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
The Obama administration wants new controls to help prevent outbreaks of drug-resistant bacteria. On Friday, a top Food and Drug Administration (FDA) official told House lawmakers that the agency was “very concerned” about the threat of bacteria that are immune to drugs.More info
In response to final Senate passage of the Drug Quality and Security Act—legislation that establishes a national standard for tracing pharmaceuticals through the drug supply system and clarifies federal authority over pharmaceutical compounding—Allan Coukell, senior director of drugs and medical devices at The Pew Charitable Trusts, issued the following statement.More info
A year after a meningitis outbreak from contaminated pain injections killed at least 64 people and sickened hundreds, Congress is ready to increase federal oversight over compounding pharmacies that custom-mix medications.More info
It's been more than a year since a deadly fungal meningitis outbreak traced to a filthy New England compounding pharmacy put a shocking spotlight on the risks of medications mass-produced by underregulated firms.More info
On July 9, 2012, the Generating Antibiotic Incentives Now, or GAIN, provisions were signed into law by President Barack Obama as part of the Food and Drug Administration Safety and Innovation Act. This bipartisan legislation extends by five years the exclusivity period during which certain antibiotics—those that treat serious or life-threatening infections—can be sold without generic competition. This additional period of exclusivity increases the potential for profits from new antibiotics by giving innovative companies more time to recoup their investment costs.More info
Letter from Pew and The Pharmaceutical Distribution Security Alliance to Senate Leadership Calling for Passage of Track and Trace Legislation
Pew and the Pharmaceutical Distribution Security Alliance, or PDSA, PDSA have co-signed a letter asking Majority Leader Harry Reid (D-NV) and Republican Leader Mitch McConnell (R-KY) to pass The Drug Quality and Security Act (HR 3204), which would implement a “track and trace” system for the U.S. pharmaceutical distribution supply chain and enhanced federal oversight of compounding pharmacies to safeguard the nation’s drug supply against counterfeit and contaminated medicines.More info
A year after a deadly fungal meningitis outbreak tied to tainted pain shots, victims like Margaret Snopkowski say they remain devastated by the ordeal — but determined to rebuild their lives.More info
Last spring, Arjun Srinivasan, an associate director of the CDC, delivered a presentation to state health officials with some alarming information. Before the year 2000, he said, it was rare to find cases of bacteria resistant to carbapenems, a class of powerful, last-resort antibiotics. But by February 2013 they had been seen in almost every state. On March 5, Thomas Frieden, director of the CDC, issued a public warning about “nightmare” bacteria, a family of germs known as CREs. They can kill up to half the patients who get bloodstream infections from them, resist most or all antibiotics and spread resistance to other strains.More info