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Miriam Carey, 34 Woman shot and killed by Capitol police after chaotic chase from White House Barack Obama was obamas daughter
Miriam Carey, 34 Woman shot and killed by Capitol police after chaotic chase from White House Barack Obama was obamas daughter
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Wednesday, October 15, 2014
OBAMA GAVE THE MONEY FOR EBOLA TO HIS TOP DONOR FOR SMALL POXX
Obama awards $433 million no-bid contract for questionable drug to top donor!
Sunday, November 13, 2011
Senior officials have taken unusual steps to secure the contract for New York-based Siga Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, one of the world’s richest men and a longtime Democratic Partydonor.
When Siga complained that contracting specialists at the Department of Health and Human Services were resisting the company’s financial demands, senior officials replaced the government’s lead negotiator for the deal, interviews and documents show.
When Siga was in danger of losing its grip on the contract a year ago, the officials blocked other firms from competing.
Siga was awarded the final contract in May through a “sole-source” procurement in which it was the only company asked to submit a proposal. The contract calls for Siga to deliver 1.7 million doses of the drug for the nation’s biodefense stockpile. The price of approximately $255 per dose is well above what the government’s specialists had earlier said was reasonable, according to internal documents and interviews.
Read the rest of this Patriot Update article here: http://patriotupdate.com/2011/11/obama-awards-433-million-no-bid-contract-for-questionable-drug-to-top-donor/#T4rQcfhlZSHQkCLY.99
Cost, need questioned in $433-million smallpox drug deal
A company controlled by a longtime political donor gets a no-bid contract to supply an experimental remedy for a threat that may not exist.
November 13, 2011|By David Willman, Los Angeles Times
Reporting
from Washington — Over the last year, the Obama administration has
aggressively pushed a $433-million plan to buy an experimental smallpox
drug, despite uncertainty over whether it is needed or will work.
Senior officials have taken unusual steps to secure the contract for New York-based Siga Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, one of the world's richest men and a longtime Democratic Party donor.
When Siga complained that contracting specialists at the Department of Health and Human Services were resisting the company's financial demands, senior officials replaced the government's lead negotiator for the deal, interviews and documents show.
When Siga was in danger of losing its grip on the contract a year ago, the officials blocked other firms from competing.
Senior officials have taken unusual steps to secure the contract for New York-based Siga Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, one of the world's richest men and a longtime Democratic Party donor.
When Siga complained that contracting specialists at the Department of Health and Human Services were resisting the company's financial demands, senior officials replaced the government's lead negotiator for the deal, interviews and documents show.
When Siga was in danger of losing its grip on the contract a year ago, the officials blocked other firms from competing.
Siga was awarded the final contract in May through a "sole-source"
procurement in which it was the only company asked to submit a proposal.
The contract calls for Siga to deliver 1.7 million doses of the drug
for the nation's biodefense stockpile. The price of approximately $255
per dose is well above what the government's specialists had earlier
said was reasonable, according to internal documents and interviews.
Once feared for its grotesque pustules and 30% death rate, smallpox was eradicated worldwide as of 1978 and is known to exist only in the locked freezers of a Russian scientific institute and the U.S. government. There is no credible evidence that any other country or a terrorist group possesses smallpox.
If there were an attack, the government could draw on $1 billion worth of smallpox vaccine it already owns to inoculate the entire U.S. population and quickly treat people exposed to the virus. The vaccine, which costs the government $3 per dose, can reliably prevent death when given within four days of exposure.
Siga's drug, an antiviral pill called ST-246, would be used to treat people who were diagnosed with smallpox too late for the vaccine to help. Yet the new drug cannot be tested for effectiveness in people because of ethical constraints — and no one knows whether animal testing could prove it would work in humans.
The government's pursuit of Siga's product raises the question: Should the U.S. buy an unproven drug for such a nebulous threat?
"We've got a vaccine that I hope we never have to use — how much more do we need?" said Dr. Donald A. "D.A." Henderson, the epidemiologist who led the global eradication of smallpox for the World Health Organization and later helped organize U.S. biodefense efforts under President George W. Bush. "The bottom line is, we've got a limited amount of money."
Dr. Thomas M. Mack, an epidemiologist at USC's Keck School of Medicine, battled smallpox outbreaks in Pakistan and has advised the Food and Drug Administration on the virus. He called the plan to stockpile Siga's drug "a waste of time and a waste of money."
