Washington, D.C. - U.S. Senator Mike Enzi, R-Wyo., chaired two committee hearings this week that will directly affect consumers. The first explored how to improve food safety conditions to limit or prevent future outbreaks, such as the E. coli bacteria outbreak in spinach this past summer that resulted in three deaths. In another committee hearing Enzi promoted legislation that would require drug makers to engage in better safety planning before a drug is approved for the release to the public.
Food Safety
Enzi chaired the hearing, "Food Safety: Current Challenges and New Ideas to Safeguard Customers" Wednesday. This hearing focused on the need to improve the food safety system, and included witnesses from federal and state agencies, as well as the food industry.
"We can and must improve coordination and cooperation between federal and state officials because they are critical in identifying, tracking and responding to outbreaks of food-borne illness," Enzi said. "We must also look into new technologies that could help limit or even prevent future outbreaks being developed by small businesses nationwide. No one innovates like small business, and there is no shortage of companies with great new ideas to improve food safety."
This past summer a strain of E. coli bacteria caused 204 people to become sick in 26 states and resulted in three deaths. In October, the CDC began investigating a Salmonella outbreak, which was traced back to tomatoes served at restaurants. Twenty-one states have reported 183 cases of illness due to these tomatoes.
"We rely upon a system of checks and balances that take place behind the scenes that we are often unaware of - until something goes wrong. Then and only then do we realize how dependent we are on the food safety system that is supported by the activities carried out by federal, state, and local government agencies, as well as by the food industry itself,"Enzi said.
Drug Safety
Enzi chaired the "Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation" hearing Thursday. The focus of this hearing was on a bill Enzi introduced that would require drug makers to engage in better safety planning before a drug is approved for the release to the public, and improve the FDA’s response to risks identified after a drug is on the market.
"The ‘Enhancing Drug Safety and Innovation Act,’ S.3807, will raise the bar to ensure that drug safety is not an afterthought, but an integral part of the process from the very beginning," Enzi said. "This bipartisan bill is designed to provide better, flexible, adaptive, and rapid safeguards to protect the millions of Americans who take prescription drugs daily."
"When new information comes to light that demonstrates previously unknown risks about a drug, the FDA, together with the drug industry and physicians, must be ready and able to take swift, appropriate, and decisive action to ensure patient safety," Enzi said.
Enzi said the bill, which reflects the comments and input of dozens of stakeholders, including the FDA, patient and consumer groups, industry trade associations, individual companies, and scientific experts, will:
*Integrate safety issues and the approval process by requiring earlier and more focused consideration of safety issues;
*Establish a flexible planning mechanism to obtain the necessary safety information about each unique new drug or indication;
*Permit adaptation of the safety plan in response to new information; and,
*Bring fairness, timeliness and finality to the dispute resolution process.
Video of both hearings are available on the HELP Committee Web site at http://help.senate.gov/
