Tag Archives: FDA

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

(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)

U.S. GMO food labeling bill passes Senate

A customer picks up produce near a sign supporting a ballot initiative in Washington state that would require labelling of foods containing genetically modified crops at the Central Co-op in Seattle, Washington October 29, 2013. REUTERS/Jason Redmond

By Chris Prentice

(Reuters) – The U.S. Senate on Thursday approved legislation that would for the first time require food to carry labels listing genetically-modified ingredients, which labeling supporters say could create loopholes for some U.S. crops.

The Senate voted 63-30 for the bill that would display GMO contents with words, pictures or a bar code that can be scanned with smartphones. The U.S. Agriculture Department (USDA) would decide which ingredients would be considered genetically modified.

The measure now goes to the House of Representatives, where it is expected to pass.

Drawing praise from farmers, the bill sponsored by Republican Senator Pat Roberts of Kansas and Democrat Senator Debbie Stabenow of Michigan is the latest attempt to introduce a national standard that would override state laws, including Vermont’s that some say is more stringent, and comes amid growing calls from consumers for greater transparency.

“This bipartisan bill ensures that consumers and families throughout the United States will have access, for the first time ever, to information about their food through a mandatory, nationwide label for food products with GMOs,” Stabenow said in a statement.

A nationwide standard is favored by the food industry, which says state-by-state differences could inflate costs for labeling and distribution. But mandatory GMO labeling of any kind would still be seen as a loss for Big Food, which has spent millions lobbying against it.

Farmers lobbied against the Vermont law, worrying that labeling stigmatizes GMO crops and could hurt demand for food containing those ingredients, but have applauded this law.

Critics like Senator Bernie Sanders, an independent from Vermont, say the bill’s vague language and allowance for electronic labels for scanning could limit its scope and create confusion.

“When parents go to the store and purchase food, they have the right to know what is in the food their kids are going to be eating,” Sanders said on the floor of the Senate ahead of the vote.

He said at a news conference this week that major food manufacturers have already begun labeling products with GMO ingredients to meet the new law in his home state.

Another opponent of the bill, Democratic Senator Jeff Merkley of Oregon, said it would institute weak federal requirements making it virtually impossible for consumers to access information about GMOs.

LOOPHOLES

Food ingredients like beet sugar and soybean oil, which can be derived from genetically-engineered crops but contain next to no genetic material by the time they are processed, may not fall under the law’s definition of a bioengineered food, critics say.

GMO corn may also be excluded thanks to ambiguous language, some said.

The U.S. Food and Drug Administration (FDA) raised concerns about the involvement of the USDA in a list of worries sent in a June 27 memo to the Senate Agriculture Committee.

In a letter to Stabenow last week, the USDA’s general counsel tried to quell those worries, saying it would include commercially-grown GMO corn, soybeans, sugar and canola crops.

The vast majority of corn, soybeans and sugar crops in the United States are produced from genetically-engineered seeds. The domestic sugar market has been strained by rising demand for non-GMO ingredients like cane sugar.

The United States is the world’s largest market for foods made with genetically altered ingredients. Many popular processed foods are made with soybeans, corn and other biotech crops whose genetic traits have been manipulated, often to make them resistant to insects and pesticides.

“It’s fair to say that it’s not the ideal bill, but it is certainly the bill that can pass, which is the most important right now,” said American Soybean Association’s (ASA) director of policy communications Patrick Delaney.

The association was part of the Coalition for Safe and Affordable Food, which lobbied for what labeling supporters termed the Deny Americans the Right to Know, or DARK Act, that would have made labeling voluntary. It was blocked by the Senate in March.

(Reporting by Chris Prentice in New York; Additional reporting by Karl Plume in Chicago, Lisa Baertlein in Los Angeles and Kouichi Shirayanagi and Eric Beech in Washington; Editing by Marguerita Choy and Ed Davies)

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

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)

New U.S. Food label overhaul to require added sugars detailed

By Lisa Baertlein

(Reuters) – The United States plans a major overhaul of the way packaged foods are labeled, the Food and Drug Administration announced on Friday. Serving sizes will be adjusted to reflect how much people actually eat, and for the first time labels will list added sugars.

