The USDA "Seal of Approval"

The Food and Drug Administration more commonly known as the FDA is an agency within the U.S. Department of Health and Human Services. The drug division of the administration is devoted to maintaining the health and wellbeing of the public by assuring the safety and efficiency of medical drugs and products. The FDA is responsible for regulating the approval of prescribed, or over-the-counter, pharmaceuticals, which are then sold and distributed legally in the United States. In other words, the FDA is important. Extremely important. The FDA is the only reason a prescription is needed to legally obtain addictive drugs like Xanax, Oxycodone and Ritalin at the local pharmacy.

In recent years, the growing number of Americans unsatisfied by the approval of certain drugs has brought attention to the issue of what exactly it means for a drug to have the FDA's seal of approval. A common misconception about the approval process is that every drug is studied and approved under the same conditions, in numerous clinical trials involving humans, and that these drugs are proven to be very effective and show no serious side effects. This, however, could not be further from the truth.

Huge differences in the amount of testing that drugs and medical devices undergo throughout the approval process prevent this from being an accomplishable goal. Trials differ vastly with respect to time duration, intensity, the number of patients studied, and completion rates. While some drugs are approved after a series of intensive trials with a large group of subjects, others are approved on the basis of single, non-rigorous trials, often with small sample sizes of human subjects, or, in some cases, none at all.

In many cases, researchers only measured a drug's effect on surrogate endpoints, which are merely substitutions that may correlate with a real clinical outcome, and not its actual effects on real health conditions in humans. This method falsely assumes that every clinical endpoint of a treatment will be the same as its surrogate endpoint, which could be dangerous for the small percentage of drugs for which this is not the case. In other instances, updated versions of many medical devices are approved under the assumption that newer models are just as safe as previous models, despite the fact that both models may use completely different technologies and look nothing alike. In addition, the fact that certain drugs have been shown to work and meet the FDA's requirements in shorter studies means nothing when compared to the uncertainty of the long term effects these drugs could have in the future of a patient's health.

A large portion of the public is beginning to question whether this growing flexibility in drug approval is the most practical way to go. Why did the FDA make a conscious choice of changing the system of approval if it meant that new drugs weren't going to be proven to be as effective or as safe as they could be if they underwent stricter trials?

In many cases, researchers only measured a drug’s effect on surrogate endpoints, are merely substitutions that may correlate with a real clinical outcome, and not its actual effects on real health conditions in humans. This method falsely assumes that every clinical endpoint of a treatment will be the same as its surrogate endpoint, which could be dangerous for the small percentage of drugs for which this is not the case.

A few years ago, drugs had to undergo much lengthier processes to obtain FDA approval. The slower process affected a large range of patients diagnosed with a long range of diseases, such as cancer and diabetes, by prolonging their wait to access promising treatments. While some may argue that under the FDA's expanded access rule terminally ill patients may be allowed to experiment with unapproved drugs, the FDA has the power to deny this access if it believes that the risks of a drug is too great, even if the patient is terminally ill and has no other choice.

Such was the case for 21-year-old cancer patient Abigail Burroughs, when her family sought two experimental drugs that were still undergoing trials that doctors felt would help save her life. The FDA hindered her chance at receiving these drugs, despite the fact that Burroughs was running out of options, well aware of the risks of taking this experimental drug, and supported by her oncologist. She died in 2001, only a few years before the two drugs eventually became FDA approved.

In order to allow room for approval of treatments for diseases in which no other effective options exist, the agency must remain flexible in its drug approval process. Although this flexibility may seem as though the FDA is slacking off, this new method is a deliberate effort to put more drugs on the market that may or may not help treat more severe diseases, and as a result potentially decrease mortality rates throughout the United States.