Executive Summary Center for Drug Evaluation and Research’s long-time director of oncology/hematology products office will continue as signatory on drug reviews even after new Cancer Moonshot-driven structure takes effect. FDA’s new Oncology Center of Excellence will not take Richard Pazdur away from his drug approval duties. Pazdur, who is the acting director of…
The FDA is considering ways to review more medical treatments by clinical area, following in the steps of the cancer center established this summer. “Historically, as almost everyone knows, FDA has been remarkably siloed,” Food and Drug Administration Commissioner Robert M. Califf said Nov. 4. “But what you hear loud and clear from patients…
Regarding the Nov. 2 PowerPost article “FDA continues to grapple with hundreds of vacancies”: For cancer patients, every day matters, and the Food and Drug Administration is a vital player in speeding lifesaving treatments to those who need them. Patients expect the FDA to hire and retain world-class talent. But for nearly a decade,…
The decision to approve a controversial rare-disease treatment has haunted the Food and Drug Administration in recent weeks. But instead of shying away from the controversy, the FDA has been remarkably transparent about how the decision was made. On Thursday night, the agency laid bare the disagreements between its highest officials by releasing 300 pages…
Executive Summary Bradley Thompson has been shepherding the Combination Products Coalition for more than a decade. In a recent interview, he said the recent policy spotlight on the combo-products space, including in a recent user-fee deal, is a welcome development after a period of neglect. He also spoke about the numerous reforms in the works…
Executive Summary Express Scripts’ Eichholz says clinicians may be less inclined to use a biosimilar in ‘life or death’ oncology indications compared to inflammatory diseases. Clinical decisions on whether to prescribe a novel biologic or a biosimilar may be driven, in part, by the condition and stage of disease, representatives from the pharmacy benefit,…
Vice President Joe Biden and the National Cancer Moonshot Task Force published their final reports Oct. 17, summarizing the moonshot’s achievements, and outlining five strategic goals and action plans for the years to come. The two reports conclude the 2016 National Cancer Moonshot Initiative, and the Obama administration’s efforts to develop a national conversation…
Executive Summary FDA’s user fee deal with sponsors sets target dates for documents on interchangeability, naming and labeling, but non-industry stakeholders urge agency to accelerate their release; guidance development efforts will get boost in BsUFA II with funding for new dedicated biosimilars unit starting in fiscal year 2018. The FDA/industry-negotiated agreement to renew the…
Mark McClellan, director of Duke’s health policy center and former head of FDA and CMS, said the 15 percent price cut for Pfizer’s biosimilar of Johnson & Johnson’s Remicade is significant and cautioned the United States might not see as sizable drops in price for biosimilars as for generic drugs. But McClellan, in an interview…
Generic drugs generally cost 80 percent less than brand-name drugs, so hopes were high when a law enacted in 2010 paved the way for competition among the highest-priced drugs of all, known as biologics. But, as these competing drugs start to appear on the market, consumers aren’t reaping a windfall. On Monday, Pfizer…
