are sick should not have to work so hard at getting decent medications!

  5. KR
    Reply

    As odd as it sounds, I think a little more capitalism needs to be injected into the pharmaceutical market. The consumers are too far removed from the transactions. For example, I take drugs for ADHD, and I can tell the effects of various generics are quite different. Since my insurance company pays for my meds, and my insurance company considers them equivalent, my pharmacy stocks only the cheapest (ie worst) generic brand. I have to find small, independent pharmacies to request a specific manufacturer.
    The chains tell me a “distributor” determines which generics they can stock, and they can’t even order another brand. I keep thinking- if the consumers had a little more choice in this, regulation would be a bit easier. If we as consumers had some choice amongst generics, we’d stop buying the ones that don’t work, and the market would force better quality control. I am not suggesting this as a replacement for what the FDA is doing, but as a supplement. I find it so odd that in our capitalist economy, that this industry is exempt from consumer-driven demand. Forcing patients to purchase shoddy medications just reinforces poor quality control standards.

  6. Deb
    Reply

    Update to my March 6 comment when I first called local store of big chain that will stop selling tobacco products asking for USA source of generic drug instead of India, China, etc was told not available. Then I called big chain customer service and registered complaint about their lack of options other than cheapest generics from India given recent FDA actions against these companies. Didn’t receive any call back from higher up the chain but called local store two days later and suddenly pharmacy found generic version from Mylan.
    Doesn’t solve issue of ineffective generic drugs but at least better than being forced to accept drugs from countries to far away to be effectively monitored.
    So as consumers, it might help to be vocal about our concerns about generic drugs and suppliers.

  7. Deb
    Reply

    What are consumers supposed to do about the large chains now solely getting their generics from India. Given the recent FDA actions against several Indian countries, if a consumer is forced by insurance to accept a generic, shouldn’t they at least have a choice to get it from a US company who, due to proximity might be more easily monitored? These chains are getting the cheapest generics they can find and no one will be able to measure the harm done to the most vulnerable taking them. To the big chain that will stop selling tobacco products, please look into your policies on what you offer the helpless consumer in the way of generic drugs.

  8. Mike
    Reply

    Last week my doctor ordered benazepril from Prime Pharmaceuticals, which is owned by 14 BCBS orgs. They filled it with product from Ranbaxy.
    I talked with a pharmacist there yesterday. She told me Ranbaxy is now outsourcing to US sources, mentioning one in North Brunswick, NJ, but I asked her to confirm the source of what they’d sent me. They called back today to assure me that all is well because it came not from India but from a Ranbaxy factory in China!
    I said that if I were a pharmacist, I wouldn’t want to give anyone anything from Ranbaxy and maybe not China and asked for another source. Today’s pharmacist gave me 3-4 names, one of which was Teva. I know I’ve taken Teva’s products (and probably others on her list), so they sent a fax to my doctor for a new Rx to special order Teva. Fortunately, as a generic, it won’t cost me extra.
    For further information, just google “ranbaxy fda”.

  9. BZ
    Reply

    I have been a pharmacy tech for over 20 years and have seen many drugs come and go off the market. I have heard numerous complaints from our customers about this issue and a lack of credibility for their concerns from the pharmacists. I believe because the statement from the FDA is shoved down their throats as an absolute. It is both validating and frustrating to hear this NOW. How could we as Americans EVER allow this!!!!!!
    Really…. send something as critical and life changing and the ability to do whatever to the drugs we must take to treat our health needs, and not allow inspections or inspectors to get Visas, really? How big of a RED FLAG do you need FDA!!!! China, as we all know was putting lead in exports, like children’s toys and you let these people make our drugs?????
    This is so beyond comprehension that this was EVER allowed under these circumstances. WOW. This is HUGE.

  10. kst
    Reply

    I KNEW IT!!! like so many others I had to suffer through what I knew was happening to me when FORCED to switch to generic Welbutrin but insurance companies, one physician and pharmacists would tell me otherwise.
    I am STILL struggling and United HealthCare is STILL refusing to pay for brand Welbutrin while also trying to take brand name asthma medication (XOpenex anyone?) as well as brand name migraine medicine (if you ever had to go through the trial and error of find one that will finally work). The fight over this issue is exhausting.

  11. RBH
    Reply

    In the past month I was put on the generic drug Mirtazapine (30Mg.) for Remeron to control my clinical depression; why the drug I had been taking stopped working I don’t know; altho that was a generic substitution as well. I have almost felt as if I have gone “crazy” since taking Mirtazapine. I just can’t tell you how I have reacted to this drug!! I just want to be by myself as I am awful to my friends, if I can any longer call them “friends”. My behavior has been bizarre.
    Today, I finally called my therapist to tell her I no longer wanted to take any drugs, I just wanted to “check out”. This evening I stopped taking the drug and just hope my behavior will revert back to normal. If not, I don’t know what is next for me. After reading several articles about various Pharmaceuticals in India, I wonder if my behavior as well as my depression has anything to do with these generics?

  12. JThorpe
    Reply

    So glad to see this information on the FDA testing the generics. I, too, had problems with the generic Wellbutrin 300XL that had worked so well. We changed insurance last month because of Obamacare, and now BCBS won’t cover the brand name anymore. Surprise! My prescription would be $430. I didn’t want to go back on the generic, since I’d tried it three times before.
    On Wellbutrin’s website, I found a program that lets me get BRAND NAME Wellbutrin for $50 a month. This applies to everyone, insurance or no insurance. Another problem- I’ve been taking Adderall XR generic for a couple of months with no problem. For the last two nights I have had difficulty sleeping (up past 2 a.m.!) I noticed today around 5 that I felt jittery.
    Tonight I am still jittery and can feel my heartbeat like when I had Graves’ disease. I took the generic amphetamine salts, 30 mg at 7:30 this morning. No way they should still be active, but I can feel the effects. I am going to check to see if the manufacturer changed.
    I switched from Vyvanse to save money using a generic. At least I’ve figured out why I can’t get to sleep. I’ll skip the med tomorrow for sure. It’s great the med is lasting longer and keeping my appetite down all day, but I have to sleep- I’m getting cranky.

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