Tom Price starts listening tour on drug pricing. The HHS secretary hosted patient and disease advocacy groups on Monday in the first of a series of meetings on drug prices, Pro’s Sarah Karlin-Smith first reported on Monday. Price’s expected to meet with additional groups focused on drug prices, according to a source close to…
Executive Summary US FDA Commissioner nominee favors making up-to-date, accurate information available to patients and providers, but will that translate to more freedom for sponsor communications? Scott Gottlieb admitted to not fully briefed on the US FDA’s off-label communications issues, but seems interested in policy tilting toward more information disclosure on drug uses. The…
Executive Summary Given that ‘right to try’ is intended to be a patient-centered proposal, patient organizations are a strong voice in opposition, working behind the scenes to revise – or entirely exclude – the legislation as part of the user fee package. But the bill also has powerful advocates among Senate Republicans and in the…
HHS Secretary Tom Price met with patient and disease advocacy groups at HHS today in the first of a series of meetings on drug prices, according to people who attended the session. Price is expected to meet with additional groups focused on drug prices, according to a source close to the administration who said HHS…
HHS Secretary Tom Price met Wednesday with patient advocacy groups to discuss options for reducing drug prices, participants in the meeting told BioCentury. Price told the patient advocates that the Trump administration is planning to act quickly on the president’s promises to slash prescription drug prices dramatically. “This is not going to be a…
The Senate health committee voted 14-9 Thursday to approve physician Scott Gottlieb to be the next commissioner of the Food and Drug Administration, sending the nomination to the full Senate. All 12 Republicans on the committee voted in favor of Gottlieb, a former venture capitalist who served as an FDA deputy commissioner during the…
My favorite stories are the ones that fork from the thing you initially set out to cover. I was already looking forward to interviewing Dr. Richard Pazdur, who heads the Food and Drug Administration’s new oncology center for excellence, and his colleague Julia Ann Beaver on this paper they published about eligibility criteria for…
Development of pediatric cancer drugs has long lagged behind adult drug development for two major reasons: The process is more difficult, and childhood cancer is rarer by far than adult cancer. These and other phenomena in pediatric oncology were the subject of a workshop held by the Friends of Cancer Research (Friends) and sponsored by…
Cancer clinical trial sponsors need to enroll a broader scope of subjects, including HIV patients and children, and the FDA is working on guidance to make that happen, the agency’s oncology chief told Bloomberg BNA. “We would like clinical trials to more accurately reflect the patient population that will actually be using the drug,…
Executive Summary Friends of Cancer Research seeks way of allowing high-quality efficacy data into label when supplemental NDA is not feasible. The US FDA may have to create a new system to incorporate post-marketing information into labeling for older off-patent drugs long used off-label. Jeff Allen, president and CEO of the Friends of Cancer…
