Tag Archives: Department of Health and Human Services

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)

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.