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Weekly UpdatesEven as FDA, in response to requests from the U.S. Centers for Disease Control, issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel diagnostic and therapeutic tools to identify and respond to the swine flu virus, news broke that some states have not stockpiled sufficient supplies of these drugs to meet potential demand should swine flu truly reach epidemic proportions.
FDA issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRTPCR Swine Flu Panel diagnostic test.
The EUA authority allows FDA to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved products following a determination and declaration of emergency. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency.
Currently, Relenza is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older. Tamiflu is approved for the treatment and prevention of influenza in patients 1 year and older.
The EUAs allow for Tamiflu also to be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year. In addition, under the EUAs, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They may also be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.
In authorizing an EUA for the rRT-PCR Swine Flu Panel diagnostic test, FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests. This EUA allows the CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and personnel who are trained to perform and interpret the results.
The EUA authority is part of Project BioShield, which became law in July 2004.
But whether supplies of Relenza and Tamiflu will hold is an open question. "The Washington Post" reported May 1 that more than two dozen states and the District of Columbia have not stocked enough of the emergency supplies of antiviral medications considered necessary to treat victims of swine flu should the outbreak become a full-blown crisis, according to federal records.
The Strategic National Stockpile, created during the Clinton administration a decade ago to provide a federally coordinated response to disasters, maintains a massive collection of antibiotics, vaccines, gas masks and other supplies in a dozen secret locations. The program was expanded in 2004 to include drugs needed in a pandemic and is designed to link with stockpiles kept by state governments, pharmaceutical companies and federal agencies.
But the District, Maryland and 26 other states are 10 million dosages short of the levels that the federal government has determined they should have in their stockpiles for a pandemic, The Post reported. Federal agencies, which under the plan are expected to create their own stockpiles, are also falling short.
The federal government has met its goal of accumulating 50 million courses of the antiviral medications. Officials said last week that the rollout of those drugs to states has gone smoothly. More than $6 billion has been invested in efforts to fight a pandemic, and President Obama asked for an additional $1.5 billion from Congress. The Department of Health and Human Services said that it will purchase an additional 13 million treatment courses.
Along with the federal doses, the plan called for states together to create a cache of 30 million doses, but they have fallen short of that figure by one-third. Maine, for example, which has three confirmed cases of swine flu, has stockpiled no medications.
The combined federal-state stockpile would provide enough medication to treat 25% of the population. Health officials believe that treatment at such levels would be sufficient to stop a pandemic.
Some states, however, were reluctant to invest in their share for two reasons: The drugs have a shelf life of four years, and they were proving ineffective for avian flu, which seemed to pose the greatest risk. Some officials cited financial constraints, despite a 25% federal funding match for the antiviral medications.
Federal agencies were asked last year to create their own stockpiles. But the response has been uneven. The Defense Department has stockpiled 8 million treatment courses for military service members and their families. The Postal Service, whose carriers could be needed to deliver medications in a pandemic, has no antiviral medications stocked for its 330,000 mail carriers.
Even Health and Human Services is behind schedule with its stockpiling effort. Last year, the department asked for $2 million for antiviral medications for its workers, but none have been purchased.
Roche, which makes Tamiflu, and GlaxoSmith-Kline, which manufactures Relenza, are ramping up production, and Cipla, an Indian company, has promised to produce 1.5 million doses of a generic drug in the next four to six weeks, "Newsweek" reported May 1. Roche said it has a stockpile of 3 million packages of Tamiflu ready for use by the World Health Organization (WHO), half held in the United States and half in Switzerland.
"So far the WHO has not requested we deploy this stockpile. Of course, as soon as the WHO requires that we deploy it we will do so," said Roche spokeswoman Claudia Schmitt.
Both Roche and Glaxo said they were in contact with WHO, U.S. authorities and the government in Mexico.
Potentially complicating the supply picture even further is the practice of hoarding, which may have already begun in some areas. The Newsweek article reported that a customer trying to fill a prescription for Tamiflu on the island of Oahu, Hawaii, found supplies of the drug and of Relenza exhausted. Representatives for both Longs and Walgreens drug stores on the island confirmed to Newsweek that their retail stores have been seeing increased demand and that some had "temporary stock outages" over the weekend. CVS also reported increased demand in New York City, while Walgreens has seen interest spike in New York, California, Texas and Illinois.
Jeffery Goad, an associate professor of clinical pharmacy at the University of Southern California, explained to the news magazine that the unique nature of flu medications makes the market particularly vulnerable in situations like this one.
Tamiflu and Relenza "never took off as a commercial product," he said, because they are used by only a small percentage of the population for a few months each year. When panic strikes, "very few pharmacies have it [in stock]. They wouldn't usually have it." The U.S. government, which controls 25% of the country's supply of flu medication, isn't much help to would-be stockpilers: all the doses released by the Department of Homeland Security will go to public clinics and support teams, not private distributors.
Faced with empty pharmacy shelves, Goad expects consumers to buy drugs wherever they can--and, once they find them, to buy as much as possible.
Goad also warned that even those who get prescriptions ahead of time are likely to misdiagnose themselves later--mistaking a bad cold for the flu, for instance--and take drugs they don't need. That can help existing strains of the flu virus develop resistance to commonly prescribed medications, which makes them more difficult to treat in the future.
The longer-term battle against any pandemic, however, depends not on antiviral drugs but a successful vaccine. Baxter is working with WHO on a potential vaccine. However, it was reported by the "Times of India" that the firm's vaccines were contaminated with deadly live H5N1 avian flu virus and were distributed to 18 countries last December by a lab at Baxter's Austrian branch. However, no humans got the shot and it was recalled.
About 70% of the world's flu vaccines are made in Europe, and WHO is trying to figure out how many doses of seasonal flu vaccine remain worldwide before asking vaccine manufacturers to start pumping out pandemic vaccine instead.
Marie-Paule Kieny, director of WHO's Initiative for Vaccine Research, told Reuters that the decision would be like guessing which vaccine the world will need most, but that WHO would try to hedge its bets by tallying existing seasonal flu vaccine stocks.
"We are gambling whether or not we will have enough seasonal vaccine, but it will not be an 'either-or' situation," she said.
Vaccine makers can make limited amounts of both seasonal flu vaccine and pandemic vaccine--though not at the same time--but they cannot make massive quantities of both because that exceeds capacity.
Regular flu kills between 250,000 to 500,000 people worldwide every year. So far, swine flu appears relatively mild, except in Mexico. Until experts know how contagious and deadly the virus is, they won't know how many people actually need to be vaccinated. If it remains mild, it's possible many people won't need a shot.
But if swine flu evolves into a more deadly strain, more shots may be needed to protect wider swathes of the population. Another possible complication is that the pandemic vaccine will be made using the strain available now; whether that will work if the virus mutates isn't certain.
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