Opinion: The Deadly Gap in the Drug Safety Net

(May 3) -- Each day, about two out of every 100 prescriptions filled at pharmacies around the country are for drugs that have never -- repeat, never -- been approved by the Food and Drug Administration.

These unapproved drugs often make unsubstantiated claims not supported by scientific data or laboratory testing. Many of them are wrongly deemed safe and are often incorrectly labeled as "generics." None of them has ever seen the light of an FDA laboratory.

As a result, patients often end up taking drugs unaware that by doing so they are putting themselves at risk of a dangerous side-effect or potentially life-threatening adverse drug interaction.

Here in the 21st century, in the country with the best health care in the world, where patients assume that any prescription drug has been cleared by the FDA, it's hard to imagine that this goes on. But it does.

To respond to patient concerns over the potential dangers of taking unapproved drugs, the FDA established its Unapproved Drugs Initiative in 2006. This important step specifically encourages pharmaceutical companies to get their unapproved drugs into the agency's pipeline for testing and, if found to be safe and effective, approved. And to encourage drug companies to do so, the FDA also started removing unapproved drugs from pharmacy shelves.

To date, however, many remain.

Especially troubling are the unapproved drugs that remain on the market and are used by unsuspecting patients, even though a tested, safe and FDA-approved alternative is available. For example, versions of oxycodone, thyroid medication, ephedrine, codeine, acetaminophen, hydrocodone, colchicine, nitroglycerin and morphine have been approved; yet, dozens of unregulated versions of these drugs are still available.

The FDA's stamp of approval is backed by its unmatched pharmacological drug analysis and testing procedures, which implant the world's gold standard to any FDA-approved drug.

It gives patients and doctors the assurance that their medicine was made using the best ingredients, with sterile equipment, packaged in safe and tamper-resistant containers, and will act as predictably as science can determine. It guarantees that each product is properly labeled to reduce the risk of adverse reactions but also recorded and tracked so that any side effects can be properly cataloged and used for further study.

Conversely, unapproved drugs fly under the agency's radar, so adverse reactions remain unknown -- allowing preventable reactions to go unexposed, waiting to claim other potential victims.

Recently, regulators have signaled they are willing to re-engage and reprimand companies that produce, distribute and sell unapproved drugs. The FDA is sending letters to manufacturers of some of these illicit products urging them to stop producing, distributing and selling them. This must continue, since patients and many doctors incorrectly believe that if a drug is readily available, it must be FDA approved.

Public and private sectors alike need to work together to ensure a safe and effective prescription drug supply. Policymakers, physicians and other health care professionals, patients, the pharmaceutical industry and drug store chains should all work together to ensure that the prescriptions people take will heal them -- not harm them. Physicians should not write prescriptions for unapproved drugs, especially when ones already cleared by the FDA are available.

Patients can visit Drugs@FDA or the Did You Know Project to learn more about approved and unapproved drugs. They can also ask their doctors and their pharmacists about their medications to ensure they are FDA approved and won't interact with their other treatments. Ultimately, drug store chains and distributors should clean their aisles of unapproved drugs.

Until unsafe, unapproved and potentially harmful drugs are taken out of the marketplace, there will always be the risk that another patient will lose her life, unnecessarily, because we didn't do enough.

Dr. Gary Puckrein is founder and president of the National Minority Quality Forum, which is focused on educating the public about the dangers of unapproved drugs with its new Did You Know Project.


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