The generic medication industry makes headlines this month—thanks to the investigations of journalist Katherine Eban. She is the author of Bottle of Lies: The Inside Story of the Generic Drug Boom.
Generics have been long touted as a cost-savings to consumers. For the most part, they are. Many physicians and pharmacists guarantee that they are “exactly the same as brand.” For the most part, they are not.
Yes, many consumers benefit from generic versions of brand medications. For them, the differences between brand and generic make little difference in efficacy. Please be assured that I do not want to unduly scare people who are taking generic medications.
But here’s the thing: Many people do not benefit from generics, and they have no idea why when they did so well on the brand.
“Bioequivalence”— The Small Print
Social media brims with rants against “Big Pharma.” My concerns, however, have long been with “Big Generic.”
Since 2009, I’ve reported here about the particular problems that generic medications can present for people with ADHD—and indeed all psychiatric conditions. (I’ve linked to a few posts below.)
These posts culminated a few years ago when two generics for Concerta resulted in many readers’ lives going off the rails. Most did not connect their problems to their new generic medication. At least not right away. Why would they if their pharmacist or physician repeatedly assured that “generic is exactly the same as brand”? Many made the connection only after they found my blog posts.
With psychiatric medications, the dosing can be everything; too much up or down can have little or even a bad effect. As I write in Consumer Alert: Three New Concerta Generics as Janssen/Actavis Deal Ends:
In the U.S., the FDA requires the “bioequivalence” for the generic product to be between 80% and 125% of the original product.
Yes, that’s roughly 20 percent up or down—a huge window of variance.
Even that number will not be constant; it might vary each time the prescription is filled because pharmacies often switch suppliers.
The FDA Responded—But Slew of Concerta Generics Continues
Along with Kansas City pediatrician Kristen Stuppy, we issued a warning about these Concerta generics. I spoke with an FDA representative and opened a MedWatch file. Dr. Stuppy and I urged our readers to file a complaint if they had experienced problems with their Concerta generics. We had barely finished celebrating our successful effort to have the FDA to downgrade these generics when boom boom boom—three new generics for Concerta. Talk about a game of Whack-a-mole.
Over the past decade, many insurance policies (including employer-sponsored) have pushed more and more consumers toward generics. Pharmacy profit margins are often higher for generics than for brand; this might also be true for some medical insurance policies. Certain pharmacy chains have even balked at filling prescriptions for the Concerta’s “authorized generic” (the brand marketed as a generic), saying that it is unavailable when it is not.
Americans Need Generic Drugs, But Can They Trust Them?
Now back to journalist Katherine Eban’s book. She has written a comprehensive examination of the generic medication industry. Most American consumers rely upon generics for their medical conditions but most know very little. Until recently, even I didn’t know that most generic medications are made in places such as India and China. As it turns out, 90% of generics are manufactured overseas in plants that hardly resemble the highly regulated U.S. plants.
“Bottle of Lies” Book Excerpt:
Here is an excerpt from Eban’s op-ed in The New York Times: Americans Need Generic Drugs. But Can They Trust Them?
The F.D.A., which approved more than 1,000 new generic drug products last year, faces a vast challenge in safeguarding these medications. Nearly forty percent of all our generic drugs are made in India. Eighty percent of active ingredients for both our brand and generic drugs come from abroad, the majority from India and China. America makes almost none of its own antibiotics anymore.
Of course, overseas manufacturing can work perfectly well and the F.D.A. contends that it has a reliable review system for all approved drugs. “The F.D.A. inspects all brand-name and generic manufacturing facilities around the world which manufacture product for the U.S. market to confirm they meet F.D.A.’s requirements for manufacturing process,” it said recently.
My reporting on the generic drug industry over the last decade led me to four continents, and into the overseas plants where America’s generic drugs are made. Interviews with more than 240 people, including numerous whistle-blowers, helped expose what was going on behind the boardroom doors at generic-drug companies. Some companies have encouraged data fraud as the most profitable path to securing approvals from regulators, and have used deceit to hold the F.D.A.’s investigators at bay.
In the United States, F.D.A. investigators typically show up unannounced to inspect plants. But overseas, the F.D.A. has opted to announce the vast majority of its foreign inspections in advance. Overseas plants even “invite” the F.D.A. to inspect; the investigators then become the company’s guests and agree on an inspection date in advance. Plant officials have served as hosts and helped to arrange local travel.
The F.D.A. has defended this system as the best way to ease the complex logistics of getting visas and ensuring access to the plants. But the resulting inspections are largely “staged,” say a number of F.D.A. staff members. With advance notice and low-cost labor, the plants can make anything look like anything. “You give them a weekend, they’ll put up a building,” as one F.D.A. investigator put it.
FDA Ramped Up Investigations: 2015-2017
Starting about 2015, the FDA was cracking down on plants in India, China, and elsewhere. This piece explains: As India, China drug industries mature, FDA scrutiny an overhang
If this continued into 2018, I have found no evidence. But I’ve yet to finish Eban’s book.
From the ADHD Roller Coaster Archives: Posts about Generic Medications
Here is a sampling of my posts about generics from 2009 to today: