For decades the FDA has reassured physicians, pharmacists and patients that generic drugs are identical to their brand name counterparts. Insurance companies love this guarantee. They often require patients to switch to a low-cost generic if any are available.
In an unexpected about-face, however, one of the FDA’s top administrators has admitted that there may be problems with some generic drugs. Janet Woodcock, MD, is Director of the FDA’s Center for Drug Evaluation and Research. She spoke recently to the Generic Pharmaceutical Association, a trade group that represents many of the biggest generic drug companies.
Dr. Woodcock said, “I’ve heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards. They say, ‘I know there are products out there that aren’t equivalent,’ and typically they’re manufacturing folks.”
In other words, employees at generic drug firms have whispered in Dr. Woodcock’s ear about their own concerns regarding quality control. We too have heard from insiders about their fears: “I once worked for a pharmaceutical company that ordered a raw ingredient from China. That ingredient was diphenhydramine [an antihistamine found in allergy medicine and many OTC sleeping pills].
“I was a quality assurance inspector and had to inspect incoming material. That ingredient was so trashy with what looked like a lot of floor sweepings–black blobs of something I could not identify. I placed the ingredient on reject. The next day the boss told me that he had authorized the release of that ingredient to be used in production!
“When I left work later that day I called the FDA and reported the whole thing. I don’t know if the FDA acted on my complaint but I called in the next day and quit my job.”
Many consumers also have doubts. They have told their stories on our website (www.peoplespharmacy.com).
Here is one: “I took Keppra for epilepsy. In January 2009 I was given generic Keppra.
“I felt sick to my stomach and had multiple seizures. My neurologist told me to stay on the brand med and even wrote ‘brand necessary’ on the script, but the insurance company refused and gave me generic.
“I had seizures for five weeks before they allowed me to go back on the brand. My blood level on the generic was much lower than on the brand and I found the generic was not as effective.”
Sometimes switching from one generic to another produces problems. A reader reported doing well on generic Wellbutrin (bupropion) for depression: “My local pharmacy filled the original prescription with little round blue pills. When it came time to refill the prescription, I received yellow oblong tablets. Within 24 hours I experienced high anxiety and nausea. I had never felt either of these side effects with the blue bupropion tablets.”
Having acknowledged that there is a problem, the FDA appears poised to tighten standards on certain generic drugs such as anticoagulants, anti-seizure medicines, some antidepressants and medications to regulate heart rhythms. If you have experienced a problem with a generic drug bring it to the FDA’s attention: www.fda.gov/medwatch.