The spread of the 2009-H1N1 flu virus in the U.S. is not prompting FDA to accelerate work on a proposed program for home stockpiling of antiviral drugs, acting Commissioner Josh Sharfstein says.

FDA's actions in response to the global epidemic include issuing Emergency Use Authorizations to make Roche's Tamiflu (oseltamivir) and GlaxoSmithKline's Relenza (zanamivir) more widely available to public health and medical personnel (see ¹ Also see "FDA Learned Consumer Protection Lesson From 2004 Flu Scare" - Pink Sheet, 4 May, 2009. ).

However, FDA's plans so far do not include making the antivirals available by prescription for home stockpiling, Sharfstein said April 30 following a House Energy and Commerce subcommittee hearing on Department of Health and Human Services agencies' H1N1-related efforts.

Home stockpiling is "part of the discussion, but it's not urgent," Sharfstein said.

The strategic national stockpile of drugs and other materials needed to manage flu outbreaks is sufficient to support public health needs, he said.

Sharfstein pointed out, though, that FDA remains interested in receiving new drug applications from Roche and GSK related to the proposed MedKit program for home stockpiling of anitvirals.

The Department of Health and Human Services approached Roche and Glaxo in early 2008 about developing MedKits with Tamiflu or Relenza.

In October 2008 a joint panel of the Antiviral Drugs and Nonprescription Drugs advisory committees discussed preliminary proposals for prescription-based home stockpiling of Tamiflu and Relenza.

FDA is working on MedKit development with the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority, which is under the HHS assistant secretary for preparedness and response (² Also see "Roche’s Flu MedKit Seeks “Alternate Pathway” For OTC Drugs" - Pink Sheet, 1 December, 2008., p. 3).

Under a proposed timeline presented at the meeting, both firms would file NDAs by late 2010.

What's Next For MedKits

Roche did not respond to requests for comment as to whether it would seek to file sooner.

A Glaxo spokeswoman said the firm has not been asked about moving up the schedule for its MedKit NDA plans to submit an application under the late 2010 deadline.

A BARDA spokeswoman said the HHS program is deferring to FDA and CDC on decisions about MedKit development.

But Ian McGowan, chairman of the joint panel and of the antiviral committee, said the current public health emergency should hasten work on the MedKit program and ask Roche and Glaxo to submit NDAs well before late 2010, he said.

"I would think that the events of this last week would have focused peoples' minds and perhaps increased the perception that there's an urgent need to at least evaluate and come to some sort of a decision about whether home stockpiling is the appropriate way to move forward," McGowan, an immunologist and a professor of medicine at the University of Pittsburgh, said in an interview.

The joint advisory panel discussion ended with multiple unsettled issues, McGowan pointed out.

The unanswered questions include determining who would have access to antivirals for home stockpiling. If access is limited to people who can afford it or have insurance to pay for it, "that's clearly not the whole of the United States population," McGowan said.

The committees also were not convinced that consumers would be able to correctly dose children with the antivirals or understand that the drugs are used for treatment and not as vaccines for prevention.

"There are a lot of practical issues which just came up. Our expectation was that there's going to be ongoing talks between Health and Human Services, FDA and the two companies who have proposals to try and move into this area," McGowan said.

One infectious disease expert maintains that so far, this flu outbreak does not point to home stockpiling of antivirals.

"I think it's very, very hard to anticipate what's going to happen with this," John G. Bartlett, chief of Johns Hopkins' Infectious Disease division said during an April 28 Morgan Stanley Healthcare Roundtable conference call.

"Is this going to be a big one in terms of morbidity and mortality? Or is this just going to be another flu season?" Bartlett asked.

One thing is certain, though. "It is a good event for companies that sell drugs," he observed.

Antiviral Supply And Demand

Sharfstein approved Emergency Use Authorizations April 27 to temporarily expand the use of Tamiflu and Relenza following the release of 25 percent of the U.S. national antivirals stockpile with HHS' public health emergency declaration April 26.

The EUA allows Tamiflu - which is approved for the treatment and prevention of influenza in patients 1 year and older - to be used in children under 1 year of age. It also provides alternate dosing recommendations for children older than 1 year.

Relenza currently is approved to treat acute uncomplicated illness due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for flu prevention in adults and children 5 years and older.

Under the EUAs, both antivirals 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.

The drugs also may be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with state and local laws.

During the hearing by Energy and Commerce's Health Subcommittee, Sharfstein told Maryland Democrat John Sarbanes that Tamiflu is proving stronger against H1N1 than it was against the most recent seasonal influenza.

However, the H1N1 virus could change and become more resistant to Tamiflu, Sharfstein pointed out.

"We are starting off with a little bit of good news there, but it's going to depend on how this" virus changes, he said.

Bartlett said Relenza is "very active" against all the resistant strains. "On paper" Glaxo's antiviral inhalant "looks like a better drug; the problem is the delivery system," he said.

More people will choose a pill over an inhalant, which can be difficult for some, especially lung disease patients. "The CDC has said use one or the other, but people generally have preferred the pill, and that's Tamiflu," Bartlett said.

Drugstore chain Rite Aid reports an increase in demand and has been working to grow and manage its supply of the antivirals.

"We did see a pickup in [antiviral] prescriptions since [April 25], when the outbreak started getting more publicity, although the number of prescriptions being sold is still really small," said Cheryl Slavinsky, public relations director for the chain.

"As you can expect we saw a marked increase in prescription sales in New York last week," she added.

Slavinsky said the Camp Hill, Pa.-based chain of nearly 4,900 stores implemented a system to transfer Tamiflu and Relenza between stores in the event a particular store's supply runs low, rather than rely only on shipments from distribution centers.

Since the current flu outbreak was reported, GSK asked health agencies in the U.S. and other countries about their antiviral supplies, a spokesman said. The firm will determine whether to increase its Relenza production after comparing the expected global need to its supply level.

Glaxo said the EUA is one factor that will influence its decision on whether to accelerate Relenza production.

- Malcolm Spicer (m.spicer@elsevier.com)

MedKit Development For Flu Outbreak Is “Part Of The Discussion”– Sharfstein

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