FDA identified 20 drugs with shortage risks due to coronavirus outbreak

NEW YORK (Reuters) – The U.S. Food and Drug Administration has contacted producers of about 20 drugs that either source all of their main ingredients from or are finished in China to gauge if they will face shortages due to the coronavirus outbreak.

None of the companies reported that a shortage is expected for their drugs due to the outbreak, an FDA spokeswoman said.

“We have been in contact with those firms to understand if they face any drug shortage risks due to the outbreak,” FDA spokeswoman Stephanie Caccomo said in a statement late on Monday. “None of these firms has reported any shortage to date.”

Caccomo did not identify any of the drugs or the companies.

She said the FDA has also reached out to more than 180 manufacturers to remind them of their requirement to notify the regulator of any expected supply disruptions.

U.S. officials raised concerns this week about the security of the U.S. drug supply chain in the wake of the coronavirus outbreak in China, where a significant portion of the ingredients used to make prescription drugs is manufactured.

Around 88 percent of the active pharmaceutical ingredients used in drugs for the U.S. market were manufactured overseas in 2018, according to the FDA. About 14 percent of the API for U.S. drugs in that year were produced in China, the FDA said.

(Reporting by Michael Erman; Editing by Dan Grebler)

Toxin at heart of drug recall shows holes in medical safety net

FILE PHOTO: The headquarters of the European Medicines Agency (EMA), is seen in London, Britain, April 25, 2017. REUTERS/Hannah McKay -/File Photo

By Alexandra Harney and Ben Hirschler

SHANGHAI/LONDON (Reuters) – A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.

China’s Zhejiang Huahai Pharmaceutical, which produces bulk ingredients for drugmakers, told its customers in late June it had found NDMA in its valsartan, an off-patent blood pressure drug originally developed by Novartis.

The discovery means that some of the 10 billion pills containing valsartan sold worldwide last year to prevent heart attacks and strokes had traces of N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen. No one has been reported as sickened by the toxin, once used in the production of liquid rocket fuel.

Regulators and industry experts say the toxin almost certainly was introduced when Huahai changed the way it produced valsartan in 2012 – a modification that was signed off on by the European body that sets standards. Subsequent inspections by European, U.S., and Chinese regulators also found no problem.

“Everyone failed – the company, the inspectors, the FDA (U.S. Food and Drug Administration), the Europeans, the Chinese,” said Philippe André, an independent pharmaceutical auditor who inspected two Huahai facilities last August and found no critical concerns. “It’s a system failure.”

Reuters was unable to determine how Huahai first discovered the problem. In a July 7 statement released through the Shanghai Stock Exchange, it said it detected the toxin during the “optimization and evaluation” of its manufacturing process.

A Novartis spokesman told Reuters that its generic drugs arm, Sandoz, spotted the NDMA in the course of intensive testing to prepare for expanding its purchases of valsartan. He declined to comment further, including on the identity of the manufacturer or when the tests took place.

Two other smaller bulk suppliers – Zhejiang Tianyu Pharmaceutical and a unit of India’s Hetero Drugs – have since also discovered traces of NDMA in some of their valsartan.

The three companies declined to comment to comment about the case.

REDUCE WASTE

Huahai said in a document released through the Shanghai Stock Exchange it changed the production process to reduce waste and improve yields.

“The NDMA impurity was produced in trace amounts during the normal manufacturing process according to the company’s current registered process,” it said in a statement on July 24.

“All changes in the company’s valsartan manufacturing process have been approved by each country’s drug regulator, and the company manufactures in compliance with legal and regulatory standards.”

The European Medicines Agency (EMA) regulator, which first publicly raised the alarm in a statement on July 5, told valsartan suppliers in a subsequent memo dated July 16 that the NDMA may have been connected to the combined use of the solvent dimethylformamide and sodium nitrite.

The FDA is also going on that hypothesis, said Janet Woodcock, director of its Center for Drug Evaluation and Research. She stressed the investigation was still going on.

