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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Date Issue Briefs Topic
Jun 10, 2009

FDA Globalization Act of 2009: Drug Safety Provisions

The 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.

 

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Drug Manufacturing and Distribution, Drug Safety

May 1, 2009

Testimony of Allan Coukell, Director of the Pew Prescription Project, on Protecting Consumers from Adulterated Drugs

Protecting 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.

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Drug Manufacturing and Distribution, Drug Safety

Apr 12, 2012

Reviving the Pipeline of Life-Saving Antibiotics

Antibiotic-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.

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Drug Safety, Antibiotic Innovation

Mar 8, 2012

Testimony before the House Committee on Energy and Commerce, Subcommittee on Health

Allan 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.

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Drug Safety, Antibiotic Innovation

Jul 25, 2012

Testimony of Allan Coukell Before the Committee on Commerce, Science and Transportation

Pew'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.

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Drug Safety

Apr 18, 2012

Testimony before the Committee on Energy and Commerce Subcommittee on Health

U.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

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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..."

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Drug Safety

Jul 10, 2009

Bill Comparison - Regulation of Overseas Drug Manufacturing

This 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.

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Drug Safety

Sep 12, 2012

Written Statement of Record Regarding the Sunshine Act by Dr. Daniel J. Carlat of the Pew Health Group

Dr. 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.

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Drug Manufacturing and Distribution, Conflicts of Interest

Apr 11, 2012

Focus Group Findings on Prepaid Debit Cards

This fact sheet focuses on the lessons learned from consumers who purchase and use prepaid debit cards.

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Checking, Credit Cards

Apr 13, 2010

Comments Submitted to the Federal Reserve by the Pew Safe Credit Cards Project (Regulation Z, Reasonable and Proportional Penalty Charges and Other Rules Under the Credit CARD Act of 2009)

The Pew Health Group’s Safe Credit Cards Project submitted comments to the Federal Reserve Board regarding the Board’s proposed rules under Regulation Z (Docket No. R-1384).  The rules cover “reasonable and proportional” penalty charges and other requirements under the Credit CARD Act of 2009.

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Credit Cards

Mar 23, 2010

Federal Reserve Issues Final Rules on Gift Cards

The Federal Reserve Board issued its Regulation E Final Rule on gift cards as required by the Credit Card Accountability Responsibility and Disclosure (CARD) Act of 2009. The Pew Safe Credit Cards Project submitted a letter to the Federal Reserve during its proposed rule comment period requesting that the Fed consider limiting the amount of any such monthly fee.

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Credit Cards

Feb 22, 2010

Moving Towards Safer Credit Cards

On February 22, major new consumer protections took effect as part of the second implementation phase of the Credit Card Accountability, Responsibility, and Disclosure (CARD) Act of 2009. Just two practices addressed in this second phase will save American consumers at least $10 billion a year. The Pew Health Group's Safe Credit Cards Project is looking ahead to the third and final phase of the Credit CARD Act, to take effect August 22, 2010, which will require all credit card penalties to be “reasonable and proportional” and will direct card issuers to review all interest rate increases since the beginning of 2009.

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Credit Cards

Nov 19, 2009

Regulatory Comment on Credit Card Disclosure Requirements

The Pew Safe Credit Cards Project submitted comments (PDF) to the Federal Reserve Board regarding the Board’s latest proposed rulemaking under Regulation Z (Docket No. R—1370). The rules implement provisions of the Credit CARD Act of 2009 that are effective February 22, 2010. Pew’s comments focused on clarifying the rights of consumers in a credit card contract and increased responsibility for and disclosure from credit card issuers.

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Credit Cards

Sep 21, 2009

Regulatory Comment on Credit CARD Act Rule: Advanced Notice and Cancel Requirements

The Pew Safe Credit Cards Project submitted comments (PDF) to the Federal Reserve Board regarding the Board’s interim final rules under Regulation Z (Docket No. R-1364). The rules cover advance notice and right to cancel requirements under the Credit CARD Act of 2009. Pew’s comments focused on a number of exceptions the Board proposed, which could allow issuers to raise interest rates, change minimum required payment levels and impose potentially large deferred interest charges with little or no advance warning.

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Credit Cards