- The Washington Times - Saturday, August 23, 2003

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. They make it easier to market products in distinct therapeutic classes to different groups of consumers. The results of an FDA survey of physicians earlier this year concluded that direct-to-consumer advertising “appears to increase patient awareness about the availability of effective treatments for their health problems.” According to the survey, 88 percent of the patients who asked their doctors for an advertised product actually had the condition for which the drug is intended. Consumer advertisements also increase awareness of underdiagnosed and undertreated diseases and prompt greater patient-physician dialogue.

Another rationale for multiple trademarks is to enable patients to avoid the stigma of taking a drug widely known to treat an ailment regarded as somehow ignominious or humiliating, such as AIDS, schizophrenia, sexual dysfunction, or leprosy. Depression offers a compelling example. A 1999 study by the National Mental Health Association of American attitudes about clinical depression and its treatment concluded that despite concerted efforts to educate the public, the negative attitudes surrounding depression had actually increased in prevalence over the previous decade.

What happens, then, if a drug is used to treat multiple illnesses, including some that carry a social stigma and some that do not. How would a patient with premenstrual dysphoric disorder (PMDD) feel, for example, about receiving a drug better known for treating depression, perhaps implying that she suffers from a form of mental illness? Presumably, this is an important reason that Eli Lilly and Co. decided to market its PMDD drug fluoxetine under the trademark Sarafem, instead of its more commonly known name Prozac.

Multiple trademarks may be an advantage, and they are certainly in no way injurious. Therefore, drug companies should have the prerogative of adopting them.

Most FDA decision-making is (or is supposed to be) made in the context of balancing risks and benefits, but on this issue the agency seems willing to consider only risks — and highly conjectural ones at that.

The FDA’s decision to prohibit multiple trademarks is an autocratic governmental solution to a nonproblem, a disturbing example of Big Brother dictating corporate strategies. More important, arguably it exceeds the agency’s legal authority. Attorney Marc J. Scheineson, former FDA associate commissioner for legislative affairs, argues that the agency’s policy toward multiple trademarks is possibly illegal under several theories, including the absence of required formal notice-and-comment rulemaking, interference with constitutionally protected commercial speech, impermissible “taking” of corporate “property,” and arbitrary and capricious action.

But it is in the self-interest of bureaucrats to seek ever-greater mandates, which require larger empires and budgets. Moreover, it is in their nature. As former FDA Commissioner Frank E. Young used to quip, “Dogs bark, cows moo and regulators regulate.” These are the reasons overregulation and regulatory creep have become the FDA’s own multiple trademarks.

Henry I. Miller, a physician, is a fellow at the Hoover Institution. From 1979-1994, he was an official at the Food and Drug Administration.



Click to Read More

Click to Hide