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Capitol Checkup: Flu fretting; FDA lab lapses; CDC cuts; opioid actions

The public health threat that is keeping the top U.S. government infectious disease experts up at night fretting over a lack of preparedness is not Ebola, or smallpox or even the recent case of bubonic plague in Idaho. It's influenza.

"It can affect everyone rapidly and is constantly changing, and with pandemics, all of the population of the world can be susceptible," said Anne Schuchat, principal deputy director at the Centers for Disease Control and Prevention, or CDC.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health said he expects a highly deadly form of the flu, not some other devastating disease, to cause the next big infectious disease outbreak in the U.S. And if not a flu pandemic, possibly an influenza-like respiratory infection, such as severe acute respiratory syndrome — a highly contagious virus that nearly crippled Canada in 2003 when it spread to that nation from China, causing some panic in the U.S.

"When you have a respiratory virus that can be spread by droplets and aerosol and then you have the situation if there's a degree of morbidity associated with that, you can have a catastrophe," Fauci told members of the House Energy and Commerce Oversight and Investigations Subcommittee during a June 15 hearing.

Fauci noted that the CDC has considered the H7N9 avian flu to have the greatest potential risk for causing a pandemic if it ever achieved a sustained human-to-human transmission.

The virus, first identified in China in 2013, has caused more than 1,500 illnesses, with nearly 40% of those infected dying of the disease.

No human cases of H7N9 influenza have been detected to date in the U.S.

The NIH is sponsoring two phase 2 trials of an experimental H7N9 vaccine developed by Sanofi.

But Fauci warned that if Congress and the American public were waiting for a universal flu vaccine to protect them from all strains of the virus, including the H7N9, that is going to be "years and years and years away."

"There's not going to be one home-run universal flu vaccine" against all strains of the virus, he said.

Rather, there will be various iterations of a universal flu vaccine.

"What we're hoping for is that the first iteration will cover, for example, all of a particular type, like all of the H3N2s," Fauci said. "And if we get that successful, then maybe all of the H1N1s."

Fauci and his colleagues in late February published their strategic plan for pursuing a universal flu vaccine.

At the June 15 hearing, he noted that the NIH and BiondVax Pharmaceuticals Ltd. are running a phase 2 trial of the company's universal flu vaccine candidate, M-001, which got underway earlier this year. The trial is seeking to enroll up to 120 healthy volunteers ages 18 to 49 years.

BiondVax also plans to conduct a pivotal clinical efficacy phase 3 trial in Europe later this year. That trial, which is co-funded by the European Union's European Investment Bank, is seeking to enroll 9,630 participants ages 50 years or older across four to six countries over a period of two flu seasons.

Having the U.S. phase 2 trial underway "means that you're another step closer to getting a product that you'll be able to use," Fauci told lawmakers.

He said that in March, Congress allotted $100 million to the NIH for its universal flu vaccine research — a $40 million boost over last year.

And on June 14, the House Appropriations Committee proposed an additional $30 million for fiscal 2019, Fauci said.

Having a platform technology "where you don't have to wait six to seven months to get a vaccine" should be the highest biopreparedness priority for the U.S., he added.

"It's doable if we put our mind and our resources to it," said Fauci, who has long called for the biopharmaceutical industry to move away from the 70-year-old antiquated egg-based process of developing a flu vaccine.

FDA lab-acquired infections

During the June 15 hearing, Food and Drug Administration Chief Scientist Denise Hinton confirmed there were two laboratory-acquired infections in the past year at the agency's labs.

"The staff that had acquired those infections have been observed and the case is closed," Hinton told the subcommittee.

Hinton did not identify the types of infections.

An FDA spokeswoman told S&P Global Market Intelligence that because there had been so few incidences of exposure, "disclosure of the specific type of exposure could violate patient privacy."

At the hearing, Hinton emphasized that those infections were not caused by any federal select agents — biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products — and as far as she knew, there had been no exposures to those threat agents at the FDA's labs in the past year.

Rep. Morgan Griffith, R-Va., noted that in 2014 and 2015, there were several high-profile incidents in which select agents, including smallpox, Ebola and anthrax, were inadvertently released from high-containment laboratories operated by the FDA, CDC, NIH and the Department of Defense.

House seeks CDC funding cuts

While the NIH stands to gain big in the House proposed fiscal 2019 federal budget — possibly garnering an additional $1.25 billion, for a total of $38.3 billion — the CDC would again see its funding cut, this time by as much as $663 million below the fiscal 2018 enacted level. The House's proposed total of $7.6 billion for the CDC, however, is still $2 billion more than what President Donald Trump requested for the agency.

House appropriators noted that drop in the CDC's funding is due to Trump's proposed transfer of the Strategic National Stockpile — a cache of drugs and other medical supplies stored for responding to large-scale emergencies, like a bioterrorism attack or a pandemic virus — from the agency to the Office of the Assistant Secretary for Preparedness and Response, or ASPR.

Rep. Gregg Harper, R-Miss., chairman of the Oversight and Investigations Subcommittee, noted that the Health and Human Services Office of Inspector General in June 2017 reported systemic issues with security and inventory management of the stockpile, risking the CDC's ability to deploy the supplies during a public health emergency.

"These issues need to be addressed, as does improving the training of state and local stakeholders on deployment of medical countermeasures," Harper said at the June 15 hearing.

In moving the stockpile to ASPR, the program would gain an additional $100 million under the House proposal.

The House appropriations bill also includes a proposal to establish a $300 million Infectious Disease Rapid Response Reserve Fund intended for pandemic response and for tracking children and families affected by the Zika virus. The fund, which will be overseen by the CDC, also would be used to address infectious diseases in high-risk areas, especially those disproportionately affected by the opioid crisis.

But under the House proposal, the CDC would lose its climate change program. The spending bill also calls for continuing the longstanding prohibition against using federal funds to advocate or promote gun control — the so-called Dickey Amendment.

Opioid funding, more bills

Another winner in the House appropriations bill, if adopted, would be the Substance Abuse and Mental Health Administration, whose fiscal 2019 budget would rise by $448 million over the current enacted level. The $5.6 billion total funds the House is seeking to pass for the agency also would be $2.1 billion over what Trump requested.

The House this week is expected to take up another slew of bills aimed at addressing the U.S. opioid crisis. On June 12, the chamber adopted 25 measures that were advanced out of the Energy and Commerce Committee.

On June 13, the House also adopted the Stop Illicit Drug Importation Act, which will give the FDA additional tools to intercept packages containing illicit drugs.

And on June 14, the chamber passed an additional measure — the Synthetic Trafficking and Overdose Prevention — which is aimed at preventing illicit fentanyl and its synthetic analogs from being shipped into the U.S. through the nation's mail system.

But opponents of the bill said the legislation placed too heavy of a burden on the U.S. Postal Service by requiring it to transmit advance electronic data to U.S. Customs and Border Protection for 70% of the international packages by the end of 2018 and all of them by 2020.

Also last week, the Senate Finance Committee advanced the Helping to End Addiction and Lessen Substance Use Disorders Act. That measure is expected to be folded into a large legislative package advanced to the Senate floor in April by the Health, Education, Labor and Pensions Committee.