The Obama administration official who has overseen the buying of Siga's drug says she is trying to strengthen the nation's preparedness. Dr. Nicole Lurie, a presidential appointee who heads biodefense planning at Health and Human Services, cited a 2004 finding by the Bush administration that there was a "material threat" smallpox could be used as a biological weapon.
Smallpox is one of 12 pathogens for which such determinations have been made.
"I don't put probabilities around anything in terms of imminent or not," said Lurie, a physician whose experience in public health includes government service and work with the Rand Corp. "Because what I can tell you is, in the two-plus years I've been in this job, it's the unexpected that always happens."
Once feared for its grotesque pustules and 30% death rate, smallpox was eradicated worldwide as of 1978 and is known to exist only in the locked freezers of a Russian scientific institute and the U.S. government. There is no credible evidence that any other country or a terrorist group possesses smallpox.
If there were an attack, the government could draw on $1 billion worth of smallpox vaccine it already owns to inoculate the entire U.S. population and quickly treat people exposed to the virus. The vaccine, which costs the government $3 per dose, can reliably prevent death when given within four days of exposure.
Siga's drug, an antiviral pill called ST-246, would be used to treat people who were diagnosed with smallpox too late for the vaccine to help. Yet the new drug cannot be tested for effectiveness in people because of ethical constraints — and no one knows whether animal testing could prove it would work in humans.
The government's pursuit of Siga's product raises the question: Should the U.S. buy an unproven drug for such a nebulous threat?
"We've got a vaccine that I hope we never have to use — how much more do we need?" said Dr. Donald A. "D.A." Henderson, the epidemiologist who led the global eradication of smallpox for the World Health Organization and later helped organize U.S. biodefense efforts under President George W. Bush. "The bottom line is, we've got a limited amount of money."
Dr. Thomas M. Mack, an epidemiologist at USC's Keck School of Medicine, battled smallpox outbreaks in Pakistan and has advised the Food and Drug Administration on the virus. He called the plan to stockpile Siga's drug "a waste of time and a waste of money."
The Obama administration official who has overseen the buying of Siga's drug says she is trying to strengthen the nation's preparedness. Dr. Nicole Lurie, a presidential appointee who heads biodefense planning at Health and Human Services, cited a 2004 finding by the Bush administration that there was a "material threat" smallpox could be used as a biological weapon.
Smallpox is one of 12 pathogens for which such determinations have been made.
"I don't put probabilities around anything in terms of imminent or not," said Lurie, a physician whose experience in public health includes government service and work with the Rand Corp. "Because what I can tell you is, in the two-plus years I've been in this job, it's the unexpected that always happens."
Negotiations over the price of the drug and Siga's profit margin were
contentious. In an internal memo in March, Dr. Richard J. Hatchett,
chief medical officer for HHS' biodefense preparedness unit, said Siga's
projected profit at that point was 180%, which he called "outrageous."
In an email earlier the same day, a department colleague told Hatchett that no government contracting officer "would sign a 3 digit profit percentage."
In April, after Siga's chief executive, Dr. Eric A. Rose, complained in writing about the department's "approach to profit," Lurie assured him that the "most senior procurement official" would be taking over the negotiations.
"I trust this will be satisfactory to you," Lurie wrote Rose in a letter.
In an interview, Lurie said the contract was awarded strictly on merit. She said she had discussed buying a smallpox antiviral for the nation's emergency stockpile with White House officials and with HHS Secretary Kathleen Sebelius, but that the conversations focused on policy, not the manufacturer.
"We discussed the need for the product, and a need for a product to be stockpiled," Lurie said. "And we discussed an impending procurement."
In an email earlier the same day, a department colleague told Hatchett that no government contracting officer "would sign a 3 digit profit percentage."
In April, after Siga's chief executive, Dr. Eric A. Rose, complained in writing about the department's "approach to profit," Lurie assured him that the "most senior procurement official" would be taking over the negotiations.
"I trust this will be satisfactory to you," Lurie wrote Rose in a letter.
In an interview, Lurie said the contract was awarded strictly on merit. She said she had discussed buying a smallpox antiviral for the nation's emergency stockpile with White House officials and with HHS Secretary Kathleen Sebelius, but that the conversations focused on policy, not the manufacturer.
