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Generic Drug Maker Pleads Guilty to Felony

Generic Drug Maker Pleads Guilty to Felony

Ranbaxy USA has just pleaded guilty to felony charges involving adulterated drugs made in India for the U.S. market. It is the largest drug safety settlement in history.

Despite continuous reassurances by the FDA that all generic drugs are identical to brand name counterparts, this guilty plea makes it clear that some generic drug manufacturers have been cutting corners. In the case of Ranbaxy, the company will pay a total of $500 million in fines and civil claims.

What did the company do wrong? Ranbaxy has admitted that some of the drugs it sold in the U.S. were adulterated. These medications were produced at its facilities in Paonta Sahib and Dewas in India. The company finally fessed up to inadequate quality control, incomplete testing records, inadequate stability programs and deviations from good manufacturing practice. In particular, batches of the anti-seizure drug gabapentin did not meet requirements, had unknown impurities and “would not maintain their expected shelf life.”

The FDA list of medications manufactured at the two substandard Indian facilities included:

  • Acyclovir
  • Amoxicillin
  • Amoxicillin and Clavulanate Potassium
  • Carbidopa and Levodopa
  • Cefaclor
  • Cefadroxil
  • Cefpodoxime Proxetil
  • Cefprozil
  • Cefuroxime Axetil
  • Cephalexin
  • Ciprofloxacin HCl
  • Clarithromycin
  • Fenofibrate
  • Fluconazole
  • Fosinopril Sodium
  • Fosinopril Sodium and Hydrochlorothiazide
  • Gabapentin
  • Ganciclovir Sodium *
  • Glimepiride
  • Isotretinoin
  • Loratadine (OTC)
  • Metformin HCl
  • Nefazodone HCl
  • Nitrofurantoin; Nitrofurantoin and Macrocrystalline
  • Ofloxacin
  • Pravastatin Sodium
  • Ranitidine
  • Terazosin HCl
  • Valacyclovir HCl
  • Zidovudine

Drugs from these facilities have not been allowed into the U.S. since September 16, 2008. That’s when the FDA slapped an injunction on the company to keep drugs from these two plants out of the U.S. until they comply fully with FDA standards.

On the one hand this may seem like good news. But we worry about other manufacturing plants in countries where FDA’s inspection capabilities are limited. A little known fact is that in countries like India and China, inspectors often must request government permission to visit manufacturing facilities. The drug or chemical companies know well in advance before inspectors arrive, so they can clean up their paperwork and premises in time for inspection.

Imagine restaurant inspectors telling the owners ahead of time about inspection dates. Public health policy recognizes that such an inspection would be meaningless. That’s why food inspectors and FDA investigators show up unannounced in the U.S. Shouldn’t the same be true abroad?

The FDA has admitted to us that it still does not have the resources to inspect most foreign plants. That means that the majority of generic drugs that are imported into the U.S. come from factories that have no official FDA oversight. If we are supposed to trust the FDA to verify that $4 generic drugs from India, China, Thailand, Brazil or Mexico are up to snuff, we need to be sure inspectors are making unannounced visits and looking carefully at the manufacturing process and the records to insure that there are no falsifications like those that occurred with Ranbaxy.

What has been your experience with generic medications? We would like to hear both the pros and cons of your experience.

Here are some generic drug stories from visitors to this website.

“I recently filled two prescriptions, gabapentin and tramadol, which had been the same prescription for months. It took me forever to find a combo of pills which allowed me to manage my pain comfortably, so I could go about my daily life.

“Now I get two different versions of my pills and ALL my comfort is GONE; I’m experiencing problems I’d not had since I’d found my perfect combo of meds.

“Well, the ‘different’ versions of these pills were from new manufacturers/suppliers. I looked them up online which was not an easy task. Both companies seem to have a focus on animal meds, and I am NOT IMPRESSED.

“Why are all sorts of companies being allowed to provide meds to people who rely on these meds for their quality of life?”

J.L.

“I also had trouble with a generic medicine. I use Keppra for neuropathic pain syndrome in my hands from carpal tunnel syndrome and surgery on both hands. My doctor had changed me to generic levetiracetam and I started having awful pains in my hands. I went to a doctor after a while because the pains were worse than when they originally started.

“The doctor changed me back to Keppra, and it took a couple of weeks before the pain eased up.

“I reported it to FDA and they commented to me that they never heard of the generic not working. But you have warned on your website about generic for Keppra not working. I love reading your column and it is very helpful. Thank you so much!”

Kathleen

 “I’ve been taking the brand name Wellbutrin XL 300mg for many years now.  I just recently ran out of my last bottle of the brand name.  When I went to refill it shortly before I was completely out, I found out my insurance company will no longer cover the brand name even with a prior authorization from the doctor.

“I tried the generic version in the past and found that it did not work.  I tried it at least 3 different times with the same results.  I figured I’d give the generic another shot, given the circumstances.  I decided to try it before I was completely out of the brand name so I could do some direct comparisons.

“I took the generic for 3 days.  It felt like I hadn’t taken anything except for the fact that I felt nauseated and dizzy for those 3 days.  I decided to switch back to the brand name on the 4th day and noticed a huge difference immediately.  Everything seemed to be working properly.  The nausea & dizziness were gone.

“I took the generic the next day just to make sure I wasn’t just sick those first 3 days.  Once again, it was like night and day compared to the brand name.  The nausea and dizziness came back and along with it, the symptoms of my depression.

“For the following two days, I took my last 2 brand name pills and found everything back to normal.  I am absolutely 100% convinced that the generic does not work.

“I’ve read numerous posts from patients describing the same kinds of problems with the generic, but it seems to be all of the manufacturers of the generic.  When I read the FDA’s statement about pulling one manufacturer’s version, Budeprion, completely off the market because they found it to be ineffective, I felt as if what I have been experiencing may not be a fluke.  In addition to that, they ordered that the other 4 manufacturers of the generic conduct studies to prove that their drug is in fact the bioequivalent to the brand name.

“What I do not understand is why they didn’t pull those 4 manufacturer’s versions off the market until they could be proven to be as effective?  After all, they would not be demanding for those studies to be submitted if they were sure that the drugs were as effective.  Also, why isn’t the FDA conducting its own independent study of each of the 4 manufacturer’s versions of this drug?

“This all seems crazy to me.  Isn’t the FDA supposed to be protecting us?  I am very frustrated because I cannot afford to pay for the brand name with no insurance coverage.  I’d like to know what options I have.  I can tell you after being completely off the medication for almost a month now, I am very concerned.  My depression seems to be worse than it has ever been.  I am even starting to have suicidal thoughts, which is very new to me.

“I’m so desperate that I’m even considering trying to find a Canadian pharmacy to get the brand name at a price I can afford.  This is certainly not what I want to do, but what other choices do I have?”

L.L.

Share your own story below in the comment section. Are you concerned about the ability of the FDA to oversee the generic supply chain? We have been told that the agency does not have adequate resources to do its job in this country, let alone overseas. If we are supposed to trust the FDA to verify that $4 generic drugs from India, China, Thailand, Brazil and Mexico are up to snuff, we need to see the data. Sadly, the FDA does not reveal this information.

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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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