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 |
|---|---|---|
| Aug 3, 2010 |
Drug Safety and Accountability Act of 2010The Drug Safety and Accountability Act of 2010 (S.3690) seeks to strengthen industry standards to ensure the quality and safety of drugs made for the U.S. market, and to improve the U.S. Food and Drug Administration’s (FDA) oversight abilities through modernized information systems and new authorities, such as the power to order a drug recall. More info |
Drug Manufacturing and Distribution, Drug Safety |
| Mar 10, 2010 |
Pew Statement on Energy and Commerce Drug Safety Hearing"Two years after dozens of Americans lost their lives to contaminated heparin, we are still unable to protect U.S. consumers from many of the risks of pharmaceuticals manufactured in foreign factories. It is time for Congress to take action to better protect health." More info |
Drug Manufacturing and Distribution, Drug Safety |
| Jun 10, 2009 |
FDA Globalization Act of 2009: Drug Safety ProvisionsThe Food and Drug Administration Globalization Act of 2009 (H.R.759) seeks to secure the safety of imported prescription drugs and active pharmaceutical ingredients through greater FDA authority and manufacturer responsibility, and increased inspections of prescription drug and active pharmaceutical ingredient manufacturing sites abroad. More info |
Drug Manufacturing and Distribution, Drug Safety |
| May 1, 2009 |
Testimony of Allan Coukell, Director of the Pew Prescription Project, on Protecting Consumers from Adulterated DrugsProtecting consumers against the risk of adulterated products is, of course, the original mission of the FDA. Today, the vast majority of pharmaceutical products sold in the United States today are not adulterated, but an increasingly complex supply chain creates new challenges and new risks – as recent events demonstrate. More info |
Drug Manufacturing and Distribution, Drug Safety |
| 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 |
| 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 13, 2011 |
Testimony before the Committee on Energy on Commerce, Subcommittee on Oversight and Investigations, United States House of Representatives"Chairman Stearns, Ranking Member DeGette, and members of the Oversight and Investigations Subcommittee, thank you for the opportunity to submit testimony about the essential steps Congress must take to protect Americans and ensure the integrity of our drug supply..." More info |
Drug Safety |
| Jul 10, 2009 |
Bill Comparison - Regulation of Overseas Drug ManufacturingThis issue brief from the Pew Prescription Project outlines the differences between bills from the U.S. House of Representatives and the U.S. Senate regarding regulation of overseas drug manufacturing. More info |
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 |
| Aug 3, 2010 |
Americans' Attitudes on Prescription Drug SafetyThis issue brief presents key findings from a nationwide survey about the safety of the U.S. drug supply among voters conducted March 29 –April 1, 2010 for the Pew Prescription Project by Hart Research Associates Public Opinion Strategies. More info |
Drug Safety, Medical Safety Policy |