"We discussed the need for the product, and a need for a product to be stockpiled," Lurie said. "And we discussed an impending procurement."
Cost, need questioned in $433-million smallpox drug deal
A company controlled by a longtime political donor gets a no-bid contract to supply an experimental remedy for a threat that may not exist.
November 13, 2011|By David Willman, Los Angeles Times
Lurie denied that she had spoken with or written to Rose regarding the
contract, saying such contact would have been inappropriate.
But in a subsequent statement, an HHS spokeswoman acknowledged Lurie's letter to Rose, saying it "reflects the critical importance of the potential procurement to national security."
Representatives of Siga, speaking on the condition they not be identified, said the new drug has been effective in animal testing and that the company is being paid a price commensurate with its value.
Neither the HHS spokeswoman nor the Siga representatives would disclose the agreed-upon profit margin or the per-treatment price. Siga has cited terms of the contract in its public financial statements — but without those financial details.
But in a subsequent statement, an HHS spokeswoman acknowledged Lurie's letter to Rose, saying it "reflects the critical importance of the potential procurement to national security."
Representatives of Siga, speaking on the condition they not be identified, said the new drug has been effective in animal testing and that the company is being paid a price commensurate with its value.
Neither the HHS spokeswoman nor the Siga representatives would disclose the agreed-upon profit margin or the per-treatment price. Siga has cited terms of the contract in its public financial statements — but without those financial details.
Worst-case scenarios
Worrying about worst-case scenarios is what biodefense planners do. In the case of smallpox, millions of Americans have no immunity because the vaccination of civilians ended in 1972. And there is no way to guarantee that a rogue regime such as North Korea is not holding smallpox.
Nonetheless, no such threat has been verified. The Bush administration suspected Saddam Hussein of possessing smallpox and other biological weapons, but inspectors did not find any after the U.S. invaded Iraq in 2003.
Still, pressure to move quickly and spend more has helped shape U.S. biodefense policy since the Sept. 11, 2001, terrorist attacks and the anthrax mailings that fall.
Investors such as Perelman saw opportunity. In 2003, Perelman, through his holding company MacAndrews & Forbes Holdings Inc., invested heavily in Siga and installed a team of executives to run it.
The move seemed prescient when Bush, in June 2004, signed Project BioShield, a 10-year, $5.6-billion initiative to fund the development and stockpiling of medications to counter bioterrorism.
Two months later, Siga purchased the rights to what became known as ST-246 and other assets from a Pennsylvania company, ViroPharma Inc., for $1 million in cash and 1 million shares of Siga's common stock. Over the next three years, the National Institute of Allergy and Infectious Diseases awarded Siga two research grants and a related contract, worth a total of $23.5 million, to develop the new drug.
From the outset, there was only one potential customer: the U.S. government.
For Siga, the stakes were high. ST-246 was its most promising experimental compound.
From 2005 through September, the company has paid three lobbying firms $800,000 to represent its interests in Washington, public records show. Disclosures filed by the lobbyists said they focused on Project BioShield and "issues related to homeland security and HHS," along with "government procurement of vaccines."
Siga representatives told The Times that the company had lobbied only "generally" for biodefense spending, adding: "Neither Siga nor anyone else on Siga's behalf ever lobbied anyone to get this contract."
Perelman and others at Siga's affiliate, MacAndrews & Forbes, have long been major political donors. They gave a total of $607,550 to federal campaigns for the 2008 and 2010 elections, according to records compiled by the Center for Responsive Politics. About 65% of that money went to Democrats. Perelman donated an additional $50,000 to President Obama's inauguration.
Worrying about worst-case scenarios is what biodefense planners do. In the case of smallpox, millions of Americans have no immunity because the vaccination of civilians ended in 1972. And there is no way to guarantee that a rogue regime such as North Korea is not holding smallpox.
Nonetheless, no such threat has been verified. The Bush administration suspected Saddam Hussein of possessing smallpox and other biological weapons, but inspectors did not find any after the U.S. invaded Iraq in 2003.
Still, pressure to move quickly and spend more has helped shape U.S. biodefense policy since the Sept. 11, 2001, terrorist attacks and the anthrax mailings that fall.
Investors such as Perelman saw opportunity. In 2003, Perelman, through his holding company MacAndrews & Forbes Holdings Inc., invested heavily in Siga and installed a team of executives to run it.
