(USA TODAY) The Food and Drug Administration will conduct fewer food safety inspections this year because of the government sequester, commissioner Margaret Hamburg said Wednesday in an exclusive interview with USA TODAY.
While consumers may not feel the impact immediately, the loss of $209 million from its budget will force the agency to conduct about 2,100 fewer inspections, an 18% decline compared to last year.
The funding loss, part of the $85 billion in automatic budget cuts that took effect March 1, will also delay the agency's implementation of the 2011 Food Safety Modernization Act, Hamburg said in an interview with the USA TODAY Editorial Board.
The FDA could also take longer to review and approve new drugs, she said. "All of those programs will be compromised by the cuts," she added. "Sequester is a big hit for us. ... The cuts are real and will have impacts."
The FDA will prioritize programs that have the greatest effect on public health, including disease outbreaks, she said. Hamburg does not expect to furlough workers.
One in six Americans, or 48 million people, develop a food-borne illness each year, according to the Centers for Disease Control and Prevention. About 3,000 die, and 128,000 are hospitalized.
The FDA is already facing sharp criticism, and even legal action, for being slow to implement the food safety law. The law aimed to refocus the FDA's efforts on prevention, rather than responding to crises.
After being signed into law by President Obama in 2011, the law sat for two years with the White House Office of Management and Budget where it was rewritten in ways that weakened FDA's oversight, says Food Safety News, an industry watchdog publication. A federal judge in California has ordered the FDA to work with two food-safety advocacy groups to create a new timetable to speed up the process.
"Nobody is more frustrated than we are" that the law isn't yet in practice, said Michael Taylor, the FDA's deputy commissioner for foods and veterinary medicine.
With every year that passes before the law is in practice, more people are at risk of getting sick, Taylor said.
Even before the sequester, the FDA was able to inspect less than 2% of all food imports, Taylor said.
Jean Halloran, director of food policy initiatives at Consumers Union, said she's concerned that the cuts will lead to more outbreaks.
"That's fairly alarming," Halloran said. "It's a huge step in the wrong direction."
Others, such as Douglas Powell, a professor of food safety at Kansas State University, said private companies have no reason to slack off on food safety, with or without inspections.
Because companies are legally liable for the safety of their food, they have a strong economic incentive to inspect their own products and prevent outbreaks.
"The government is there to maintain a minimal standard, but they really inspect very little food," Powell said. "It is in a company's best interest to take that seriously and not make their customers barf."
Hamburg also addressed other key issues:
• The FDA has made progress in fighting drug shortages, which have disrupted care for cancer patients and others. The number of shortages fell from 251 in 2011 to 121 in 2012, she said. In addition, the FDA prevented 280 drug shortages last year, by working with manufacturers and finding substitutes.
• Hamburg noted the difficulty of monitoring and overseeing compounding pharmacies, such as the one responsible for an outbreak of fungal meningitis last fall that killed 53 people and sickened more than 700. "We have a system that is broken," she said. Hamburg said these pharmacies -- many of which are now acting like manufacturers -- are governed by a "patchwork of state laws." A report released last week by Rep. Ed Markey (D-Mass.) found that no states require pharmacies to disclose the volume of compounded drugs they produce, or whether these drug were sold across state lines. Hamburg in the past has called on Congress to give the FDA explicit authority to regulate compounders.
• Hamburg said the FDA has not yet decided how to respond to a court's recent ruling that emergency contraception, sold as Plan B, should be sold over the counter to anyone, regardless of age.