Trump administration to announce changes to anti-kickback rules for healthcare providers

By Carl O’Donnell

(Reuters) – The Trump administration will announce plans to change healthcare regulations on Wednesday to loosen anti-kickback provisions that restrict the kinds of outside services providers can refer patients to, administration officials said.

President Donald Trump on Thursday will explain how the new rules advance his broader healthcare agenda, which includes reducing regulatory burdens and promoting innovative ways to reimburse healthcare providers, in a speech in Minnesota, the officials said.

The plan will change how the Department of Health and Human Services (HHS) enforces the Physician Self Referral Law, also known as the Stark law, which penalizes healthcare providers for referring patients to outside services that the provider could stand to benefit from financially.

HHS will create exceptions for healthcare providers that enter into agreements with other parties if they are aimed at cutting costs and improving patient health, the officials said.

Trump issued an executive order last week that sought to woo seniors by strengthening the Medicare health program.

The order was the Republican president’s answer to Democrats like Bernie Sanders, who is running to become the party’s nominee in the 2020 presidential election and is promoting the idea of Medicare for all Americans.

The Trump administration has also rolled out measures in recent months designed to curtail drug prices and address other problems in the U.S. healthcare system.

Policy experts say the efforts are unlikely to slow the rise of drug prices in a meaningful way, however.

(This story corrects lead to show Trump administration officials, not President Trump, announcing plans on Wednesday)

(Reporting by Carl O’Donnell; Editing by Sonya Hepinstall)

Planned Parenthood sues to block U.S. rule that may limit abortions

FILE PHOTO: A sign is pictured at the entrance to a Planned Parenthood building in New York August 31, 2015. REUTERS/Lucas Jackson/File Photo

By Jonathan Stempel

NEW YORK (Reuters) – Planned Parenthood and other nonprofits offering family planning services sued the Trump administration on Tuesday to block a new federal rule letting healthcare workers refuse abortions and other services because of religious or moral objections.

The two lawsuits filed in Manhattan federal court said enforcing the “conscience” rule would encourage discrimination against women, minorities, the poor, the uninsured, and lesbian, gay, bisexual, transgender and queer people by curbing access to legal healthcare procedures, including life-saving treatments.

They also said the rule, issued by the Department of Health and Human Services and scheduled to take effect on July 22, would impose heavy costs on healthcare providers dependent on federal funding, which they could lose by refusing to comply.

The plaintiffs also include Planned Parenthood of Northern New England Inc, the National Family Planning and Reproductive Health Association and Public Health Solutions Inc. The American Civil Liberties Union represents the latter two nonprofits.

“Trust is the cornerstone of the physician-patient relationship,” Leana Wen, president of Planned Parenthood Federation of America, said in a statement. “No one should have to worry if they will get the right care or information because of their providers’ personal beliefs.”

HHS pledged to defend the rule vigorously. Planned Parenthood said the rule might affect more than 613,000 hospitals, health clinics, doctors’ offices and nonprofits.

The lawsuits escalate the legal battles over a rule announced on May 2 by Republican President Donald Trump, who has made expanding religious liberty a priority, in a Rose Garden speech marking the National Day of Prayer.

They were filed after California, New York, New York City, Chicago and 20 other mostly Democratic-controlled or Democratic-leaning states and municipalities sued the government on May 21 over the rule. San Francisco filed its own lawsuit on May 2.

HHS has said the rule protects the rights of workers who might oppose particular procedures, such as sterilizations and assisted suicides.

It has also said the rule requires compliance with roughly 25 federal laws protecting conscience and religious rights, some of which date back decades.

Roger Severino, director of HHS’ Office for Civil Rights, on Tuesday repeated his May 21 statement that the rule “gives life and enforcement tools” to those laws.

The cases are Planned Parenthood Federation of America Inc et al v Azar et al, U.S. District Court, Southern District of New York, No. 19-05433; and National Family Planning and Reproductive Health Association et al v Azar et al in the same court, No. 19-05435.

