The Department of Health and Human Services will take another crack at allowing home stockpiling of a MedKit, scheduling a joint FDA advisory committee meeting to discuss OTC use of the antibiotic doxycycline hyclate to treat anthrax.

While HHS’ Biomedical Advanced Research and Development Authority failed in its 2008 proposal for home use of an antiviral MedKit for pandemic influenza, officials say they have a more measured, incremental plan mapped out to gain approval of the emergency anthrax treatment kit.

According to a Feb. 28 Federal Register notice, FDA’s Nonprescription Drugs and Anti-Infective Drugs advisory committees will meet April 2 in Silver Spring, Md., to recommend the “types of consumer studies needed to assess proper use of a MedKit containing doxycycline,” as well as advise on the feasibility of employing such an OTC product as a public health strategy.

Home-use antibiotic MedKit

Photo courtesy of BARDA

Since FDA issued an emergency use authorization in October 2008, doxycycline MedKits have been stockpiled in the homes of U.S. postal workers who volunteer to participate in the Cities Readiness Initiative sponsored by the Centers for Disease Control and Prevention. The initiative is designed to ensure quick and efficient distribution of antibiotics in case of bioterrorism.

In 2006, CDC oversaw a pilot project in which 4,076 households in the St. Louis area were given prototype antibiotic MedKits and kept them in reserve for eight months. At the study’s conclusion, 97% of respondents returned the MedKits, having followed directions and not used the medication Also see "Pandemic Flu Home MedKits Headed To NDAC/Antiviral Joint Panel" - Pink Sheet, 22 September, 2008..

BARDA – HHS’ arm for developing and implementing medical countermeasures to pandemic and biological threats – says the postal workers and their families similarly have not tampered with or misused the antibiotics in their homes over the past three years. The authority now proposes expanding use of the doxycycline MedKits to additional first responders.

BARDA Reaches Out

The flu pandemic MedKit faltered even with GlaxoSmithKline Inc. and Roche subsidiary Genentech Inc.behind the concept Also see "FDA Panel To Influenza Home MedKit Sponsors: Get Real" - Pink Sheet, 3 November, 2008.. Glaxo sponsors Relenza (zanamivir) and Genentech sponsors Tamiflu (oseltamivir), both of which were considered for the flu prophylaxis kit.

GSK demurred at submitting a new drug application to FDA and froze its Relenza MedKit program because the firm “did not receive enough interest from government or regulatory authorities to pursue development,” a spokesman said in an email. Roche likewise halted its Tamiflu MedKit plans.

BARDA hopes to eventually recruit a commercial sponsor for the anthrax MedKits, but that is not a priority heading into the advisory committee meeting.

“We wanted to go to the agency as well as the committee to ask about the feasibility before we would even begin … to see if any commercial entities would be willing to do this,” said Debra Yeskey, director of BARDA’s Regulatory and Quality Affairs Division.

Should the MedKit development process move forward with a commercial sponsor, the company would need to face a subsequent FDA advisory committee meeting to discuss its application.

BARDA will ask the FDA advisory committees about the feasibility of an OTC doxycycline MedKit for anthrax treatment before seeking out a commercial sponsor.

Doxycycline is marketed by Pfizer Inc. under the brand name Vibramycin and is available as a generic from many other firms.

According to FDA’s website, doxycycline’s common side effects include nausea, vomiting and diarrhea, with less common but serious side effects such as a life-threatening allergic reaction, unusual bleeding and liver damage. The agency says the risks of such side effects may be acceptable when weighed against anthrax infection, which is especially deadly in inhaled form.

BARDA intends to educate and recruit organizations, such as the Infectious Diseases Society of America, to support the anthrax MedKit, said BARDA Director Robin Robinson.

“One of the things that we learned from the experience with influenza antiviral drugs that were proposed to be in a MedKit was that you do have to have an outreach with the public, including medical organizations and other experts,” he said.

NDAC Back In Action

The April 2 meeting will mark the first for the Nonprescription Drugs Advisory Committee since May 2011, when it joined with the Pediatric Advisory Committee to recommend that FDA require standardization of pediatric acetaminophen products to a single strength Also see "Acetaminophen Panel Recommends Standardizing Solid Dose Strength" - Pink Sheet, 23 May, 2011..

Chairing NDAC for the anthrax MedKit discussion will be Richard Neill, chief of the Department of Family Medicine at Penn Presbyterian Medical Center in Philadelphia, who took over leadership of the committee in December 2011. His term expires May 31, 2014.

As a temporary voting member of the panel that considered the flu pandemic MedKit in 2008, Neill voiced support for the home stockpiling concept.

“I think that it would be wise for us to mutate the processes that we use to take care of traditional risks in the face of non-traditional threats,” he said at the time.

OTC Anthrax MedKit Development Relies On Incremental Approach

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