The People's Perspective on Medicine

938 FDA to Begin Monitoring Generic Drug Quality

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938 FDA to Begin Monitoring Generic Drug Quality

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Tune in to our radio show on your local public radio station, or sign up for the podcast and listen at your leisure. Here’s what it’s about:

A number of foreign drug firms have been cited by the FDA for poor quality control (and in some cases data manipulation). Perhaps in response, the agency has decided to establish a new Office under its jurisdiction. The Office of Pharmaceutical Quality will actually test the drugs Americans take to see if they meet appropriate standards. While the program applies to brand name drugs as well, it is concerns about generic drug quality that are driving this welcome initiative. What steps will the FDA take to ensure drug quality?

A recent article indicates that stethoscopes are just as likely as hands to be contaminated after a doctor examines a patient. But while everyone pays attention to hand hygiene, hardly any institutions require stethoscope disinfection between patients. Isn’t it time to start?

Some parents are trying to fight child obesity by starting their toddlers on skim milk at an early age. Dr. Alan Greene tells us why that might not be ideal.

We also discuss home remedies that help for common health conditions.

Call in your questions and comments at 888-472-3366 or email between 7 and 8 am EDT.

Guests:  Janet Woodcock, MD, is Chief Medical Officer and head of the Center for Drug Evaluation and Research at FDA, Rockville, MD. 

Alan Greene, MD, FAAP, is founder of, cited by the AMA as “the pioneer physician Web site.” He was founding president of the Society for Participatory Medicine, a practicing pediatrician and founder of the WhiteOut Now movement to change how babies are fed from their very first bite of solid food. His books include Feeding Baby Green and Raising Baby Green.

The podcast of this program will be available the Monday after the broadcast date. The show can be streamed online from this site and podcasts can be downloaded for free for four weeks after the date of broadcast. After that time has passed, digital downloads are available for $2.99. CDs may be purchased at any time after broadcast for $9.99.




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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies. .
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So where can one have their questionable generic medications tested? I’ve got a medication right now that’s severely lacking it’s main ingredients…. so much so that I’d easily bet a kidney it was less than 50%….

Are you maintaining a database where people can send in experience with drugs from various sources. That would be very helpful!

Hello. Did I hear correctly? Surprise visits to other countries are not conducted because they have to get passports etc?… and other lame excuses, but FDA can do them in the US? I never know when my boss is going to show up and and it keeps me on my toes.

I take generics because I can’t afford the brand names save for one – Cardizem. The generic that I took just once, had me on a gurney at the clinic inside an hour.
I don’t know why the pharmacist said it had the same amount of ingredients but they must have been dumped all at once. I almost passed out and had pains in my heart.
My feet sometimes wonder if I really am getting Neurontin generic as they hurt but the condition does worsen over time.
I read that some brand name companies also produce the generic – why would they have it the same for lower price; fiddle with it so people go back on the brand name? The FDA should have been on this decades ago but their budget keeps getting cut.

Even if the FDA releases bioequivalence data (blood levels, dissolution rates, etc.) generated by the drug sponsor, why should anyone trust that data? Do you trust generic manufacturers to submit truthful data to the FDA?

I read recently that generics can be up to 20% outside (above & below) the brand name equivalent. That is a 40% spread!!
People’s Pharmacy response: It is a bit more complicated than that, but yes, there is a certain amount of variation, even sometimes within name brands.

My experience with generics is this: an allergic person such as myself must read the patient insert diligently to discover whether any ingredients could be a problem. Then they must have a pharmacist willing to find a generic without offending ingredients.
I had this problem with my low-dose, long-term azithromycin prescription (the Sandoz version had polyvinyl alcohol and made my mucous membranes swell up). I also take a very low dose of quinapril. One manufacturer must make these in the same factory as they make a statin, to which I am exceptionally sensitive (causes extremely high blood pressure).
So my pharmacist orders the generic made by Greenstone, which works just fine with no adverse effects. Thanks for your comment that Greenstone makes some exact-brand-equivalent drugs.

It was not just what Dr. Woodcock SAID.
It was the MUSIC of how she said it.
There was NO enthusiasm in her voice for what the FDA was doing.
As I heard it, anyway.

I have found that generic estrace does not prevent hot flashes like the brand name does.

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