The move seemed prescient when Bush, in June 2004, signed Project BioShield, a 10-year, $5.6-billion initiative to fund the development and stockpiling of medications to counter bioterrorism.
Two months later, Siga purchased the rights to what became known as ST-246 and other assets from a Pennsylvania company, ViroPharma Inc., for $1 million in cash and 1 million shares of Siga's common stock. Over the next three years, the National Institute of Allergy and Infectious Diseases awarded Siga two research grants and a related contract, worth a total of $23.5 million, to develop the new drug.
From the outset, there was only one potential customer: the U.S. government.
For Siga, the stakes were high. ST-246 was its most promising experimental compound.
From 2005 through September, the company has paid three lobbying firms $800,000 to represent its interests in Washington, public records show. Disclosures filed by the lobbyists said they focused on Project BioShield and "issues related to homeland security and HHS," along with "government procurement of vaccines."
Siga representatives told The Times that the company had lobbied only "generally" for biodefense spending, adding: "Neither Siga nor anyone else on Siga's behalf ever lobbied anyone to get this contract."
Perelman and others at Siga's affiliate, MacAndrews & Forbes, have long been major political donors. They gave a total of $607,550 to federal campaigns for the 2008 and 2010 elections, according to records compiled by the Center for Responsive Politics. About 65% of that money went to Democrats. Perelman donated an additional $50,000 to President Obama's inauguration.
A spokeswoman for Perelman said his contributions reflected nothing
more than "his right as a citizen to support candidates he believes in."
From December 2007 to January of this year, Rose, Siga's chief executive, served on the U.S. National Biodefense Science Board, which has advised Lurie on how to respond to biological terrorism and other potential health emergencies. (Rose was appointed during the Bush administration.)
In June 2010, Siga further heightened its presence in Washington by naming to its board Andrew Stern, former head of the Service Employees International Union and a frequent visitor to the Obama White House. The union is a wellspring of campaign money and volunteers for Democratic candidates.
On Oct. 13, 2010, Siga announced that the government intended to award it a contract for ST-246 worth as much as $2.8 billion. Within days, Siga's stock price soared. In its year-end financial statement, the company said:
"Our ability to generate near-term revenue is particularly dependent on the success of our smallpox antiviral drug candidate."
But the federal contract required that the winning bidder be a small business, with no more than 500 employees. Chimerix Inc., a North Carolina company that had competed for the contract, protested, saying Siga was too big.
Officials at the Small Business Administration investigated and quickly agreed, finding that Siga's affiliation with MacAndrews & Forbes disqualified it.
The Obama administration could have awarded the contract to Chimerix as the only eligible small-business applicant. Or it could have reopened the competition to companies of any size.
From December 2007 to January of this year, Rose, Siga's chief executive, served on the U.S. National Biodefense Science Board, which has advised Lurie on how to respond to biological terrorism and other potential health emergencies. (Rose was appointed during the Bush administration.)
In June 2010, Siga further heightened its presence in Washington by naming to its board Andrew Stern, former head of the Service Employees International Union and a frequent visitor to the Obama White House. The union is a wellspring of campaign money and volunteers for Democratic candidates.
On Oct. 13, 2010, Siga announced that the government intended to award it a contract for ST-246 worth as much as $2.8 billion. Within days, Siga's stock price soared. In its year-end financial statement, the company said:
"Our ability to generate near-term revenue is particularly dependent on the success of our smallpox antiviral drug candidate."
But the federal contract required that the winning bidder be a small business, with no more than 500 employees. Chimerix Inc., a North Carolina company that had competed for the contract, protested, saying Siga was too big.
Officials at the Small Business Administration investigated and quickly agreed, finding that Siga's affiliation with MacAndrews & Forbes disqualified it.
The Obama administration could have awarded the contract to Chimerix as the only eligible small-business applicant. Or it could have reopened the competition to companies of any size.
Cost, need questioned in $433-million smallpox drug deal
A company controlled by a longtime political donor gets a no-bid contract to supply an experimental remedy for a threat that may not exist.
November 13, 2011|By David Willman, Los Angeles Times
Instead, the administration moved to block all companies — except Siga — from bidding on a second offering of the contract.
In early December, officials completed a required "justification for other than full and open competition," which said an antiviral against smallpox was needed within five years and Siga was the only company able to meet that timetable.
