Tag: FDA

Categories
national politics & policies too much government

FDA Chief Gets It Right

We want safe foods and drugs. But should we want the Food and Drug Administration? Or more regulation from it?

We can use third-party investigations of the nature and effects of pharmaceuticals; but a government agency doing the investigating sure has its drawbacks. The bureaucracy’s coercive regulations and costly mandates should certainly not trump individual judgments about whether one may use a drug.

The FDA exists, however, and its massive presence in modern medicine isn’t going away any time soon. Luckily, some of its decisions are better than others. And now that it has authorized sale of the painkiller Zohydro ER, we can say it made the right call here.

The rightness of the decision is highlighted rather than contradicted by mounting political pressure to reverse it.

U.S. Senator Joe Manchin, a Democrat, and U.S. Senator Mitch McConnell, a Republican, are among those demanding that Zohydro be outlawed. Their main complaint seems to be that the drug’s very effectiveness makes it more addictive, and more prone to abuse, than other painkillers. Officeholders from 29 states have chimed in to demand a ban.

I don’t know the ratio of benefits to risks in taking this drug. I know that if I’m writhing in pain, and other painkillers can’t do much to alleviate it, but Zohydro ER can, I want the freedom to decide for myself whether the benefits are worth the risks.

We have the right to make such decisions about our own lives.

In the meantime, FDA Commissioner Margaret Hamburg deserves credit for resisting political demands that the agency rescind its approval.

My prescription for her? Don’t back down.

This is Common Sense. I’m Paul Jacob.

Categories
free trade & free markets too much government

This Is the Government We Pay For

We live in a time when the governing political party and the dominant strain in the major media constantly harp on two themes:

  1. Capitalism is wasteful, not environmentally sound, and
  2. We need more regulation from government.

So, it is especially droll to witness the Food and Drug Administration pounce upon an age-old recycling practice between breweries and farms. In the name of “better regulation,” and “safety,” of course.

For well over a century beer brewers have disposed of their spent grain product — the non-beer product of the beer-making process — by giving or selling it cheaply to farmers, who feed it to livestock.

It would cost a lot to dispose of this in landfills, so brewers save money by letting farmers take the dregs off their hands.

But now the FDA, in a new set of proposed rules (proposed not by Congress, by the way), wants to protect cattle’s food supply by requiring brewers to dry the spent grain before shipping it off.

That’s a killer cost. One Oregonian brewer referred to it as an “enormous burden,” and warned that higher consumer prices would be the result.

I’m with Oregon Senator Ron Wyden (D), who demands that the agency go back to the drawing board.

“I don’t know everything about beer,” Wyden has been quoted, “but I do know when a federal agency acts like it has had one too many.”

For my part, I don’t see this as aberrant behavior from a federal agency. I see it as typical.

Typically drunk on power.

This is Common Sense. I’m Paul Jacob.

Categories
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.

Categories
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.