Sigal: $75 Million Not Enough for FDA Reform President Barack Obama’s Feb. 8 budget request for fiscal year 2017 slates $75 million in additional funding for FDA for the creation of a virtual Oncology Center of Excellence. The proposal is arguably the most tangible component of Vice President Joe Biden’s National Cancer Moonshot program,…
The Obama administration announced on Monday that it hoped to spend $1 billion to fund a cancer “moonshot” in search of a cure. But in the costly world of biological research, such a sum may be better described as a cancer slingshot, researchers said. “The good news is that the budget is no longer being…
THE WHITE HOUSE Office of the Vice President FOR IMMEDIATE RELEASE February 1, 2016 FACT SHEET: Investing in the National Cancer Moonshot During his 2016 State of the Union Address, President Obama called on Vice President Biden to lead a new, national “Moonshot” initiative to eliminate cancer as we know it. Today, the White House…
The White House’s “moon shot” to accelerate the search for a cancer cure has the scientific research community abuzz over the possibilities raised by such a high-profile push. Vice President Joe Biden may announce some specifics as soon as Friday when he visits a cancer center in Philadelphia to kick off the effort outlined in…
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…