The rationale was questioned by some in HHS, including contracting officer Brian K. Goodger, who in an internal email called it "a stretch."
On Feb. 18, HHS terminated the original contract and requested a proposal from Siga.
Siga and government officials soon began tangling over the price the company would be paid. Because the contract was no longer to be awarded based on competition and because the only customer was the government, officials sought to assess whether the company's proposed price was "fair and reasonable," as required by federal law.
In early December, officials completed a required "justification for other than full and open competition," which said an antiviral against smallpox was needed within five years and Siga was the only company able to meet that timetable.
The rationale was questioned by some in HHS, including contracting officer Brian K. Goodger, who in an internal email called it "a stretch."
On Feb. 18, HHS terminated the original contract and requested a proposal from Siga.
Siga and government officials soon began tangling over the price the company would be paid. Because the contract was no longer to be awarded based on competition and because the only customer was the government, officials sought to assess whether the company's proposed price was "fair and reasonable," as required by federal law.
In so doing, officials looked at how much government money had already
gone into developing ST-246. Public records show $115 million in federal
support, not including the stockpile contract.
After reviewing Siga's costs and the prices of other drugs produced in low volumes compared with commercial products, the HHS negotiators wanted to pay about $170 for each treatment. The company argued for more based on ST-246's potential value to the nation.
"Siga did not derive its price based on any cost information, and, from Siga's viewpoint, such information is not relevant to determination of an appropriate price," the company's chief financial officer, Daniel J. Luckshire, wrote to Lurie's office and others on March 4.
"Siga has created extremely valuable intellectual property, embodied in ST-246, and Siga has priced ST-246 based on the value of that intellectual property," Luckshire added.
After the two sides had conferred and again aired their differences, a senior HHS official, Michael A. Balady, told a colleague in an email April 4 that the negotiations "went extremely badly.… They are intransigent on price."
On April 6, Rose emailed the government's chief negotiator, D. Andre Early, saying the two sides were "at impasse." Rose said "any further negotiation should occur with a more senior official [with] the authority to take into account the important policy issues that surround this procurement."
Two days later, Lurie wrote her conciliatory letter to Rose, pledging to install a new lead negotiator. Her top subordinate, Balady, followed through by naming Goodger to replace Early, who continued to work on the contract but not as lead negotiator.
A financial analyst for RBC Capital Markets reported to investors in May that the agreed-upon price per dose appeared to be $255. He arrived at that estimate by dividing the $433-million contract by the 1.7 million doses to be delivered. Siga told The Times that this would give a rough approximation of the per-treatment price.
On May 13, HHS announced what amounted to the second awarding of the contract, worth between $433 million and $2.8 billion, depending on whether the government exercised options to buy more of the drug in future years. Siga hailed it as a "historic event for the biodefense industry."
FDA skepticism
Throughout the negotiations over price and profit, a separate issue loomed: uncertainty over whether the Food and Drug Administration would approve ST-246 for use in humans.
After reviewing Siga's costs and the prices of other drugs produced in low volumes compared with commercial products, the HHS negotiators wanted to pay about $170 for each treatment. The company argued for more based on ST-246's potential value to the nation.
"Siga did not derive its price based on any cost information, and, from Siga's viewpoint, such information is not relevant to determination of an appropriate price," the company's chief financial officer, Daniel J. Luckshire, wrote to Lurie's office and others on March 4.
"Siga has created extremely valuable intellectual property, embodied in ST-246, and Siga has priced ST-246 based on the value of that intellectual property," Luckshire added.
After the two sides had conferred and again aired their differences, a senior HHS official, Michael A. Balady, told a colleague in an email April 4 that the negotiations "went extremely badly.… They are intransigent on price."
On April 6, Rose emailed the government's chief negotiator, D. Andre Early, saying the two sides were "at impasse." Rose said "any further negotiation should occur with a more senior official [with] the authority to take into account the important policy issues that surround this procurement."
Two days later, Lurie wrote her conciliatory letter to Rose, pledging to install a new lead negotiator. Her top subordinate, Balady, followed through by naming Goodger to replace Early, who continued to work on the contract but not as lead negotiator.
A financial analyst for RBC Capital Markets reported to investors in May that the agreed-upon price per dose appeared to be $255. He arrived at that estimate by dividing the $433-million contract by the 1.7 million doses to be delivered. Siga told The Times that this would give a rough approximation of the per-treatment price.
