The People's Perspective on Medicine

Why Is EpiPen Maker in Trouble Again?

EpiPen maker Mylan has received notice from the FDA that one of its manufacturing facilities in India has come up short on quality control.

The drug company Mylan got into trouble last year because of the extraordinary increase in its price for its epinephrine auto-injector. The EpiPen maker is now in a different type of trouble with the Food and Drug Administration.

FDA Finds Fault with Indian Facility of EpiPen Maker:

This global generic pharmaceutical manufacturer fell short during an inspection in India. The FDA has sent a letter saying:

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

The facility, in the Indian state of Maharashtra, makes antiviral drugs for treating HIV. The FDA found missing, deleted and lost data and unexplained discrepancies between drug batches.

Mylan Is Not the Only Manufacturer to Run into Trouble:

Increasingly, generic drug companies are relying on Indian manufacturing facilities to produce inexpensive medications. Many have run afoul of the FDA’s expectation of quality control.

The problem is not new. We have been writing about it for years, as we did in this 2014 post. It cited an extensive analysis of the problem by Gardiner Harris of The New York Times.

With most of our medications now in generic form, and most generics being made outside the country, such problems are widespread. We also wrote about them in 2015. How will drug companies, including the EpiPen maker, clean up their quality control processes so that consumers can trust them again?

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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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Within the past few years, I have experienced the all-too-common conundrum of brand name vs generic drugs. For many years, I took Effexor, then Effexor XR made by Wyeth and enjoyed reduction of depression and anxiety symptoms. About 18 months ago, because of my medicare rx restrictions, I was switched to the generic venlafaxine. Within a week I began to feel the old anxiety and depression creeping back and reported this to my pharmacist and my pcp. After some researh including phone calls to Wyeth, I discovered that a subsidiary of theirs, Greenstone, marketed a Venlafaxine XR product that contained the exact same dosage of venlafaxine as did the non-generic. At this point, my doctor wrote a script that specified only the Greenstone product and, for about nine months, my pharmacy was able to obtain this medication. Unfortunately, with the purchase of Wyeth by Pfizer, Greenstone went out of business, and Pfizer began supplying its own version of the Venlafaxine XR. When I began taking this drug, I immediately recognized its ineffectiveness. After doing my “homework.” I discovered that, in fact, 1) the pharma companies do, indeed, vary the amount of active drug in their venlafaxine xr medications, 2) some of the supposed xr meds are not, in truth, xr, as labeled, but instead drop all of the drug at one time, and 3) many of the venlafaxine meds are manufactured in India in unsanitary conditions and sometimes without proper FDA dosage testing. The next step in my saga led me to an Effexor XR reduced cost card and a NO SUBSTITUTION designation from my pcp, I was able to obtain the brand name Effexor from Pfizer for six months at $30 a month and felt that the drug had some efficacy … but, alas. I reached my maximum yearly subsidy. So, here I am at almost 71 years old wondering how I can obtain the medication I need to live the highest quality of life. Your comment and suggestions will be appreciated.

President Trump has said he wants to make it more financially appealing to have US companies manufacture their goods in the US. If the foreign companies making generics are a subsidiary of US drug makers maybe we could expect lower drug costs if they bring their production back stateside. Just a thought.

Bring Back Made In The U.S.A! Please!

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