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Fake Quality-Control Data Raises Concerns About Safety of Drugs

Low-cost generic drugs account for 90 percent of drug supply

Fake Quality-Control Data Raises Concerns About Safety of DrugsThere is no denying that Americans need generic drugs, but a new report suggests there may be a serious lack of quality control when it comes to the manufacturing of these drugs.

The beginning of this story dates to the fall of 2012 when a Food and Drug Administration (FDA) worker, Peter Baker, took on the job of inspecting Indian manufacturing plants that make a large majority of the generic drugs sold in America.

What he found was less than ideal, to say the least.

America and Generic Drugs  

While many people are opting to go the more natural route in regards to healthcare and medications (think acupuncture, chiropractic care, and herbal supplements), the reality is that America needs generic drugs in some capacity. In fact, low-cost generic drugs account for 90 percent of our country’s overall drug supply.

This is a huge number that cannot be ignored.

Without these drugs, healthcare programs such as Medicare and Veterans Health Administration would be in some serious trouble.

Unfortunately, during six years of inspecting our foreign manufacturing plants, what the FDA discovered was shocking and disturbing.

Foreign Manufacturing Plants Compromise Safety 

The FDA has regulations in place designed to control the quality of the drugs that are being manufactured overseas, ensuring the product that is then placed on the shelves for Americans to buy meets these standards.

But just six months into Baker’s inspection, he visited a plant headed by Indian manufacturer, Wockhardt, a leading manufacturer of drugs for our market. Not long after his arrival at the plant, an employee tried to hide documents that showed that Wockhardt had knowingly provided other markets with insulin that had metallic fragments in it, supposedly from a sterilizing machine that was not working properly.

And this was just the beginning.

As Baker’s inspections continued all over the world, he found numerous deceptive practices at the majority of the plants he visited. This raises serious concerns about the safety of these drugs and brings into question whether the entire process of outsourcing the production of generic drugs is safe.

Medical Malpractice Against Manufacturers 

Medical malpractice is the third-leading cause of death in the United States, behind only heart disease and cancer. One of the most common forms of medical malpractice is poor drug manufacturing practices, such as what we’ve discussed above. Unfortunately, the deceptions and poor practices of these manufacturing plants are causing some serious harm in the United States and other foreign markets. Drugs with toxins, impurities, and unapproved ingredients are on store shelves as we speak, unbeknownst to the general public. While doctors have tried to rectify the negative side effects of these generic drugs by prescribing brand names, oftentimes these medications are well out of the budget of patients.

The bottomline? Baker’s discoveries show that these generic drugs are not only largely ineffective, but could cause some serious harm. He is quoted as saying: “If people knew how some of those drugs were manufactured overseas, then no one would take them.”

If you have been injured or made sick after taking low-cost generic drugs, please contact Wormington & Bollinger today and ask about filing a medical malpractice case. We are keeping a close eye on this story and will update you as we learn more. In the meantime, don’t hesitate to contact us with questions.