Food and Drug Administration

The New York Times

The Food and Drug Administration is the oldest comprehensive consumer protection agency in the U. S. federal government. The agency, charged with protecting public health, has been criticized for its failure to monitor the flood of imported foods, drugs and medical devices.

In January 2011,  President Obama signed legislation that gave the F.D.A. new powers to police foreign foods. For instance, the law for the first time gave the F.D.A. the authority to order companies to withdraw foods suspected of being contaminated. Previously the F.D.A. could only ask manufacturers to withdraw suspect foods.

The legislation is also meant to change the mission of the F.D.A., focusing it on preventing food-borne illnesses rather than reacting after an outbreak occurs. Dr. Margaret Hamburg, the head of the F.D.A., has said that the passage of the bill “has laid the critical foundation for a prevention-based 21st-century food safety system.”

The law directed the agency to inspect at least 600 foreign food facilities within a year, then increase that number every year afterward. But instead of increasing the agency’s budget to perform those inspections, House Republicans voted to cut it.

Many in the food industry, angered by contamination scares that have cost hundreds of millions of dollars, have volunteered to pay fees directly to the F.D.A. to underwrite more inspections. Consumer groups have cheered this suggestion.

In June 2011, the F.D.A. released a rare special report titled“Pathway to Global Product Safety and Quality” that acknowledges that “the safety of America’s food and medical products remains under serious threat.” The report recommended that the F.D.A. cooperate with regulators in other countries to ensure safety.

In July, F.D.A. officials were stunned when a scientific panel it had convened reported that the government’s system for regulating many medical devices like artificial hips should be abandoned and replaced because it fails to examine their safety and effectiveness before sale.

The report by the Institute of Medicine follows several recalls of medical devices in recent years, like one involving so-called metal-on-metal hip replacements used in thousands of patients, crippling some of them. In its report, the panel found that existing rules used to approve many devices were never intended to play the critical role of screening out dangerous or ineffective products.

Currently, makers of "moderate risk'' medical devices are required only to show that they were “substantially equivalent” to one already on the market. The panel said the rule creates a daisy-chain system of regulation, in which new devices simply piggy-back on earlier ones, without any examination of their safety or their value to patients.

Claims: 
The copyrights of articles in the website belong to authors. Please inform us if there is any violation of intellectual property and we will delete the articles immediately.