(Reporting by Jonathan Stempel in New York; Editing by Tom Brown and Richard Chang)

U.S. health secretary says agency has power to eliminate drug rebates

U.S. Health and Human Services Secretary Alex Azar listens to U.S. White House Press Secretary Sarah Huckabee Sanders introduce him during the daily briefing at the White House in Washington, U.S., May 11, 2018. REUTERS/Leah Millis

By Yasmeen Abutaleb

WASHINGTON (Reuters) – U.S. Health and Human Services Secretary Alex Azar said it was within his agency’s power to eliminate rebates on prescription drug purchases, a key element of the Trump administration’s plan to lower prescription medicine costs.

Such rebates are negotiated in the United States by pharmacy benefits managers (PBMs) to lower the cost of medicines for their clients, including large employers and health plans that cover tens of millions of Americans.

Drugmakers say they are under pressure to provide rebates to the few PBMs that dominate the market and that those payers do not pass on enough of those savings to patients – a contention the PBMs dispute. The drugmakers say the rebates force them to raise the price of their therapies over time to preserve their business.

The Trump administration has been receptive to that argument. Azar, in an interview with Reuters on Friday, said rebates created a perverse incentive to continuously raise drug prices.

Azar, a former top executive at drugmaker Eli Lilly Co, is trying to deliver on President Donald Trump’s promises to lower the cost of prescription drugs for Americans, which Trump made a major priority during his 2016 presidential campaign.

The Department of Health and Human Services last month proposed regulations that would scale back protections for rebates that might otherwise be illegal under a federal anti-kickback law.

The PBM industry has challenged that move, saying HHS cannot eliminate rebates on its own and would need Congress to change the federal statute. The ultimate responsibility for high drug prices, those companies say, lies with the manufacturers who set those prices.

Azar contends that the current rebates are a product of previous HHS regulation. “What one has created by regulation, one could address by regulation,” he added.

He did not say when such new regulations, which are being reviewed by the Office of Management and Budget, might take effect. “The question of rebates may very well be fundamental to the issue of how you reverse these constant incentives to higher list prices (for medicines).”

CAMPAIGN ISSUE

The cost of healthcare, and prescription drugs specifically, is expected to be a major campaign issue ahead of November elections, in which Democrats are seeking to take control of the U.S. House of Representatives and Senate from Trump’s Republicans.

In May, Trump unveiled a “blueprint” comprising dozens of proposed policies to give the government greater leverage over drug prices but did not support changes to give the federal government’s Medicare health plan for seniors direct negotiating power with drugmakers. Critics say that has spared the pharmaceutical industry any real challenge to its pricing practices.

Azar defended the administration’s actions, noting that more than a dozen leading drugmakers, including Pfizer Inc, Merck Co and Celgene Corp, had pledged to hold off on further price increases this year.

“They are seeing where this is going, they are seeing that we are ticking off the blueprint items one by one,” Azar said. “We are not dependent on the voluntary action of pharmaceutical companies. We are not counting on their goodwill or their altruism. … They’re just changing because they see that’s the future.”

Critics say the drug price pledges by major drugmakers are largely window dressing.

Since May, HHS has given Medicare Advantage health plans, which are administered by private-sector health insurers, new tools to lower prescription drug costs.

The agency’s Food and Drug Administration has unveiled a plan to boost the use of biosimilars, which are cheaper versions of expensive biotech medicines. Azar has directed the FDA to establish a working group to study how to import drugs safely from other countries if a drugmaker dramatically raises prices.

The actions have already sparked concerns. Last week, a leading group of rheumatologists met with Azar to discuss changes to Medicare Advantage that could force some patients to try a less effective, cheaper medication for a period of time before their health plan would cover a more expensive therapy.

HHS said Azar emphasized the agency’s interest in lowering drug prices but expressed openness to alleviating burdens that could be placed on physicians as a result of the new rule.

Azar said he spoke with Trump every few days, either in person or over the phone and that in every conversation, the president wanted to hear about progress on lowering prescription medicine costs.

