By Chris O'Brien
The U.S. Food and Drug Administration has announced plans to hire as many as 1,300 new employees this year in order to meet regulatory demands surrounding food safety and new drug applications.
Seven hundred positions stem from the FDA Amendments Act of 2007, a bill signed by the President that requires pharmaceutical and biotechnology companies to pay additional "user fees" to the FDA in exchange for shorter approval times for New Drug Applications and Biological License Applications.
"The motivation behind this act is to make sure we have standards for new drug applications, devices and biological applications," said Kimberly Holden, assistant commissioner for operations at the FDA. "We are hiring to ensure we have processes and systems in place to get those through to market quickly for the benefit of the public."
The FDA is also looking to hire an additional 600 medical and safety officers, scientists, consultants and mathematicians to keep up with the current demands for food safety and inspection based on revisions in the Food Protection Plan and Import Safety Plan.
Currently, the FDA regulates $417 billion of domestic food and $49 billion of imported foods each year, everything except meat, poultry and some egg products, which are regulated by the USDA.
While the FDA's primary charge is food safety, a recent report by Trust for America's Health said some of the U.S. food safety systems are outdated and inefficient.
"The U.S. food safety system has not been fundamentally modernized since its inception over 100 years ago," said the report, Fixing Food Safety: Protecting America's Food Supply from Farm-to-Fork (www.healthyamericans.org). "Current food safety polices are largely based on early twentieth century laws written to deal with concerns that rarely pose significant threats today because of changes in farming and processing practices and technologies."
The report said that the foundations of the FDA's safety function are rooted in statutes dating back to 1906 and 1938, forcing the FDA to be reactive to food safety issues instead of proactive. Further, the report said Congress needs to provide the agency with a modern, public health mandate to prevent foodborne illness, update the agency's legal tools to meet the challenges of a high-tech, globalized food supply; and provide the funding stream FDA needs to carry out research and safety inspections.
While the FDA couldn't comment on the Fixing Food Safety report, they did say that the recent changes to policy and the subsequent hiring were enhancements to existing food safety protocols.
"The Food Protection Plan is based on prevention, intervention and response," said Holden. "The new plan is a more robust strategy that we put in place to protect the food supply from unintentional contamination and any deliberate attacks."