Both brand name drug companies and generic drug manufacturers have earned the distrust of the American public. In just the last week we have learned about another lawsuit filed against some of the leading generic drug manufacturers for collusion and price fixing. We have also read that one of the world’s biggest brand name companies, Novartis, “could settle for $1B as part of federal kickback lawsuit” (FiercePharma, May 16, 2019). How can you trust the pharmaceutical industry when key companies are accused of such egregious behavior?
The Generic Drug Scandal(s)
There have been so many generic drug company missteps we have lost count. We continue to learn about contaminated blood pressure medicines as well as fraud (Bottle of Lies: The Inside Story of the Generic Drug Boom).
To refresh your memory, generic drug companies have had to recall tens of millions of blood pressure pills (irbesartan, losartan and valsartan) because of nitrosamine contamination. This week Bloomerg reports that two drug companies in India that were supposed to make valsartan replacements are themselves in trouble with the FDA:
“Heart-Drug Suppliers for Millions Faulted Over Data, Bugs, Dirt,” (May 16, 2019)
Although Cadila Healthcare Ltd and Alkem Laboratories Ltd were recently granted FDA approval to make generic valsartan, they have violated good manufacturing practices in the past. According to Bloomberg’s Anna Edney:
“Workers ignored testing data showing product flaws; destroyed records indicating that drugs were failing key quality measures; and didn’t properly clean equipment, FDA inspection reports stated. Inside one factory, inspectors said they saw swarms of insects.”
Cadila got a green light from the FDA on March 16 to produce valsartan plus hydrochlorothiazide. The Food and Drug Administration is on the hot seat to solve the drug shortage problem. But Bloomberg notes that:
“Inspectors found in April and May that equipment at Cadila’s facility wasn’t cleaned appropriately to prevent contamination and that workers ignored signs of impurities.”
Collusion and Price Fixing in the “Sandbox”
You might think that concerns about contamination would be enough to explain why many Americans no longer trust the pharmaceutical industry. Just wait. The REALLY BIG generic drug story this week has to do with a lawsuit brought by over 40 states attorneys general. They are suing 20 generic drug makers for fixing prices. At last count there are 300 drugs involved in this litigation including antibiotics, arthritis medications, HIV treatments, blood thinners, cancer drugs and contraceptives.
According to the lawsuit, American consumers have lost billions of dollars because they were overcharged. It is alleged that executives met face-to-face at industry conferences and social events to divide up the market and determine prices.
In an interview on the show PBS News Hour (May 15, 2019) the attorney general of Connecticut, William Tong, responds to a question about how much money has been lost:
“Billions of dollars.
“We think this is potentially the largest private sector cartel in history. And what we’re seeing is pervasive, widespread, industry-wide price-fixing and dividing up of market share.”
Key company officials have been accused of getting together to divvy up the marketplace and set prices over golf, during “girls night out” cocktail parties, lunches, dinners and other industry gatherings.
They were, according to the lawsuit, reminded to “play nice in the sandbox.” Instead of competing head-to-head, companies were apparently encouraged to cooperate. That is not the way the generic drug industry is supposed to work. The generic drug companies deny wrongdoing and state that they will vigorously defend themselves against the charges.
It’s Not Just Generic Drugs on the Hot Seat
Another big story this week is about a big brand name drug company. An industry monitoring organization, FiercePharma, reports on one of the largest brand name drug companies in the world. In its May 16, 2019 online newsletter the headline reads:
“Novartis could settle for $1B as part of federal kickback lawsuit: report”
Here’s the summary:
“The most eye-popping claims in the lawsuit read like corporate corruption out of the world of fiction, with Novartis allegedly treating doctors to $10,000 dinners at Nobu, a chic New York seafood restaurant, and wild nights out at Hooters. In one instance, whistleblowers said the company held a sham promotional speaker event on a fishing boat.”
The judge in the case:
“…said those incidents were just a few of some 79,000 events admissible as trial evidence after federal prosecutors alleged a ‘companywide scheme’ to boost scripts that defrauded the U.S. government of millions in Medicare and Medicaid billing over the span of nearly a decade.”
Do You Trust the Pharmaceutical Industry?
We wouldn’t blame you if you are becoming cynical about FDA oversight of the generic drug industry abroad. We wouldn’t blame you if you no longer trust the pharmaceutical industry to police itself. We wouldn’t blame you if you no longer trust the pharmaceutical industry to price medicines fairly.
If you read Katherine Eban’s book, Bottle of Lies, you will learn why so many Americans no longer trust the pharmaceutical industry. That’s Period…Full Stop!
Share your own story in the comment section below.
Deloris no longer trusts the pharmaceutical industry, especially the generic drug industry:
“Not only do consumers have to worry about the ineffectiveness of generic drugs, we also have to worry about unknown, undocumented additives and contaminants and the effects they may have on our overall health. If anyone takes more than one generic, tracking any harmful ingredients is impossible. Generic drug manufacturers show no concern and cannot be sued, and pharmaceutical distributors are only looking for the cheapest products. The FDA does nothing about this.”
William T. has also lost trust in the pharmaceutical industry and the FDA:
“In my opinion the FDA is failing its owners. That happens to be us, the taxpayers of the USA! They fail to ensure safe drugs, they fail to ban pharmaceutical companies that make pills which are not equivalent to the original. They continue to maintain that all the drugs they approve are safe.
“Congress should demand better, safer medicines. Otherwise it is allowing people to be harmed by the FDA. Are there not enough good Congressional members left to protect us?