“I have never once had a meeting or phone call with the president where we have not talked about drug pricing,” Azar said.

(Reporting by Yasmeen Abutaleb; Editing by Michele Gershberg and Peter Cooney)

Trump says would back both House immigration bills as separation crisis grows

U.S. President Donald Trump speaks briefly to the news media after leaving a closed House Republican Conference meeting with House Majority Leader Kevin McCarthy (R-CA) at the U.S. Capitol in Washington, D.C., U.S., June 19, 2018. REUTERS/Leah Millis

By Sarah N. Lynch and Susan Cornwell

WASHINGTON (Reuters) – U.S. President Donald Trump told Republican lawmakers on Tuesday he would back either of the immigration bills making their way through the House of Representatives, as the outcry grew over his administration’s separation of immigrant parents and children at the U.S.-Mexico border.

Representative Mark Meadows said Trump told Republican members of the House at a meeting on Capitol Hill that they needed to get something done on immigration “right away.”

In the meeting, Trump said separating families was “certainly not an attractive thing and does look bad,” added Representative Tom Cole.

Congressional Republicans have been scrambling to craft legislation as videos of youngsters in cages and an audiotape of wailing children have sparked anger at home from groups ranging from clergy to influential business leaders, as well as condemnation abroad.

A Reuters/Ipsos national opinion poll released on Tuesday showed fewer than one in three American adults supporting the policy. The June 16-19 poll found that 28 percent of people polled supported the policy, while 57 percent opposed it and the remaining 15 percent said they did not know.

Trump, who has made a tough stance on immigration a centerpiece of his presidency, has staunchly defended his administration’s actions. He has cast blame for the family separations on Democrats, although his fellow Republicans control both chambers in Congress and his own administration implemented the current policy of strict adherence to immigration laws.

The president has sought to link an end to the family separations to passage of a wider bill on immigration, which would include funding for his long-sought border wall with Mexico, prompting Democrats to accuse him of using children as hostages.

“In his remarks, he endorsed both House immigration bills that build the wall, close legal loopholes, cancel the visa lottery, curb chain migration, and solve the border crisis and family separation issue by allowing for family detention and removal,” White House spokesman Raj Shah said of Trump.

An unidentified person yelled an obscenity at the president before he entered the meeting.

Earlier on Tuesday, the president tried again to blame Democrats for what he called “loopholes” in the law that require families detained for entering the country illegally either to be separated or released.

“These are crippling loopholes that cause family separation, which we don’t want,” he said in remarks to the National Federation of Independent Business, adding he wanted Congress to give him the legal authority to detain and deport families together.

A U.S. border patrol truck drives along the border fence with Mexico and pass the Christo Rey Statue on Mt. Chirsto in Sunland Park, New Mexico, U.S. June 18, 2018. REUTERS/Mike Blake

A U.S. border patrol truck drives along the border fence with Mexico and pass the Christo Rey Statue on Mt. Chirsto in Sunland Park, New Mexico, U.S. June 18, 2018. REUTERS/Mike Blake

BILL WOULD PREVENT SOME SEPARATIONS

House Republicans were working on a revised draft of one version of an immigration overhaul that would prevent family separations in some cases for those attempting an illegal border crossing for the first time, according to a House Republican aide.

The draft bill was seen just days ago as unlikely to pass, but has gained support in the House, and it was unclear whether the new language about preventing family separations would improve its chances for passage.

Both Republican bills under discussion, which have been blasted by Democrats and immigration advocacy groups, would fund the border wall and reduce legal migration, in part by denying visas for some relatives of U.S. residents and citizens who are living abroad, sometimes referred to as “chain migration.”

The more conservative bill from Representative Bob Goodlatte would also deny “Dreamers,” immigrants brought illegally to the United States as children, the chance of future citizenship.

Several hundred protesters marched in New York City, chanting “Keep families together!”

Anne Heaney, 74, a retired teacher, held a sign that read, “Children do not belong in cages. Maybe Trump and Pence do.”

