The Pew Charitable Trusts

Letter From New Democrat Health Care Task Force to FDA on Unique Device Identification System

The three co-chairs of the New Democrat Health Care task Force – Reps. Allyson Schwartz, Kurt Schrader and Bill Owens – sent FDA a letter inquiring about the status of the agency’s final regulations to establish a unique device identifier (UDI) system and database.

''Need to Know: Medical Devices''

The PBS program "Need to Know" devoted a portion of their March 22 program to discuss medical devices. Joining host Jeff Greenfield on the program was Pew's Dr. Josh Rising, project director of the medical devices initiative at The Pew Charitable Trusts.

''The Loophole That Keeps Precarious Medical Devices in Use''

The U.S. Food and Drug Administration announced last month that it will classify metal-on-metal hip implants as high-risk devices. That comes after the artificial joints were found to have failed at high rates, causing disability and meaning additional surgery for thousands of people. But hundreds of other potentially high-risk medical devices remain in use without what many consider to be adequate testing

Comments on the Health Information Technology Patient Safety Action and Surveillance Plan

In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology, Consumers Union, the National Women's Health Network, the National Research Center for Women and Families, the Trust for America's Health, and The Pew Charitable Trusts urge the ONC to promote adoption of the unique device identification (UDI) system for medical devices to improve the safety of medical care.

Comments on Stage 3 of the the Meaningful Use of Health Information Technology

In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology and The Pew Charitable Trusts urge the ONC to incorporate medical device identifiers developed under the FDA’s unique device identification (UDI) system into both electronic health record (EHR) certification criteria and Stage 3 meaningful use (MU) objectives.

Kathleen Stratton

Kathleen Stratton directs an initiative that promotes the development of safe and effective medical treatments by fostering and supporting improvements in the FDA’s scientific staff, tools, and regulatory processes.

''One-Stop Shopping Proposed For Conflict Disclosure''

"Harmonizing conflict-of-interest standards will depend on the Centers for Medicare & Medicaid Services moving forward to implement the federal Sunshine law, which is now more than a year behind schedule. Industry, consumers and academic stakeholders are all waiting on CMS to issue a final rule."

Strengthening Our National System for Medical Device Postmarket Surveillance

The Medical Device Initiative submitted comments to the U.S. Food and Drug Administration concerning the FDA's National Medical Device Postmarket Surveillance Plan, "Strengthening Our National System for Medical Device Postmarket Surveillance."

Pew Comments to the FDA Regarding the Unique Device Identification System

Pew’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.

Expert Profile: Kathleen Stratton

Kathleen Stratton, Project Director, Innovate FDA

Expert Profile: Gabrielle Cosel

Gabrielle Cosel, Project Manager, Drug Supply Safety

Expert Profile: Josh Rising

Josh Rising, Project Director, Medical Device Initiative

''Delays and Difficulties in Assessing Metal-on-Metal Hip Implants''

More than 500,000 U.S. patients have received metal-on-metal hip prostheses, most of which were implanted between 2003 and 2010. These prostheses entered the market through the 510(k) pathway at the Food and Drug Administration (FDA), whereby manufacturers need only demonstrate substantial equivalence to a device already on the market to gain approval. Unfortunately, there is now compelling evidence that these implants fail at a higher rate than hip prostheses made of other materials.

''Drug, device reform gets bipartisan push''

"The U.S. Supreme Court's eagerly awaited Affordable Care Act ruling unfortunately overshadowed the unusually bipartisan work underway at the U.S. Capitol last week, where Congress finalized sweeping legislation crammed with smaller-scale but still vital health reforms."

Pew Applauds Passage of Bipartisan User Fee Legislation by U.S. House of Representatives

The U.S. House of Representatives today passed bipartisan legislation to ensure that the U.S. Food and Drug Administration (FDA) has the funds it needs to approve products that improve health and protect consumers from unnecessary risks.

''Study: FDA reviews new drugs faster than Europe, Canada''

"Researchers say the U.S. approved more new medicines in less time than Europe and Canada in the last decade, challenging long-standing criticisms that the Food and Drug Administration lags behind its peers in clearing important new drugs."

FDA Reviews New Drug Applications Faster than European, Canadian Regulators

WASHINGTON—The U.S. Food and Drug Administration (FDA) approves new drugs more quickly than its counterparts in Europe and Canada, according to a new paper, “Regulatory Review of Novel Therapeutics Comparing FDA, EMA and Health Canada,” published online on May 16

''User Fees Clear E&C, But Waxman, Consumer Advocates Still Seek GAIN Changes''

"As FDA user fee legislation heads to the House floor, a key Democratic lawmaker called for antibiotic incentive to be focused on serious and life-threatening infections and an HHS directive to work on stewardship programs while the lead sponsor of antibiotic incentives pushed back against attempts to change the incentive structure outlined in the Generating Antibiotic Incentives Now section of the bill."

''Lawmakers to Tweak Antibiotic Incentives, Online Pharmacy Measures Prior to Full E&C Markup''

"House lawmakers said they will continue efforts to narrowly tailor antibiotic incentives and clarify an online pharmacy measure before the full Energy and Commerce Committee takes up FDA user fee legislation that gained bipartisan subcommittee backing Tuesday morning."

''FDA Fee Reauthorization a Prescription for Debate''

"Every five years, lawmakers, lobbyists, patient groups and agency regulators line up to take their shot at changing how things get done at the Food and Drug Administration."

Testimony before the Senate Committee on Health, Education, Labor and Pensions

Allan 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.

Pew Urges Congress to Pass Medical Device User Fee Act and Improve Marketplace Monitoring

We applaud the FDA and the medical device industry for reaching an agreement that will spur the innovation of new therapies for improving health and saving lives.

''FDA unveils user fee program for generic drugs''

"The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs ... "

Pew Commends Pharmaceutical User Fee Agreements, Urges Swift Action by FDA and Medical Device Industry

We commend the FDA and the pharmaceutical industry for working together on agreements that support the agency’s review activities. Under PDUFA, the FDA has reduced the time it takes to approve new drugs.

Josh Rising

Dr. Josh Rising oversees the Medical Device Initiative, which seeks to facilitate innovation of certain new medical devices and to strengthen medical devices by improving the tracking of their safety once they are on the market.