“This (NDMA) was not what you look for in an inspection,” Woodcock said in an interview. “If you don’t test for this you’re not going to have an idea that it’s in there, and you’re not going to see it on an inspection.”

The European Directorate for the Quality of Medicines (EDQM), responsible for setting manufacturing standards, told Reuters it was aware the solvent was being used when it approved the changed process, but that NDMA as a by-product was unexpected and not tested for.

Detecting NDMA would have required gas chromatography coupled with mass spectrometry, a very sensitive level of testing, an EDQM spokeswoman said.

“These techniques are not normally used routinely to test pharmaceutical products,” she said.

RECALLS

Built by Novartis into the $6 billion-a-year brand Diovan, valsartan’s European and U.S. patents expired in 2011 and 2012.

Global sales totaled 10.4 billion pills last year, including combination products, healthcare data consultancy IQVIA estimates. People with high blood pressure typically take one pill daily and heart failure patients two.

More than 50 companies around the world making finished tablets from the tainted valsartan have recalled products in recent weeks, according to a Reuters analysis of national medicines agencies’ records. They include major generic drug manufacturers such as Teva Pharmaceutical Industries, Ranbaxy Laboratories, and Sandoz.

Based on the average NDMA impurity detected at Huahai of 60 parts per million (ppm), the EMA says there could be one additional case of cancer in every 5,000 people taking the highest dose for seven years.

The contamination puts a spotlight on manufacturers in China and India, which supply more than two-thirds of all active pharmaceutical ingredients used in medicines, industry executives estimate. China accounts for the lion’s share.

Huahai, founded in 1989 and listed in Shanghai in 2003, was one of the first Chinese companies to get drugs approved in the U.S. market.

The FDA has inspected the site that made the contaminated valsartan three times since 2010, its records show. European inspectors also visited regularly.

The provincial branch of the Chinese FDA (CFDA) also inspected Huahai facilities 10 times in connection with new drug applications between January 2016 and June 2018, the national online database shows.

SCRUTINY

U.S. and European regulators have increased scrutiny of Chinese and Indian drug factories after the adulteration of the blood thinner heparin sickened hundreds and caused the deaths of at least 81 Americans in 2007 and 2008.

The CFDA is also on alert.

Last month, it revealed that Changsheng Bio-technology , a vaccine maker, had fabricated data and sold ineffective vaccines for children. It also found that a diphtheria, tetanus and pertussis vaccine sold by the state-owned Wuhan Institute of Biological Products was substandard.

The fact that international inspections do not appear to have detected the NDMA contamination alarms Anders Fuglsang, a former European medicines regulator who runs a pharmaceutical consultancy in Denmark.

“We need to ask ourselves how it is possible – despite pharmacopoeias and agency guidelines, inspection programs with coordination across continents, a system of public quality control, and companies complying with all rules – that a nasty carcinogen can find its way into our drugs and be there for years without anyone noticing,” he said.

(Additional reporting by Shanghai newsroom, Zeba Siddiqui in Mumbai and Sharnya G in Bengaluru; Editing by Sonya Hepinstall)

Pharma’s Puerto Rico problems could mean drug shortages: FDA chief

U.S. Food and Drug Commissioner Scott Gottlieb attends an interview at Reuters headquarters in New York City, U.S., October 10, 2017. REUTERS/Eduardo Munoz

By Bill Berkrot

NEW YORK (Reuters) – The head of the U.S. Food and Drug Administration said on Tuesday the country may start to see a small number of drug shortages within two or three weeks due to delays in restoring manufacturing operations in Puerto Rico, where 10 percent of drugs prescribed in the United States are made.

Hurricane Maria slammed into the Caribbean island on Sept. 20, knocking out electricity and causing widespread damage to homes and infrastructure. Almost three weeks later, just 16 percent of electricity service has been restored to the U.S. territory.

Drugmakers are working to get facilities fully online, but face an uncertain power supply and difficulty obtaining materials used in the manufacturing process.

“A lot of companies say they’re online, but they basically have one of five lines running at 20 percent or 80 percent or 50 percent,” FDA Commissioner Scott Gottlieb told Reuters in an interview in New York. “They are not manufacturing at full capacity. They are manufacturing well short of that.”

“It’s unclear when they are going to be able to bring that up to full capacity,” he said.

Asked when U.S. hospitals and pharmacies might see shortages as a result, he said: “You might see some in the next two or three weeks if there’s going to be additional shortages coming out of this situation.”

The FDA has warned of 40 drugs made in Puerto Rico that could face shortages, including treatments for cancer, rheumatoid arthritis and HIV, but has not named specific medicines.

Most major drug companies have manufacturing facilities on the island, including Merck & Co, Johnson and Johnson, Amgen Inc, Bristol-Myers Squibb Co, Eli Lilly and Co, Pfizer Inc, AstraZeneca and GSK

The FDA leader said he wants drugmakers to provide the public with more information about the extent of the problems they are facing. He said the plants were all relying on backup generators for electricity, some of which were not designed to operate for sustained periods of time.

“I’m going to ask some of these companies to be a little more transparent around some of these issues,” he said, adding that improvements would likely come slowly, with potential setbacks along the way. “As time goes on, we’re going to see secondary impacts like the generators could start going down.”

Gottlieb said he was “troubleshooting for individual companies” on a daily basis and working with the U.S. Federal Emergency Management Agency and the Department of Homeland Security to address issues such a fuel shortages and shipping problems that could stall operations.

Most of the companies contacted by Reuters said they are working to avoid product shortages.

Bristol-Myers said it has resumed limited operations to ship warehoused products. “As of today, no product supply impact is expected, however we continue to assess the challenging operational conditions on the island,” spokesman Ken Dominski said.

Amgen, in a statement, said it was “preparing to resume manufacturing in various plants over the next several weeks” and did not anticipate an impact on supply to patients.

Merck has one manufacturing facility on the island. “We have brought power back online via on-site generators that will allow most operations to proceed,” spokeswoman Claire Gillespie said.

Of the list of drugs being closely monitored by FDA, 14 medicines are sourced solely out of Puerto Rico, Gottlieb said.

He said the agency was working with drugmakers and would consider approving manufacturing sites in other countries, such as Mexico, Canada or Ireland, to alleviate possible shortages if companies have plants there.

(Additional reporting by Caroline Humer and Michael Erman in New York and Toni Clarke in Washington; Editing by Michele Gershberg and Bill Rigby)

ACLU sues over FDA restrictions on abortion pill access

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. Picture taken August 14, 2012. REUTERS/Jason Reed

By Nate Raymond

(Reuters) – The American Civil Liberties Union filed a lawsuit on Tuesday seeking to challenge U.S. Food and Drug Administration restrictions that limit the ability of women to access the so-called abortion pill.

The ACLU filed the lawsuit in U.S. District Court in Hawaii to challenge FDA restrictions that limit the dispensing of the pill, Mifeprex, to clinics, medical offices or hospitals rather than retail pharmacies.

The ACLU said that as a result, the FDA’s restrictions delay and in some cases block a woman’s access to abortion by requiring her to be handed Mifeprex by healthcare providers who have arranged to stock it in their facilities.

That is despite the fact that Mifeprex, which can be used for abortions up to 10 weeks into a pregnancy, is considered safe and has been recognized by the FDA itself as providing “meaningful therapeutic benefit,” the lawsuit said.

“The unique and harmful restrictions the FDA imposes on where and how a patient may receive Mifeprex deny women meaningful access to this safe and effective treatment with no medical justification,” the complaint said.

The FDA declined to comment.

Mifeprex, manufactured by Danco Laboratories, was approved in 2000 to terminate early pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

The lawsuit came after the FDA in March 2016 announced a decision to relax restrictions on the use of Mifeprex that were in place for over a decade.

