Posted by Bill Sandweg on 24 June 2019.
The promise of generic drugs is enticing: quality replacements for name-brand drugs at a fraction of the price. Regardless of whether that promise was ever anything more than an illusion, it is a proven lie today.
I read two recent articles which deal with two separate ways in which generic drug manufacturers have betrayed patients. In both cases, the betrayal is rooted in money. The first betrayal is discussed in a book about generics and the ways in which it has betrayed its promise by cheating on quality. Lightly regulated plants in India and China are paying off regulators, using substandard ingredients and cutting manufacturing corners to increase profits.
Most of the bad and dangerous drugs that are produced by these manufacturers end up in places like Africa and Asia but, beginning in the 1980’s, the United States began importing foreign generic drugs. While the F.D.A. has done a masterful job of overseeing American drug production and made sure that quality control is high, the same is not true of its efforts to assure the safety of these Asian generics. When the F.D.A. inspectors to get to these plants, and apparently their visits are few and far between, they announce themselves in advance, which gives the manufacturers plenty of time to cover their tracks. This is not the case in the United States where no notice inspections are the rule rather than the exception.
Some of these dangerous drugs have made it to the United States. In 2007 a number of dialysis patients died from allergic reactions to a contaminant in a generic blood thinner manufactured in China. The F.D.A. had never inspected the Chinese plant and someone there had diluted the product to make it go further.
So one betrayal by the generic industry has been its production of poor quality, dangerous copies of name-brand drugs. The other betrayal has been the generic industry’s price fixing. Instead of providing low cost alternatives to name-brand drugs, the big boys in the generic industry have been engaging in schemes intended to drive up prices. For example, the generic antibiotic, doxycyclene, cost about $20 for a prescription in 2013. A year later, the price had risen over 8,000% to $1,829. Similar, but not quite so outrageous, increases were seen in other generics. Manufacturers would sometimes agree to raise prices in lock step. Other times they would agree to assign certain drugs exclusively to certain manufacturers.
Now 43 states are part of a massive price fixing suit against 20 manufacturers alleging billions of dollars of harm to American consumers. The likelihood of success seems high as the states have e-mails, text messages and testimony from insiders supporting the claim that the manufacturers were conspiring to raise prices.
There is another betrayal here as well. It is the betrayal of the American citizen by the federal government. The F.D.A. did not protect us from bad drugs made overseas. The Congress did not protect us from generic price fixing at home. It is a sad day when we must rely upon the attorneys general of the states to get together to address a national problem. That is supposed to be the job of the federal government. I am just happy that someone is doing the job.