How good are generic drugs? The FDA tells everyone–patients, physicians, pharmacists, hospitals and insurance companies–that generic drugs are identical to their brand name counterparts.

But the FDA has no police force. It relies mostly on the honor system to ensure the integrity of the nation’s drug supply.

Drug manufacturers, wholesalers and other drug distributors are expected to monitor the quality of their products and fill out forms honestly. Do they deserve our trust?

Over the last few years, the international market in raw ingredients has grown enormously. In many ways it resembles a wild west show without a sheriff.

The first inkling of a problem came when thousands of pets were poisoned by melamine. Chinese manufacturers added it to gluten (a pet food ingredient) to help them game the tests and increase profits.

Something similar happened to the blood thinner heparin last year. The consequences were even more tragic. People died because the Chinese suppliers of raw ingredients seemed to have added a compound to once again fool the tests and boost their income.

Chinese drug manufacturers aren’t the only ones suspected of taking short cuts. Ranbaxy is India’s largest drug company. It supplies a large number of generic drugs to the U.S. market.

Investigators have accused Ranbaxy of falsifying statements and fabricating information. U.S. prosecutors have alleged that the company forged documents regarding drug quality and covered up violations of manufacturing practices.

What did the FDA know about this and when did it know it? Lawmakers charge that the agency knew about Ranbaxy’s problems for at least 18 months but did not address them. The FDA has continued to approve generic drugs from the company during the ongoing investigation.

Now that many discount drugstores are offering generic medicines for about $1 per week, Americans are starting to ask where the raw ingredients come from. When people buy a shirt or a pair of shoes, the label tells you whether it was made in Brazil or Thailand. Even food has country-of-origin labeling. But drugs do not.

The next time you pick up a prescription, ask the pharmacist where the pills were made. Chances are that the pharmacist will not have a clue.

Readers of this column have noted some apparent differences in quality among generic drugs: “I was prescribed Toprol XL 50 mg for high blood pressure and an irregular heart rhythm (PVCs) about six years ago. It worked well to control these problems.

“At some point I was switched to a generic (small oval pills) that also seemed to work OK. Recently I got a refill, but my pharmacy had switched generic providers and now gave me some large oval pills.

“Over the next two weeks my PVCs increased and I had a number of bouts with racing heartbeat. My blood pressure was 150/100.

“I took that generic back to the pharmacy and asked for regular Toprol XL instead. Today the PVCs are gone and my blood pressure is 126/79.”

Americans should be able to trust their medicines. Until the FDA can monitor the marketplace more thoroughly, patients must be vigilant. Anyone who would like to report a generic drug problem may do so at www.peoplespharmacy.com or go to the FDA’s web site: www.FDA.gov/MedWatch.

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  1. MB
    Reply

    Many, but not all, generics seem to be effective. It is unfortunate that there is no scientific evaluation of safety and effectiveness. It would be good if the Federal budget provided the resources for the FDA to do the job. Many people cannot afford the high copay required by insurance companies if they choose the brand name.

  2. michelle
    Reply

    I have restless leg syndrome and was taking Requip until they came out with the generic Ropinirole. During the first month of taking the generic, I called my doctor and told him that it wasn’t working anymore and so he increased the mg. It still wasn’t working and I asked to be put back on the Requip and I haven’t had any problems since going back to the Requip.

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