The FDA eased access to it by updating the prescribing information on the drug’s label, thus expanding use to 70 days of gestation from 49 days, cutting the recommended dose of the drug and reducing the number of required visits to a doctor.

The ACLU filed its lawsuit on behalf of three healthcare associations and a family medicine doctor, Graham Chelius, who is based on the Hawaiian island of Kauai, which has no abortion providers.

According to the ACLU, while Chelius is qualified and willing to provide the pill, he cannot stock it at the hospital where he works due to objections from some colleagues and as a result his patients must fly to another island for abortions.

To support its case, the ACLU cited a June 2016 U.S. Supreme Court ruling that struck down a Texas abortion law imposing strict regulations on doctors and facilities.

(Reporting by Nate Raymond in Boston; Editing by Jonathan Oatis)

Exclusive: Vomitoxin makes nasty appearance for U.S. farm sector

FILE PHOTO -- Cobs of corn are held at a corn field in in La Paloma city, Canindeyu, about 348km (216 miles) northeast of Asuncion August 7, 2012. Corn export is second only to soybean export in Paraguay. REUTERS/Jorge Adorno/File Photo

By P.J. Huffstutter and Michael Hirtzer

CHICAGO (Reuters) – A fungus that causes “vomitoxin” has been found in some U.S. corn harvested last year, forcing poultry and pork farmers to test their grain, and giving headaches to grain growers already wrestling with massive supplies and low prices.

The plant toxin sickens livestock and can also make humans and pets fall ill.

The appearance of vomitoxin and other toxins produced by fungi is affecting ethanol markets and prompting grain processors to seek alternative sources of feed supplies.

Researchers at the U.S. Department of Agriculture first isolated the toxin in 1973 after an unusually wet winter in the Midwest. The compound was given what researchers described as the “trivial name” vomitoxin because pigs were refusing to eat the infected corn or vomiting after consuming it. The U.S. Corn Belt had earlier outbreaks of infection from the toxin in 1966 and 1928.

A vessel carrying a shipment of corn from Paraguay is due next month at a North Carolina port used by Smithfield Foods Inc [SFII.UL], the world’s largest pork producer.

The spread of vomitoxin is concentrated in Indiana, Wisconsin, Ohio, and parts of Iowa and Michigan, and its full impact is not yet known, according to state officials and data gathered by food testing firm Neogen Corp.

In Indiana, 40 of 92 counties had at least one load of corn harvested last fall that has tested positive for vomitoxin, according to the Office of Indiana State Chemist’s county survey. In 2015 and 2014, no more than four counties saw grain affected by the fungus.

And in a “considerable” share of corn crops tested in Michigan, Wisconsin and Indiana since last fall’s harvest, the vomitoxin levels have tested high enough to be considered too toxic for humans, pets, hogs, chickens and dairy cattle, according to public and private data compiled by Neogen. The company did not state what percent of each state’s corn crop was tested.

Smithfield would not confirm it had ordered the corn from Paraguay, but two independent grain trading sources said Smithfield was the likely buyer. A company source said corn Smithfield has brought in from Indiana and Ohio, to feed pigs in North Carolina, has been “horrible quality” due to the presence of mycotoxins.

TOXIN LEVELS

The U.S. Food and Drug Administration allows vomitoxin levels of up to 1 part per million (ppm) in human and pet foods and recommends levels under 5 ppm in grain for hogs, 10 ppm for chickens and dairy cattle. Beef cattle can withstand toxin levels up to 30 ppm.

Alltech Inc, a Kentucky-based feed supplement company, said 73 percent of feed samples it has tested this year have vomitoxin. The company analyzed samples sent by farmers whose animals have fallen ill.

“We know there is lots of bad corn out there, because corn byproducts keep getting worse,” said Max Hawkins, a nutritionist with Alltech.

