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 |
|---|---|---|
| Nov 8, 2012 |
Pew Comments to the FDA Regarding the Unique Device Identification SystemPew’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. More info |
Drugs and Devices at the FDA |
| Oct 22, 2012 |
Pew's Comment Letter on FDA’s Advanced Notice of Proposed Rulemaking Regarding Data CollectionOn behalf of The Pew Charitable Trusts (Pew), we are writing to urge the U.S. Food and Drug Administration (FDA) to strengthen regulations pertaining to record-keeping and public reporting of antibiotic use in food animal production. More info |
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| Sep 12, 2012 |
Written Statement of Record Regarding the Sunshine Act by Dr. Daniel J. Carlat of the Pew Health GroupDr. Daniel Carlat, Director of the Pew Prescription Project, appeared before the U.S. Senate Special Committee on Aging to testify about the importance of implementing the Physician Payments Sunshine Act as quickly as possible. More info |
Drug Manufacturing and Distribution, Conflicts of Interest |
| Aug 31, 2012 |
Save Antibiotics August Newsletter (2012)What's in your Lunchbox? & Senators Call for FDA ActionAIP Generating ActBelow is your August 2012 newsletter from the Pew Campaign on Human Health and Industrial Farming. This edition features a video of Supermoms visiting Capitol Hill, a new report on More info |
Antibiotics in Food Animal Production |
| Aug 28, 2012 |
Members of Congress Write Letter to FDA About Antibiotics in Food Animal ProductionTwelve United States congressmen have penned a letter to the Food and Drug Administration making recommendations on improvements to the FDA's policies on food animal production and the use of antibiotics in industrial farming. More info |
Antibiotics in Food Animal Production |
| Aug 23, 2012 |
Pew Biomedical Scholar Profile: Sohini RamachandranSohini Ramachandran, a population geneticist at Brown University in Providence, Rhode Island, received two high-profile awards this year. In June, she was named a Pew Scholar in Biomedical Sciences by the Pew Charitable Trusts, based in Philadelphia, Pennsylvania; and in February, she received a fellowship from the Alfred P. Sloan Foundation in New York. She plans to use the grants to distinguish herself in a fast-moving field. More info |
Biomedical Research |
| Aug 16, 2012 |
The Battle on the Home Front: The Jonathan Gadsden StorySince Operations Iraqi Freedom and Enduring Freedom began, many American servicemen and women have been infected with antibiotic-resistant bacteria. While our men and women in uniform increasingly survive severe wounds sustained in combat, their injuries leave them susceptible to life-threatening, hard-to-treat infections. Marine Lance Corporal Jonathan Gadsden’s story reflects the growing need for new antibiotics that can treat these dangerous diseases, against which most drugs are useless. More info |
Antibiotic Innovation |
| Aug 13, 2012 |
U.S. Senators' Letter to FDA Commissioner Margaret HamburgThirteen U.S. Senators, including Sen. Dianne Feinstein and Sen. Susan Collins signed a letter to U.S. Food and Drug Administration Commissioner Margaret Hamburg calling for improvements to Guidance for Industry 209 -- which proposes voluntary reductions in the use of antibiotics in food animal production. More info |
Antibiotics in Food Animal Production |
| Aug 9, 2012 |
Human Health and Industrial Farming 101Are you interested in writing about the overuse of drugs in food animal production? Below you can find background information, key facts, photos, and other resources. More info |
Antibiotics in Food Animal Production |
| Aug 3, 2012 |
Pew Comments on Draft Guidance for Industry Regarding Nanotechnology in FoodThe 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 |
Food Additives |
| Jul 31, 2012 |
Leading Physicians and Scientists Ask FDA to Rein in Drug Use in Food AnimalsSeveral recognized leaders in the U.S. scientific and medical community have signed a letter to President Obama and the U.S. Food and Drug Administration, urging the FDA to implement stronger regulations regarding the use of antibiotics in food-producing animals. More info |
Antibiotics in Food Animal Production |
| Jul 27, 2012 |
What Did Pew Health Group Find in its Review of the U.S. Food Additive Regulatory Program?In the November 1, 2011, edition of the peer-reviewed journal Comprehensive Reviews in Food Science and Food Safety (CRFS), Pew Health Group published a rigorous analysis of the U.S. food additive regulatory program. Key among the findings is that more than 10,000 chemicals were allowed in human food as of January 2011. More info |
Food Safety |
| Jul 27, 2012 |
Review of the Scientific Basis for Safety Decisions on Hazards of Substances Added to FoodIn 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. More info |
Food Additives |
| Jul 25, 2012 |
Testimony of Allan Coukell Before the Committee on Commerce, Science and TransportationPew's Allan Coukell submitted a statement of record to the Congressional Committee on Commerce, Science and Transportation regarding concerns with the pharmaceutical supply chain. The focus of Coukell's testimony was the drug distribution system – the weaknesses in the system and the risks of counterfeit and stolen drugs. More info |
Drug Safety |
| Jul 24, 2012 |
Save Antibiotics July Newsletter (2012)Below is your July 2012 newsletter from the Pew Campaign on Human Health and Industrial Farming. In this edition we offer two new videos highlighting chefs and farmers encouraging responsible use of antibiotics, we urge President Obama to keep his promise and fix the dangerously outdated food safety system, and much more. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
Save Antibiotics June Newsletter (2012)Here is your June 2012 newsletter from the Pew Campaign on Human Health and Industrial Farming. In this edition, we ask that you urge the FDA to strengthen its antibiotic policies, the Consumers Union asks grocery stores, "where’s the meat raised without antibiotics?" and the FDA's updated plan on food safety. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
Pew Seeks More Veterinary Oversight of Antibiotic Use on Industrial FarmsGail Hansen, a senior officer with the Pew Health Group, thanks the U.S. Food and Drug Administration (FDA) for issuing draft codified language expanding the Veterinary Feed Directive (VFD). She also raises several concerns with the language that should be addressed. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
Pew Asks FDA to Close Loopholes in New Guidelines to Protect Antibiotics From OverusePew's Laura Rogers, program director of the Human Health and Industrial Farming initiative, commended the U.S. Food and Drug Administration (FDA) for issuing Draft Guidance 213 for industry on antibiotics in animal feed and water and urged the agency to consider improvements that would better protect public health. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
Pew Asks FDA to Strengthen Guidelines on Antibiotic Use in Food AnimalsPew's Human Health and Industrial Farming team has applauded the U.S. Food and Drug Administration (FDA) for issuing Guide 209. However, they would like to see additional strengthening measures, which can help begin the process of making progress toward reducing the development and spread of antibiotic-resistant bacterial infections in people. 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 |
| 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 |
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 |
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 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 |
