Agency’s oncology office director reflects on his wife’s experience with cancer and urges patient community to tackle ‘big picture issues’ like clinical trial eligibility and informed consent. The patient advocacy community should focus on overarching issues, such as expanding clinical trial eligibility and reforming the informed consent process, that will help drive progress in…
To the Editor: In their Perspective article (June 25 issue),1 Avorn and Kesselheim argue that the 21st Century Cures Act, which is currently being debated in Congress, would lower the regulatory standards of the Food and Drug Administration (FDA) by giving it greater discretion to approve drugs on the basis of less rigorous data. In particular,…
The United States currently is using a regulatory framework for drugs and devices that was developed during the 20th century when iron lungs were still in use, the polio vaccine was just being discovered, genomics were just a science fiction dream, and personalized medicine meant your doctor made house calls. While the long standing requirements…
It is an excruciating question for cancer patients with a prognosis of only months to live. Should they try another round of chemotherapy? Guidelines for oncologists say no for very sick patients, those who are often bedridden and cannot handle most daily needs themselves. But for patients who are more self-sufficient, chemotherapy is considered a reasonable option. Despite its well-known…
Congress Must Pass 21st Century Cures Act Now Posted: 07/08/2015 7:38 pm EDT This is an incredibly exciting time in biomedical research. New discoveries are announced almost every week that bring us closer to managing cancer and other life-threatening diseases. We are attacking these illnesses at the molecular and genetic levels. In cancer, for example, scientists…
The enactment of FDASIA, including the fifth reauthorization of PDUFA, really put patient engagement on the radar beyond some of the traditionally active disease communities (e.g., HIV/AIDS, cancer, neurological diseases). FDASIA’s section 1137, the provision on Patient Participation in Medical Product Discussions, led FDA to seek input on “strategies to solicit the views of patients…
Roughly half of deaths from 12 smoking-related cancers may be linked directly to cigarette use, a U.S. study estimates. While the largest proportion of deaths associated with smoking were for cancers of the lung, bronchus, trachea and larynx, about half of fatalities from tumors of the oral cavity, esophagus and bladder were also tied to…
The amount of genetic variation between cancer patients is astounding. Two people diagnosed with cancer in the same organ may, in fact, have two very different diseases. Consequently, we are now in the middle of a transition: we no longer classify cancer based solely on its tissue of origin, but also on the key mutations…
FDA codified an expedited review pathway for breakthrough-designated drugs in a manual of policies and procedures (MAPP) released this week, instructing FDA review teams to act at least one month before the Prescription Drug User Fee Act (PDUFA) goal date for these applications. FDA confirmed it had been informally putting drugs through expedited review for…
Dr. Margaret Hamburg, who as commissioner of the U.S. Food and Drug Administration (FDA) for almost six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine and drug approvals, is stepping down, the agency said on Thursday. Hamburg, 59, is one of the longest-serving FDA commissioners in the…
