Forget the nuts.

Pistachios and peanuts have dominated the headlines early in 2009, but the threat of swine flu means the new public health team at FDA, Margaret Hamburg and Josh Sharfstein, are facing a health challenge that may define their tenure at FDA just as it is getting started. The first decisive actions by Sharfstein on pistachios could look puny by comparison to what face them.

Hamburg (still waiting in the wings to be FDA commissioner) and Sharfstein (in his third week as the top official at FDA as deputy commissioner) were introduced by the administration as an executive team to re-orient the agency to it public health role ("¹ Also see "Hamburg, Sharfstein Nominations Shift Focus To Career FDAers’ Plans" - Pink Sheet, 16 March, 2009., p. 8).

The developing swine influenza AH1N1 threat out of Mexico puts the team right in the middle of assuring the public that the Obama Administration can respond to a public health threat that rises to the level of a natural security situation.

One short-term political outcome: It wouldn't be surprising if the Obama administration tried to get Congress to speed up Hamburg's confirmation process.

The new administration is fortunate to have Sharfstein already in place at FDA, but Hamburg, as the past head of the New York City health department and the veteran of issues like tuberculosis medicine shortages, has the type of credentials that will impress Congress as swine flu stays in the headlines.

For now, FDA has been on the periphery of the Administration's initial response to the swine flu outbreak. The public face has come from Homeland Security (where there is a confirmed Secretary, Janet Napolitano) and the Centers for Disease Control & Prevention (whose acting head, Richard Besser, formerly headed CDC's counter-terrorism activities). A link on Swine flu on FDA's website connects to the CDC information page.

FDA's response will be helped by the fact that Jesse Goodman has recently moved from head of the Center for Biologics Evaluation & Research, the chief regulatory entity within FDA for vaccines, to be the agency's top medical advisor. His background and his good political connections (his wife was a key part of the Obama health transition team) mean a trusted expert in vaccine issues is available to back-up and counsel Sharfstein. (See "² FDA's Jesse Goodman is Rising Star Within Agency," The RPM Report, April 2009.)

Still, the pressure to accelerate the confirmation process for Hamburg may already be beginning--albeit one level up in the department, with the pending nomination of Kathleen Sebelius as HHS Secretary. Several reporters raised questions during an April 26 White House briefing about the ability of the Administration to respond effectively to a potential pandemic in the absence of a confirmed HHS secretary. Press Secretary Robert Gibbs disputed the assumption that HHS' response is hampered in any way by the absence of a confirmed secretary. "It is all hands on deck and we're doing fine," Gibbs said. Still, "I would say that we're hopeful that we have a new Secretary very shortly."

Recent Spending on Flu Vaccine Infrastructure Should Help

Longer term, the flu scare could change the character and priorities of the new FDA management team from safety advocates into product expediters.

It has been generally assumed within the Beltway that the new FDA team was chosen to take forceful action on two public health issues: (1) assuring the public that food safety is a top public health top priority; and (2) continuing the effort to reduce tobacco use.

Instead, the Hamburg-Sharfstein duo may be remembered for how quickly they assess the seriousness of the Mexican flu outbreak and how fast they can use the FDA apparatus to get the right products through development and into use.

The key task for FDA is to identify potential manufacturing capacity and to define a pathway for expedited or emergency approvals for vaccines if necessary. CDC is already raising the possibility of adding a fourth component to the flu vaccine already in production for 2009-2010; if that is going to be feasible it will require close coordination between manufacturers, FDA and other public health authorities.

FDA's ability to respond should be helped by the aggressive government spending on vaccine infrastructure during the Bush Administration. Although new production methods such as the cell culture plant being built by Novartis in ³ North Carolina are not far enough along to help in the near term, there is increased capacity for egg-based production from a much larger number of vaccine producers.

There are also prepandemic vaccines: some of which pose regulatory challenges to FDA because they incorporate new adjuvants. Those adjuvants pose a challenge in a risk-averse regulatory climate, but offer two potential benefits in the context of a crisis, since they can heighten immune responses and lessen the amount of antigen needed - thereby facilitating production as well as increasing protection.

GlaxoSmithKline's Prepandrix , approved in Europe, contains an adjuvant and is designed for the H5N1 type flu, the avian flu which has been watched closely for five years. Novartis is developing a prepandemic vaccine in Europe called ⁴ Aflunov .

The expanded flow of money into pandemic preparations also spawned a number of development-stage firms with short-cut steps to develop new flu vaccine components and begin manufacturing.

One of the development-stage firms, ⁵ Novavax, claims to be able to deliver vaccine in 10-12 weeks after identification of the genetic strain of a virus. Novavax uses a virus-like particle formulation process and small-scale disposable manufacturing to produce the product. FDA would have to approve that new process: a clear regulatory challenge. Novavax got a crisis bump on Wall Street jumping 75% in price to $1.42 per share on 1.6 million shares traded on Friday, April 24.

Public Will Look to FDA for Right Products, Adequate Supply

The story of the 1918 "Spanish Flu" pandemic disaster is a well-known dark chapter in modern history: the outbreak killed nearly 20 million in a war-weakened world. There are other less well-known responses that are more reassuring. The story of how a developing modern pharmaceutical industry responded effectively 50 years ago to the H2 pandemic of 1957 (which killed 4 million worldwide, including 70,000 Americans) is engagingly told by vaccine expert Paul Offit in a short section of his book, ⁶ 'Vaccinated.'

During that crisis, a Merck vaccine executive stepped in to convince the government that a new strain of virus could cause a pandemic and took personal steps to assure that an adequate supply of eggs would be available for manufacturers to produce a vaccine.

The public will expect the FDA leaders to fill that role now.

-Cole Werble (c.werble@elsevier.com)

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