Neogen, which sells grain testing supplies, reported a 29 percent jump in global sales for toxin tests – with strong demand for vomitoxin tests – in their fiscal third quarter, ending Feb. 28.

“We’re polling our customers and continually talking to them about the levels they’re seeing. Those levels are not going down,” said Pat Frasco, director of sales for Neogen’s milling, grain and pet food business.

The problem, stemming from heavy rain before and during the 2016 harvest, prompted farmers to store wet grain, said farmers, ethanol makers and grain inspectors.

The issue was compounded by farmers and grain elevators storing corn on the ground and other improvised spaces, sometimes covering the grain piles with plastic tarps. Grain buyers say they will have a clearer picture of the problem later this spring, as more farm-stored grain is moved to market.

Iowa State University grain quality expert Charles Hurburgh said the sheer size of the harvest in 2016 – the largest in U.S. history – complicates the job of managing toxins in grain, especially in the core Midwest.

“Mycotoxins are very hard to handle in high volume,” he said. “You can’t test every truckload, or if you do, you are only going to unload 20 trucks in a day.” By comparison, corn processors in Iowa unload 400 or more trucks a day.

BIOFUEL IMPACTS

Ethanol makers already are feeling the impact. Turning corn into ethanol creates a byproduct called distillers dried grains (DDGs), which is sold as animal feed. With fuel prices low, the DDGs can boost profitability.

But the refining process triples the concentration of mycotoxins, making the feed byproduct less attractive. DDG prices in Indiana fell to $92.50 per ton in February, the lowest since 2009, and now are selling for $97.50 per ton, according to USDA.

Many ethanol plants are testing nearly every load of corn they receive for the presence of vomitoxin, said Indiana grain inspector Doug Titus, whose company has labs at The Andersons Inc, a grain handler, and energy company Valero Energy sites.

The Andersons in a February call with analysts said vomitoxin has hurt results at three of its refineries in the eastern U.S. “That will be with us for some time,” Andersons’ chief executive Pat Bowe said.

Missouri grain farmer Doug Roth, who put grain into storage after last year’s wet harvest, has seen a few loads of corn rejected by clients who make pet food after the grain tested positive for low levels of fumonisin, a type of mycotoxin.

Roth said he paid to reroute the grain to livestock producers in Arkansas, who planned to blend it with unaffected grain in order to mitigate the effect of the toxins.

“As long as this doesn’t become a widespread problem, we’re all fine,” said Roth, who said toxins have shown up in less than 1 percent of the grain loads he has sold.

U.S. farmers with clean corn are reaping a price bump. A Cardinal Ethanol plant in Union City, Indiana, is offering grain sellers a 10-cent per bushel premium for corn with less than one-part-per-million (ppm) or less of vomitoxin in it, according to the company’s website.

(Additional reporting by Karl Plume and Julie Ingwersen in Chicago; Editing by Matthew Lewis)

Trump chooses Gottlieb to run FDA; Pharma breathes sigh of relief

Dr. Scott Gottlieb is seen in this American Enterprise Institute photo released in Washington, DC, U.S., March 10, 2017. Courtesy The American Enterprise Institute/Handout via REUTERS

By Toni Clarke

WASHINGTON (Reuters) – U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the White House said on Friday.

If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.

Gottlieb is well known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by drug companies and pharmaceutical investors. He sits on the boards of several small drug and biotech companies and is an adviser to GlaxoSmithKline Plc <GSK.L>.

“Thank God it’s Gottlieb,” Brian Skorney, an investment analyst at Robert W. Baird, wrote in a research note. “We view this as a favorable development for the sector.”

Gottlieb was chosen over Jim O’Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a PayPal co-founder who now advises Trump on technology and science matters. O’Neill’s stated view that drugs should be approved before being proven effective generated widespread alarm.

Gottlieb, 44, is a resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund. He is a former FDA deputy commissioner who has advocated a loosening of requirements needed for approval of new medical products.