On May 13, HHS announced what amounted to the second awarding of the contract, worth between $433 million and $2.8 billion, depending on whether the government exercised options to buy more of the drug in future years. Siga hailed it as a "historic event for the biodefense industry."
FDA skepticism
Throughout the negotiations over price and profit, a separate issue loomed: uncertainty over whether the Food and Drug Administration would approve ST-246 for use in humans.
For more than a year, the enthusiasm of HHS officials for stockpiling
the drug has stood in contrast to the skepticism of the FDA. The
agency's stance is important because the contract requires Siga to
develop its drug "for ultimate approval by the FDA."
In a June 2010 email, Gary Disbrow, a virologist in HHS' biomedical unit, shared with colleagues his assessment of where the FDA stood on the smallpox drugs being developed by Siga and Chimerix, the North Carolina company: "My interpretation of their current position is that there is NO foreseeable path to licensure."
The problem was the inherent limits of animal testing in determining whether the drugs would be safe and effective in fighting smallpox in humans. Researchers are prohibited from infecting humans with the virus.
In May of this year, Robert G. Kosko Jr., a manager in the FDA's antiviral-products division, wrote that there was "no clear regulatory path" for approving antiviral drugs for smallpox — again because of the uncertainty surrounding proof of effectiveness.
The FDA has scheduled a public meeting in December to discuss Siga's and Chimerix's drugs. Siga's contract requires it to conduct additional studies to seek the agency's approval.
Lurie said she hoped the FDA would ultimately approve ST-246. "We would not have gone ahead with a procurement unless we thought there was a pathway," she said.
Short shelf life
Unlike the smallpox vaccine, which remains potent for decades, Siga's drug is guaranteed for only 38 months.
The administration had intended to award Siga the exclusive option to replenish or expand the stockpile, but officials relented after Chimerix formally protested. In June, the government settled the dispute by dropping the exclusivity provision. That limited the value of Siga's contract to $433 million and meant that other companies could compete to fill future orders for the drug.
"Though unhappy about it, Eric [Rose of Siga] would rather remove the options than take the chance of possibly losing the protest and thus the entire contract," Goodger wrote to his superiors on June 11.
HHS officials, however, were concerned about how Siga might react. Goodger reassured his higher-ups that despite its disappointment, the company would not seek "any negative publicity."
david.willman@latimes.com
In a June 2010 email, Gary Disbrow, a virologist in HHS' biomedical unit, shared with colleagues his assessment of where the FDA stood on the smallpox drugs being developed by Siga and Chimerix, the North Carolina company: "My interpretation of their current position is that there is NO foreseeable path to licensure."
The problem was the inherent limits of animal testing in determining whether the drugs would be safe and effective in fighting smallpox in humans. Researchers are prohibited from infecting humans with the virus.
In May of this year, Robert G. Kosko Jr., a manager in the FDA's antiviral-products division, wrote that there was "no clear regulatory path" for approving antiviral drugs for smallpox — again because of the uncertainty surrounding proof of effectiveness.
The FDA has scheduled a public meeting in December to discuss Siga's and Chimerix's drugs. Siga's contract requires it to conduct additional studies to seek the agency's approval.
Lurie said she hoped the FDA would ultimately approve ST-246. "We would not have gone ahead with a procurement unless we thought there was a pathway," she said.
Short shelf life
Unlike the smallpox vaccine, which remains potent for decades, Siga's drug is guaranteed for only 38 months.
The administration had intended to award Siga the exclusive option to replenish or expand the stockpile, but officials relented after Chimerix formally protested. In June, the government settled the dispute by dropping the exclusivity provision. That limited the value of Siga's contract to $433 million and meant that other companies could compete to fill future orders for the drug.
"Though unhappy about it, Eric [Rose of Siga] would rather remove the options than take the chance of possibly losing the protest and thus the entire contract," Goodger wrote to his superiors on June 11.
HHS officials, however, were concerned about how Siga might react. Goodger reassured his higher-ups that despite its disappointment, the company would not seek "any negative publicity."
david.willman@latimes.com
Hillary Clinton Open to GOP Obamacare Demand on Medical Devices
Hillary Clinton Open to GOP Obamacare Demand on Medical Devices
Oct. 9 (Bloomberg Politics) -- Hillary Clinton signaled she
might be open to repealing a key component of Obamacare during a
speech yesterday at a medical device conference in Chicago.
