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 |
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| May 9, 2013 |
Pew Testimony on the Safety of Compounding PharmaciesThe U.S. Senate Committee on Health, Education, Labor and Pensions held a hearing on May 9 entitled "Pharmaceutical Compounding: Proposed Legislative Solution." Pew's Allan Coukell, a pharmacist and drug safety expert, testified on the need to strengthen oversight of the compounding industry. More info |
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| Apr 9, 2013 |
Pew Comments on Centers for Medicaid and Medicare Services' Information Collection Activities Draft GuidanceThe Pew Charitable Trusts appreciates this opportunity to submit comments to CMS's "Information Collection Activities" draft guidance. We suggest that both the research and non-research payment templates be modified in order to make it easier for consumers to identify which drugs, devices, biologicals, or medical supplies are associated with particular transfers of value. More info |
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| Apr 4, 2013 |
Pew Comments on Draft Recommendations for Meaningful Use, Stage 3The Pew Charitable Trusts submitted comments on preliminary recommendations regarding Stage 3 meaningful use objectives and standards for electronic health records (EHRs) to the Office of the National Coordinator for Health Information Technology. These comments follow remarks at recent meetings of the Health Information Technology (HIT) Policy Committee and HIT Standards Committee. More info |
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| Mar 20, 2013 |
Washington Food Leaders Urge Sen. Murray to Shine a Light on Industrial Farms' Antibiotic UseSixteen of Washington state’s most celebrated chefs, farmers, and other food leaders wrote a letter to Senator Patty Murray, member of the Senate HELP Committee, asking to reauthorize the Animal Drug User Fee Act and include in it provisions to help preserve the efficacy of antibiotics vital to protecting public health. More info |
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| Mar 15, 2013 |
Groups Urge Obama to Take Action Against Drug-Resistant BacteriaPew and 46 other public health, medical, environmental and consumer leaders urged President Obama to take swifter action to protect the public from drug-resistant bacteria. In a joint letter, they call on his administration to eliminate industrial farms’ non-therapeutic use of medically important antibiotics and to support legislation that requires the Food and Drug Administration to shine more light on farming practices that are breeding superbugs. More info |
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| 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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| Feb 22, 2012 |
Recommendations to the FDA Regarding the Use of Antibiotics in Food Animal ProductionIt is estimated that up to 70 percent of antibiotics sold in the U.S. are used on industrial farms in healthy food animals, to promote growth and to compensate for the effects of overcrowded and unsanitary conditions. This practice promotes the development of deadly strains of antibiotic-resistant bacteria that can spread to humans. More info |
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| Jun 26, 2013 |
Drug Development for Limited Populations: A New Proposed PathwayThe lack of new antibiotics and the rise in drug resistance have rendered some serious and life-threatening infections untreatable, and the health care community is searching for ways to bring innovative new drugs to patients whose treatment options are limited or nonexistent. More info |
Antibiotic Innovation |
| 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 |
| 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 |
| Mar 1, 2012 |
MRSA on the Appalachian Trail: The Story of Steve WeiselHiking the Appalachian Trail, Steve Weisel thought little of the blisters on his feet until he discovered they were infected with life-threatening methicillin-resistant Staphylococcus aureus (MRSA) -- an increasingly common "superbug" that does not respond to first-line antibiotics. Mr. Weisel's story demonstrates the urgent need for new and innovative therapies to treat this growing threat. More info |
Antibiotic Innovation |
| Mar 1, 2012 |
The Threat of Multidrug-Resistant Infections to ChildrenExpert testimony, research, and commentary More info |
Antibiotic Innovation |
| Mar 1, 2012 |
When Multiple Bugs Strike: The Story of Alice BrennanA healthy immune system may be all the protection someone needs to overcome a bacterial infection, but once one disease takes hold, it may beget more illnesses. Such is often the case with Clostridium difficile, a potentially deadly bacterium that can flourish in the wake of other infections. Senior citizens, such as Alice Brennan, are particularly vulnerable and serve as a reminder that new and powerful antibiotics are needed as protection from dangerous bacterial threats. More info |
Antibiotic Innovation |
| Mar 1, 2012 |
The Superbug ThreatAs Drug-resistant bacteria spread, the pipeline for antibiotics is drying up More info |
Antibiotic Innovation |
| Mar 1, 2012 |
The Threat of Multidrug-Resistant Infections to the U.S. MilitaryExpert Testimony, Research, and Commentary Learn More “MDRO multidrug resistant organism infections have become an international health problem during the past several decades and now pose a challenge to the care of our wounded military personnel.” — D. Hospenthal More info |
Antibiotic Innovation |
| Jan 2, 2012 |
Patient Story: Jamel Sawyer: A Young Man Fights MRSAOne of the most notorious multidrug-resistant superbugs, MRSA is responsible for an estimated 19,000 deaths and 360,000 hospitalizations each year in this country. Jamel’s story illustrates the twin dangers presented by emerging multidrug-resistant bacterial infections and the waning effectiveness and availability of drugs to treat them. More info |
Antibiotic Innovation |
| Sep 20, 2011 |
National Headlines Reporting on the Need for New, Lifesaving AntibioticsNational and international headlines warn that multidrug-resistant superbugs are on the rise and the pipeline of new antibiotics is running dry. More info |
Antibiotic Innovation |
| Sep 20, 2011 |
What Leading Experts are Saying about Emerging Drug-Resistant Infections and the Need for New Drugs to Treat ThemLegislators, regulators, scientists and academics agree: we are running out of antibiotics to treat drug-resistant infections—and we need new ones now. Here is what leading voices are saying about how economic, scientific and regulatory factors are impeding the development of new antibiotics, and what we can do about it. More info |
Antibiotic Innovation |
| Sep 20, 2011 |
Bill Summary: The Generating Antibiotic Incentives Now Act (H.R. 2182)The Generating Antibiotic Incentives Now (GAIN) Act of 2011 (H.R. 2182) seeks to create incentives to encourage the development of products to treat, prevent, detect and diagnose antibiotic-resistant infections. It extends the length of time an approved drug is free from competition and clarifies the regulatory pathway for new antibiotics. More info |
Antibiotic Innovation |
| 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 |
| 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 |
| 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 10, 2013 |
Antibiotics and Industrial Farming 101Each year, tens of thousands of Americans die and hundreds of thousands are hospitalized because of bacterial infections resistant to antibiotics. Antibiotic overuse on industrial farms is a big part of the problem. The largest U.S. meat and poultry producers feed antibiotics to healthy animals over much of their lives to make them grow faster and to compensate for the overcrowded and unsanitary conditions in which they are bred and slaughtered. More info |
Antibiotics in Food Animal Production |
| Apr 8, 2013 |
Multiple Organizations - Including Pew - Support DATA ActOn behalf of the undersigned organizations representing medical, public health, scientific, agricultural, environmental, animal protection, and other organizations, we urge you to include H.R. 820, the Delivering Antimicrobial Transparency in Animals (DATA) Act, as part of the final Animal Drug User Fee Act (ADUFA). This legislation provides a reasonable, common-sense approach to better understanding antibiotic use in agriculture. More info |
Antibiotics in Food Animal Production |
| Feb 26, 2013 |
Health, Science Leaders Call on Congress for More Antibiotics DataA broad coalition of medical, public health, scientific, agricultural, consumer, environmental and humane organizations, representing more than 11 million supporters, wrote a letter urging Congress to reauthorize the Animal Drug User Fee Act (ADUFA) and include in it provisions to help preserve the efficacy of antibiotics vital to protecting public health. More info |
Antibiotics in Food Animal Production |
