FDA Announces Plan to Simplify Drug Inserts

If ever there was a misnomer, it is referring to the inserts that accompany drugs as labels. Those “labels” invariably consist of tiny origami-like creations that, when unfolded, yield massive, tissue-thin, two-sided information sheets in microscopic print, often up to 10 or 20 pages in length.

Couple that with the fact that no attempt is ever made to make the data comprehensible to anyone without a degree in medicine or pharmacology and you have the “label” patients are presented with and expected to read and understand before taking drugs that can have deadly side-effects, the potential for dangerous interactions with other drugs, foods, alcohol, or environmental conditions (like sunlight), or other critical warnings.

Now, after decades of complaints from consumer groups and medical experts, the FDA has announced that it intends to implement a plan to make prescription drug labels and inserts less confusing, clearer, and more concise with respect to prescribing information thereby making them physician- and patient-friendly.

The FDA says that some 300,000 people are injured each year due to side-effects of drugs that were not clearly explained in the warning and information labels accompanying drug packages.

Studies have also shown that, in the past, even the most serious warnings added to drug labels usually had very little effect on how often the drug was prescribed or patients’ knowledge of the heightened warning.

According to a prepared statement from FDA Acting Commissioner Andrew C. von Eschenbach, M.D. "The new label design makes it easier for doctor to get access to important information and benefits, and this in turn will help them have more meaningful discussions with their patients."

All drugs released in the past five years will receive new versions of package inserts providing several different sources of information for patients. A section called Highlights will outline the most important information about both the risks and benefits of a given medicine.

A table of contents will guide doctors and patients through long drug labels. Labels will also have the date of a drug’s initial approval.

In addition to these embellishments, the label will now have a toll-free number and an Internet address to allow ease in reporting side-effects and to encourage doctors and patients to report potential problems.

Dr. Janet Woodcock, deputy commissioner for operations for the FDA added: "The rule we will be publishing today represents the first major overhaul of the format and content or prescribing information in 25 years. With this step, the FDA believes we are driving into the information age, out of the 20th century and into the 21st century. These changes will not only enable better access to paper information but will enable the revolution in electronic prescribing information."

The changes to drug labels are a welcome improvement from the old models, allowing both patients and doctors to have the information they need immediately without having to resort to the now voluminous Physician’s Desk Reference (PDR), the Internet, or other reference materials.

The changes will also allow patients to check information for themselves in situations where they are concerned about the information they have been given by their doctor or when the drug is being given t o them for an unapproved off-label use.

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