As EUAs expire, HHS says pandemic emergency is over

Jun 23, 2010 (CIDRAP News) – Federal officials today allowed the public health emergency declaration that was prompted by the H1N1 influenza outbreak last year to lapse, signaling an end to emergency authorizations for certain special uses of antiviral drugs and other items.

The Department of Health and Human Services (HHS) first declared the emergency Apr 26, 2009, and has renewed it quarterly since then, the last time on Mar 26. "The current March 26 determination is scheduled to expire on June 23, and, based on the current circumstances, will not be renewed," says a statement released by an HHS official today.

The decision to let the declaration expire comes after several months of low flu activity. The HHS statement says the decision was based on many factors, including low pandemic flu activity, a low level of hospitalizations for flu-like illness, and the vaccination of 80 million Americans.

Further, "There is no longer a significant demand for the medical countermeasures that required a public health emergency declaration and emergency use authorizations," HHS stated. "It is likely that other countries will be taking similar actions in the coming weeks and months based on their own assessments."

The HHS move comes as the World Health Organization maintains its full phase 6 pandemic alert. After a meeting of its Emergency Committee on Jun 1, the WHO said peak H1N1 activity had probably passed for much of the world but that the virus continued to circulate in some regions. The committee is due to meet again in July to consider whether to change the alert level.

HHS says the end of the emergency declaration "does not mean that Americans should stop taking H1N1 or seasonal flu seriously," as the virus is still circulating. Vaccination remains a good idea, particularly for people traveling to the Southern Hemisphere, currently in its winter flu season, and for children heading for summer camps, the statement says.

Implications of EUA expirations
With the end of the emergency declaration, emergency use authorizations (EUAs) for certain antiviral drugs, medical tests, and respiratory protection devices also come to an end today. They were issued by the Food and Drug Administration (FDA).

The EUAs covered the use of the licensed antiviral oseltamivir (Tamiflu) in babies under 1 year old and the use of intravenous (IV) peramivir—an unlicensed antiviral still in the testing stages—in critically ill patients. Such uses will still be possible henceforward, but may be more complicated.

"Physicians and public health officials will still be able to get access to these tests, drugs, and tools, but there will be a different process for doing so," the HHS statement says. "For example, clinicians will be able to obtain intravenous antiviral drugs through participation in clinical trials."

HHS adds that another health emergency could be declared in the event of a new wave of H1N1 infections.

Andrew Pavia, MD, a pediatric infectious disease expert at the University of Utah, told CIDRAP News today that the EUAs for the antivirals filled an important need.

"First and foremost, the EUA for use of oseltamivir in infants really allowed clinicians to feel comfortable using this drug, based on pretty good data," said Pavia, who chairs the pandemic flu task force for the Infectious Diseases Society of America.

The FDA issued the peramivir EUA last October to make an IV antiviral drug available for H1N1 flu patients. The licensed antivirals indicated for H1N1 are oseltamivir, taken orally, and zanamivir (Relenza), which is inhaled. Those routes of administration may not be feasible for critically ill patients, especially those on ventilators. (An IV formulation of zanamivir is being tested and has been available under special "emergency investigational new drug rules," but the FDA did not announce an EUA for it.)

Pavia said the EUA for IV peramivir was "potentially very important" in providing an IV formulation for critically ill patients. "There were some real successes in terms of getting drugs to patients on a timely basis," he added.

With the end of the EUA for oseltamivir in infants less than a year old, clinicians can still prescribe it, but it will be an off-label use, Pavia said.

"Clinicians know how to use it and have confidence in the safety, but it's unlikely the label will be changed anytime soon," he said. He added that doctors often prescribe medications for off-label uses, but some clinicians may feel uncomfortable using oseltamivir in babies without the EUA.

Pavia said he doesn't think the end of the peramivir EUA will be a problem, because physicians will still be able to access the drug by participating in ongoing clinical trials.

More than 1,000 people have been treated successfully with IV peramivir, according to an HHS document supporting a 2011 budget request.

Jon Stonehouse, president and CEO of BioCryst Pharmaceuticals, maker of peramivir, said the end of the peramivir EUA is giving the company more motivation to get the drug licensed.

"I think it just reinforces the importance now, because there is no access to an IV antiviral, that we move rapidly to get the drug approved," he said.

Peramivir is currently in a phase 3 trial. "I think a reasonable target for approval is in time for the 2012-13 flu season," he said, assuming the company can enroll enough patients in the ongoing trial and the results continue to be positive.

Other expiring EUAs covered the use of some lots of oseltamivir and zanamivir beyond their labeled expiration dates. Others covered the use of certain N-95 respirators to protect wearers against airborne pathogens and the use of certain in vitro diagnostic tests for the pandemic virus. The Centers for Disease Control and Prevention (CDC) has posted information about the various authorizations, including some guidance for the handling of leftover supplies, on its Web site (see below).

See also:

CDC page on EUA terminations, with links to various information resources
http://www.cdc.gov/h1n1flu/eua/

Oct 26, 2009, CIDRAP News story on peramivir EUA
http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/oct2609peramivir.html

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