Tag: Botox

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free trade & free markets too much government

Good FDA, Bad FDA

You’re sick and need medicine that has proved its benefits to you. Will the Food and Drug Administration let you use it?

The FDA recently extracted $600 million from Allergan, makers of Botox, for promoting uses for Botox different from those for which it was approved. It’s not illegal to use the drug for unapproved uses; it’s just illegal, sometimes, to tell you about those other uses. This, despite the fact that the First Amendment doesn’t exclude members of the pharmaceutical industry.

Now we’re hearing that the FDA has flip-flopped about letting people use midodrine, which quells dizziness. Back in 1996, midodrine was approved under “an abbreviated process,” one too brief to determine whether it really helps with dizziness. So, recently the agency outlawed sales of midodrine until its effectiveness could be shown. But — oops! — during the intervening 14 years, patients have come to depend on it. These patients swamped the FDA with complaints. So now the agency, in good-cop mode, says, okay okay, you can use it.

Thus, if you can persuade bureaucrats to let you medicate yourself as you and your doctor see fit, you get to do so. If not . . . sorry.

The New York Times talks about the “tough choices” facing the FDA, since banning a drug can mean “stranding desperate patients.” Congress should represent patients by stripping the agency of any power whatever to dictate when and how we may act to improve our own health.

This is Common Sense. I’m Paul Jacob.

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First Amendment rights too much government U.S. Constitution

Allergic to the First Amendment

The drug manufacturer Allergan is taking the Food and Drug Administration to court.

The FDA has ordered Allergan to violate the FDA’s own rules against disseminating information about “off-label” uses of a drug, uses that may be medically common but which, unlike “on-label” uses, were not specifically certified as safe and effective during the FDA’s approval process.

Once a drug has been approved, doctors may legally prescribe the drug for safe off-label uses.

The FDA now wants Allergan to send detailed safety information to physicians about both off-label and on-label uses of Botox®. Yet the FDA bans promoting drugs for off-label uses. A company may convey truthful information about such uses in only very restricted ways.

Companies have paid through the nose for violating these restrictions. In 2009, Pfizer had to pay $2.3 billion for promoting off-label uses of its drugs. Another $1.4 billion was looted from Eli Lilly for the same “crime.”

Allergan is understandably reluctant to obey a government agency’s edict to disobey other edicts promulgated by that same agency — especially when the price of disobedience can be so high. Better to solicit some judicial clarity.

Better, certainly, than following orders and hoping for the best.

Will the court vindicate and enforce constitutional protections for freedom of speech in the realm of pharmaceuticals? Such a ruling would unshackle drug companies from ludicrous hindrance, freeing them to speak.

And it would help doctors and patients.

This is Common Sense. I’m Paul Jacob.