of an Obama administration proposed that would have fixed the problem.
This regulation would have allowed consumers harmed or killed by a generic drug due to the drug’s inadequate labeling or defective design, to hold the manufacturer accountable in court. It would have restored rights to injured patients that were taken away by the U.S. Supreme Court in 2011.
Incredibly, we were almost there with a rule change. Obama’s FDA proposed the rule change, had a powerful public hearing about what these Supreme Court decisions had done to people (here’s our and received many comments in support of the change. ( from us and other consumer groups.) But generic drug industry lobbyists were already swarming the agency, guns ablazin’. Don’t do this, they screamed. Generic drug prices will skyrocket if you make us accountable.
We all knew this was . But that’s not the shocking part.
At the same time these companies were jumping up and down about the rule change, they were illegally raising prices on drugs to such an extent (e.g., “1,215 generics, many of them the most prescribed drugs, jumped on average more than 400 percent in a single year”), that their activities are now perhaps “the biggest price-fixing scheme in U.S. history.” In fact, the Attorney General of Connecticut, William Tong, is calling the generic drug industry “the largest private sector corporate cartel in history.”
Shame on the generic drug industry.
As reported last night on ,Tong’s office has been examining the generic drug industry for almost five years. On Friday, with massive evidence of fraud, more than 40 other states joined Connecticut in filing a 500-page price-fixing lawsuit against the generic drug industry. (At least state AG’s still have the right to sue these companies.) Tong’s office found evidence of price-fixing involving “every kind of drug that touches our everyday lives.” (The drugs “treatments for diabetes, cancer, arthritis and other medical conditions.” ) And they are putting “Americans' lives at risk.”
His office was able to catch the fraud with some stealth and tedious law enforcement techniques, leading them to “hard evidence, in the form of text messages, emails, documents, witnesses that demonstrate clearly that [the price hikes weren't] about product shortages. It was about profit. It was about cold, hard greed.” As far as the average consumer, said Tong, “It's devastating. it affects health insurance premiums and health insurance plans. It impacts Medicare and Medicaid. And it is a chain reaction that drives up the price of American healthcare to unnatural heights.”
The , “also names 15 individual senior executives responsible for sales, marketing and pricing.” It says that by 2012, for example, “Teva and its co-conspirators embarked on one of the most egregious and damaging price-fixing conspiracies in the history of the United States” as they sought to “significantly raise prices on as many drugs as possible.” They picked companies with which it already had “very profitable collusive relationships,” and developed understandings to lead and follow each other’s price increases,” which “resulted in many billions of dollars of harm to the national economy over a period of several years.”
Kelley Dougherty, a Teva vice president, said, “The allegations in this new complaint, and in the litigation more generally, are just that — allegations … The company delivers high-quality medicines to patients around the world and is committed to complying with all applicable laws and regulations in doing so.”
High-quality medicine. So that’s another thing. NBC is coincidently running a frightening (featured on this morning’s Today Show) about tainted generic drugs manufactured oversees, where most are made. As the Center for Justice & Democracy noted in its 2013 , “America's Unaccountable Generic Drug Industry; How Legal Immunity Could Be Making You Sick,” generic drugs are manufactured in countries like India and China米兜彩票合法吗, to supposedly “keep prices low." (Sound familiar?) In these countries, the FDA rarely inspects factories or the supply chain. History shows that generic drugs or ingredients can be manufactured in dilapidated, dirty factories. And now, one former FDA inspector is ringing an alarm.
The main NBC story focused on the recent recall of the very popular blood pressure generic drug, valsartan, which apparently contained a carcinogenic “contaminant formerly used in the production of rocket fuel.”
came as little surprise to Massoud Motamed, a former inspector with the U.S. Food and Drug Administration (FDA). More than a year before the notices went out, Motamed had tried to sound the alarm on what he flagged as potential systemic problems at two facilities in China米兜彩票合法吗 and India that produce the active ingredients in generic valsartan and other blood pressure medications.
Speaking out publicly for the first time, Motamed told NBC News that the FDA ultimately overruled his recommendation to crack down on one of the plants. Perhaps more alarming, he says the issues at the two overseas drug production facilities are hardly unique.
"This is only the tip of the iceberg," Motamed said in an exclusive interview.
Blomberg wrote about some of this earlier this year, ,
Data integrity was also at the heart of FDA inspector concerns at a plant halfway across the world, where was supplying the active ingredient valsartan—a widely used treatment for high blood pressure that is taken alone, as well as sold in combination with other cardiovascular drugs—for major pharmaceutical companies such as , the largest generic drug maker in the world.
The inspection in May 2017 found that the Chinese ingredient maker ignored quality checks that showed unnamed drugs didn’t meet U.S. standards. Four months later, higher-ups at the FDA once again overrode the concerns of those on the ground who wanted to slap Zhejiang Huahai with harsher penalties. Instead, the agency gave the company a chance to fix its problems.
Motamed says “a more systemic issue has largely gone unreported: FDA inspectors struggling to keep up with foreign drug manufacturers that may bury or hide problems in their production. Last year, the FDA inspected only one in five registered human drug manufacturing facilities abroad, according to agency data.”
Catch ‘em if you can.