In Washington, activists stood next to a table occupied by Department of Homeland Security Secretary Kirstjien Nielsen in a Mexican restaurant, voicing criticism of the administration’s policy, according to video obtained by Reuters.

Two top U.S. business groups, the U.S. Chamber of Commerce and the Business Roundtable, decried the separation policy on Tuesday and called for its immediate cessation.

“My heart goes out to the impacted families,” said JPMorgan Chase & Co Chief Executive Jamie Dimon, who chairs the Business Roundtable, in a memo to the bank’s employees. “Fixing these issues will clearly boost the economy,” he added.

Apple Chief Executive Tim Cook described the separation of children from parents at the U.S.-Mexico border as “inhumane” and promised to be a “constructive voice” in seeking to end the issue, the Irish Times newspaper reported.

Microsoft Corp CEO Satya Nadella called the policy cruel and abusive in an email to employees that was posted on Linkedin.com. He also said the company is not working on any projects with the U.S. government related to separating children from their families at the border.

U.S. Customs and Border Protection said on Tuesday that 2,342 children had been separated from their parents at the U.S.-Mexico border between May 5 and June 9.

The separations began after Attorney General Jeff Sessions announced in April that all immigrants apprehended while crossing the U.S.-Mexico border illegally should be criminally prosecuted.

Parents who are referred by border agents for prosecution are held in federal jails, while their children are moved into border shelter facilities under the custody of the Office of Refugee Resettlement, a Department of Health and Human Services agency.

LEGISLATIVE POSSIBILITIES

A number of Republican senators called on Trump on Tuesday to allow families to stay together if they had crossed the border illegally, and Senate leaders said their chamber could have legislation to address the family separations matter in a matter of days.

Senate Majority Leader Mitch McConnell said: “We hope to reach out to the Democrats and see if we can get a result, which means making a law and not just get into some kind of sparring back and forth that leads to no conclusion,” he said.

Top Democrats contended that Trump could change the policy with the stroke of a pen.

“The president is trying set this trap in the public mind that somehow there is a law requiring him to do this and Congress can undo it,” said Senator Chris Van Hollen, who visited a detention center in Brownsville, Texas, over the weekend. “We know this is a problem that was manufactured six weeks ago, and we’re seeing the awful results today.”

Decrying “internment camps,” Democrats and their supporters disrupted a U.S. congressional hearing on Tuesday about an FBI probe.

With the sound of a young child crying in the background, the top Democrat on the House of Representatives Judiciary Committee, Jerrold Nadler, broke from traditional protocol and started reading from a statement, saying: “These children are not animals.” His Republican colleagues tried to shout over him: “Out of order!”

(Reporting by Sarah N. Lynch and Susan Cornwell; Additional reporting by David Morgan, Amanda Becker, Tim Ahmann, Makini Brice, Doina Chiacu and Lisa Lambert in Washington, Alice Popovici in New York, Richard Lough in Paris and Tom Miles in Geneva; Writing by Doina Chiacu and Dan Burns; Editing by Frances Kerry and Peter Cooney)

Obamacare 2018 enrollment clouded by uncertainty

A man looks over the Affordable Care Act (commonly known as Obamacare) signup page on the HealthCare.gov website in New York in this October 2, 2013 photo illustration.

By Yasmeen Abutaleb

WASHINGTON (Reuters) – As Americans begin signing up for Obamacare health insurance plans on Wednesday, experts expect reduced participation as a bitter political debate clouds the program’s future.

Republicans in Congress have repeatedly failed to repeal and replace former President Barack Obama’s healthcare law, which they have said drives up costs for consumers and interferes with personal medical decisions. Democrats have warned that repeal would leave millions of Americans without health coverage.

President Donald Trump promised to kill the law in his 2016 election campaign, and he has taken executive and administrative actions to undermine it.

“The market’s going to be extremely confusing. There’s going to be entire complexity of choice,” said David Anderson, a health policy researcher at Duke University.

The Center for American Progress, a liberal think tank, estimated this week that 2018 enrollment would have held steady from 2017, with 12.2 million people either signing up for or being automatically re-enrolled in individual health coverage under the Affordable Care Act had there not been administration efforts to undercut it.

