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Reciprocal Drug Approval Between the FDA and Europe Surfaces in the Presidential Race

Ted Cruz and his Senate colleague, Mike Lee, want Americans to be able to buy drugs that have been approved by other developed countries.

A couple years ago, James Joyner, a professor at the Marine Corps Command and Staff College, shared a story about how his doctor advised him to treat a cataract. “My surgeon suggested that, if I were willing to wait a couple of months and were willing to pay a couple thousand dollars out of pocket, a revolutionary new lens that had been in use in Europe for years would be approved by the FDA,” hewrote. “The expected approval didn’t come but we agreed to wait another six months. Still, no approval. Meanwhile, the cataract has gotten considerably more advanced and we’re in agreement that waiting around for the FDA no longer makes sense.”

He got the inferior lens, but he wasn’t happy about it. “The absurdity of a lens that’s in widespread use in Sweden and Germany not being available because the FDA hasn’t gotten around to it is mind boggling,” he complained. “We’re not talking about a back alley in Tijuana or Marrakesh; these are at least comparably advanced countries.” Musing that it could have as easily been a better heart valve or cancer drug, he reasoned, “Surely, pooling our combined knowledge is mutually beneficial.”

That is a major premise behind a bill to overhaul the FDA approval process that Senators Ted Cruz and Mike Lee have just introduced. Approval in a “trusted country” would give doctors and patients here the ability to use a drug or medical device.

(The bill has other provisions that are beyond the scope of this article.)

Libertarians have long theorized that pernicious incentives would cause bureaucrats to be too cautious in approving new drugs and treatments––approving a dangerous drug would cost them their career, whereas withholding a good or even lifesaving drug from the public would have no cost at all. The lost lives would be invisible.

Here’s Milton Friedman articulating the argument:

More recently, economists Daniel Klein and Alex Tabarrok studied actual FDA drug approvals.

“We believe FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has increased costs, with a net result of more morbidity and mortality,” they wrote. “A large body of academic research has investigated the FDA and with unusual consensus has reached the same conclusion.”

They advocated for reciprocity among developed countries, and cited cases like this one:

Bacterial meningitis causes swelling of the membranes covering the brain and spinal cord. In the United States the disease kills approximately 500 people a year, often within days of infection. Survivors can have permanent disabilities including paralysis and mental disabilities.

Since March seven cases of the type B strain have been diagnosed at Princeton University, with one case just last week. A vaccine exists and is available in Europe and Australia but the FDA has not permitted the type B vaccine for use in the United States. The Centers for Disease Control and Prevention, however, has lobbied the FDA and they have now received special and unusual permission to import the type B vaccine. Following the CDCs recommendation, Princeton University has agreed to  administer and pay for the vaccine for any student that wants it.

It’s good that the FDA has lifted the ban on the type B vaccine but why should Americans have to wait for the FDA? Americans living in Europe or Australia can be prescribed the vaccine so why not here? I believe that Americans should have the right to be prescribed any drug that has been approved in Europe, Australia, Canada, Japan or other developed nations.

Critics of the idea cite the experience of Thalidomide, the anti-nausea medication that produced thousands of horrifying birth defects in Europe, where it was approved, but was largely held off the American market by tighter FDA regulation. And they worry that reciprocal recognition of drugs could lead to a “race to the bottom,” with drug and device makers going through the approval process in whatever country makes it easiest.

Could a desire for business tempt a foreign regulatory agency into being too lax? Risk and reward both depend in part on how many countries are deemed reciprocal. Here’s what the bill treats as “trusted” countries:

Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the United Kingdom, Iceland, Liechtenstein, and Norway. (This list makes reciprocity seem significantly riskier than it is since for EU countries, drug and device approvals are handled by the European Medicines Agency.)

Derek Lowe worries most about Japan, but not about the safety of its approved drugs, just their usefulness:

There are a number of drugs that are available in Japan that are not available here, and that, to a very good approximation, is because they don’t really do much of anything. The Japanese authorities are strict on safety, but not so much on efficacy, so there are putative Alzheimer’s drugs on the market there that don’t actually do anything for Alzheimer’s, but primum non nocere, they at least don’t make things any worse... (I should note that it’s not like the Alzheimer’s drugs approved here, all of which are also available in Japan, do all that much good, either).

On the whole, reciprocity seems like exactly the sort of reform that a libertarian-leaning Republican ought to be sponsoring in Congress: drawing on research by respected academics to flag a problem with potentially huge costs; tweaking the system so that perverse bureaucratic incentives don’t retard medical progress; expanding the freedom of American patients and doctors; speeding the approval of drugs, which would seem to at least potentially allow for inventing more of them; and all without putting us at any more risk of dangerous drugs than people in Europe, Canada, or Japan, where most of us would fill a prescription without worry.  

It’s nice to see constructive policy of this sort come from two Tea Party senators––and a bit depressing that Cruz doesn’t seem to see it as worth touting while trying to win the votes of an electorate that doesn’t value policymaking unless liberals hate it.

(Image via jordache/Shutterstock.com)

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