EpiPen injector, EpiPen maker

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?

Join Over 140,000 Subscribers at The People's Pharmacy

Each week we send two free email newsletters with breaking health news, prescription drug information, home remedies and a preview of our award-winning radio show. Join our mailing list and get the information you need to make confident choices about your health.

  1. Marianne
    Atlanta
    Reply

    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.

  2. Patty
    Reply

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

What Do You Think?

We invite you to share your thoughts with others, but remember that our comment section is a public forum. Please do not use your full first and last name if you want to keep details of your medical history anonymous. A first name and last initial or a pseudonym is acceptable. Advice from other commenters on this website is not a substitute for medical attention. Do not stop any medicine without checking with the prescriber. Stopping medication suddenly could result in serious harm. We expect comments to be civil in tone and language. By commenting, you agree to abide by our commenting policy and website terms & conditions. Comments that do not follow these policies will not be posted.