The U.S. Food and Drug Administration (FDA) is responsible for policing all prescription and over the counter medications and medical devices. The agency ensures devices and drugs comply with mandated safety standards and ensures manufacturers abide by advertising rules. Unfortunately, the FDA sent far fewer advertising letters out this past year.

In 2017, the FDA only sent out three warning letters for advertising violations compared to 11 in 2016. While some might believe the decrease is caused by better adherence to guidelines, this isn’t entirely true. Advertising regulations are meant to protect consumers from false claims made by drug and device manufacturers, and without strict policing of violators, consumers can easily be duped.

One of the warning letters the FDA sent out for advertising violations was for false and misleading information included in promotional materials for the insomnia drug Zolpimist. Promotional materials must be sent to the FDA for approval before use, but certain materials including a webpage did not receive approval. The other two warning letters addressed false and misleading claims from the manufacturers of the opioid ConZip and the weight loss drug Contrave.

False or Misleading Claims

Most advertising violations are for false or misleading claims. For the FDA, this can mean manufacturers minimized risks in advertisements, presented information or data that is untrue, or failed to include important information regarding the drug or device. Manufacturers must always include risk information on all advertising materials so physicians and consumers can make informed decisions about using a drug or device use. Without including the appropriate risk information, many consumers could end up taking medications and suffering serious side effects they knew nothing about.

All patients have a right to know the risks associated with medications and devices. Unfortunately, not all manufacturers express these risks and abide by advertising rules and the FDA only catches some of the violators.

As patients, we expect the prescriptions our doctors give us to be safe to take. However, a recent study found this might not be the case. Researchers determined one out of every three medications poses additional safety risks after approval from the U.S. Food and Drug Administration (FDA).

The study, published in the Journal of the American Medical Association (JAMA), looked at 222 separate medications approved by the FDA between 2001 and 2010 and tracked them through February 2017. Researchers discovered the FDA took some kind of action on nearly 32% of the medications.

Three of the tracked medications were completely removed from the market and 61 were given black box warnings, the most severe warning issued by the FDA. Unfortunately for patients, the average amount of time it took for the FDA to take action on a medication was 4.2 years.

Patients Facing Increasing Drug Dangers

The high number of medications posing additional safety risks coupled with the length of time the FDA takes to issue warnings, leaves patients facing increasing dangers from prescription drugs. One of the reasons behind increasing drug dangers is that drug companies often use very small samples of patients and many of their drug studies only last six months or less.

Because drug manufacturers produce insufficient clinical data, the true effects of their products are not known until long after they are released onto the market. The increasing dangers of prescriptions drugs put patients in a tough position.

Know Your Rights

Drug manufacturers are required to warn both patients and doctors of the risks associated with their products. This allows patients and doctors to make informed decisions about their care. When a pharmaceutical company harms patients through failing to warn of risks, improper labeling, inadequate testing, or other negligent actions, it can be held legally responsible for the resulting damages.

The Food and Drug Administration (FDA) has a detailed process for approving medications and medical devices. Sometimes the process is sped up for medications or cures that are the first of their kind or substantially better than currently available medications. Neither all medications nor all medical devices go through the same expedited approval process.

The FDA has four methods of making medications available as quickly as possible. Based upon consideration of various circumstances, a medication will be assigned to the appropriate process.

The Fast Track process is designed for medications that treat serious medical conditions that currently have an unmet medical need. While what is considered a serious medical condition is a matter of judgment, some conditions includes AIDS, Alzheimer’s, heart failure, cancer, epilepsy, depression, and diabetes, among others. The manufacturer must request Fast Track designation, but the request can be initiated at any stage during the FDA approval process.

Breakthrough Therapy is used for any medications that demonstrate via clinical trials that they will provide a substantial improvement over available treatment options. The manufacturer must request breakthrough therapy before the end of the second phase of its clinical trials.

Accelerated Approval allows medications for serious conditions that can fill an unmet medical need to be approved based on a surrogate endpoint, or a marker that can indicate the clinical benefit of a drug. Accelerated approval was created because it can take many years to understand whether a medication successfully treats a condition, and accelerated approval can save valuable time in the approval process. The manufacturer is required to continue to conduct studies to confirm the drug’s benefit. The FDA can withdraw the approval if the studies fail to prove any benefit.

Priority Review designation commits the FDA to take action on the new drug application within six months (rather than the standard 10 months). The FDA reviews each application and designates each one for either priority or standard review, but a manufacturer can also request priority review. Priority review is applied to any drugs that, if approved, would greatly improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

While the FDA has formal processes for both expedited and standard new drug applications, many medications and medical devices that obtain approval are later shown to have adverse effects. Medication and medical device manufacturers have a responsibility to test the safety and efficacy of their products and to properly warn patients and doctors of the associated risks.