PhRMA, PhRMA, PhRMA. Why do you do it?
I'm talking about the Pharmaceutical Research and Manufacturers of America, an industry association that seems hell-bent on strangling its members. Earlier this year, it was a "voluntary" ban on tchotchkes, Post-It pads, and other gifts to doctors (except those with a purely medically educational purpose), enacted in fear of stricter constraints should such gift bans have been imposed by the federal government (as some states have already done). PhRMA should have stood up proudly for its members' rights to market their drugs as they please; instead, the organization took the route of appeasement. The result is that pharmaceutical companies are even more hampered in their communication than they were before -- and watchdog groups and regulators are still calling for government bans.
PhRMA's latest is far worse. It's now advocating for an expansion of Medicaid, in the hopes that if more people have insurance, more people will buy its members' drugs. This is incredibly short-sighted. If PhRMA gets its wish, demand for pharmaceuticals will indeed go up -- and it won't be long before politicians are calling for price controls when the bills get too big to pay. The damage to the industry that would result is far worse than the temporary swell in profits PhRMA's members would see at the beginning of an expanded Medicaid.
PhRMA needs to wake up and realize that the best thing for its members is to compete in a fully free market -- free of regulators and free of bureaucrat buyers who want to set the prices for the drugs Americans take.
Tuesday, April 21, 2009
Thursday, April 16, 2009
Raising a teacup for freedom
Not a health-related post, but I wanted to say that, along with some Objectivist friends of mine, I attended the NYC Tea Party last night. It was great to see that, even in this liberal-packed city, there were at least a few thousand people turned out to protest the government's outrageous spending spree.
Plus, our "Ayn Rand was right -- read Atlas Shrugged" signs meant that we met another NYC Objectivist! A few of us have carefully built a circle of rational friends in the city over the course of several years, and it's always nice to find more to add to our little "collective." I was especially gratified to see that he had a copy of the current issue of The Objective Standard with him -- and said that yes, I was that Stella Daily. :)
Long live Lady Liberty!
Plus, our "Ayn Rand was right -- read Atlas Shrugged" signs meant that we met another NYC Objectivist! A few of us have carefully built a circle of rational friends in the city over the course of several years, and it's always nice to find more to add to our little "collective." I was especially gratified to see that he had a copy of the current issue of The Objective Standard with him -- and said that yes, I was that Stella Daily. :)
Long live Lady Liberty!
Monday, April 6, 2009
Poison pen letters from the FDA
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.
According to the FDA's letters (which you can see here), 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.
According to the FDA's letters (which you can see here), 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.
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