Since the passage of the landmark health care bill, Republicans have wanted to kill a 2.3 percent excise tax on devices such as defibrillators and pacemakers, usually paid by the devices’ manufacturer or importer. The money it raises -– an estimated $29 billion over a decade – is central to the financing of Obamacare, and the White House opposes its repeal.
In a paid appearance before the Advanced Medical Technology Association, or AdvaMed, Clinton told a ballroom filled with more than 2,000 industry representatives that they “have an argument to make” when it comes to repealing the tax. “We have to look and see what are the pluses and minuses,” she said. “I don’t know what the right answer about the tax is.”
“Let’s look at what we need to do to make sure that the medical technology industry in this country remains innovative, profitable, effective, strongly partnering to lower costs and improve quality,” she said.
AdvaMed includes some of the biggest names in the industry, including Johnson & Johnson, based in New Brunswick, New Jersey; Medtronic Inc. of Minneapolis; Abbott Laboratories (ABT), of Abbott, Illinois; Boston Engineering Corp. of Waltham, Massachusetts, and Baxter International Inc. (BAX) of Deerfield, Illinois.
More broadly, Clinton praised Obamacare, saying it’s helping families avoid bankruptcy and ensuring that “women are no longer charged more solely because of our gender.” At the same time, she said “there is more work to be done” to improve the law and American health care delivery.
“All of this work will be easier if we get beyond politics,” she said. “Too often our health care debates are clouded by ideology, rather than illuminated by data.”
Over time, she said, the law will help the U.S. economy.
“We’re among the many American families who have stories about why what you do is truly life changing and life-saving,” she said.
Clinton’s Chicago visit also included an appearance with Illinois Governor Pat Quinn, one of many political stops she’s expected to make before the Nov. 4 midterms. At a minimum, she’s expected to also campaign for Senate candidates in Colorado, Georgia, Iowa, North Carolina and New Hampshire.
To contact the author on this story: John McCormick at jmccormick16@bloomberg.net
To contact the reporter on this story: John McCormick in Chicago at jmccormick16@bloomberg.net To contact the editors responsible for this story: Kerry Luft at kluft2@bloomberg.net Elizabeth Wasserman
Since the passage of the landmark health care bill, Republicans have wanted to kill a 2.3 percent excise tax on devices such as defibrillators and pacemakers, usually paid by the devices’ manufacturer or importer. The money it raises -– an estimated $29 billion over a decade – is central to the financing of Obamacare, and the White House opposes its repeal.
In a paid appearance before the Advanced Medical Technology Association, or AdvaMed, Clinton told a ballroom filled with more than 2,000 industry representatives that they “have an argument to make” when it comes to repealing the tax. “We have to look and see what are the pluses and minuses,” she said. “I don’t know what the right answer about the tax is.”
“Let’s look at what we need to do to make sure that the medical technology industry in this country remains innovative, profitable, effective, strongly partnering to lower costs and improve quality,” she said.
AdvaMed includes some of the biggest names in the industry, including Johnson & Johnson, based in New Brunswick, New Jersey; Medtronic Inc. of Minneapolis; Abbott Laboratories (ABT), of Abbott, Illinois; Boston Engineering Corp. of Waltham, Massachusetts, and Baxter International Inc. (BAX) of Deerfield, Illinois.
‘Damages Innovation’
“AdvaMed has consistently and strongly opposes the $30 billion medical device tax because it harms job creation, deters medical innovation and increases the cost of health care,” the group says in a position statement on its website. “Congress should repeal it before it can do more damage to American Innovation.”More broadly, Clinton praised Obamacare, saying it’s helping families avoid bankruptcy and ensuring that “women are no longer charged more solely because of our gender.” At the same time, she said “there is more work to be done” to improve the law and American health care delivery.
“All of this work will be easier if we get beyond politics,” she said. “Too often our health care debates are clouded by ideology, rather than illuminated by data.”
Over time, she said, the law will help the U.S. economy.
Bypass, Stents
Clinton also praised the many “contributions” the industry has made, citing her husband’s “quad bypass” heart surgery in 2004 and stents implanted in 2010.“We’re among the many American families who have stories about why what you do is truly life changing and life-saving,” she said.
