Drugs Should Meet 2010 Standards for Drug Safety

Benjamin Franklin, from his own experience, warned: "Be temperate in wine and eating, or the Gout will seize you." Were he alive today, he might append a cautionary note: "But in treating it, make sure that the medicine is FDA-approved."

Such wisdom might have saved the lives of three Oregon residents a few years back. In 2007, Oregon's Medical Examiner determined the cause of death for three patients to be an unapproved version of colchicine, an anti-gout medication. Three years later, multiple versions of the drug remain available; yet only one, called Colcrys, has been approved by the Food and Drug Administration (FDA) as safe and effective.

According to the FDA, up to 2 percent of all prescription drugs for sale in the US have bypassed the FDA drug approval process and are therefore unapproved.

Why are unapproved drugs so readily available in the US? To understand the problem, consider the history. The current drug approval process was launched in 1962, following a previous overhaul in 1938. Since 1962, the FDA has prohibited the dispensing of any prescription drug unless it has been proven safe and effective by a science-based system designed to put the patient's safety first.

But in 1938 and again in 1962, Congress created a loophole for drugs already on the market - allowing drugs already in use prior to 1938, and then prior to 1962, to be "grandfathered in," exempting them from the requirement to be proven safe or effective. Each time, the loopholes made sense: immediately removing nearly every existing drug from the market en masse would have left the United States bereft of the best medicines available at the time.

But that was then. While it is true that there are a limited number of drugs not subjected to the FDA approval process for which no substitute exists and so they should continue to be available unless there is information that they are unsafe, we have to ask whether most of these once-reasonable exemptions have lived past their natural age, becoming great- and great-great-grandfather clauses. After all, science has evolved; new drugs have been approved; and our collective understanding of drug safety has improved beyond measure.

The FDA defines a grandfathered drug as a drug whose scientific make-up or labeling have not changed. The fact is that the composition and labeling of most "grandfathered" drugs have been altered which, according to the FDA, makes them ineligible for the grandfathering exemption. Yet some drug manufacturers continue to argue that their drugs should not be subject to FDA approval.

Consider a court decision from July in a case filed by two drug makers. The FDA had warned each company against their continued manufacturing of unapproved versions of morphine sulfate. Just two weeks ago, the court summarily dismissed the drug manufacturers' argument that they were protected under the 1938 loophole, firmly recognizing the legitimacy of the FDA's authority to order unapproved drugs off the market.

This is good news. But the lawsuit, as well as the court's decision, highlights the importance of drug makers getting FDA approval.

Failure to do so exposes consumers to serious risks of potentially severe side effects and even death. And an unapproved drug does not have to be toxic to cause harm, if it is not as effective as the approved version of the drug. Silent inefficacy is dangerous as it leads patients to believe they are receiving an effective and approved medical treatment while their condition only continues to deteriorate.

Our lives are significantly improved because of the availability and quality of pharmaceutical products. But life-saving drugs work only to the extent that they are safe and effective per the guarantees offered by our modern drug approval process. As the FDA renews its focus on removing unapproved drugs from the market, physicians, pharmacists, distributors and patients should insist that drugs meet 2010 standards for drug safety -- not those from 1962 or 1938.

John Horton is the President of LegitScript, the largest verification and monitoring program for online pharmacies. Horton previously served as an Associate Deputy Director at the Office of National Drug Control Policy