“Scott knows how the agency works and he will move it forwards, though maybe not always in ways the agency is comfortable with,” said John Taylor, a lawyer and president of compliance and regulatory affairs with the consulting firm Greenleaf Health and a former acting FDA deputy commissioner.

In addition to his public health and health policy roles, Gottlieb has for the past decade been a partner at New Enterprise Associates, a large venture fund with investments in the life sciences, medical technology and healthcare services.

Critics of the nomination say Gottlieb’s financial background present an array of potential conflicts of interest.

Dr. Michael Carome, director of Public Citizen’s Health Research Group, said Gottlieb “has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry.” If confirmed, he added, “he will have to be recused from key decisions time and time again.”

SIGNIFICANT CHANGES AT FDA EXPECTED

Stephen Ubl, a spokesman for the Pharmaceutical Research and Manufacturers of America, said it “looks forward to working with Dr. Gottlieb in his new role and engaging with him and the Agency as they seek to modernize the drug discovery and review process.”

Gottlieb, who declined to comment on the nomination, is unlikely to up-end the FDA in the way O’Neill might have, but he is nonetheless expected to bring significant change, including moving the agency to increase flexibility in the clinical trial development process.

In this he will be supported by the recently passed 21st Century Cures Act which instructs the FDA among other things to consider the use of “real world evidence” to support new drug applications. This could include anecdotal data, observational studies and patient reports

“People don’t want to take chances with safety, but there’s increasingly some clamor to be more flexible on the efficacy side,” said Kathleen Sanzo, who leads the FDA practice at the law firm Morgan, Lewis & Bockius. “You need to have some signal of efficacy. The question is, how much?”

The FDA has attempted to push back against moves to sideline randomized clinical trials, long considered the gold standard. In January it issued a report documenting 22 cases in which drugs that appeared to show promise in early trials turned out to be either ineffective or unsafe or both in larger trials.

One of Gottlieb’s priorities will likely be to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards.

“He’s a thoughtful and nuanced kind of guy, and not solely an industry shill,” said Jim Shehan, head of Lowenstein Sandler’s FDA regulatory practice.

A survey conducted by Mizuho Securities USA Inc of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced.

“Gottlieb is someone who the industry and investors view as an incremental positive,” said RBC Capital Markets analyst Michael Yee. “The industry and investors need rational scientific logic and an understanding of risks and benefits.”

Patient advocates welcomed the news.

Gottlieb “has firsthand experience at the FDA and as a physician that has treated patients understands the breadth of work that needs to be achieved on their behalf,” said Ellen Sigal, founder of Friends of Cancer Research.

(Reporting by Toni Clarke; Additional reporting by Deena Beasley; Editing by Alistair Bell and Lisa Shumaker)

U.S. Senate joins House to pass sweeping new health bill

A participant prepares to receive an antibody infusion of a drug that is part of a clinical trial for a functional HIV cure at the National Institutes of Health in Bethesda, Maryland, U.S. November 22, 2016 in this still image from video.

By Toni Clarke

(Reuters) – The U.S. Senate voted overwhelmingly on Wednesday to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines.

It will also provide funding for cancer and Alzheimer’s research, help fight the opioid epidemic, expand access to mental health treatment and advance research into precision medicine.

Two years in the making, the 21st Century Cures Act was passed last week by the House of Representatives and will now go to President Barack Obama to sign into law. Supporters say it will speed access to new drugs and devices, in part by allowing clinical trials to be designed with fewer patients and cheaper, easier-to-achieve goals.

“For the second consecutive year, the Senate is sending the President another Christmas miracle for his signature,” Senator Lamar Alexander, a Republican from Tennessee said in a statement. “Last year, it was the Every Student Succeeds Act, and this time, it’s the 21st Century Cures Act — a bill that will help virtually every American family.”

Critics of the legislation say it gives massive handouts to the pharmaceutical industry and will lower standards for drug and medical device approvals.

