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Prescription Drug Regulation Infringes On Citizens’ Right to Life December 9, 2006

Posted by federalist in Government Regulation, Healthcare.
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Does it make any sense to respect the liberty of citizens to strap waxed boards to their feet and slide down snowy slopes with trees whizzing by for the thrill of it (I am not making this up), yet deny the dying access to potentially life saving drugs that have been proven safe?

That’s from Randy Barnett’s excellent discussion today of federal courts’ disappointing tendency to uphold the government’s right to deny pharmaceutical technology to Americans.  Even when said technology has passed FDA Phase I trials.  Even when said Americans are terminally ill.

Federal government has certainly overstepped its bounds by using its authority over Interstate Commerce to infringe on our fundamental rights to life and the pursuit of happiness, in this case through the informed consumption of pharmeceuticals.

In Abigail Alliance v. von Eschenbach, a three judge panel of the D.C. Circuit Court of Appeals ruled that, when a drug passed Phase I trials establishing its safety, a terminally ill patient has a right to try the drug before its efficacy is established, provided the patient has no other FDA-approved drug available for treatment. However, two weeks ago the circuit granted the government’s motion for an en banc rehearing before all the members of the court.

At stake is the right to life. Although the parties are pleading the Due Process Clause of the Fifth Amendment, their claim also finds textual support in the original meaning of the judicially neglected Ninth Amendment, which reads: “The enumeration in the Constitution of certain rights shall not be construed to deny or disparage others retained by the people.”

The Ninth Amendment’s author, James Madison, explained to the first Congress that it was added to guard against the implication “that those rights which were not singled out, were intended to be assigned into the hands of the general government, and were consequently insecure.”

Barnett later contrasts the stiff regulation of pharmaceuticals with the government’s liberal zeal in guarding the “right” to perform partial-birth abortions, simply because there is always to be found an expert who claims this widely-offensive procedure might be necessary to save the life of a woman.  Apparently the right to life is less expendable when there are political points to score.

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1. federalist - March 9, 2007

Wonderful proposal over at Overcoming Bias:

[G]overnments could just tell us that certain doctors or drugs are unsafe, instead of outlawing them. Now one can imagine inefficient warning systems, such as having to go look up each drug at some badly organized government website. But we can also imagine no-fuss government warnings: let anything the government would have banned be sold only at special “would have banned” stores, whose customers pass a test showing they understand that regulators disapprove.

2. federalist - July 10, 2007

Christopher Shea summarizes arguments of Eugene Volokh and the Abigail Alliance, among others, in favor of “a right to medical self-defense.”

If you can shoot a man who breaks into your house at 1 a.m., they ask, why can’t you try an unproven drug or purchase an organ?

“There is a longstanding tradition of self-defense” in American law, says Eugene Volokh, a UCLA law professor and well-known blogger. “This tradition ought to logically entail defending yourself when doing so does not involve killing people.”

3. federalist - July 10, 2007

CATO highlights another misguided government intrusion on citizens’ right to pain relief in their policy analysis “Treating Doctors as Drug Dealers: The DEA’s War on Prescription Painkillers“.

4. federalist - August 10, 2007

Amicus brief in Abigail Alliance v. Eschenbach argues:

I. The Food & Drug Administration Has Historically Been Too Slow To Approve New Treatments

II. Permitting Terminally-Ill Patients To Access Potentially Life-Saving Phase I Approved Drugs Will Not Discourage Patient Participation In Randomized Clinical Trials

III. Affirming The Decision Of The Original Panel Will Not Reduce Incentives For Manufacturers To Conduct Randomized Clinical Trials Of Available Drugs

5. federalist - August 13, 2007

Roger Pilon illuminates the disturbing judicial activism on display in the D.C. Circuit court, which last week reversed the panel decision in Abigail Alliance v. Eschenbach:

[F]or most of our history individuals were free to take whatever drugs they wanted without a doctor’s prescription. It was only in 1951 that Congress created a category of prescription drugs. Then in 1962 it began requiring drug companies to conduct extensive tests to ensure drug “efficacy,” which led to long delays for drug approval and to the deaths of countless patients who would gladly have borne the unknown risks for a chance at life.

6. federalist - October 4, 2007

Baby Steps: “FDA May Ease Prescription-Drug Rules” … by setting up an intermediate regulatory classification for pharmaceuticals: “Behind-the-counter.”

7. federalist - February 16, 2008

Seth Faler suggests,

Instead of “safe and effective,” let the FDA determine merely that a drug is “safe,” and let doctors, patients (especially terminally ill patients), and the market determine which safe drugs are used to treat various illnesses — as we already do with drugs that are used off-label. The vast majority of the time and expense of the FDA approval process is spent on proving “efficacy” in Phase II and III trials.

8. federalist - June 16, 2008

WSJ prints a letter from a formerly productive member of society incapacitated because the FDA and tort lawyers decided to destroy Merck’s ability to sell him a useful drug:

I am an 87-year-old man who was very active until Vioxx was taken off the market. Now I can hardly walk even after trying many types of medication including steroid injections to my left foot. I, as well as many other patients, would gladly give up a few days of life if we could live them without pain. Many of the doctors have also said that for some people Vioxx is the only medication that works.

The tort lawyers have made a killing as well as a few individuals who may or may not have suffered a loss; they have no concern as to what they have done to the lives of others. I pray that Merck will again allow us to purchase its wonderful product; I would gladly sign a release paper. I donate my time, effort and money to help others start small businesses; the lack of pain relief impairs this effort and as a result hurts this effort and the economy.


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