April 2 was a busy day for FDA bureaucrats. Apparently, although drugmakers have been buying Google sponsored search terms for years, it is now illegal for them to do so, and on April 2, the FDA informed 18 pharmaceutical companies that they were in violation of regulations for having bought the search terms.
The sponsored searches are misleading because they present efficacy claims without any corresponding risk information, and the FDA is further upset because the links omit the drugs’ generic names. Let’s look at some of the examples the agency cites:
From Pfizer: “CELEBREX ® Official Site www.CELEBREX.com Review Arthritis Signs, Symptoms & Discuss CELEBREX® With Your Doctor.”
From Novartis: “What is Hypertension? www.DIOVAN.com Get The Facts & Effective Treatment Now – Receive Free Info At Home.”
From Merck: “Allergy Medication Relief of Allergy Symptoms: Learn About A Treatment Option. www.SINGULAIR.com”
From Roche: “Free Trial Offer www.Boniva.com BONIVA® (ibandronate sodium). Learn About Postmenopausal Osteoporosis.”
These are just a few of the statements deemed unacceptable by the regulators.
By what standard are these called “claims”? The consumer is merely invited to click on a link; he is not told that this drug will cure his disease. At most, he sees the name of the drug and is told that it is “a treatment option.” It is incomprehensible to me that these statements could be considered a claim about the efficacy of the drug that needs to be “balanced” by risk — aka, the company being forced to denounce its own product. Even if the FDA’s codifying of “no efficacy claims without ‘fair balance’ statements about risk” were a law that made sense (it isn’t, because it violates the pharmaceutical companies’ right to freedom of speech; fraud law is more than sufficient to cover any actual criminal activity), the bureaucrats aren’t even adhering to their own standards.
What all that means, of course, is that pharmaceutical companies cannot rely on the laws that are actually on paper to direct their conduct. They must guess: What will the bureaucrats decide to focus their energies on next? Today it’s declaring Google search terms illegal; tomorrow it might be “in every TV ad, the amount of risk information must exceed the number of efficacy claims,” and next week it might be “no magazine ads without a giant red box calling out how many people have died while taking this drug, even if there’s no correlation whatsoever between the drug and the number of deaths.”
Just another way in which the FDA makes it impossible to do business.