The Trump administration has cut the 2018 enrollment period in half to six weeks from Nov. 1 to Dec. 15 for states using the federal Healthcare.gov website. Enrollment previously ran until Jan. 31, and many consumers often signed up in the last two weeks, according to state officials and organizations that help people choose insurance.

Senate Republicans and Democrats are working on legislation to stabilize Obamacare markets in the short term. The nonpartisan Congressional Budget Office estimates that four million fewer people will sign up for Obamacare private insurance than previously forecast due to Trump administration policies.

Still, CBO expects total enrollment to reach 11 million in 2018, up from the around 10 million who obtained and paid for coverage in 2017.

The administration has cut off billions of dollars in subsidies that insurers use to discount out-of-pocket medical costs for low-income Americans, slashed Obamacare advertising and cut funding to groups that help people enroll in health insurance. Several insurers have exited Obamacare markets due to concerns over subsidies and other Trump actions.

The Department of Health and Human Services said on Monday that premiums for the most popular Obamacare plans would rise 37 percent in 2018. Americans eligible for Obamacare tax credits to buy insurance may pay less for coverage, but costs would increase for middle-class consumers who do not get subsidies.

“It’s been such a flood of information. A lot of the population thinks the Affordable Care Act has already been put under,” said Daniel Polsky, a professor at the University of Pennsylvania and executive director of the Leonard Davis Institute of Health Economics. “The strange premium increases are going to be very confusing for consumers.”

The Trump administration is now planning changes for 2019. Last week, it proposed a rule giving states more flexibility over the benefits that must be covered by insurance. Under Obamacare, all insurers have to cover a set of 10 benefits, such as maternity and newborn care and prescription drugs.

(This version of the story corrects reference to CBO estimate on enrollment in paragraphs 7-8, clarifies estimate from think tank in paragraph 5)

 

(Reporting By Yasmeen Abutaleb; Editing by Michele Gershberg)

 

U.S. government shifts $81 million to Zika vaccine research

Zika prevention kit for pregnant women

By Julie Steenhuysen and Toni Clarke

CHICAGO/WASHINGTON (Reuters) – The U.S. Department of Health and Human Services has shifted $81 million in funds from other projects to continue work on developing vaccines to fight Zika in the absence of any funding from U.S. lawmakers.

In a letter addressed to Nancy Pelosi, a Democrat and minority leader of the U.S. House of Representatives, HHS Secretary Sylvia Burwell said she was allocating $34 million in funding to the National Institutes of Health and $47 million to the Biomedical Advanced Research and Development Authority (BARDA) to work on Zika vaccines.

Burwell said the funding was intended to keep Zika vaccine research going despite the lack of funding from U.S. lawmakers, who left for summer recess before allocating any funding to Zika research and preparedness.

The mosquito-borne Zika virus has spread to more than 50 countries and territories since the outbreak began last year in Brazil. On Thursday, Governor Rick Scott said state health officials have identified three additional people in the affected area with locally transmitted Zika, bringing the total to 25.

The Obama administration in February requested $1.9 billion to fight Zika, but congressional lawmakers have been considering a much smaller sum. A bill providing $1.1 billion was blocked by Democrats after Republicans attached language to stop abortion-provider Planned Parenthood from using that government funding for healthcare services, mainly in U.S. territories like Puerto Rico.

The Republican legislation also would siphon off unused money under President Barack Obama’s signature 2010 healthcare law to combat Zika. In addition, Democrats balked at a Republican provision that they said would gut clean water protections.

The new bolus of funds from HHS comes on top of the $589 million in repurposed funds previously allocated for Ebola efforts. HHS has said these funds will run out at the end of August.

At a press briefing in Washington, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he needs $33 million to prepare to move the first potential Zika vaccine to the second phase of human clinical trials. The first phase of that testing is expected to end in late November or December.

