When It Comes to Prescription Drugs, What Does “Safe” Mean? by Edmund F. Haislmaier

Pending legislation to add a drug benefit to Medicare and make it easier to import prescription drugs from other countries has focused attention on something most of us take for granted – the safety of the drugs we consume.

We are used to assuming that when we get a drug from the pharmacist it will be safe to take. But who makes sure the drug is safe, and what does “safe” really mean?

Since 1938, Congress has charged the U.S. Food and Drug Administration with responsibility for what could be called “medical safety.” This means the manufacturer must demonstrate to the FDA’s satisfaction that the drug is safe to use as intended before the FDA will allow it to be sold.

Now, safe in this context is a relative term. As Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research notes, “Safe does not mean harmless. Every drug comes with risks, and our tolerance for risk is higher for drugs that treat serious and life-threatening illnesses. There is no question that cancer drugs can be highly toxic. But they also save lives.”1

Thus, when the FDA approves a drug as “safe” it is essentially saying that the likely benefits of the drug are greater than the possible risks, when taken in the recommended dose to treat the specified disease or condition. Note here that the FDA is making a carefully caveated statement. It is implicitly saying that taking the same drug in the wrong dose or for another condition could or might be “unsafe.”

However, for the FDA, “safe” also has another meaning, which can be called “physical safety,” and this meaning is absolute, not relative. Indeed, back in 1906, Congress created the FDA to make sure that drugs were safe from “adulteration” or “misbranding.” Today, this definition of safety means: that the accompanying information about the drug and its uses (called the “label”) is the correct information approved by the FDA; that the product contains active ingredients of the kind and amount specified in the label, and; that the product does not contain harmful impurities.

There are lots of ways a drug can be unsafe in the “adulterated” or “misbranded” sense of the term. For example, if the product has more (“superpotent”) or less (“subpotent”) of the active ingredients than stated on the label, it can be unsafe to take, since the patient would unknowingly get the wrong dose. Similarly, contaminants or impurities can make the product unsafe. Alternatively, the product itself can be fine but the accompanying label information can be inaccurate or incomplete, which could result in unintended harmful use of the drug. Also, to be safe, drugs must not be consumed beyond their expiration dates and must be stored and transported correctly. For example, some drugs, like some foods, must be kept refrigerated before use.

The FDA does a variety of things to ensure that drugs are “physically safe.” First, it approves, monitors and inspects drug manufacturing plants, equipment and processes. It also tests batches of drugs and operates phone and e-mail systems for health professionals and patients to report possible drug problems. That way, if something goes wrong, any imperfect or contaminated batches of a drug can quickly be taken off the market. Second, the FDA works closely with state regulators overseeing pharmacists and drug wholesalers to prevent or catch any problems as drugs go from manufacturers to patients.

Third, the FDA works with various law enforcement agencies to pursue criminals trying to make money by tampering with or counterfeiting drugs, and take those products out of circulation. Finally, the FDA works with the U.S. Customs Service and Postal Service to prevent drugs that might be unsafe because of improper or careless manufacturing or handling, improper label information or deliberate criminal tampering, from entering the U.S.

Drug safety is a large, complex task and one that the FDA handles reasonably well using laws that have been refined over almost a century. Congress should give careful thought before approving any changes to existing drug safety laws, such as less regulation of imported drugs, to make sure the drug safety we take for granted isn’t compromised.


Edmund F. Haislmaier is a member of the board of directors of The National Center for Public Policy Research. 


1 As quoted in: Michelle Meadows, “Why Drugs Get Pulled Off the Market,” FDA Consumer, January-February 2002, available at http://www.fda.gov/fdac/features/2002/102_drug.html as of September 2, 2003.

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