safety concerns

The Food and Drug Administration is caught between two hard rocks. On the one hand the agency has been criticized for inadequate oversight of foreign drug manufacturing facilities, especially in China and India. On the other hand, the FDA has been hammered for allowing drug shortages to persist, especially when many of the drugs are essential for the public health.

The Latest FDA Boondoggle:

According to the industry insider newsletter, FiercePharma, the FDA is ignoring its own cautions. The agency  will allow importation of pharmaceutical ingredients from Chinese and Indian manufacturing plants that have been found to have problems:

“To avoid shortages, FDA allows imports from 8 drug plants banned for quality shortfalls.”

“Banned Hisun plant in China gets exemptions on 15 ingredients.”

“Facing Cancer Drug Shortage, U.S. Relies on Banned Chinese Plant” (Bloomberg)

Chinese Drug Imports from Problem Plants:

In the last few years the FDA has increased the number of inspectors it has on the ground in India and China. It hasn’t been easy. FDA inspectors have had a hard time getting visas to enter China. Unlike the unannounced inspections that occur in the U.S., the FDA must alert officials in China and India that they are coming well in advance of a visit.

Even with such obstacles, the inspectors have found troubling lapses in quality. The more inspections, the greater the number of problems that have been uncovered. There has been out-and-out fraud, where companies have been found to fabricate data. In other cases there has been poor quality in manufacturing.

In the case of one of China’s major drug exporters, Hisun, the FDA revealed that there had been “broad data manipulation” at its factory in Taizhou. Despite an FDA ban on exports from the factory to the U.S., the agency has apparently allowed the pharmaceutical company to continue exporting various key ingredients to the United States. That’s because those ingredients are considered essential to treat patients with leukemia, breast and ovarian cancer. Antibiotics and heart medicine have also been exempted from the ban.

This would be a little like a elevator inspector saying that there were such significant problems with an elevator that it should not be permitted to carry passengers. Then, in the next breath the inspector allows the elevator to stay in service  because it would be difficult for people to reach their floor without the elevator. Would you feel comfortable riding in such an elevator?

FDA Does Little to No Testing:

You might imagine that if the Food and Drug Administration banned a pharmaceutical company in India or China from exporting its products to the U.S. and then overturned its own ruling, the agency might test those products for quality. Au contraire. The FDA does virtually no testing itself. It relies on the companies to do their own testing or hire outside companies to audit their products. To us that seems a bit like asking the foxes to guard the henhouses.

Why Would We Accept the Honor System for Foreign Drug Manufacturers?

We are not the first to suggest that the FDA relies on the honor system when it comes to drugs manufactured abroad. Companies are allowed to submit test results that the agency does not check. We would prefer Ronald Reagan’s approach: “Trust but verify.”

People with cancer deserve to know where their chemotherapy drugs are coming from and be assured that the FDA is guaranteeing absolute quality. Although the agency continues to reassure the American public that everything is fine with Indian and Chinese drug imports, we would like to know why there have been bans on the one hand and exemptions on the other.

What do you think? Share your own thoughts in the comment section below.

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  1. Frustrated in Memphis
    Memphis, TN
    Reply

    I have taken Amoxicillin for tooth problems and kidney infections over the years with great success. I am now paying 3 to 4 times the original price and they don’t work. They are manufactured in India. Real Antibiotics have a really bad taste. The last 3 prescriptions had no taste at all, just chock and no results. I told my Dr. and it fell on deaf ears. I wonder if there are any good antibiotics still available, made in America?

  2. Bill
    Canton, Mi.
    Reply

    All the big Pharmacies i.e.; CVS, Target, Walgreens will only buy the Generic drugs that are cheapest. If you have an issue with a generic (many people do) go to a local small Pharmacy and see if they will order a different brand for you, most are more than willing!

  3. Bill
    Canton, Mi.
    Reply

    A caution note to anyone taking any medications, especially generics. After hours and hours of research, the FDA and the CDC are inept at best (possibly criminal) when it comes to allowing all these generic meds. to be marketed to the U.S. Never except anything made by TEVA (a gigantic corporation) or MYLAN. These 2 companies are known to make trash coming from “Who knows where”. Also be careful and do your homework, just because the Med. has a different name does mot mean one of these 2 evil corporations didn’t make it. It’s a shame our federal agencies allow the American public to be put at such risk with all these trash generic meds. coming from all over the world with NO oversight.