These are the first significant changes since the Nutrition Facts label was introduced more than 20 years ago. They come as an increasing number of Americans battle obesity, diabetes and heart disease and will affect roughly 800,000 products from Coca-Cola and ice-cream to soup and spaghetti sauce.

Speaking at a health summit in Washington, first lady Michelle Obama said she was “thrilled” about the new label and said she believes it is going to make “a real difference in providing families across the country the information they need to make healthy choices.” Her “Let’s Move!” initiative aims to increase the health of young people.

Manufacturers have until July 2018 to comply with the new rule. Small businesses with fewer than $10 million in annual sales have an additional year to comply. The FDA, which first proposed the rule in 2014, estimated at the time that the cost to industry of updating the labels would be about $2 billion.

The Grocery Manufacturers Association, which represents the world’s biggest food and drink companies, said the changes were “timely,” as diets and eating patterns have changed dramatically over the past two decades.

“Food and beverage manufacturers have responded by creating more than 30,000 healthier product choices since 2002,” Dr. Leon Bruner, GMA’s chief science officer, said in a statement.

Under the new rules, companies will have to provide details on the amount of added sugar such as corn syrup and white and brown sugar.

The Sugar Association, which represents U.S. sugar cane farmers, refiners, sugar beet farmers and processors, said it was “disappointed” at the requirement to list added sugars on the label and said the FDA had not demonstrated a scientific link between sugar and disease.

Information about calories from fat will be removed because research shows the type of fat is more important than the amount, the FDA said.

The new rules require serving sizes on the label to reflect what, on average, consumers actually eat. About 20 percent of all package labels will be adjusted, the FDA said. Some, such as ice-cream will be adjusted upwards, while others, such as yogurt, will be adjusted downwards.

“What and how much people eat and drink has changed since the last serving size requirements were published in 1993,” the agency said.

HOW WILL CONSUMERS REACT?

It was unclear how much the new label will actually impact consumer behavior.

Professor Jeremy Kees, a nutrition label expert at Villanova University School of Business who has consulted for both the FDA and industry, said he believes the impact will be “relatively small” because the information is on the back of the package.

“I think front of pack labeling has more potential to have a bigger impact on consumers,” he said.

Some changes have already been made, analysts say.

“Carbonated soft drinks have been on the decline before any of this happened,” said Darren Seifer, an analyst at The NPD Group, a market research company. “It might not make it exponentially greater, but it may help sustain it.”

The largest U.S. chocolate maker, The Hershey Company &lt;HSY.N&gt;, said it “will work diligently to make the necessary updates to our Nutrition Facts labels as requested by the FDA.”

In the United States more than one-third of adults and about 17 percent of youth aged 2 to 19 are obese, according to the Centers for Disease Control and Prevention.

Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of preventable death. The estimated annual medical cost of obesity in the U.S. was $147 billion in 2008 U.S. dollars, according to Centers for Disease Control.

The FDA estimated the cost to industry of updating the labels at about $2 billion and the benefit to consumers at between $20 billion to $30 billion.

(Additional reporting by Dipika Jain, Sruthi Ramakrishnan, Melissa Fares and Chris Prentice; editing by Phil Berlowitz and Cynthia Osterman)

U.S. environmentalists sue to overturn approval of GMO salmon

An AquAdvantage Salmon is pictured in this undated handout photo provided by AquaBounty Technologies

By Tom Polansek

CHICAGO (Reuters) – U.S. health regulators are facing a lawsuit from a coalition of environmental organizations seeking to overturn the government’s landmark approval of a type of genetically engineered salmon to be farmed for human consumption.

