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FDA Launches a New Program to Test Generic Drugs for Quality

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The Food and Drug Administration is about to launch the first generic drug testing program in America's history. Thank goodness. We have relied upon the honor system for far too long.

Physicians, pharmacists and patients assume that the FDA has been testing the quality of generic drugs for decades. That is rarely the case. The agency relies upon generic drug manufacturers to perform their own quality testing. This dependence upon the integrity of these companies and their self-generated data has led to poor quality products.

Over the last few years there has been a series of damaging revelations about quality control, especially in foreign countries. A whistleblower at the largest Indian drug company, Ranbaxy, notified the FDA in 2007 that workers at the company were "cooking the books" to make their generic drugs look better than they actually were.

The FDA inspected one of the Ranbaxy plants in December 2004, and gave it a clean bill of health. This was during the time the whistleblower was uncovering evidence of serious systemic problems at the company.

Eventually, the FDA discovered that Ranbaxy facilities did not have proper standards for quality control or record keeping. The company eventually pleaded guilty to felony charges related to drug safety and paid $500 million in fines. This was the largest such settlement with a generic drug manufacturer. At the moment, no drugs manufactured by Ranbaxy in India are allowed into the U.S. market.

The Ranbaxy debacle is not an isolated event. Another Indian drug company, Wockhardt, ran afoul of the FDA when an inspection last year uncovered violations of good manufacturing practice at its Waluj facility. An import ban was imposed on products from that plant.

A reader of our newspaper column noted that her mother appeared anxious and depressed after being switched to Wockhardt's bupropion. She noticed that the pills smelled terrible, a sign of chemical deterioration.

Quality control problems do not always originate abroad. A Houston testing laboratory, Cetero Research, analyzed data for both generic and brand name drug companies. Although the FDA inspected the lab on numerous occasions, it found no serious flaws. But a whistleblower from within the company revealed in 2009 that some of the chemists were falsifying data. Eventually the FDA concluded that drug tests between April 2005 and June of 2010 were unreliable.

With so many questions about quality control, it is not surprising that physicians, pharmacists and patients have begun to question the FDA's ability to monitor pharmaceutical manufacturing. That is why the new $20 million dollar generic drug testing program is so welcome. This program will enlist leading academic centers to analyze samples of generic antidepressants, anti-seizure medications, heart drugs and immunosuppressants.

Such a program, if well run, should allow the FDA to detect problems before they cause harm to the public health. Perhaps the new Office of Pharmaceutical Quality can restore trust in generic medications. 

To listen to a one-hour interview with investigative journalist Katherine Eban about the problems of generic drug manufacturing abroad, click here.  To hear more about the FDA's new Office of Pharmaceutical Quality and other quality control initiatives, click here.

 

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I just wrote a suggestion to the Doctor Oz show that they invite the Graedons to give the real story behind generic drugs. Dr. Oz influences millions of people with his show, but his credibility went down a notch in my opinion with his March 10 show when a representative from Consumer Reports praised the efficacy of generic drugs (why this person/publication and not one with a credible medical background baffles me).

The insane facts this reporter said were that 1) "Generic drugs are regulated for quality in the exact same manner that brand name drugs are by the FDA; 2) generic drugs are truly the same product with exactly the same mononuclear structure, 3) they had found 'not one' problem with any generic drug so there is evidence that there are no problems whatsoever; 4) generic drugs are manufactured on the same equipment as brand name drugs."

What dangerous and inaccurate information was given on this show! How many people really have their heads in the sand about generic drugs, and I wonder if Big Pharma in any way influenced this episode.

I don't trust Consumers Reports much anymore. I've subscribed for many years, and will probably be dropping it. I don't find them as reliable as they used to be, and they are much more industry oriented, in my opinion.

I mentioned before that my insurance company changed my Cymbalta to a generic drug. As I was used to taking it in the morning I realized, after a few days feeling like a zombie, that it could be the generic Cymbalta. I switched to taking it at night and it does make me sleep well. However, I plan to let my physician know I want to ease off Cymbalta and use other methods to help me.