  4. Do something!!!
    TN
    Reply

    Everyone needs to complain! Bullshit! I just read this I had no idea why my ambien from INDIA wasn’t fking working!!!!!!!!!!!! I called the pharmacy they said the fda was robbing us with generic brands that don’t come from the USA I didn’t really get what they were saying now I do!!!!!!!!!!! Pathetic!!!!!!!! Been awake 2 days. Have a child and can’t sleep. Have had chronic insomnia since I was young but is much worse now. Going from 1 ambien making u sleep all night to “running a mArathon on 5. “What a joke

  5. Ralph
    TX
    Reply

    As an 80 year old I take 5 prescription medications. All but one are generic. My medicare Part D plan won’t approve anything else unless a generic is not available. This article has reinforced my concerns about their safety and/or efficacy.

    Additionally I find the media ranting about the safety of supplements because they are not FDA inspected amusing and aggravating. I know some supplements are dangerous but so are prescription drugs that get very little oversight. Due diligence and being an involved patient go a long way toward better health.

  6. Virginia
    Lula
    Reply

    Pitiful that the USA cannot (or will not) manufacture its own drugs, putting all of us at risk. Big Pharma has us totally under their control.

  7. Elizabeth
    Florida
    Reply

    I began subscribing to The People’s Pharmacy newsletter since looking up information about this very subject. Which they’ve written about a few times. Even Fortune magazine has an article on “Dirty Drugs” from a couple years back. Yet Dr’s and pharmacies will adamantly deny that there’s a problem. Anywhere that sells medications apparently have to say that they’ve not had any complaints because, otherwise they’d be admitting that they’d sold them to you even though they’d had even a few complaints and then they’d be able to be sued.

    I’ve gotten sick from generics more times than I can count. Most recently from Mylan brand Tramadol and Actavis brand Xanax causing me to have serious crying and irrational fear that I don’t typically have. Walmart wouldn’t do anything about refunding my money and my Dr expects me to run all over town to find a pharmacy that carries another brand because, he didn’t feel like just writing another script even though I brought in the full bottle.

    God knows what would have happened if the Tramadol, which is something he just recently prescribed, had been taken at the 4×per day amount instead of just once a day as I did. Plus, when you ask the pharmacies about the original Brand name medication and cost, they laugh and say they’ve not even carried it in years. People are dying and have been from these medications. If you Google it you can find out about companies like Ranbaxxy and other’s who’ve been “fined” but, are back in business. I (and many others) are seriously considering a class action lawsuit. Thank you and, when possible, use any quality natural alternatives.

  8. Joan
    St Petersburg Fl
    Reply

    I would think that with a major election coming up that both candidates would be on top of this. It is a crime that Big Pharma is said to be paying the FDA a fee to approve and supposedly test the latest drugs. We, the consumer, are guinea pigs. Most of the drugs that big pharma pays a “fee” to have the FDA test are not tested at all. The factories in India and China have no inspections by any US company.

    The FDA has actually taken some older drugs off the market for further testing. When the drug comes back on the market, the prices have gone up so high that people cannot afford to take them. I have been taking a drug for RA. It was originally priced at the low cost of $4 a month. It had been grandfathered in by the FDA. All of a sudden, the FDA said it needed further testing. When it came back on the market, I now pay $120 a month.

    Why did it need further testing? Was there a new high-priced drug on the market? Yes. We are being bamboozled. I decided the drug at $120 a month was not doing me enough good to make me broke. I stopped taking it and feel about the same as I did before.

    If you find that a drug your Dr has written you a script for is very expenceive, ask your Dr if there is another that will work just as well. Most of the time, Drs don’t even realize that the prices have gone sky high.

  9. Nita, RN
    Siler City, NC
    Reply

    What a good wake up call to be pro-active for oneself and listen to the advice of those who are telling us to take better care of ourselves so we won’t need drugs or to seek out other methods of healing besides conventional medicine. I will be 75 next month, take only bio-identical hormones as my rx med, have survived two chronic, serious illnesses, do not even take antibiotics unless I have exhausted everything else (and I have been told I colonize staph!),
    And the upside of that is that I am mistaken either for my children’s sister or wife! As a former ED nurse, I’ve seen too many mishaps, too many people who’ve gotten into trouble with medications, esp with “polypharmacy”. Seems to me the public is playing Russian Roulette with generic meds.

