FDA's Multiple Trademarks

Article excerpt

Byline: Henry I. Miller, SPECIAL TO THE WASHINGTON TIMES

We're all familiar with virtually identical drugs that have different names, such as ibuprofen, which is marketed under the trademarks Motrin, Advil and Advil-M. Is there anything wrong with this?

Most physicians and pharmacists see no safety problems, but the Food and Drug Administration's view seems to be that if it's the same stuff, it should have the same name - never mind that it may be a different dose and regimen of administration, and for a different ailment. The FDA intends, therefore, to prohibit multiple trademarks by the same company for the same active ingredient.

Patients will suffer from this decision, which is yet another example of "regulatory creep": regulators' tendency constantly to redefine the scope of their activities, and to add new restrictions and requirements.

The FDA's decision reverses its longstanding policy of permitting multiple trademarks, so long as the follow-on trademarks pass the agency's usual hurdles. For example, the agency allowed two trademarks for fluoxetine - Prozac for the treatment of depression, and Sarafem to treat premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome. Another example is finasteride, known as Propecia for treatment of hair loss and Proscar for the treatment of benign prostatic hyperplasia.

The FDA's objections to multiple trademarks seem to stem from fear they may lead to medication errors, and from the conviction that pharmaceutical trademarks in general offer no benefits. The concerns about medication errors focus on double dosing caused by practitioners and patients being unaware that two products with different names are the same, and on the possibility that visual and phonetic similarity of trademarks may lead to physicians' and pharmacists' mistakes in drug prescribing and dispensing.

However: (1) there are demonstrable societal advantages to pharmaceutical trademarks, (2) there is no evidence multiple trademarks cause a significant problem of double dosing, and (3) the possibility of confusion between the names of drugs is already carefully vetted by the FDA, and in any case has nothing at all to do with multiple trademarks.

The FDA requires that every product has an established name, usually the generic name plus the product form, e.g. tablets, cream, injection, etc. The manufacturer may also designate a trademark, or brand name, which is chosen only after a diligent search of the marketplace to ensure that it is sufficiently different from any preexisting marks.

Trademarks are designed to be distinctive and easy to say and remember, attributes that reduce confusion. Over time, a trademark becomes a single word that encompasses the public awareness of, and experience with, the product. (Think Viagra, Prozac and Valium.)

In effect, the FDA itself tests the "safety" of a proposed trademark, by gathering data from volunteer health professionals, such as pharmacists and nurses at the FDA, who interpret phoned and written prescriptions for the new trademarked drug. These respondents report back what they see and hear, helping the agency to avoid the kind of confusion that occurred between the anti-arthritis drug Celebrex and the anti-seizure medication Cerebyx.

Although the adoption of multiple trademarks entails some added manufacturing and packaging expense, drug companies favor them. …