America’s doctors and healthcare facilities offer health products, therapies and treatments that were unimaginable 50 years ago. Continued progress depends on robust innovation and an efficient regulatory system that protects consumers by ensuring that drugs and medical devices are safe and effective.
The Pew Charitable Trusts works to protect the public by advancing solutions to ensure the safety of medical products and services. Our initiatives, including established programs on prescription drug safety, antibiotics and innovation, and Food and Drug Administration modernization, increase both government and corporate accountability. Our campaigns carefully assess health risks, promote safe practices, and strengthen federal laws and regulations. The work is grounded on sound science and pragmatic goals.
Medical Safety News & Resources
''Drug Manufacturer Agrees to $500 Million Penalty''
''A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S."
More info''Community Pharmacies Will Now Back Supply Chain Legislation''
"As differing bills for securing the pharmaceutical supply chain wind their way through the US House and Senate, a key hurdle to passing legislation may have just been cleared. Earlier this week, the National Community Pharmacists Association – which is a member of an influential industry coalition that has been floating its own proposals – is now willing to back either bill."
More info''Senators Say They Are Close to Writing a Final Pharmacy Compounding Bill''
"U.S. senators considering fundamental changes to how the practice of pharmacy compounding is regulated heard almost unanimous support for reform at a Washington committee hearing Thursday."
More info''Senate Moves Closer to Law to Prevent More Pharmacy Outbreaks''
"At least 67 people have died in 20 outbreaks caused by contaminated drugs since 2001, experts told a Senate hearing Thursday. The Food and Drug Administration says there have likely been more cases than that, but they have no way of telling now."
More info''State Pharmacy Boards Back More FDA Oversight''
"State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications."
More info''The Senate Aims to Clean Up Compounding Pharmacies''
When a doctor sticks a needle in you, you expect that the drugs it carries won’t be tainted. But, possibly owing to a strange gray area in federal law, thousands of patients last October got injections for back pain that contained highly dangerous fungal meningitis, and dozens of them died. Members of the Senate Health, Education, Labor and Pensions Committee are now seeking to fix the government’s oversight of the obscure world of compounding pharmacies. The reforms they want are overdue.
More info''Overused Antibiotics are Becoming Ineffective''
"As a nation, we need to exercise greater care with our use of antibiotics, in both humans and animals, so that these medications remain effective in treating serious bacterial infections."
More infoPew Comments to Senate HELP Committee on Drug Distribution Security
The Pew Charitable Trusts commented on the draft proposal to secure drug distribution in the United States. Although recognizing that the draft is the product of a sustained effort to address a complex system and balance sometimes competing imperatives, Pew shared areas of significant concern.
More infoLetter 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.
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