Don’t Get Bitten by a Coral Snake

Wyeth began producing coral snake antivenom, Antivenin, more than 40 years ago — in 1967. There are about 100 coral snake bites a year in the United States. Physicians prophylactically administer Antivenin if they believe that a patient might have been bitten by a coral snake. They do this because neurological symptoms from the snakebite cannot be reversed once they have started. Since 1967 there has been only one documented death from a coral snake bite. It was in an untreated patient.

Now, as Popular Mechanics reports, the U.S. supply of Antivenim is about to run out.

In 2003, Wyeth shut down the factory that produced Antivenim. It notified the FDA in advance, and worked with the FDA to create a 5 year supply before production ceased. Rather than using the time to work with manufacturers like Wyeth to ensure that U.S. patients will be able to access coral snake antivenom in the future, the FDA dawdled. Even as late as 2009, it was holding meetings. It also extended the expiration date on existing antivenom supplies. Twice.

Abstracts from one of the meetings conclude that existing FDA rules for approving new drugs make it “next to impossible to demonstrate efficacy of coral snake antivenoms in humans.” Never mind that Antivenin has been demonstrating that it is safe and effective in 40 years of actual use.

Even if a new coral snake antivenom were under study, and it is not, researchers concluded that it would be impossible to hold the drug trials required by existing drug approval rules. “Only about 4 percent of people have serious outcomes from possible bites,” and one would need “thousands of patients” to detect improvements in outcomes with a new antivenom. Even under the “animal rule,” approving a new antivenom will cost “several million dollars” and “with less than a hundred bites per year, a financially viable product is doubtful.”

There was discussion of licensing pathways and the incentives embedded in the Orphan Drug Act. It waives the $1,405,500 filing fee for a new prescription drug (yes, that’s $1,405,500 just to get the imperious federal government to even look at the application), provides the usual gimmick of tax credits (which doesn’t help development companies that probably aren’t paying much in taxes anyway), and maybe provides grants of up to $400,000 a year for clinical testing that costs millions. While regulations push development costs into the stratosphere, incentives like this probably have the most value as political talking points.

 A Mexican manufacturer makes coral snake antivenom but it is unlicensed for sale in the United States. The red tape for an import license?

1. File an Investigational New Drug Application, FDA 1571. The lengthy directions are here. The goal is a number identifying the new drug.
2. A statement naming a local physician who will supervise the antivenom along with a Statement of Investigator, FDA 1572, which is a mere two pages long if one doesn’t include the demands for proof of qualifications, names of laboratories, institutional review boards, and protocols.
3. A lot of information from the foreign drug’s manufacturer.
4. A copy of the package insert for the foreign drug.
5. A statement that the antivenom is being imported solely for emergency use and that the product will not be resold.
6. A statement that if the product is administered a complete case report will be filed with the FDA.

Once the investigational drug receives its number, all communications with the FDA must be in triplicate. Because three agencies are involved, one must also apply to the U.S. Department of Agriculture Plant Health Inspection Service for a permit to import antivenom. If it is approved, red labels must be sent to the foreign manufacturer.  The antivenom must be precleared through U.S. Customs, and a log must be kept for each import indicating how much was imported and the final disposition of each dose.

In the latest round of health care reform, rather than reforming the US drug approval process so that pharmaceutical manufactures have an incentive to continue producing known products that prevent deaths from rare events like coral snake bites, Congress chose to heap new taxes on manufacturers. This virtually ensures that they will not have the money to build the future factories needed to produce drugs for other rare conditions.

After two decades of experimenting with health care reform proposals that have sought to change attitudes regarding who should control health care, have systematically increased government control over medical decisions, and have relentlessly demonized private physicians, private hospitals, and private pharmaceutical manufacturers, leftist reformers finally have at least one concrete result to show for the efforts: a formerly preventable condition, death by coral snake bite has now been upgraded to an acceptable risk.

Hat tip: Instapundit

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