- - Friday, July 5, 2013

As though double-digit increases in insurance premiums weren’t enough, how about triple-digit cost inflation for drugs? It is really simple to do, and the U.S. Senate is about to do it.

If you’re a drug manufacturer, and you’d like to make 100 times more than a person would otherwise have to pay for a drug, get Congress to expand the tremendous power of the Food and Drug Administration (FDA), perhaps already the most powerful anti-competitive force on the planet.

The proposed bill is S. 959, the Pharmaceutical Compounding Quality and Accountability Act, also known as the “FDA power-grab bill,” still another example of “never letting a crisis go to waste.”

There was an outbreak of meningitis traced to a product from a compounding pharmacy that was injected into or near the nervous system. That problem is not a risk from the usual type of injections into the muscle or the skin, but never mind. Any pretext will do to extend the tentacles of the FDA into small, state-regulated, intrastate enterprises that provide individualized prescriptions on a doctor’s order. These compounding pharmacies could not survive the crushing regulatory burdens placed on giant, multibillion-dollar firms. So whatever the stated intentions of the bill, these little businesses will be wiped out.

Compounding pharmacies are a safety net in cases in which a drug becomes unavailable, an increasingly common occurrence these days, even for common lifesaving drugs. They also provide formulations that individual patients need that are not profitable to mass-produce.

S. 959 would forbid compounding pharmacies to copy FDA-approved but nonpatented medicines. One such medicine is 17 alpha-hydroxyprogesterone (17P), which is a synthetic form of the female hormone progesterone. Compounding pharmacies currently provide this medication at an affordable cost to thousands of pregnant women who are prone to premature delivery. The compounded version costs as little as $15 per injection. The price for the manufactured one rocketed to $690 when the FDA awarded exclusive manufacturing rights to K-V Pharmaceuticals. The cost per pregnancy would rise from $300 to an unaffordable $30,000.

Pregnant women who can’t pay it are likely to lose babies who might be normal and healthy if birth could be a little delayed. For some, insurance might cover the cost, but why should insurance subscribers have to pay this through their premiums? And why should state Medicaid programs pay 100 times as much?

Then there’s the example of Anascorp, an antivenin for scorpion stings. This has been manufactured by a small Mexican biotechnology company for years, and costs $100 per dose in Mexico. When a Tennessee company called Rare Disease Therapeutics won exclusive U.S. distribution rights (the product is still made in Mexico), it marked the price up to $3,750 per dose.

The FDA’s anti-competitive policy is driving costs of formerly cheap drugs like doxycycline sky-high — if you can get them at all. As for breakthrough innovations, as in adult stem cells, you can forget them altogether if S. 959 passes. Blood transfusions, thankfully, will be exempt, but no one will be able to prepare a patient’s own stem cells for reinjection without doing a billion dollars’ worth of studies. At least not in the United States.

S. 959 would make much-needed medical care unaffordable or unavailable to Americans while empowering unaccountable bureaucrats and enriching crony special interests.

Dr. Jane M. Orient practices internal medicine in Tucson, Ariz., and is executive director of the Association of American Physicians and Surgeons.

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