The Center for Food Safety, Food and Water Watch, Friends of the Earth and other groups allege in the lawsuit, filed on Wednesday, that the Food and Drug Administration (FDA) failed to consider all of the environmental risks of the fish when the agency approved it in November.

The FDA also cleared the product, made by Massachusetts-based AquaBounty Technologies, without having the proper authority to regulate genetically engineered animals produced for food, according to the complaint.

The agency declined to comment on the lawsuit on Thursday. Its approval of AquaBounty salmon followed a 20-year review and was the first such approval for an animal whose DNA has been scientifically modified.

AquaBounty is confident the FDA’s approval will stand, Chief Executive Ron Stotish said in a statement. The agency was “extraordinarily thorough and transparent in the review and approval of our application,” he said.

The company has said its salmon can grow to market size in half the time of conventional salmon, saving time and resources.

However, the FDA approval process included “an extremely limited environmental assessment” that did not fully evaluate the potential for AquaBounty salmon to escape from the facilities where they are grown, among other risks, according to the lawsuit.

The legal challenge comes as the U.S. food industry is facing increased pressure from consumers to provide more information about the use of genetically engineered ingredients.

General Mills Inc and other major food companies are rolling out new disclosures on products to comply with a Vermont law that will require labels on foods made with genetically modified organisms, or GMOs.

Major retailers, including Kroger Co and Target Corp, have already said they do not plan to stock AquaBounty salmon on store shelves. It is not yet available for sale.

Activists worry the FDA’s approval of the salmon will serve as a precedent for other genetically engineered food animals.

Their lawsuit seeks to prohibit the FDA from taking further action on the fish or any other genetically engineered animal for human consumption until Congress grants an agency clear authority over such products.

The case is Institute for Fisheries Resources et al v Sylvia Mathews Burwell et al, U.S. District Court, Northern District of California, No. 16-cv-01574.

(Reporting by Tom Polansek; Editing by Richard Pullin and Andrew Hay)

FDA backs expanded use of medical abortion pill

WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Wednesday agreed to allow more access to Danco Laboratories’ abortion pill Mifeprex, likely making it easier and cheaper for women to have an abortion by medication.

The FDA increased authorized use of the pill to 70 days of gestation from the current 49 days, cut the recommended dose of the drug and reduced the number of required visits to a doctor.

The changes are expected to allow greater access to medication abortions, particularly in Texas, North Dakota and Ohio, which have laws that require providers to prescribe the drug according to a more restrictive FDA label in place since 2000.

On Wednesday, the agency updated the Mifepfrex requirements to bring them in line with the most up-to-date scientific studies, which have shown that a third of the dose works as well.

“The FDA label has finally caught up to the evidence based practice in the United States,” said Vicki Saporta, president and chief executive of the National Abortion Federation, an organization of abortion providers. “It has the potential of opening medical abortion care in more rural areas because it does not have to be given by a surgical abortion provider,” she added.

The FDA decision comes amid a heated 2016 presidential race.

Earlier this month, the Supreme Court took up a major abortion case which represents a test for a strategic shift that abortion opponents have taken in recent years: to apply restrictive regulations to abortion doctors and facilities rather than try to ban the procedure outright.

Mifeprex 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.

Under the new prescription information on the label, patients will take one 200 mg tablet of Mifeprex on day one instead of three 200 mg tablets. They will take 800 mcg of misoprostol 24-48 hours after taking Mifeprex. Previously they took 400 mcg on day three.

Under the old label, patients were asked to return to their doctor 14 days after taking Mifeprex for an examination. The new label requires that they return between seven and 14 days for an “assessment.”

As far back as 2001, an estimated 83 percent of U.S. providers were no longer using the old FDA-approved regimen, according to the Guttmacher Institute, which backs abortion rights but whose research is used by both sides of the debate.

(Reporting by Toni Clarke, Jilian Mincer and Jon Herskovitz; Editing by Alistair Bell)