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More $$ Needed for Health Emergencies, Senators Told

More $$ Needed for Health Emergencies, Senators Told

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WASHINGTON — The Department of Health and Human Services (HHS) needs more funding to effectively prepare for public health emergencies, an HHS official said at a Senate hearing Wednesday.

“We can’t do more things with limited resources,” Robert Kadlec, MD, HHS assistant secretary for preparedness and response, told members of the Senate Health, Education, Labor, & Pensions (HELP) Committee. “We have to highlight the fact that right now we’re operating with about half an aircraft carrier [in terms of the] resources to do this mission, to protect 320 million people. And that’s a challenge.”

“We have a $3.3 trillion healthcare system, of which we invest $250 million for preparedness … It’s just a drop in the bucket.”

The hearing focused on the pending reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), a 2006 law that established Kadlec’s position at HHS and implemented several programs aimed at getting the nation ready for emergencies, such as developing and acquiring drugs and vaccines to be used when needed.

“We should be proud of the accomplishments of PAHPA and the progress made over the past decade,” said committee member Sen. Richard Burr (R-N.C.). “It’s created greater certainty and accountability … and established a clear strategy with which we can combat public health threats we face today. But despite this progress, we’re not fully prepared, and more work remains to accomplish this goal.”

The hurricane in Puerto Rico provided solid evidence that much work still remains, testified FDA Commissioner Scott Gottlieb, MD. “The hurricane showed the importance of Puerto Rico to the medical product manufacturing base, and the inadequacies of our supply chain,” he said.

Saline solution in particular has been in and out of shortage for several years, and when one manufacturers lowers production there is stress on the entire system, Gottlieb continued. “One [major saline manufacturer] is Baxter and their [big site] is in Puerto Rico … Many plants lost power after the storm and roads were disabled … We worked to make sure they could get back on the power grid on priority basis to stabilize production.” The agency also worked to get saline imported from abroad.

But the shortage also had ripple effects, he added. “One strategy had hospitals compounding the product themselves, causing an increased demand for empty IV bags … The FDA is taking steps to address this situation; I’ve reached out to some [bag] manufacturers personally to [find out about] increased production should the shortage continue to increase.”

Sen. Patty Murray (D-Wash.) the committee’s ranking member, asked what was being done to help special needs patients during public health emergencies, including people with disabilities, children, and pregnant women. “PAHPA acknowledges that specific attention needs to be paid to at-risk individuals,” she said.

Stephen Redd, MD, director of the office of public health preparedness and response at the CDC, said guidance at his agency “requires states to have a plan for persons with functional needs. We also work closely with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists to make sure those needs are being covered.” And in the drug stockpile that the government keeps for emergencies, “we’ve made progress producing products for kids, such as oseltamivir (Tamiflu) in suspension form which is targeted to children.”

While the law gave the FDA new authority with regard to pediatric dosing requirements, “we need better animal models … that allow us to predict what the therapeutic impact is going to be on the pediatric population,” said Gottlieb. “This is a scientific base that still needs further development.”

HHS worked to help patients with disabilities during the hurricanes, Kadlec noted. The agency’s emPOWER initiative, for example, “allows us to identify people who are dependent on medical equipment. In Florida we were able to do reverse 911 calls to people at risk, well before evacuation orders, to advise them that they should consider leaving before things get worse.”

The National Disaster Medical System is one area that needs more work, he added. “We would like to take the lessons we learned from Ebola, where we created a national center of excellence in Nebraska for infectious diseases, and replicate that” in other areas, such as pediatrics, as a way to create a critical mass of expertise.

Although the hearing was generally convivial, Murray expressed disappointment at the meeting’s outset that CDC director Brenda Fitzgerald, MD, couldn’t testify because of conflicts of interest presented by her investments.

“Our CDC director still has to recuse herself on some of the important health issues that we face, including issues related to data collection and information sharing, which are very relevant to the conversation we’re having today. I’m concerned she still can’t give her full attention to all of the pressing health threats we face, and I hope all these conflicts will be resolved soon,” she said.

Committee member Sen. Johnny Isakson (R-Ga.) responded that, as chairman of the Senate Select Committee on Ethics, he had spoken with Fitzgerald on Wednesday “and I have gotten her in touch with the appropriate people to deal with the issue. She is forthrightly dealing with it to the best I can determine and I’m working expeditiously to see that we can get it done as quickly as possible, so she will not be in conflict to testify whatsoever. And that is her desire as well.”

The committee will continue discussing PAHPA at a hearing next Tuesday.

2018-01-17T16:45:37-0500

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