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Sunday, November 24 2019

Are generic drugs safe?

A generic drug is a version of a brand name drug that has gone off patent, so it’s no longer legally protected, or if the generic company has successfully challenged the brand name in court and the FDA gives them permission to make a generic.  It isn’t identical, but the central molecule which has already been tested for safety and efficacy is present.  Additionally, the generic company must show the FDA that their testing has the same bio equivalency as that of the brand name drug with a small allowable variance from the original molecule.  What the generic doesn’t have to show is whether their processes to reverse engineer and replicate the central molecule results in carcinogenic chemicals or other impurities that can show up in the final product. 


Katherine Eban is a noted investigative reporter who has been researching the generic pharmaceutical industry since 2008.  Repeated reports of the failure of generics to work as well as brand name drugs led her to write Bottle of Lies, which details some of the historical changes in the generic drug industry for the past 35 years and how a lack of oversight of generic drug companies mainly outside the U.S. are threatening our health.


A bit of history

The F.D.A. originated in 1930 after it was determined that children were dying from a cough syrup with arsenic.  In 1960 it was the F.D.A. that refused the application for thalidomide to be brought over to the U.S. from Great Britain based on the recommendation of one of the scientists at the F.D.A., Frances Kelly.  Thalidomide later was proven to be the reason for an outbreak of horribly deformed babies mainly from European women who had taken it while pregnant.  In 1984, President Reagan signed the Hatch Waxman Act which created a new pathway for generic drug makers to apply for approval so that cost savings (primarily because of the price gouging occurring from antibiotic manufacturers) could be passed along to consumers.  During the George Bush presidency it was thought expensive drugs for treating the H.I.V. epidemic especially in Africa could be economically bought from generic drug companies in India and donated to halt the spread of infection.  This law idealistically dictated that generic companies must adhere to what is defined above, bio equivalency of the central molecule and performance data such as absorption in patients, and shelf life stability with various temperature fluctuations.  Additionally, in return for being first to make a generic, that company would get a six- month exclusive from any other generic company.  Since a generic is priced at about 80% of the brand name drug, this leads to quite a large incentive.  For instance, the first six months that a generic Lipitor was on the market it had sales of 600 million dollars. 


It was going so well until…

Greed set in.  In 1989, Mylan Laboratories hired a private investigator to find out why their applications were not being approved at the FDA.  The information that was discovered led to a congressional investigation that found the F.D.A. was corrupted by payments from some generic drug companies to be first to market a drug so that they could get the six-month exclusivity.  On the day a drug went off patent there were literally representatives from generic drug companies pushing and fighting to be first in line at the F.D.A. 


Ten thousand people work at the FDA and they are tasked with ensuring the safety of our food, our prescription and over the counter medications.  Prescription medications alone in the U.S. account for over 300 billion dollars in sales, and what most people don’t realize is that 90% of that are generic drugs, with 40% of those drugs coming from outside the U.S., (primarily India and China).  Additionally, 80% of the ingredients are from overseas.  Essentially, the FDA and the 10,000 people who work there, have the responsibility of ensuring the safety of our prescription medications, over the counter medications and our food supply.  This equates to about a quarter of our economy being safeguarded by 10,000 people who work at the FDA. 



Perhaps the clearest example of what could go wrong with generics can be seen by the largest Indian generic drug company, Ranbaxy.  Thanks to a whistleblower, Dinesh Thakur who worked at Ranbaxy from 2003-2005 as director and global head of research information and portfolio management and an astute FDA inspector Peter Baker, investigations into the companies 200 generic drugs showed falsified data, in all 200 of their drugs that was submitted to 40 countries. Thanks to the cooperation between Thakur and the F.D.A. over 8 years, Ranbaxy received the harshest penalty ever given to a generic drug company.  In May of 2013, Ranbaxy pleaded guilty to seven felonies and was ordered to pay a fine of 500 million dollars.  Thakur got close to 49 million for his efforts. 


The F.D.A.’s Peter Baker who had worked in quality control labs was able to investigate foreign generic drug companies computers, and by tracking meta data he found that 4/5ths of the 86 generic drug manufacturers in India and China committed data fraud and irregularity in their drug applications. 


Final Thoughts

Although I practice without a prescription pad, I know many of my patients take prescription medications.  With medications, following the rule of “buyer beware” seems appropriate.  While there seems to be some improvement in the past several years in the F.D.A.’s ability to identify cheaters in the generic drug game, there are always players who try to bend the rules, so getting brand name medications seems to be the safer way to go.  Another choice might be an authorized generic.  Authorized generic drugs are the same drug and made from the brand name company’s manufacturing line but packaged with a different label.  Some branded pharmaceuticals do this to beat generics to the punch before going off patent.  The F.D.A. has a database of all authorized generics and that can be viewed here:


There is also an online pharmacy   They do their own independent analysis of each batch of drugs that they order.  Their testing is so much more advanced that they were instrumental in finding out that the popular drug Zantac used for heartburn was high in NDMA (a carcinogenic chemical). Thanks to Valisure filing a citizen’s petition for its removal, 30 countries to date have removed the drug from use.  The U.S. was slow to respond but it too, has removed it from sale this month. 


Posted by: Dr. Goldstein AT 09:31 am   |  Permalink   |  0 Comments  |  Email

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