Pew Commends Congress for Passing FDA User Fee Legislation
WASHINGTON—The U.S. Senate today joined the House in passing Food and Drug Administration Safety and Innovation Act (S. 3187), a bill to support the U.S. Food and Drug Administration’s drug and device reviews.
"We commend the Senate for passing the bipartisan FDA Safety and Innovation Act, and the Health, Education, Labor and Pensions Committee for its leadership throughout this process,” said Allan Coukell, director of medical programs at the Pew Health Group.
"This legislation will, for the first time, enable the FDA to:
Regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications
Spur the development of new antibiotics specifically to treat serious and life-threatening infections; and
Actively monitor the safety of high-risk medical devices already on the market and promote innovation by streamlining the review process for new low- and medium-risk devices.
"We applaud Republicans and Democrats in both chambers of Congress for collaborating with each other and with businesses, consumer and patient advocates, and the medical community to develop and pass this bill. We now urge President Obama to sign and implement this legislation as swiftly as possible."
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
The Pew Charitable Trusts sent a letter to Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) of qualified support of the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, a welcome step towards establishing a new regulatory pathway to bring desperately-needed antibiotics to the patients who need them most. The letter was also signed by 31 organizations representing healthcare providers, hospitals, pharmacists, clinical laboratory scientists and medical microbiologists, public health experts, patients and advocates. More info