Featured Issue Briefs
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
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
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
More Issue Briefs
| Date | Issue Briefs | Topic |
|---|---|---|
| Mar 8, 2012 |
Testimony before the House Committee on Energy and Commerce, Subcommittee on HealthAllan Coukell, Director of Medical Programs, and Sharon Ladin, Director of the Antibiotics and Innovation Project, testify before the House Committee on Energy and Commerce, Subcommittee on Health on stimulating the development of new antibiotics urgently needed to fight serious and life-threatening bacterial infections. More info |
Drug Safety, Antibiotic Innovation |
| Mar 8, 2012 |
Testimony of Allan Coukell on the Lack of a National Pharmaceutical Tracking SystemOn March 8, 2012, Pew Health Group’s Director of Medical Programs Allan Coukell testified before the Energy and Commerce Committee’s Subcommittee on Health regarding the drug distribution system – the risks of counterfeit and stolen drugs, and the pragmatic steps Congress can take to reduce those risks. More info |
Drug Manufacturing and Distribution, Drug Safety |
| Mar 29, 2012 |
Testimony before the Senate Committee on Health, Education, Labor and PensionsAllan 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. More info |
Drug Safety, Drugs and Devices at the FDA |
| Mar 30, 2012 |
Antibiotic Innovation: The Threat and the PipelineThe Superbug Threat explores the emergence of antibiotic resistant bacteria and its impact on human health, as well as the shrinking pipeline of new antibiotics. More info |
Antibiotics in Food Animal Production |
| Apr 3, 2012 |
MRSA: A Deadly Pathogen with Fewer and Fewer Treatment OptionsStaphylococcus aureus, or staph, is a common bacterium that exists in our environment and our bodies. Most of the time it does no harm. Sometimes, however, it can cause infection and require treatment. MRSA refers to strains of S. aureus that are resistant to the antibiotic methicillin and a host of other drugs used to treat infection. More info |
Food Safety, Antibiotic Innovation |
| Apr 11, 2012 |
Focus Group Findings on Prepaid Debit CardsThis fact sheet focuses on the lessons learned from consumers who purchase and use prepaid debit cards. More info |
Checking, Credit Cards |
| Apr 12, 2012 |
Reviving the Pipeline of Life-Saving AntibioticsAntibiotic-resistant infections are a growing public health threat. At the same time, antibiotic innovation is waning. Pew, the IIDSA and PhRMA hosted a one-day conference, Reviving the Pipeline of Life-Saving Antibiotics: Exploring Solutions to Spur Innovation on September 22, 2011, exploring ways to overcome the challenges that hinder the development of new antibiotics. More info |
Drug Safety, Antibiotic Innovation |
| Apr 18, 2012 |
Testimony before the Committee on Energy and Commerce Subcommittee on HealthU.S. House of Representatives PDF Download Since 1992, user fee agreements have given FDA significant and sustained resources that allow the agency to review new products quickly. In fact, preliminary findings of a study that Pew has funded show that FDA reviews new drugs faster than its cou More info |
Drug Safety |
| Apr 23, 2012 |
Save Antibiotics April Newsletter (2012)Below is your April 2012 newsletter from the Pew Campaign on Human Health and Industrial Farming. In this edition: FDA Takes Important Step to Curb Antibiotic Overuse in Food Animal Production. More info |
Antibiotics in Food Animal Production |
| Apr 23, 2012 |
Moms for Antibiotic Awareness April Newsletter (2012)Below is your April 2012 newsletter from Moms for Antibiotic Awareness. In this edition: FDA Takes Important Step to Curb Antibiotic Overuse in Food Animal Production. More info |
Antibiotics in Food Animal Production |
| May 1, 2012 |
Meet Our SupermomsWe're excited to introduce you to our "Supermoms," passionate advocates from across the country who are raising awareness about the overuse and misuse of antibiotics in food animal production and its impact on human health. More info |
Antibiotics in Food Animal Production, Moms For Antibiotic Awareness |
| May 16, 2012 |
Case Studies: How Unsafe Drugs Can Reach PatientsThe following case studies illustrate breaches to the pharmaceutical supply chain—the route a drug travels from its raw material origins to the delivery of a finished medicine. These examples, all of which are discussed in Pew Health Group’s report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways in which contaminated, fake, or otherwise unsafe medicine can reach patients, and underscore the need for reform. More info |
Drug Manufacturing and Distribution, Drug Safety |
| May 16, 2012 |
