Dozens of blood pressure medications used by millions of Americans have been recalled over the past several months.
The FDA said the drugs contained a cancer-causing impurity.
Experts said these recalls have exposed a shocking truth: China and other overseas manufactures supply most of the active ingredients in prescription and over-the-counter drugs and less than 20 percent of these overseas facilities got inspected last year.
“Millions of Americans are taking medicines made in China and don’t know it,” said Rosemary Gibson, a national authority on health care who authored the book “China RX – Exposing the Risks of America’s Dependence on China for Medicine.”
“And neither do their physicians who prescribe them.”
A glance at your prescription bottle does not reveal the origin of the ingredients that give the drugs their therapeutic value.
A News 4 Investigates review of Food and Drug Administration documents paint a concerning picture of overseas drug manufacturing facilities that lack the quality control necessary to ensure the drugs that ultimately get shipped to the United States are pure, safe and effective.
The FDA documents detail bizarre attempts of foreign companies to sidestep their inspections, which are often announced ahead of time, unlike the process for U.S. facilities.
For example, a manufacturer in India faked an employee strike to delay an inspection. When the inspector did arrive, he was forced to conduct his work in the dark with a flashlight.
When inspectors do gain access, they report finding serious problems, such as visible discolored particulates and fraying gaskets in equipment that make the drugs intended for the United States.
“I think that this realization has made us think a little bit about where we stand with our prescription medicines in our new global world and vulnerabilities that exist because of it,” said Dr. Thomas Russo, professor of medicine at University at Buffalo Jacobs School of Medicine.
The Food and Drug Administration declined interview requests but said in a prepared statement that as drug manufacturing has globalized over the years, the agency has “modernized our policies to ensure that companies – regardless of where they are located – meet the FDA’s strict standards for producing medicines for U.S. patients that are high quality, safe and effective.”
“We will remain vigilant in addressing potential issues in the global drug supply chain, in order to make sure Americans have confidence in the safety and quality of their medicines,” the FDA said.
‘This is a wake-up call’
Gibson, who has made a career of advancing the public’s interest in health care, never expected to write a book about the dangers of drugs manufactured in China and other foreign countries.
She said most of the U.S. producers were driven out by China, who dumped “a whole lot of it on the global market at a really low price.”
As a result, medicines like antibiotics, aspirin, penicillin – even Vitamin C – are made overseas. Generics drugs – birth control, antidepressants, and medicines for Alzheimer’s and Parkinson’s disease – are also being made more often overseas.
“Who knew?” Gibson said.
“It’s an untold story and millions of Americans are taking them and don’t know it.”
Her book details how China’s biggest footprint is making the key ingredients in prescription and over-the-counter drugs that give the medicines their therapeutic value. Labels on the drugs bottles and booklets are often confusing and lack specific information about from where the active ingredients are manufactured.
In 2008, a bill was introduced in Congress to improve transparency in drug labeling, but it did not pass. The law would have required labels to identify the country that manufactured each active ingredient, among other things.
“That should be clear and it should be concise,” Rep. Brian Higgins said about drug labeling.
“The problem is, you have information overload. If you ever open up a prescription, you have sheets of paper that are all folded up and there are thousands of words. Rarely do people look at them.”
Russo, the infectious disease doctor at UB, said the FDA is faced with an overwhelming task of regulatory oversight. He said there is some evidence that suggests the recent warning of tainted blood pressure medicines Valsartan and Losartan came four years late, which reflects how difficult a chore with which the FDA is tasked.
“This is a wake up call,” Russo said.
“I think we need to be aware of where our drugs are coming from and I think the best solution for this is probably to increase our regulatory oversight and give the FDA the needed resources.”
Challenges faced by FDA
Inspecting drug manufacturing facilities overseas has proved to be a challenging task for the FDA.
News 4 Investigates obtained numerous FDA inspection reports that detail the steps some overseas facilities have taken to complicate the jobs of inspectors.
Consider the tactics deployed on Dec. 14, 2015, by Nippon Fine Chemical Co. in Takasago City, Hyogo, Japan.
