Later On

A blog written for those whose interests more or less match mine.

The Generic Drugs You’re Taking May Not Be As Safe Or Effective As You Think

leave a comment »

Since the four medications I take are all generic (and thus are inexpensive: a 3-month supply of all four drugs totals US$1.80). I dislike the idea that they are not well vetted. I notice that the GOP has consistently stripped of resources the agencies most important to protecting the public and funding the government: FDA, FAA, IRS, EPA, OSHA, CFPB, FTC, and so on. Republicans seem to be on a mission to destroy the US.

Dave Davies reports at NPR:

As the cost of prescription medication soars, consumers are increasingly taking generic drugs: low-cost alternatives to brand-name medicines. Often health insurance plans require patients to switch to generics as a way of controlling costs. But journalist Katherine Eban warns that some of these medications might not be as safe, or effective, as we think.

Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban’s new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results.

“These plants know that [the FDA inspectors are] coming,” Eban says. “I discovered [some overseas drug companies] would actually … alter documents, shred them, invent them, in some cases even steaming them overnight to make them look old.”

(In a statement to NPR, the FDA said that Americans “can be confident in the quality of the products the FDA approves” and notes it has “conducted a number of unannounced inspections” at foreign plants over the past several years.)

As a result, Eban says, generic drugs sometimes go to market in the U.S. without proper vetting. She describes the FDA as “overwhelmed and underresourced” in its efforts to ensure the safety of overseas drug production.

Eban advises consumers to research who manufactures their generics and look up any problems that regulators have found out about them. But some consumers may find they are not allowed by their health plan to switch to alternatives, because of cost.


Interview Highlights

On why many drug companies moved production overseas

There were a couple of reasons for this surge in globalization in the drug industry. One was environmental regulations. … How are you going to safely dispose of all the chemicals and solvents that you’re using? And … there was less environmental regulation overseas. But another one is: If you move your manufacturing plant to India, you’re going to save a huge amount on labor costs and supplies — ingredients — overnight.

And so what you saw was a huge migration, both of manufacturing to Indian-owned companies, Chinese-owned companies, but also Western- and U.S.-based companies, buying up manufacturing plants overseas and moving their manufacturing there.

On how the 1984 Hatch-Waxman Act changed the generic-drug industry

What it created was a pathway at the FDA, a distinct application process for generics, because prior to Hatch-Waxman, basically the generic companies had to do the same set of tests [and] clinical studies that the brand did, and Hatch-Waxman said, you know what? We’re gonna give you an abbreviated application. You can do the clinical studies on many fewer patients, because we’ve already proven safety and efficacy of this molecule in the human body.

But what Hatch-Waxman did that really ignited the generic-drug revolution is it gave the companies an incentive: The incentive was called “first to file,” and it said if you are the first company to submit your application — and literally first by the minute or the second — and you get approved, you’re going to get six months of exclusivity on the market to be the lead and only generic, and you’re probably going to be able to sell your drugs at about 80 percent of the brand-name price. And that “first to file” really became the difference between making a fortune and making a living.

On how some plants that make generics prevent FDA inspectors from doing thorough inspections

In several instances I documented, the investigators were poisoned in the course of their inspections with tainted water from the tap, which you can’t drink in India. They felt sick during inspections. I mean, this was a way of running out the clock. They were followed. In one instance, an investigator had his hotel room bugged. In some cases that I had heard about, [the plants] were trying to scan passenger lists in airports to try to determine exactly who was coming when. So there were elaborate measures that the plants took to try to protect against bad inspections.

On how the quality of generic drugs can vary depending on where the drugs are being sold . . .

Continue reading.

You can hear the interview at the link.

Written by Leisureguy

20 May 2019 at 8:45 am

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.