A Senate panel on Tuesday cleared President Barack Obama’s nominee, cardiologist Dr. Robert Califf, to head the Food and Drug Administration. While the graduate of Columbia;s A.C. Flora High School was approved on a voice vote by the Senate Committee on Health, Education, Labor and Pensions, Califf’s close relationship to the pharmaceutical industry still raised…
It was October 1988, and AIDS had reached epidemic proportions in the U.S. A crowd gathered in front of the US Food and Drug Administration (FDA) in Rockville, Maryland. “Forty-two thousand dead from AIDS,” the protestors chanted. “Where was the FDA?” The Centers for Disease Control and Prevention later concluded that more than 62,000 people in…
Cancer clinical trials in three distinct phases, as they have been conducted for decades, are probably no longer the best way to bring a drug or biologic agent to market. This was the consensus of three panels at the 8th Annual Conference on Clinical Cancer Research convened by Friends of Cancer Research (FOCR) and the…
On November 17, Friends of Cancer Research (FOCR) released a white paper report, Enhancing Use of Patient-Centered Data in Regulatory Decision Making.1 The contents of that paper are summarized below. Improving Patient Input Many stakeholders agree that to ensure truly transformational therapies, patients must play a major role. They are uniquely equipped to identify critical gaps and…
Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators. So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr.…
In the three years since the FDA launched its breakthrough therapy program,1 the designation has become a coveted status for emerging agents as biopharmaceutical companies scramble to make their mark in an increasing competitive environment.The program is aimed at facilitating the development of treatments that have the potential to be transformative for patients, which has proved…
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…
