Featured Issue Briefs

Bill Summary - Counterfeit Drug Enforcement Act of 2009

This issue brief is a summary of H.R. 2726 - The Counterfeit Drug Enforcement Act of 2009, also known as the Tim Fagan Law.

Letter from Pew: Release of the Unique Device Identifier Final Rule

A letter from Josh Rising — director of Pew's Medical Device Initiative — to The White House Office of Management and Budget, requesting a speedy review of regulations to develop a unique device identifier (UDI) system. More info

Letter from Pew to FDA on Postmarket Surveillance Plan

FDA recently updated the national medical device postmarket surveillance plan – listing device identification and registries as the cornerstones for effective product monitoring. In this letter, medical devices director Josh Rising applauds the agency for making unique device identifiers and registries central to this plan.
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Comments on the Health Information Technology Patient Safety Action and Surveillance Plan

In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology, Consumers Union, the National Women's Health Network, the National Research Center for Women and Families, the Trust for America's Health, and The Pew Charitable Trusts urge the ONC to promote adoption of the unique device identification (UDI) system for medical devices to improve the safety of medical care.

Strengthening Our National System for Medical Device Postmarket Surveillance

The Medical Device Initiative submitted comments to the U.S. Food and Drug Administration concerning the FDA's National Medical Device Postmarket Surveillance Plan, "Strengthening Our National System for Medical Device Postmarket Surveillance."

Toxic Chemicals and Reproductive Health

Over the past few decades, the reproductive health of Americans appears to have declined. Diseases, disorders and conditions that affect the development and functioning of the male and female reproductive systems—including fertility problems, miscarriages, pre-term births, low birthweights and certain birth defects—have risen. In addition, incidence rates of testicular cancer have increased, and breast and prostate cancers remain among the most common forms of cancer in the U.S. More info

Pew Comments on Draft Guidance for Industry Regarding Nanotechnology in Food

The Food Additives Project of the Pew Health Group strongly agrees with the FDA's draft decision to deny "generally recognized as safe" (GRAS) status to nanoengineered chemicals and review them as food additives. However, they list their concerns with certain aspects of the document and question the agency's claim that it has not reviewed GRAS notifications sanctioning the use of nanoengineered chemicals. More info

Clostridium difficile: Rapidly Emerging Bacteria that Flourish in the Face of Antibiotics

Nearly 45,000 Americans died from CDI between 1999 and 2009.

Children and Foodborne Illness

Children are disproportionately affected by foodborne illness, a serious public health problem. Approximately half of the reported foodborne illnesses occur in children. Every year, the Centers for Disease Control and Prevention (CDC) estimates that tens of millions of Americans fall ill, hundreds of thousands are hospitalized, and thousands die from foodborne illnesses.

Obama needs to release draft food safety rules, say victims and advocacy groups

The U.S. Centers for Disease Control and Prevention estimate that one in six Americans (48 million people) suffer from a foodborne illness each year, resulting in 128,000 hospitalizations and 3,000 deaths. Americans will continue to get sick and even die from foodborne disease as your Administration continues to hold up the food safety rules. In fact, the U.S Food and Drug Administration (FDA) essentially ensured such an outcome last week in a letter to food industry representatives. In it, the FDA said that until final rules are issued, the agency would not enforce the FSMA requirements that food processors adopt prevention-based protections, and that importers assure the safety of the food products they send to the United States.

Food Products Recalled By FDA

Since President Obama signed the FDA Food Safety Modernization Act into law, at least 149 FDA-regulated food products have been recalled due to potential pathogenic contamination. A recall is needed when a failure in the food safety program in a food facility results in contaminated food products being shipped to supermarkets and other retail and wholesale outlets. A recall is the last line of defense that protects consumers from getting sick.

FDA Responsibilities and Resources

Charged with responsibility for keeping 80% of the nation's food supply (including fresh produce) safe, the FDA receives less than 25% of federal dollars spent on food safety activities.

Foodborne Pathogens Associated with Fresh Fruits and Vegetables

There are a number of foodborne microbial pathogens associated with the consumption of fresh fruits and vegetables that can cause illness or death among consumers who eat contaminated produce.

This document summarizes the major foodborne microbial pathogens that may be found in fresh produce, including Cyclospora cayetanensis, Escherichia coli O157:H7, Hepatitis A, Listeria monocytogenes, Norovirus, Salmonella spp., and Shigella spp.