While these ads are clearly a source of frustration for APCs, their specific impact on the industry is difficult to track.
Because PAs and NPs do not have medical education numbers, which are the most commonly used way of tracking a prescriber's
prescriptions, it's difficult to track prescriptions accurately. Furthermore, sometimes APC prescriptions are attributed
to a doctor who is on the Rx pad too, or pharmacists may put down a physician's name rather than a nurse's or assistant's
in an effort to ensure that an insurance company will reimburse them.
Resistance to Inclusive Language
Another roadblock to correcting the language used in these ads is FDA's requirements. FDA has the jurisdiction to regulate
DTC advertising, but only regarding information given about the products, not the professional terminology used. According
to an FDA spokesperson, the Federal Food, Drug, and Cosmetic Act requires DTC advertisements to include a "brief summary"
regarding the product's side effects, contraindications, and effectiveness. Broadcast ads may make what is called "adequate
provision," that is, feature a toll-free number and Web site address, reference to a print advertisement, and/or a suggestion
to consult a healthcare professional for more information.
FDA feels the ads should communicate that the advertised product is available only by prescription and that only a prescribing
healthcare professional can decide whether the product is appropriate for a patient. It does not require that the pharmaceutical
company tell consumers that only physicians can prescribe.
Then who makes this marketing decision? In talking to those who work at ad agencies, some have said they feel the guidance
from FDA forces them to say "Only your doctor can prescribe xxx," even though legally it does not. "We submit all our DTC
advertisements for approval by the FDA before we air them," says a spokesperson for Merck. "We've never been asked to change
'physician' to 'healthcare professional.'"
"The purpose of the guidance is to offer industry a way to convey necessary risk information to the consumer," says Lesley
Frank, a professional review group leader at FDA's Center for Drug Evaluation and Research, in an article previously published
in Clinician News. While the terminology may seem to violate the guidance, it fulfills the regulatory requirement—stating that the drug advertised
is available only by prescription and through a "qualified prescriber." Thus, FDA has no recourse to penalize a drug company
for making misstatements about who can prescribe.
Numerous APC organizations are urging drug manufacturers to adopt inclusive terminology in DTC advertising. The American College
of Clinicians (ACC), for example, would prefer that agencies use "prescriber" or "healthcare professional" rather than "doctor."
They started a letter-writing campaign directed at the Secretary of Health and Human Services, who oversees FDA, to advance
"'Prescriber' should be preferred," says Bob Blumm, president-elect of the ACC. "If a patient can understand what the drug
is used for by watching these ads on television, they can understand the word prescriber."
Furthermore, APCs aren't the only ones who can prescribe—nurse midwives and other advanced practice nurses prescribe too.
"Soon, some states will be adding psychologists," says Roger Green, president of the Florida Nurse Practitioner Network.
While some companies have included all prescribers in their marketing terminology, most have not."We really do not want to
attack the companies," Blumm says. "We want to work hand in hand with them to fix this problem."