Fauci said the health secretary has the authority to transfer 1 percent of NIH’s $33 billion budget per year from one Institute to the other. He said the director of the NIH, Dr. Francis Collins, will decide which existing programs the funds will be drawn from.

“He will probably do it on a prorated basis across the Institutes,” he said.

Fauci said the budget transfer will not fill the longer-term NIH funding needs to fight the virus and to develop a second or third potential vaccine candidate. Drugs frequently fail to realize the promise they show in early trials.

“We still need about $196 million more,” he said.

Fauci said the health secretary’s action was essentially one of desperation given the failure of Congress to authorize additional funding.

Taking money from other research programs “is extremely damaging to the biomedical research enterprise,” he said. “We’re taking money away from cancer, diabetes, all those things.”

Dr. LaMar Hasbrouck, executive director of the National Association of County and City Health Officials, said at the briefing that local health authorities are similarly siphoning off money from other programs.

“We’re robbing Peter to pay Paul,” he said.

In her letter, Burwell said the $47 million in funding for BARDA will allow the agency to enter into contracts with key partners to develop vaccines. But, she said BARDA will need an estimated $342 million in additional funding to continue its work with outside partners in the development of vaccines, diagnostics and pathogen inactivation technology used to protect the U.S. blood supply.

(Reporting by Julie Steenhuysen in Chicago and Toni Clarke in Washington; editing by Grant McCool and Bernard Orr)

Funding to fight Zika virus faces uphill battle in U.S. Senate

Aedes aegypti mosquitoes are seen inside Oxitec

By Susan Cornwell

WASHINGTON (Reuters) – Funding to battle the Zika virus faces a struggle in the U.S. Senate this week, with Democrats scornful of a Republican proposal they say short-changes the challenge posed by the mosquito-borne virus as well as other health priorities.

The U.S. House of Representatives last week approved the Republican plan providing $1.1 billion to fight the Zika virus. But the proposal drew a veto threat from the White House as it falls short of President Barack Obama’s $1.9 billion funding request, and makes $750 million in budget cuts elsewhere.

A Senate procedural vote is expected Tuesday on the Republican plan. But with key minority Senate Democrats opposed, the bill may not clear the procedural hurdle, Senate Democratic aides said. This could delay any action to combat Zika until after next week’s July 4th national holiday.

Senate Majority Leader Mitch McConnell, a Republican, warned Democrats Monday against opposing the bill, saying that it “represents the last chance we will have to address Zika for weeks.”

Democrats have been urging Republicans for months to agree to more Zika funding, and the Obama administration has already reprogrammed nearly $600 million that had been set aside to fight another virus, Ebola.

But Senate Democratic Leader Harry Reid said Monday that the minority had “no choice” but to oppose the Republican legislation. Among other things, Democrats were unhappy that the proposal would not allow funding to go to private entities such as the women’s healthcare provider Planned Parenthood.

U.S. health officials have concluded that Zika infections in pregnant women can cause microcephaly, a birth defect marked by small head size that can lead to severe developmental problems in babies. The World Health Organization has said there is strong scientific consensus that Zika can also cause Guillain-Barre, a rare neurological syndrome that causes temporary paralysis in adults.

The connection between Zika and microcephaly first came to light last fall in Brazil, which has now confirmed more than 1,400 cases of microcephaly that it considers to be related to Zika infections in the mothers.

There have not yet been any cases reported of local transmission of the Zika virus in the continental United States, but there have been more than 1,800 cases of Zika infection reported in Puerto Rico, a U.S. territory.

Health experts expect local transmission to occur in the continental United States as mosquito season gets underway with warmer weather.

Democrats were upset that $543 million of the $1.1 billion provided by the bill would come from unspent funds set aside for implementing Obamacare in U.S. territories, while $107 million would come from unused funds to fight Ebola.

Another $100 million would come from unused administrative funds at the Department of Health and Human Services.

An earlier bipartisan bill that passed the Senate last month would also have provided $1.1 billion to combat Zika, but without cutting money elsewhere.

