People have become suspicious of the quality of generic drugs. Is there a way to benefit from the lower cost of these copycat medicines without sacrificing effectiveness?
Authorized generics may be a solution to this dilemma. Many physicians and patients are unaware that this option exists. The brand-name manufacturer makes a deal with a specific generic company to supply its drug directly or provides the generic maker with precise instructions on how to duplicate the brand-name product. No one else has access to this information, as it is considered a trade secret.
We recently heard from a reader about just such a situation: “You wrote about someone whose insurance refused to pay for Celebrex and was switched to the generic celecoxib. The person had begun to experience swollen joints and the other symptoms Celebrex treats.
“I had the same reaction when I got switched but had read in your column about others with the same problem. I talked to my pharmacist, who said it was the most common complaint he heard, but that there was a solution.
“He said to ask specifically for celecoxib made by Greenstone. It is identical to Celebrex and is manufactured by the same company. Because it is a generic, insurance will pay for it, and most pharmacies will order it for you every month. (Allow a couple of extra days to get it filled.)
“Within a week I was able to use my hands again. They had gotten so bad I could not even grip my steering wheel. Now I call in my script a few days early so they can order the Greenstone celecoxib, and I’m back to doing the things I enjoy. I hope this information helps other readers as much as your column has helped me.”
The generic manufacturer Greenstone is a subsidiary of the drug giant Pfizer. It is hardly any wonder that Pfizer, maker of Celebrex, would provide its own company the right to market an authorized generic.
The Food and Drug Administration may have mixed feelings about authorized generics. That is because the agency asserts that all FDA-approved generic drugs are identical to their brand-name counterparts.
Despite such reassurances, the American public has reason to be concerned. According to Reuters, the FDA has barred 44 Indian pharmaceutical manufacturing facilities from exporting medications to the U.S. since 2011. Most of these products were generic drugs.
These companies are responsible for a significant proportion of the generic drugs taken by Americans. Companies such as Aurobindo, Dr. Reddy’s Laboratories, Polydrug, Ranbaxy, Sun Pharmaceutical and Wockhardt all have received FDA warnings about quality control.
We have received thousands of complaints about generic drugs in the past decade. Readers of this column have reported troubles with anti-seizure drugs, antidepressants such as bupropion, heart medicines like metoprolol and medications for attention deficit disorder.
Anyone with a complaint about a generic drug should report the problem directly to the FDA with the name of the manufacturer. The FDA website is: www.FDA.gov/MedWatch.
Until the FDA solves its generic-drug monitoring problem, patients may wish to ask their pharmacist for an authorized generic. When such an alternative exists, it may be worth paying a bit more for the extra reassurance such a designation provides.
Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio. In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of this newspaper or email them via their Web site: www.PeoplesPharmacy.com.