The person who is most directly involved in day-to-day drug regulation at the FDA is Janet Woodcock, MD. She is Director of the Center for Drug Evaluation and Research (CDER). When we have a drug watchdog issue involving the FDA, we contact Dr. Woodcock directly. For years we have been bugging her about generic drug quality. For most of that time the FDA has reassured us that generic drugs are just fine, thank you very much.
Maybe A New FDA Tune on Generic Drugs?
We were astonished to see Dr. Woodcock’s testimony to the House Subcommittee on Energy and Commerce. The publication FDAnews Drug Daily Bulletin (Nov. 11, 2019) summarized some of Dr. Woodcock’s key points:
“CDER Director Janet Woodcock called for an overhaul of American drug manufacturing to offset the nation’s dependence on APIs [active pharmaceutical ingredients] made in China, India and elsewhere, in remarks to a House subcommittee.
“The growing number of API manufacturing sites in China and other countries suggests the U.S.’ reliance on these countries for APIs is increasing,
“Only 28 percent of facilities making APIs for the U.S. market are domestic, while 72 percent are overseas.”
The bottom line seems to be that the pharmaceutical industry has moved its manufacturing processes oversees. That is especially true for generic drugs.
We were astonished to read that Dr. Woodcock would like to see purchasers of prescription drugs (pharmacy chains, wholesalers, pharmacy benefit managers, etc). buy medications from “manufacturers with very high reliability” (FDA, October 24, 2019). We find this ironic since the FDA has been telling everyone for years that all FDA-approved generic drugs are just as good as the brand name originals.
In her statement to Congress, Dr. Woodcock notes that:
“…drug manufacturers are more likely to keep costs down by minimizing investments in manufacturing quality, leading to quality issues that can trigger supply disruptions and shortages of needed medications.”
That is the first time to our knowledge that anyone at the FDA has admitted that some drug manufacturers may be “minimizing investments in manufacturing quality” and that could lead to “quality issues.”
Brand Name Drugs from Canada?
Many of our readers have been worried about generic drug quality for years. Some are buying brand name drugs from Canada to get quality at a lower price. One reader shared this:
Q. I have been on clonazepam, amitriptyline, levothyroxine, atorvastatin, atenolol and warfarin since 1994. Last Christmas I received my first generics from Indian manufacturers. This has been a nightmare, so I now buy brand Klonopin and attempt to get as many of my drugs as possible from Canada.
Too many generic drugs are not working because the FDA cannot monitor all off-shore Indian and Chinese manufacturers. I have had credible sources tell me that drug companies overseas check flight manifests to see when American FDA inspectors are coming.
Please send letters to the FDA to try to effect change. Bring drug manufacturing back to the US where the agency can monitor it properly!
A. You will be very interested in Katherine Eban’s new book, Bottle of Lies: The Inside Story of the Generic Drug Boom. She covers the FDA’s ineffectual struggles to oversee generic drug manufacturing outside the country, especially in India and China.
Should you wish to listen to our free interview with Ms. Eban, here is a link to the podcast:
Readers Who Buy Brand Name Drugs from Canada:
Jan shares this experience:
“I currently buy some of my medications from a Canadian pharmacy. They are so much cheaper if you don’t have good insurance.”
“My doctor gives me a paper prescription. I mail it to the pharmacy. It’s a very easy process. I only buy brand name drugs. Do your home work and ask around.”
Nathan has to take a pricey cancer drug:
“I was diagnosed with prostate cancer in May 2018. The treatment was very expensive. I was not able to afford this medication. I am very thankful to my doctor, who suggested an offshore pharmacy. They are very affordable and trusted.”
But Is it OK to Buy Brand Name Drugs from Canada?
We recently wrote about a new policy about importing drugs from Canada at this link:
Not all so-called Canadian pharmacies are trustworthy. Some masquerade as Canadian but may be on an island in the middle of nowhere. People who think they are buying brand name drugs from Canada may be getting them from halfway around the world.
To learn more about how to distinguish legitimate Canadian online pharmacies from counterfeit operations, you may wish to read our eGuide to Saving Money on Medicines. You can find this electronic resource in our Health eGuides section.
Share your own experience if you have bought brand name drugs from Canada. Was it hard or easy? Did you have problems with U.S. Customs? Did you save money? Was it worth the effort?