Testing new antibiotics to treat highly resistant bacterial infections is especially difficult, since only a small number of patients contract such infections or meet the requirements to participate in clinical trials. Following are examples of hard-to-treat pathogens that present the greatest unmet needs today, and the types of drugs that are most likely to address them.More info
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 President’s Council of Advisors on Science and Technology held a public meeting on April 4 to discuss the issue of antimicrobial resistance. Drug safety and innovation director Elizabeth Jungman testified on the need to spur the development of new antibacterial drugs.More info
Allan Coukell, senior director of drugs and medical devices, testified before the U.S.-China Economic and Security Review Commission on the global pharmaceutical supply chain security and the importance of the newly passed Drug Quality and Security Act.More info
The House Energy and Commerce Subcommittee on Oversight and Investigation held a hearing on Feb 16 entitled "Counterfeit Drugs: Fighting Illegal Supply Chains." Elizabeth Jungman, director of drug safety and innovation testified on counterfeit drugs the importance that newly passed Drug Quality and Security Act will have on the safety of the U.S. pharmaceutical supply chain.
The following case studies illustrate breaches to the pharmaceutical supply chain—the route a drug travels from its raw material origins to the delivery of a finished medicine. These examples, all of which are discussed in Pew Health Group’s report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways in which contaminated, fake, or otherwise unsafe medicine can reach patients, and underscore the need for reform.More info
On January 31, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act and addressed five topics: anticipatory and office stock compounding; quality standards; FDA / state coordination; MOUs to address inordinate interstate shipment of compounded drugs; use of bulk drug substances.More info