PhRMA Seeks to Repeal Rule on Testing Drug Names for Safety

If the Pharmaceutical Research and Manufacturers of America (PhRMA) has its way, a federal regulation crucial to drug safety will be repealed. The current regulation authorizes the Food and Drug Administration to screen drug names as part of the drug approval process – and to react when a proposed name could lead to medication errors due to mix-ups. FDA currently screens names and prevents use of some in order to minimize the chance post-launch that a name will be confused with that of an already available drug. FDA has told us that it rejects about 30 to 40% of names requested by drug companies.

PhRMA requested repeal of the regulation in a formal response to an April 27, 2011, Federal Register notice by FDA seeking suggestions for eliminating any existing rules perceived to be "outmoded, ineffective, insufficient, or excessively burdensome and thus may be good candidates to be modified, streamlined, expanded, or repealed."

PhRMA wants FDA to prove that name reviews actually prevent medication errors. They argue that FDA's program is "burdensome and disruptive without showing that it is effective in reducing medication errors." They also contend that there are no validated measures for identifying brand names that are similar enough to be confused. Given the debt-reduction climate in Washington, even some important public health programs might be cut. This sure shouldn't be one of them.

Without a doubt, drug name confusion is one of the most common causes of medication errors reported to the National Medication Errors Reporting Program operated by the Institute for Safe Medication Practices (ISMP). Drugs like Celebrex and Celexa, for example,  can sound similar when prescribed over the telephone - but Celebrex is for pain while Celexa is for anxiety and depression. A more recent example of this is the warning that FDA sounded last month about potentially dangerous errors resulting from mix-ups between risperidone (Risperdal) and ropinirole (Requip).

ISMP has been tracking name-related medication errors since the 1980s, and we even maintain a list of known name mix-ups.  There are nearly 800 confused name pairs on this list, with the majority published over a decade ago. The list bears witness to the fact that even diligent and knowledgeable professionals sometimes confuse products with similar names.  With thousands of prescription and over the counter drugs already on the market, it's a difficult challenge for a company to create a brand name it would like to use to market a new product that is not too similar to an existing drug name. So it's critical to keep this FDA regulation on the books.

Since the late 1990s, an increasing effort by FDA has focused on approving drug names that have been evaluated for safety.  So in order to minimize potential for rejection of a name, as well as do their own safety testing, companies often use external safety testing companies to evaluate risks associated with a selected brand name before submitting a drug application to FDA.  (Full disclosure: Med-ERRS, an independent ISMP subsidiary, is one of several companies that interacts with companies interested in conducting pre-market testing of brand names to promote safety, and I am president of ISMP.)

Although more empirical than scientific, and by no means perfect,  FDA screening involves computerized matching of proposed names with those already on the market as well as simulation testing for look-alike and sound-alike properties.  A name might be a homonym, for example, or it might be off by just a couple of letters from another name. Or it might be composed of the same letters as a frequently used medical abbreviation. The goal is to recognize potential dangers, whatever they might be: plain and simple, the non-medical people who come up with these names sometimes fail to recognize what's wrong with them. FDA has the authority to do this under the federal regulation under challenge, which says, in part, that labeling of a drug may be misleading when a proprietary name is used that, "because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient."

It's unclear how repeal of the regulation would impact post-marketing actions if brand name confusion was known to contribute to harmful medication errors; but even post-marketing actions might be difficult to undertake if the regulation is gone. As I pointed out in a May blog post, in order to protect the public, FDA can interact with companies and have them change a drug name if patient safety is at significant risk. They did this last year with Kapidex when it kept getting confused with Casodex and Kadian; the name is now Dexilant. Other names that have been changed in recent years include Reminyl, which was confused with Amaryl and is now Razadyne, and Omacor, which was confused with Amicar and is now Lovaza.

The FDA name-testing program provides a crucial safety benefit; it should not be repealed simply because there is not a large body of evidence regarding its effectiveness. Repeal would essentially strip away FDA's authority to incorporate name-safety reviews as part of the drug approval process. Without this set of eyes, there is little doubt that the number of serious errors could be far greater.

A far better solution would be for FDA, PhRMA leaders, and proprietary name review representatives to meet to discuss and resolve any issues associated with the current program. All involved parties should open the dialogue and find common ground on which to move forward with drug name testing for safety - not backward, by repealing the basis for it.

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