Heparin: A Wake-Up Call on Risks to the U.S. Drug SupplyWhile the vast majority of drugs in American pharmacies and medicine cabinets are safe, globalization and reliance on outsourced manufacturing creates new risks, including deliberate tampering with ingredients and inadequate quality controls in plants that operate largely outside the scrutiny of the FDA. More info |
Drug Manufacturing and Distribution, Drug Safety |
| May 21, 2012 |
Moms for Antibiotic Awareness Newsletter (2012)"Supermoms" from Maine to Hawaii came to Washington, D.C., this week to press the Obama Administration and Congress to do more to rein in the overuse of antibiotics on America’s industrial farms, a practice that breeds antibiotic-resistant bacteria. More info |
Antibiotics in Food Animal Production |
| May 21, 2012 |
Save Antibiotics May Newsletter (2012)"Supermoms" from Maine to Hawaii came to Washington, D.C., this week to press the Obama Administration and Congress to do more to rein in the overuse of antibiotics on America's industrial farms, a practice that breeds antibiotic-resistant bacteria. More info |
Antibiotics in Food Animal Production |
| May 31, 2012 |
Unmet Medical Need in Infectious DiseasesIntroduced more than 75 years ago, antibiotics have profoundly transformed health care. Thanks to these drugs and to advances in vaccines and infection control, many formerly devastating bacterial illnesses can be cured or contained. More info |
Antibiotic Innovation |
| Jun 22, 2012 |
Improving Medical Device Safety Through Better SurveillanceIn 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative, a national electronic system designed to “track the safety of drugs, biologics, and medical devices once they reach the market.” By proactively monitoring data from electronic health records and other sources rather than relying on spontaneous reporting from manufacturers and health care providers, the Sentinel system can more quickly identify safety issues. More info |
Medical Safety |
| Jun 22, 2012 |
Facilitating Medical Device Innovation: De Novo ReformThe de novo process as it exists now is not achieving its purpose of streamlining the path to move new devices onto the marketplace and has instead added unnecessary and time-consuming requirements. More info |
Medical Safety |
| Jul 16, 2012 |
Food Animal Production and Antibiotic ResistanceAntibiotics are one of the most important tools in modern medicine. These drugs can mean the difference between life and death when humans contract a bacterial infection—from staph to salmonella to bacterial pneumonia. But overuse and misuse of these drugs are making bacteria more quickly resistant to essential antibiotics. More info |
Antibiotics in Food Animal Production |
| Jul 17, 2012 |
Obama needs to release draft food safety rules, say victims and advocacy groupsThe 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. More info |
School Food, Food Hazards |
| Jul 17, 2012 |
Food Products Recalled By FDASince 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. More info |
Food Safety |
| Jul 20, 2012 |
58 Health and Consumer Groups Tell FDA to Close Loopholes in Antibiotic GuidelinesOver 50 health and consumer groups plead to the U.S. Food and Drug Administration that the federal government accelerate and expand actions to curtail the overuse and misuse of antibiotics in food animal production. Despite overwhelming scientific evidence that these practices threaten human health, the routine administration of antibiotics in industrial meat and poultry operations continues unabated, putting the health of all Americans at risk for dangerous antibiotic-resistant infections. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
Hospitals Seek Stronger Guidelines for Antibiotic Use in Food AnimalsSeveral hospitals and medical centers across the United States joined forces in a letter to the U.S. Food and Drug Administration to accelerate and expand actions to curtail the overuse and misuse of antibiotics in food animal production. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
359 Health Professionals Ask FDA to Better Protect AntibioticsIn this letter to the U.S. Food and Drug Administration, 359 health professionals requested that the federal government accelerate and expand actions to curtail the overuse and misuse of antibiotics in food animal production. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
Businesses to FDA: End Overuse of Antibiotics in Food AnimalsSeveral business leaders, including the CEO of Chipotle, wrote a letter to the U.S. Food and Drug Administration (FDA) requesting that the FDA increase its efforts to curtail the misuse of antibiotics in food animal production. More info |
Antibiotics in Food Animal Production |
