Understanding the Dangers of Drugs under FDA Grandfather Clause

Wide varieties of drugs are available in the United States. Unfortunately, up to 2% of these drugs have bypassed the Food and Drug Administration’s (FDA) approval process. The current FDA drug approval process follows standards that were set in 1962, following reorganization from the procedures initiated when the FDA was formed in 1938.

The Loopholes

The FDA has been strict regarding the marketing and prescribing of any drug that has not been proven by their standards to be safe and effective for the patient. At the same time, Congress created loopholes for drug manufacturers to skirt FDA approval if their drugs were already on the market.

At the time, it made sense to all these drugs to remain on the market as long as there was no evidence of harm. The FDA could not pull every drug off the market until each could be proven safe. Patients in need of these medications would suffer greatly.

The FDA defined grandfathered drugs as those with labeling and scientific make-up that have not changed or altered over the course of time. Although new technologies and drug delivery mechanisms have been developed, drug makers have argued that the drugs remain unchanged and should continue to enjoy the protection of the grandfather clause.

Consumer Safety

These once-reasonable exemptions no longer make sense. New technologies may interact with the body differently than the previous drug formulations, so they must be tested for safety. This is the only way to protect the consumer.

The FDA recently won a case against two drug makers who were manufacturing unapproved versions of morphine sulfate. The manufacturers argued that they were protected by the grandfather clause because the drug had been in circulation since 1938, and was thereby protected under that year’s loophole. The court dismissed these claims and reestablished the FDA’s authority to remove unapproved drugs from the market. The new formulations must be proven safe before they could be sold on the market.

The Danger

Consumers are exposed to serious health risks, potentially severe side effects, and even death from unapproved drugs. Drug makers have concerned themselves more with profits than with patient safety and it is the FDA’s job to protect consumers from corporate greed.

Unfortunately, some drugs continue to fall through the cracks and patients suffer harm. Unapproved drugs may not be as effective as their approved counterparts. In addition, they do not need to be toxic to cause serious health problems. Patients may believe they are taking a safe and effective medicine while their health continues to deteriorate.

Contact Us

If you or someone you love has been harmed by an unapproved medication, contact our office. We will provide you with a free consultation of your case, and work to ensure that you are reimbursed for any medical problems resulting from the unapproved medicine. We may also be able to secure financial compensation and future medical costs on your behalf.

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