Featured Issue Briefs

The Battle on the Home Front: Jonathan Gadsden's Story

The Battle on the Home Front: Jonathan Gadsden's Story

Marine Lance Corporal's story reflects the growing need for new antibiotics that can treat dangerous diseases, against which most drugs are useless. Read More

Facilitating Medical Device Innovation: De Novo Reform

Facilitating Medical Device Innovation: De Novo Reform

The de novo process -- which requests lower-risk reclassification of medical devices and entry into the marketplace -- as it exists now is not achieving its purpose and has instead added unnecessary and time-consuming requirements. Read More

Food Products Recalled by FDA

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. Read More

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Jul 17, 2012

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.

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Food Safety

Feb 19, 2010

Produce Safety Project: Stakeholders' Discussion Series Meetings

The Food and Drug Administration announced in December 2009, that it was going to establish a nationwide produce safety standard for the growing, harvesting and packing of fresh fruits and vegetables and opened an official docket for comments in February 2010. More

Food Safety

Nov 19, 2008

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.

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Food Safety

Nov 19, 2008

Produce-Related Foodborne-Illness Outbreaks

From 1990 through 2005, at least 713 produce-related outbreaks have occurred. This issue brief summarizes 15 years of produce-related illness outbreaks in the U.S.

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Food Safety

Nov 19, 2008

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.

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Food Safety

Nov 18, 2008

Cost of Foodborne Illness

Foodborne illnesses carry with them significant economic and social costs that extend far beyond the immediate victim.

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Food Safety

Sep 17, 2008

Top Line Poll Results

Results from Hart Research and Public Opinion Strategies survey of 1002 likely voters, conducted from July 21-August 3, 2008. More

Food Safety

Mar 1, 2012

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

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

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Food Hazards

Oct 19, 2011

Focus On: Food Import Safety

Americans’ appetite for imported food has expanded dramatically over the past few decades. For each of the past seven years, food imports have grown by an average of 10 percent. Currently, between 10 and 15 percent of all food consumed by U.S. households is imported. According to the U.S. Food and Drug Administration (FDA), nearly two-thirds of the fruits and vegetables and 80 percent of seafood consumed domestically come from outside the United States. In this issue brief, the Pew Health Group and Center for Science in the Public Interest (CSPI) address the safety of imported seafood and raw produce, two of the largest categories of FDA-regulated food items produced and processed abroad and then sold in the United States. More

Food Hazards

Nov 12, 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.

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Food Hazards

Nov 18, 2008

FDA Actions Regarding Produce Safety

For more than a decade, the U.S. Food and Drug Administration (FDA) has recognized the challenge of making fresh produce safer. However, it has relied on voluntary guidelines. This document summarizes a decade of government initiatives that fall short of the mandatory and enforceable federal safety standards needed for domestic and imported fresh fruits and vegetables.

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Food Hazards

Aug 3, 2012

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

Food Additives

Jul 27, 2012

Review of the Scientific Basis for Safety Decisions on Hazards of Substances Added to Food

In April 2011 Pew Health Group convened a workshop bringing together more than 80 experts from government, industry, academia and public interest organizations to examine the principles underlying the development and use of scientific evidence to identify and characterize chemical hazards. Based on the workshop discussions, Pew made several important observations.

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Food Additives

Jun 1, 2010

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

Environmental Risk

Apr 1, 2010

Toxic Chemicals and a Child's Brain Development

Today, one in six children in the United States has a developmental or learning disability. Some experts say many of these may be due in part to early exposures to toxic chemicals. The number of children diagnosed with these disabilities has increased dramatically over the past four decades. More

Environmental Risk

Mar 29, 2012

Testimony before the Senate Committee on Health, Education, Labor and Pensions

Allan Coukell, Director of Medical Programs, Pew Health Group: Chairman Harkin, Ranking Member Enzi, and members of this committee, thank you for the opportunity to testify about the importance of the user fee agreement legislation to patients.

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Drug Safety, Drugs and Devices at the FDA

Jul 8, 2013

Letter from Pew and Premier to the OMB on Unique Device Identifier Rule

The Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule.

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Drugs and Devices at the FDA

Jun 27, 2013

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

Drugs and Devices at the FDA

Jun 18, 2013

Letter from Pew: Updates on the Unique Device Identifier System

A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.

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Drugs and Devices at the FDA

May 30, 2013

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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Drugs and Devices at the FDA

Apr 25, 2013

Letter From New Democrat Health Care Task Force to FDA on Unique Device Identification System

The three co-chairs of the New Democrat Health Care task Force – Reps. Allyson Schwartz, Kurt Schrader and Bill Owens – sent FDA a letter inquiring about the status of the agency’s final regulations to establish a unique device identifier (UDI) system and database.

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Drugs and Devices at the FDA

Feb 5, 2013

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.

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Drugs and Devices at the FDA

Jan 15, 2013

Comments on Stage 3 of the the Meaningful Use of Health Information Technology

In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology and The Pew Charitable Trusts urge the ONC to incorporate medical device identifiers developed under the FDA’s unique device identification (UDI) system into both electronic health record (EHR) certification criteria and Stage 3 meaningful use (MU) objectives. More

Drugs and Devices at the FDA

Nov 21, 2012

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."

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Drugs and Devices at the FDA

Nov 8, 2012

Pew Comments to the FDA Regarding the Unique Device Identification System

Pew’s Medical Device Initiative, along with the American Heart Association and Trust for America’s Health, submitted comments to the U.S. Food and Drug Administration (FDA) regarding its proposed rule for a unique device identification (UDI) system for medical devices. Once implemented by the FDA and utilized by healthcare providers, the UDI system will be the cornerstone for significant improvements in postmarketing surveillance of medical devices.

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Drugs and Devices at the FDA