“This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices,” consumer watchdog Public Citizen said in a statement.

Democratic Senator Elizabeth Warren was among the handful of senators who voted against the bill, as was independent senator and former Democratic presidential candidate Bernie Sanders. Each decried what they described as big handouts to the pharma industry. Even so the bill passed 94-5. The House passed it by a vote of 392-26.

The $6.3 billion act, sponsored by Republican Representative Fred Upton, authorizes $4.8 billion for the National Institutes of Health and $500 million to the Food and Drug Administration.

It also calls for $1 billion over two years to battle the opioid epidemic. On Tuesday the Drug Enforcement Administration issued a report showing that in 2014 about 129 people died every day as a result of drug poisoning. Of those, 61 percent are opioid or heroin related.

“Opioids such as heroin and fentanyl – and diverted prescription pain pills – are killing people in this country at a horrifying rate,” Acting Administrator Chuck Rosenberg said. “We face a public health crisis of historic proportions.”

The bill also calls for $1.8 billion in funding for Vice President Joseph Biden’s Cancer Moonshot initiative designed to bolster cancer research by reducing bureaucracy and promoting research collaboration.

Critics note that the money described in the bill must be appropriated by separate funding bills and that the money may ultimately never materialize. Yet the changes to the clinical trial process, something long sought by the drug industry, will be set in stone regardless of whether money for the research projects is forthcoming.

Among those changes: Greater prominence will be given to “real world” evidence gathered outside the framework of a randomized, controlled clinical trial, the gold standard for determining whether a drug is safe and effective. Such evidence could be much easier for drug companies to collect.

“The passing of 21st Century Cures Act is a show of extraordinary bipartisan unity after a divisive election that should be celebrated,” said Ellen Sigal, chair of the patient advocacy group Friends of Cancer Research.

Under the Act patient input will be formally incorporated into the FDA’s drug review process.

Funding for the Act will be offset by reductions in some Medicaid payments and through the sale of oil from the Strategic Petroleum Reserve. The White House supports the bill but said earlier it was concerned that draining the Petroleum Reserve “continues a bad precedent of selling off longer term energy security assets to satisfy near term budget scoring needs.”

(Reporting by Toni Clarke in Washington; editing by Leslie Adler and Tom Brown)

FDA issues emergency authorization for ZIKA test

view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland

(Reuters) – Vela Diagnostics said its test for the Zika virus had received “emergency use authorization” from the U.S. Food and Drug Administration.

The test, already approved in Europe, is validated for plasma, serum and urine samples, the Singapore-based company said on Monday.

The FDA issues such emergency use authorization during public health emergencies, to quickly deploy unapproved medical products for as long as they are needed.

The regulator last month issued a similar authorization for a Zika diagnostics test from Swiss drugmaker Roche.

Zika, which was detected in Brazil, has spread to the Americas and is associated with microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.

In adults, it has been linked to Guillain-Barre syndrome, a temporary paralysis.

The disease has since spread to parts of Southeast Asia.

(Reporting by Akankshita Mukhopadhyay and Natalie Grover in Bengaluru; Editing by Sriraj Kalluvila)

FDA recommends Zika testing for all blood donated in U.S.

An edes aegypti mosquito is seen inside a test tube as part of a research on preventing the spread of the Zika

(Reuters) – The U.S. Food and Drug Administration recommended on Friday that all blood donated in the United States and its territories be tested for Zika virus, as it moves to prevent transmission of the virus through the blood supply.

The agency’s move to expand its previous guideline for blood screening comes after Florida officials on Tuesday announced the first case of Zika transmitted by mosquitoes in Pinellas County, some 265 miles from Miami, where the first locally transmitted U.S. cases were reported.

The FDA last month ordered blood banks in Florida’s two most densely populated counties – Miami-Dade County and Broward County – to stop collecting blood.

The FDA also recommended that nearby counties implement the same measures.

