For more than 25 years we were among the most enthusiastic boosters of generic drugs in America. That began to change in the late 1990s because we were receiving so many complaints from patients.
Investigating the FDA
In 2002 we actually began an investigation into the ways in which the FDA oversees generic drug quality. We were shocked with what we uncovered. It was clear to us back then that the FDA did not have the resources to adequately monitor foreign manufacturing. This became especially alarming when FDA Commissioner Margaret Hamburg, MD, acknowledged that 80% of active pharmaceutical ingredients (APIs) come from foreign sources.
Bloomberg Bombshell
More than a decade later, an expose by Bloomberg News (Dec. 3, 2014) reveals that a number of major generic drug manufacturers in India systematically fudged data. One of the biggest players is Sun Pharmaceutical Industries, Ltd. Sun has all but finalized the acquisition of Ranbaxy Laboratories, another huge Indian generic drug manufacturer. This will make Sun the largest pharmaceutical company in India.
According to Bloomberg, the company deleted bad test results. Chemical analysis (chromatography) of drug samples is essential to establish purity. If the test results are not up to standards, the entire batch of medication is supposed to be thrown out. But Bloomberg reported that a quality-control worker at Sun Pharmaceutical merely hit the delete button on the computer to get rid of the unwelcome results. As a result, a batch of medications was shipped to the U.S. that probably did not pass quality control measurements. Bloomberg News reported that:
“The FDA’s computer forensics experts eventually found 5,301 additional deleted results from chromatography tests at the facility.”
Bloomberg Obtained FDA documents
Within the previously undisclosed accounts the Bloomberg sleuths found this from FDA inspectors:
“‘Our review found that analysts regularly delete undesirable chromatographic results, and products are retested without initiating an investigation as required,’ inspectors wrote in the document. The incident ‘raises concerns about the integrity of all data generated by your firm,’ the FDA wrote in a separate warning letter to Sun in May. Two months earlier, the agency banned imports from the plant, near the western city of Vadodara.”
Both Sun and Ranbaxy have had serious problems with the FDA. Ranbaxy admitted it falsified data and paid $500 million in fines “to resolve claims that it sold subpar drugs and made false statements to the Food and Drug Administration about its manufacturing practices at two factories in India” (New York Times, May 13, 2013). Ultimately, Ranbaxy was barred from exporting drugs to the United States from its Indian manufacturing plants.
Other Problems in India
Although the combined Sun and Ranbaxy companies are the largest drug manufacturers in India, they are by no means the only players. According to the Bloomberg report, there are other problems:
“A review of FDA documents by Bloomberg News found that similar actions on quality tests have happened at dozens of other companies’ plants across India that make drug ingredients and pills for export to the U.S.”
There are 600 FDA-registered drug companies in India. They are spread out all over the vast country, but there are only 12 FDA inspectors. Not surprisingly, they have only visited a fraction of the factories. And by the way, they usually have to announce well in advance that they are coming, which to our way of thinking defeats the purpose of such inspections. In the U.S., all FDA inspections are unannounced so that the company cannot try to clean up its act in advance.
What Are The Implications?
The Bloomberg News expose reveals what we have long suspected, ie, that many Indian drug companies have long ignored FDA rules and regulations. If results don’t pass muster, delete them rather than throw out a bad batch of drugs. Goodness knows how long this has been going on. The FDA has historically relied on drug companies to do their own quality testing. In other words, it’s the honor system.
This Bloomberg report doesn’t delve into drug manufacturing in other countries. China is one of the largest suppliers of APIs (active pharmaceutical ingredients) to the United States. In April, 2014, an FDA official admitted that there were only two FDA inspectors to monitor the entire country. Really! We could not make this up. And yes, they too have to announce inspections well in advance of a site visit.
The FDA Mantra
For decades the FDA has maintained that generic drugs are identical to their brand name counterparts. But for a very long time the agency has relied upon foreign drug companies to police themselves. Even though there are only a dozen inspectors in India, that is more than there used to be. They have discovered some amazing examples of fraud and shoddy manufacturing practices. And yet the FDA still insists that your generic drugs are fine and dandy, regardless of where they were made and whether or not the plant was inspected recently.
Insurance Company Rationalization
Insurance companies often argue that patients must buy the cheapest generics available. That’s because the FDA continually asserts that it has everything under control. The argument usually goes something like ‘trust us, we’re the FDA and we know what we are doing.’ Insurance companies are more than willing to accept that assurance and insist that all generics are equal to other generics or the originator brand. This is all based on faith. It also saves the insurance companies hundreds of millions of dollars. And fighting an insurance company on the grounds that your generic drug is not working is an uphill battle.
Sadly, the FDA rarely makes any generic drug data available. This lack of transparency drives us crazy. Physicians, pharmacists, patients and insurance companies should all have ready access to the bioequivalence curves the FDA uses to determine if a generic drug is indeed equal to its brand name counterpart. We learned with the antidepressant bupropion that the FDA messed up badly when it approved generic Budeprion XL 300 for the brand Wellbutrin XL 300.
How many other mistakes has the FDA made over the last couple of decades? Thanks to our badgering, the agency is changing the rules on long-acting generic formulations, but the data are still obscure. And we have no good way of knowing how many products being manufactured in India, China, Thailand, Brazil, Slovakia or goodness know where are up to U.S. standards.
Bottom Line & News You Can Use:
Here are our recommendations about generic drugs:
- Do not assume all generic drugs are perfect and do not assume your medicine is bad either. Assess the effectiveness of each generic drug you take using your own experience and common sense.
- Always keep track of the manufacturer. Ask your pharmacist which company made your generic drug and where it came from.
- Keep records! When possible, measure things like blood pressure, blood glucose, cholesterol or thyroid function. If your results change after being switched from one generic to another, squawk.
- Monitor your body. If you experience symptoms or side effects on a new generic, let your doctor and pharmacist know.
- Challenge and re-challenge. A time-honored way to tell if a drug is posing a problem is to test it. Go back on the brand name for a few days or weeks and compare your experience with the generic drug.
- Be assertive! Make sure your pharmacist, physician and insurance company know about the Bloomberg News expose. Here is a link to the article. Share it and get feedback from your doctor, pharmacist or insurance company gatekeeper. Health professionals should be as outraged as we are about the FDA’s apparent inability to stay on top of this incredibly serious situation.
- Report any generic drug problems to the FDA. The agency assures us that they want to know if there are bad apples in the barrel. Here is a link where you can report any bad experiences.
- Visit these links to read about the kinds of generic drug problems others are experiencing.
- Share your own story below.
