Katherine Eban, author of Bottle of Lies, warns about purity issues associated with generic drugs: Shots

As the cost of prescription drugs increases, consumers are increasingly taking generic drugs – inexpensive alternatives to brand name drugs. Health insurance plans often require patients to switch to generic drugs to control their costs. But journalist Katherine Eban warns that some of these drugs may not be as safe or effective as we think.

Eban has been covering the pharmaceutical industry for over 10 years. She notes that most generic drugs sold in the United States are manufactured abroad, mainly in India and China. The US Food and Drug Administration says it imposes on foreign factories the same standards as US drug manufacturers, but Eban's new book, Bottle of lies, question this notion. She writes that the FDA often advertises its inspections overseas weeks in advance, allowing factories that manufacture generic drugs to manufacture data and results.

"These plants know that [the FDA inspectors are] come, "Eban said. I discovered [some overseas drug companies] in fact … would modify documents, shred them, invent them, or even spray them overnight to make them look old. "

(In a statement to NPR, the FDA said that Americans "can trust the quality of FDA-approved products" and notes that it "has carried out several unannounced inspections" in foreign factories over the last few years. years.)

As a result, he adds, generic drugs are sometimes placed on the US market without prior verification. She describes the FDA as "overwhelmed and underfunded" in its efforts to ensure the safety of drug production abroad.

Eban advises consumers to research who manufactures their generics and to research any problems that regulators have discovered about them. However, some consumers may think that their health plan does not allow them to switch to alternatives because of costs.

Highlights of the interview

Why Many Pharmaceutical Companies Relocated Their Production Abroad

This surge of globalization in the drug sector was explained by two reasons. One was the environmental regulations. … How are you going to safely dispose of all the chemicals and solvents you use? And … there was less environmental regulation abroad. But another solution is this: if you move your manufacturing plant to India, you will save a great deal on the cost of labor and supplies – ingredients – overnight.

So you've seen a huge migration, both manufacturing to Indian companies, Chinese companies, but also companies based in the United States and the United States, who bought manufacturing plants abroad and have transferred their manufacture.

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

What that created was a process at the FDA, a separate application process for generics, because before Hatch-Waxman, generic drug companies had to do the same set of tests. [and] clinical studies that the brand has done, and Hatch-Waxman said, you know what? We will give you an abbreviated application. You can perform clinical studies on far fewer patients because we have already proven the safety and effectiveness of this molecule in the human body.

But what Hatch-Waxman really did that triggered the generics revolution was that it gave businesses a boost: the incentive was called "first-ever" and indicated if you're the first company to present your request – and literally first by the minute or second – and you are approved, you will get six months of exclusivity on the market to become the leader and only the generic, and you will probably be able to sell your drugs to about 80% of the total price. the price of the brand. And this "first to classify" really has become the difference between making a fortune and making a living.

How some generic factories are preventing FDA inspectors from conducting extensive inspections

In several cases that I have documented, investigators have been poisoned during their inspections with contaminated tap water that you can not drink in India. They felt sick during inspections. I mean, it was a way of running late. They were followed. In one case, an investigator had his hotel room buggy. In some cases that I had heard about, [the plants] were trying to go through the passenger lists at airports to try to figure out exactly who was coming when. The factories have therefore taken elaborate steps to try to protect themselves from bad inspections.

On how the quality of generic drugs may vary depending on the place of sale of the drugs

Generic drug companies adjust the quality of their manufacturing to match the market for their drugs and the vigilance of regulators in those markets. They will therefore take their biggest shortcuts, their largest exchanges of high quality ingredients in poor quality ingredients, in markets where regulations are very poor: sub-Saharan Africa, Southeast Asia, South America regions.

On the Trump administration's efforts to relax the company's regulations

Once you understand how important these regulators are to safety and well-being, any sensible American would not normally want to take a pill from an uninspected factory. These regulators are doing an absolutely vital job, and you can not get started and think you want less regulation. I mean, it's too perilous and the cost of having, you know, non-sterile plants, non-bio-equivalent drugs – this cost is just too high.

But I think under the Trump administration you'll find a more lenient attitude toward corporations generally, which, you know, has been sort of passed on to the FDA. But on the other hand, I would like to consider the whole problem as a bipartisan failure that has not systematically reflected on how to respond to a supply of medicines in a globalized world.

How many consumers should worry about the safety of generic drugs

An addiction investigator told me that he thought the concern was greater among people undergoing treatment who take these drugs day in and day out. These drugs may have toxic impurities. These may accumulate in your liver, you may not know it, or you may have side effects that you have not thought about before, then you realize: "Wait a second , I've been replaced by another generic "or" I was changed from a brand to a generic ".

So I think once consumers have started thinking about this, I think they realize that this can have consequences for them. … You can look on the distributor label, you will have the name. Go to Google, put the name of this company and "FDA warning letter". What has the FDA discovered about this company? Has this company had any medication reminders? It's a little dig, but if you take this medicine day after day, it's worth it.

Sam Briger and Mooj Zadie produced and edited the audio of this interview. Bridget Bentz, Molly Seavy-Nesper and Carmel Wroth have adapted it for the Web.