Novartis, U.S. drug regulator agree to malaria drug trial against COVID-19

By John Miller

ZURICH (Reuters) – Novartis has won the go-ahead from the U.S. Food and Drug Administration to conduct a randomized trial of malaria drug hydroxychloroquine against COVID-19 disease, the Swiss drugmaker said on Monday, to see if it helps patients.

The decades-old generic medicine got FDA emergency use authorization this month for its unapproved use for coronavirus disease, but so far there is no scientific proof it works. There are currently no approved COVID-19 medicines.

Novartis plans to start recruiting 440 patients for its Phase III, or late-stage, trial within weeks at more than a dozen U.S. sites. Results will be reported as soon as possible, the company added.

Use of the drug, also approved to treat lupus and rheumatoid arthritis, has soared after having been promoted by President Donald Trump, with some worried the administration’s advocacy for an unproven medicine for COVID-19 has short-circuited the FDA’s oversight process.

“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Novartis’s top drug developer. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”

Companies such as Novartis, Roche and Gilead Sciences are testing older medicines developed to treat other diseases, for signs they could be repurposed to tackle the coronavirus epidemic. Gilead just expanded a trial of its Ebola drug remdesivir.

Still, some fear the championing of hydroxychloroquine by Trump and others as a potential “game changer” against COVID-19 has overshadowed dangerous side effects like vision loss and heart problems. Novartis CEO Vas Narasimhan has also said the medicine is one of his biggest hopes against the viral epidemic.

There are several additional studies of hydroxychloroquine underway, including at the University of Washington and University of Minnesota, as well as work by the National Institutes of Health in the United States.

Novartis’s Sandoz generics unit has pledged to donate 130 million doses of the medicine for use. Sanofi has also said it will donate 100 million doses of hydroxychloroquine to 50 countries.

(Reporting by John Miller, editing by John Revill)

U.S. officials hopeful about May 1 target date for reopening U.S.

WASHINGTON (Reuters) – The Trump administration views May 1 as a target date for relaxing stay-at-home restrictions across the United States, Food and Drug Administration Commissioner Stephen Hahn said on Sunday, but he cautioned that it was still too early to say that target would be met.

“We see light at the end of the tunnel,” he told ABC’s “This Week.” However, there were many factors to take into account in finally determining when it would be safe to lift restrictions, he said.

(Reporting By Ross Colvin; editing by Diane Craft)

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)

Dole recalls packaged salads after multi-state listeria outbreak

Dole is temporarily shutting down one of its production facilities and recalling all of the salads that were made there because the facility has been linked to a multi-state outbreak of listeria.

The recall notice was posted on the Food and Drug Administration website on Friday.

The Centers for Disease Control and Prevention (CDC), which has been investigating the outbreak, said 12 people in six states have been hospitalized since July. One person died.

The CDC determined that salads produced and packaged at Dole’s facility in Springfield, Ohio, were likely behind the illnesses. Dole initiated the recall and decided to temporarily suspend production at the facility “out of an abundance of caution,” according to the recall notice.

The salads in question were sold under a variety of different brand names — including Dole, Fresh Selections, Simple Truth, Marketside, The Little Salad Bar and President’s Choice, the CDC said. However, they all have the letter ‘A’ at the beginning of a product code that appears on the upper-right-hand corner of the package, according to Dole’s recall notice.

Dole said none of its other products or facilities are affected by the recall, and added that packaged salads that have ‘B’ or ‘N’ at the start of their product codes aren’t being recalled. Those salads were produced at different facilities, and the CDC added that it doesn’t currently have any evidence suggesting those salads are linked to the outbreak.

Dole said the recalled salads were sold in Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and Wisconsin, as well as the Canadian provinces of Ontario, New Brunswick and Quebec.

The company encouraged consumers and stores who still have packaged salads with product codes beginning with ‘A’ to throw them out without eating them.

According to the CDC, listeria is a bacteria that can lead to listeriosis, a rare but life-threatening condition that is often contracted by eating contaminated food. The organization estimates that listeriosis sickens about 1,600 people annually in the United States, killing about 260 of them.

Newborns, older adults people with weak immune systems and pregnant women are generally at risk, the CDC says, and the bacteria can lead to miscarriages or stillbirths. Common symptoms include fever and muscle aches, though the disease can also cause convulsions in certain people.

This particular outbreak sickened people in Michigan, Indiana, Pennsylvania, New York, New Jersey and Massachusetts, according to the CDC, and killed a person from Michigan.

Trader Joe’s recalls cashews amid salmonella concerns

A possible salmonella contamination has prompted Trader Joe’s to recall some cashews.

The grocery store chain issued a statement about the recall late last week, saying that one particular kind of Trader Joe’s Raw Cashew Pieces could be contaminated with the bacteria.

The cashews are marked “BEST BEFORE 07.17.2016TF4,” the company said, and were distributed to stores in 30 states across the country, as well as the District of Columbia.

It wasn’t clear exactly how many packages were included in the recall.

Trader Joe’s said it learned of the possible contamination from a supplier, but didn’t elaborate.

A recall notice on the Food and Drug Administration website says Heritage International (USA) Inc. was voluntarily recalling the cashew lot after routine lab tests found salmonella in it.

The bacteria can cause people to fall ill.

Trader Joe’s said it hasn’t received any reports of anyone getting sick from the cashews, though it has stopped selling all Trader Joe’s Raw Cashew Pieces in its stores pending an investigation.

The grocery chain encourages anyone who bought the cashews marked “BEST BEFORE 07.17.2016TF4” to return them for a full refund or throw them out without eating them.

According to the CDC, salmonella sickens about 1.2 million Americans every year. Symptoms include diarrhea, fever and abdominal cramps, and most people fully recover in 4 to 7 days. In extreme cases, though, infections can spread beyond the intestines and become more severe.

The bacteria leads to about 450 deaths and 19,000 hospitalizations every year, the CDC says. Children, older adults and people with weak immune systems are particularly at risk.