I just hope FDA will be honest in this job because, according to some webs about corruption at all levels, (for profit of course) we can trust anybody, and it's only up to us to, somehow, find the truth and avoid to get hurt by conventional medication. As I already reported my husband is kept on Amlo BP medication, by all the doctors by now, even though he already displayed the most serious and subtle side effects of mental decline, becoming uncaring, and a lot of others. And the worst is that he, who is a senior and so more expose to the side effects, got addicted to it, and even doesn't want to replace it with other not so dangerous medications, or the natural remedies for first stage hypertension. He's lost to Amlo and so is our relationship ! Amlodipine must be a "golden mine" for doctors, the Big Pharm. and who know who else ?!

Rodica,

You may not be familiar with a group of generics called "authorized generics". Traditional generic meds only have to be the same in the active ingredients, not the inactive ones. With an authorized generic, you get the exact same formulation as the expensive brand name, but for a generic price.

A significant number of people are reporting problems with generics and the supposedly inactive ingredients may be the problem. In the case of Amlodipine, there is a an authorized generic made by Greenstone, a company which is a subsidiary of Pfizer, the manufacturer of Norvasc (the name brand). You may want to talk with your husband's doctor about prescribing Greenstone's amlodipine only. (As an aside, I have no connection with either Pfizer or Greenstone, but have been an RN for many years.)

Also, I would talk with your husband's MD about the symptoms he is experiencing. As a senior, he may have something else going on, or he may just be on too many medications from too many docs. If you get a brushoff from the doctor, I would contact the local senior center to see if there are pharmacists in your area who specialize in the medications of older people. If so you can get him/her to review everything you husband takes, including vitamins, OTC's etc. and if necessary contact the MD to discuss changes.
Good luck!

Am having problems with bupropion hlc xl made by avtivis pharm anybody else using it made by activis pharm. DRs think I'm kidding them, I don't know who else to ask thanks. Will try different pharm in my area when I need a refill, maybe they will be using different supplier.

One of the worst aspects of the generic drugs debacle is that the FDA has publicly stated that it will not take complaints about mental health generics as seriously as complaints about other generics, since complaints about the former might simply be a manifestation of mental illness. Unscrupulous drug companies now know that they need not manufacture an acceptable generic for a psychoactive drug, and the failure of such a generic for a serious condition like schizophrenia, bipolar disorder, or severe depression may put the life of the patient or others at risk. If anything, the standards for mental health drugs should be higher than for other drugs, because of the increased potential for negative impact on others.

I sincerely hope that the new testing initiative will prove successful in ensuring that all generic drugs, including mental health drugs, are of acceptable quality.

After readying the article in todays paper about Ranbaxy I looked in my medicine cabinet and found two bottles from them. I am concerned about the article which says Ranbaxy was shut down. How is my drug company still selling this product. What year did the FDA close them down?

People's Pharmacy response: The FDA did not stop imports from all Ranbaxy Indian plants until early this year. The FDA has, however, allowed pharmacies to continue selling what they had on hand, as well as any Ranbaxy products made in the US.

I am writing in regards to my older brother who has suffered from major depression most of his adult life. He is on a mood stabilizer depakote for many years. Recently he was prescribed a generic version of depakote. I noticed his condition was gradually getting worse. He admitted himself into emergency room and they did blood work to determine his depakote levels. Instead of being in the therapeutic levelof 50-100 the results showed his level to only be at 20.

There are only two possibilities. One being that he forgot to take his meds for at least 3 consecutive days, which I highly doubt. He is very regimented about taking his meds. The other possibility is that the generic depakote was probably either not real or adulterated by the manufacturer. He was admitted into a psychiatric hospital to restore his depakote levels back to normal range. After just a few days of being given hospital grade meds his condition improved dramatically. He is to be discharged sometime this week.

I have had horrible experiences with generic Effexor. Though it has been shown problematic with so many people, my insurance refuses to pay for it and I have to deal with a $300.00 per month bill just to keep my sanity. I hope this review is helpful - though when then the insurance companies are involved, profits seem to be more important than patient health. I pray this won't be the case here.

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