  10. Joyce
    raleigh
    Reply

    Please tell us how to find out if our heart drugs etc have any ingredients from those questionable companies. What is the easiest and best way to find out? Thank you.

  11. Jeffrey
    Massachusetts
    Reply

    I’m no defender of the FDA, but folks, ask yourself which political party has done everything possible to underfund the FDA to the point where it can’t possibly do what is necessary. If you wanted cheap generics, you now get to see what that actually means. Would you also choose a low-priced heart surgeon?

  12. Trisha
    Western NY
    Reply

    Why can’t drugs be made in USA instead of China?

  13. Cynthia
    Bellevue, WA
    Reply

    I think it is unacceptable that the FDA does not test the drugs before they are released into the US market. I took one drug and it made me so sick, it exacerbated the condition it was supposed to cure so horribly, I thought I was going to die. I now only take the brand name of the drug which does it’s job. Fortunately, my doctor stood up for me with the insurance company. God only knows what was in the generic.
    It is the FDA’s responsibility to be sure that the drugs we purchase are safe and have the same active ingredients as the brand name. As it stands now, the FDA is derelict in their duty.

  14. Denise
    virginia
    Reply

    I take Avapro for hypertension. My prescription plan calls for generic meds unless the physician specifically requests brand name only. My pharmacist began importing the generic from India early last year. When I refilled my prescription, I noticed that I awoke every morning with a headache. Upon checking my blood pressure, it was abnormally above the acceptable range. I had to phone my doctor to call in a new prescription noting Brand Name Only to correct the problem. Of course I now have to pay three times more than the generic meds, but my well-being is worth it.

  15. Richard L.
    Sarasota, FL
    Reply

    Big Pharma says that importing drugs from Canada is unsafe. What hypocrisy when U.S. drug companies are manufacturing drugs with ingredients from admittedly suspect foreign sources and charging prices for them as much as 8 times more than drugs from Canada.

  16. Denis
    FL
    Reply

    The issue of supply should never have been added to the FDA’s remit! The problems of supply should be solved elsewhere (politicians should review their regulations and other disincentive for development and manufacture in this country, etc.).

  17. Lou
    Wy
    Reply

    I believe doctors believe all drugs are equal because the FDA has made sure all have been tested and manufactured according to their high standards. Then when a pt does not respond to the drug, most Drs fail to listen to their pt nor encourage pt to report problems. They do not know about these problems you reported.

  18. Phil
    Reply

    Aw, gee. It couldn’t be because the overpaid, Big Pharma puppets are corrupt, could it? All the FDA does is protect the drug companies and their profits. They really don’t seem to care one bit for the consumer’s health. As long as there is a swinging door between Big Pharma and the FDA, nothing will change. It’s like musical chairs. Same players, different chairs.

  19. Clara L.
    Prescott AZ
    Reply

    Most U.S. citizens rely on the FDA to assure that medications sold in this country are of good quality and safe to use. It’s a bit scary to know that this is not true. How are we to know? To the FDA: Please do all that is necessary to see that products sold in our country, even those coming from other countries, are safe to use. Thanks.

  20. Carol
    FL
    Reply

    As someone who was just diagnosed with cancer, I am going to speak to my oncologist about where my chemo is coming from! It is astounding that we may be ingesting inferior drugs that either do no good or can possibly harm us!

  21. Gale
    NY
    Reply

    I am thoroughly disgusted with the fact that we cannot trust the drugs that we are paying a premium for, no matter where they come from and especially when our own government agency that our tax dollars pay to protect us, is looking the other way. The whole situation is corrupt and needs a major overhaul.

  22. PP
    Reply

    Write your congressmen!

  23. Mary
    Reply

    If I knew a drug had ingredients from China and possibly, India, I would be most reluctant to take that drug.

    I was looking at a d-mannose (OTC) product online whose source was China. I ordered a different brand that did not show that.
    Would the source from China have been okay? Did the US seller test? I don’t know.

  24. Noah
    Reply

    I believe that the FDA is failing in its duties and its behavior is reprehensible.
    Yet, somehow, typical of our current Federal Government’s lack of concern for the citizen’s welfare in oh so many ways.

  25. Noah
    Chapel Hill, NC
    Reply

    I believe that the FDA is failing in its duty ND ITS BEHvior is reprehensible.
    Yet, somehow, typical of our current Federal Government’s lack of concern for the citizen’s welfare in oh so many ways.

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