(Reporting by Susan Cornwell; Editing by Bernard Orr)

FDA too slow to order food recalls, U.S. watchdog finds

FDA HQ in Maryland

By Julie Steenhuysen

CHICAGO (Reuters) – The Food and Drug Administration is too slow to order companies to recall tainted foods, leaving people at risk of illness and death, a government watchdog said in a review of the agency’s food safety program.

The Department of Health and Human Services’ Office of Inspector General reviewed 30 recalls that occurred between 2012 and 2015, including two in which companies did not recall all affected items until 165 days and 81 days after the FDA became aware of tainted foods. The watchdog issued its report on Wednesday.

“FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls,” the report said. “As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.”

The watchdog urged the FDA to address the problem immediately.

In a blog post, FDA food safety officials Stephen Ostroff and Howard Sklamberg called the report’s findings “unacceptable” and said the agency is “totally committed” to food safety.

Representative Rosa DeLauro of Connecticut in a statement said it was “mind-boggling” that the FDA does not have policies or procedures to ensure swift voluntary food recalls.

DeLauro, who oversees drug and food safety in her position on the House of Representatives subcommittee responsible for the FDA, pointed to a salmonella outbreak last year in cucumbers, which sickened nearly 900 people, hospitalized 191 and killed six. The outbreak began in July, but it took until September before producers started recalling product.

“Delays like this one – and others found in the report – are completely unacceptable and leave American consumers at risk for illness and death,” DeLauro said.

Ostroff and Sklamberg said the FDA has a plan underway to strengthen compliance and enforcement policies, including both voluntary and mandatory recalls.

But they said recalls must be based on scientific evidence borne out of an outbreak investigation. And while timeframes for recalls need to be set, “they must be done on an individual basis rather than by setting arbitrary deadlines.”

To speed the FDA’s response, Ostroff and Sklamberg said the agency has established a team of experts from different scientific disciplines to oversee outbreak investigations. They also cited FDA’s adoption in 2014 of the use of whole genome sequencing, a more precise technology for determining the genetic fingerprint of foodborne pathogens.

In addition, provisions in the 2011 Food Safety Modernization Act that require companies to minimize food safety risks, and require companies to have a recall plan, will begin to take effect this fall.

(Reporting by Julie Steenhuysen; Editing by Leslie Adler)

Patients Exposed To Fatal Disease At North Carolina Hospital

A hospital in Winston-Salem, North Carolina is apologizing for potentially exposing 18 patients to a rare and fatal disease.

Officials with Novant Health Forsyth Medical Center said Monday at a press conference that brain surgery patients have been exposed to Creutzfeldt-Jakob Disease which kills 90 percent of patients within a year of showing symptoms.

“While the CDC categorizes such risks [of transmission] as ‘very low’, any risk of transmission is simply unacceptable,” Jeff Lindsay, president of the hospital, told reporters.  “On behalf of the entire team, I apologize to the patients and their families for this anxiety.”

The instruments used in the brain surgery were sterilized using normal sterilization techniques but not the specialized procedures used for Cruetzfeldt-Jakob.

Amanda Morin, who had back surgery at the hospital and is one of the 18 potentally infected, told Fox News that she was “very, very angry something so little could cost me my life.”

The state Department of Health and Human Services said they are monitoring the situation.

HHS Spends $90 Million On Bioterror Treatments

The Department of Health and Human Services will spend $90 million over the next five years for a drug that can help stop two bacteria which security officials believe could make a deadly bioterror weapon.

HHS officials have already released $19.8 million for the purchase of Caravance, a drug that is aimed as a countermeasure to melioidosis and glanders diseases.

According to a press release from HHS, both glanders and melioidosis are considered suitable for biological weapons.  Untreated infections from the diseases have a mortality rate of 90%.   The bacteria have also developed some resistance to current antibiotics meaning even if you are treated for an infection there is still a 40% mortality rate.

Glanders is a respiratory disease transmitted either airborne or when the victim comes in contact with contaminated animals.   Melioidosis, which is often confused for other conditions like pneumonia, is also transmitted through air or contact.