According to the inspection report, the firm limited the investigator’s access to the quality control laboratory. The quality control manager directed employees to stand shoulder-to-shoulder to prohibit the inspector from accessing portions of the equipment used to analyze drugs to be distributed in the United States.
“During the inspection, our investigator reviewed complaints you received about your drugs from your customers, including complaints that your drugs contained glass, hair, cardboard, metal, product discoloration, and a black spider,” states a warning letter from the FDA
“Your firm limited the inspection by refusing to provide FDA copies of these records.”
As a result, the firm was placed on an import alert.
One of the problems, experts said, is that the FDA typically informs overseas plants of when they want to inspect.
On April 25, 2016, the FDA contacted Vikshara Trading & Investments Ltd. to facilitate an inspection of the plant in India.
With the head’s up, the plant managers made up a story that employees had gone on strike and blocked off the entrance of the facility as part of their protest. As a result, the FDA cancelled the pre-announced visit. The company even sent copies of employee resignation letters and photographs of employees blocking the entrance.
But the FDA obtained evidence that the firm continued to manufacture numerous products during the period that managers said employees were on strike.
FDA accessed the plant six month later, but the managers refused to provide records to the investigator.
“During the inspection, the lights were off in the facility,” the April 28, 2017, FDA warning letter states.
“In those areas that were physically accessible, our investigator had to perform parts of the walkthrough in the dark using a flashlight. Even with limited visibility, our investigator observed powder scattered throughout the production areas, including powder caked on the floor. In addition, our investigator observed empty boxes, trash, finished drug products covered in powder, and containers littered throughout the facility.”
And at Zhejiang Huahai Pharmaceutical Co. Ltd in China, where the tainted blood pressure medicines were made, inspectors over the past year cited numerous quality control concerns.
For example, the FDA inspection report cites inadequate cleaning procedures after an inspector found the equipment used to make the drugs contained “white particulate matter and what appeared to be red-colored metallic particle.”
An inspection report for the same facility in 2017 cited that the gasket inside the drug-making equipment had frayed with loose threads visible. The gasket was discolored brown and had white material inside, even though it was marked as being cleaned. Inspectors also found “black metallic particles” and “black particles” in a drug batches.
“It’s incumbent on Congress to exercise its oversight responsibility and to get the Food and Drug Administration to more aggressively monitor that activity by actually going into these plants and confirming what is being done,” Higgins said.
“Unless until they have full, unfettered access to these manufacturing facilities in China, they cannot accurately or consistently provide guidance as to what drugs should be approved for sale in the United States. Any resistance, I would say, should result in at least a temporary halting of those products being approved for use in this country.”
Can pharmacies take the lead?
At least one pharmacy is taking this problem head on.
David Light, the CEO and founder of the online pharmacy Valisure, said they have an analytical laboratory to test the quality of every drug it purchases.
“We’re the only pharmacy that chemically analyzes every single batch of every single medication,” Light said.
The good batches are screened out and sent to consumers, with a certificate of analysis.
Light said about 10 percent of the batches tested end up failing. Most come from China and India. Sometimes, the dosage is off or the batch is contaminated. They have even found batches contaminated with industrial solvents.
Light said what most people do not realize is there are about three drug recalls per day, and 100 recalls per year with the risk of death.
“Even direct from the FDA, they say that there’s an unacceptable level of quality issues that they’ve been seeing,” he said.
“And also it’s important to understand that the FDA does as good of a job as it can, but this is a $2-trillion global chain that’s incredibly complicated. And the FDA, for the most part, doesn’t do chemical testing.”
One of the problems, Light said, is that drug manufacturers self-report their analytical testing of the drugs to the FDA, which has already said it does not have the resources to review all of these reports.
Light, like others, believes the best first step in addressing these concerns is to provide more resources to the FDA.
“But I think even more impactful than all of that is actually doing more chemical testing,” he said.
“We can’t just rely on the industry in a self-reported fashion. It’s not even just overseas. We’ve seen problems of American manufactures that have been cited by the FDA.”