Zika was detected in Brazil last year and has since spread across the Americas. The virus poses a risk to pregnant women because it can cause severe birth defects. It has been linked to more than 1,800 cases of microcephaly in Brazil.

Health officials warned pregnant women last week not to travel to Miami Beach after Florida confirmed the mosquito-borne Zika virus was active there.

The agency had recommended in February that blood should no longer be collected from regions where the Zika virus is circulating, and that blood needed for transfusions be obtained from areas of the country without active transmission.

The FDA has authorized the emergency use of several investigational Zika screening tests, including products made by Hologic Inc &lt;HOLX.O&gt; and Roche Holding AG &lt;ROG.S&gt;.

(This version of the story corrects second paragraph to say Pinellas County is “some 265 miles from” Miami, not “near” Miami)

(Reporting by Ankur Banerjee in Bengaluru; Editing by Shounak Dasgupta and Saumyadeb Chakrabarty)

FDA takes steps to protect blood supply in Florida amid Zika probe

man having blood drawn

By Julie Steenhuysen and Toni Clarke

CHICAGO (Reuters) – The U.S. Food and Drug Administration has ordered blood banks in Florida’s two most densely populated counties to stop collecting blood as health officials determine whether Zika has begun transmission in the continental United States.

Florida has been investigating four possible cases of local transmission in Miami-Dade County and Broward County. It is the first U.S. state to report cases that may not be related to travel to other countries with active outbreaks.

Zika has struck hardest in Brazil, where the outbreak was first detected last year, and has since spread rapidly through the Americas. The virus can cause a rare birth defect, microcephaly, in newborns whose mothers have been infected, and is believed to be linked to Guillain-Barre syndrome in adults.

Zika most commonly infects people via mosquito bite. But reports of the virus being transmitted through sex and blood transfusions has prompted public health officials to recommend additional precautions for sexual partners and blood banks.

In a statement posted online on Wednesday, the FDA said blood centers in the two Florida counties should stop collecting blood until they can test each unit or put in place technology that can kill pathogens in the blood.

The FDA also recommended that nearby counties implement the same measures as it moves to prevent transmission of the virus through the blood supply.

OneBlood, Florida’s biggest blood collection center, said it will begin testing all of its collections for Zika virus, effective July 29, using an investigational screening test and that it is working as quickly as possible to comply with the FDA’s request.

The FDA has authorized the emergency use of several investigational Zika screening tests, including products made by Hologic Inc and Roche Holding AG.

The agency has also approved a pathogen inactivation technology made by Cerus Corp that kills the virus in blood platelets and plasma. The company is conducting clinical trials to show it can also kill pathogens in red blood cells.

The United States uses roughly 12 million units of red cells, four million plasma units and two million units of platelets a year.

Unlike oxygen-carrying red blood cells, which can be kept for 42 days in a refrigerator, or plasma, which keeps for a year if frozen, platelets have a shelf life of just four to seven days.

Platelets in general tend to be scarce because there are fewer donors. It can take up to two hours to extract platelets using an apheresis machine, said Dr. Richard Benjamin, chief medical officer for Cerus. And because of their short shelf life hospitals typically do not keep much surplus.

It can be hard to source them from elsewhere, too. By the time they are flown from one place to another they may only have two days of life left.

“All we need is a few more Zika hotspots and there will be a shortage of platelets across the country,” Benjamin said.

The FDA’s action follows Florida’s announcement on Wednesday that it had identified two additional Zika cases – one more in each county – that were not related to travel to an area where the virus is being transmitted.

A CDC spokesman said on Wednesday that “evidence is mounting to suggest local transmission via mosquitoes” in South Florida, noting that the cases fit transmission patterns seen with prior mosquito-borne outbreaks such as Chikungunya.

FDA said it will continue to monitor the situation in Florida in cooperation with the CDC and state public health authorities and provide updates as additional information becomes available.

(Reporting by Julie Steenhuysen; Editing by Bernard Orr)