Without admitting that there is a problem with generic drugs, the 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.