Clinton’s Chicago visit also included an appearance with Illinois Governor Pat Quinn, one of many political stops she’s expected to make before the Nov. 4 midterms. At a minimum, she’s expected to also campaign for Senate candidates in Colorado, Georgia, Iowa, North Carolina and New Hampshire.
To contact the author on this story: John McCormick at jmccormick16@bloomberg.net
To contact the reporter on this story: John McCormick in Chicago at jmccormick16@bloomberg.net To contact the editors responsible for this story: Kerry Luft at kluft2@bloomberg.net Elizabeth Wasserman
Hospital Preparedness Program (HPP)
Hospital Preparedness Program (HPP)
The
Hospital Preparedness Program (HPP) provides leadership and funding
through grants and cooperative agreements to States, territories, and
eligible municipalities to improve surge capacity and enhance community
and hospital preparedness for public health emergencies. To date,
states, territories, and large metropolitan areas have received HPP
grants totaling over $4 billion to help Healthcare Coalitions, hospitals
and other healthcare organizations strengthen medical surge and other
Healthcare Preparedness Capabilities across the nation. Learn More >>
| National Webinars and Events HPP promotes an ongoing dialogue on topics related to capabilities and preparedness activities for hospitals and healthcare coalitions. During these events, you can learn about real-world examples and lessons learned from experts in the field. Learn More >> | |
| Funding and Grant Opportunities HHS is dedicated to improving preparedness and health outcomes throughout the United States and its territories. HPP grants promote health care and public health systems that are prepared to respond successfully to emergency and recover quickly from all hazards. Learn More >> | |
| Guidance, Research and Reports HPP issues guidance, research and reports to help hospitals and healthcare coalitions meet their preparedness goals, respond to specific threats, leverage lessons learned, and expand their capabilities. These resources can help and healthcare coalitions improve their overall level of preparedness. Learn More >> | |
| HPP in Action: Stories from the Field HPP plays a vital role in providing the funding that hospitals and healthcare coalitions need to prepare themselves to respond in emergencies. Learn how hospital preparedness funding has translated to better health outcomes for people across the country in a wide variety of disasters. Learn More >> | |
| |
Contact Us The Hospital Preparedness Program is excited to engage in a dialogue with our partners. If you have questions or comments about the program or any of our events, guidance or reports, please contact us via e-mail at HPP@hhs.gov. |
- This page last reviewed: October 15, 2014
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Assistant Secretary for Preparedness and Response (ASPR), 200 Independence Ave., SW, Washington, DC 20201Pandemic and All-Hazards Preparedness Reauthorization Act
Pandemic and All-Hazards Preparedness Reauthorization Act
In March 2013 Congress passed and the President signed the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law No. 113-5.
The 2013 law builds on work the U.S. Department of Health and Human
Services has undertaken to advance national health security. These
include authorizing funding for public health and medical preparedness
programs, such as the Hospital Preparedness Program
and the Public Health Emergency Preparedness Cooperative Agreement,
amending the Public Health Service Act to grant state health departments
greatly needed flexibility in dedicating staff resources to meeting
critical community needs in a disaster, authorizing funding through 2018
for buying medical countermeasures under the Project BioShield Act, and
increasing the flexibility of BioShield to support advanced research
and development of potential medical countermeasures. PAHPRA also
enhances the authority of the U.S. Food and Drug Administration to
support rapid responses to public health emergencies.
The purpose of the Pandemic and All-Hazards Preparedness
Reauthorization Act is “to reauthorize certain programs under the Public
Health Service Act and the Federal Food, Drug, and Cosmetic Act with
respect to public health security and all-hazards preparedness.”
Major Program Areas
- National Health Security Strategy
- Assistant Secretary for Preparedness and Response
- National Advisory Committee on Children and Disasters
- Modernization of the National Disaster Medical System
- Temporary reassignment of State and local personnel during a public health emergency
- Improving State and local public health security
- Hospital preparedness and medical surge capacity
- Enhancing situational awareness and biosurveillance
- Enhancing medical countermeasure review
- Accelerating medical countermeasure advanced research and development
Pandemic and All Hazards Preparedness Act
- This page last reviewed: March 18, 2014
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Assistant Secretary for Preparedness and Response (ASPR), 200 Independence Ave., SW, Washington, DC 20201
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