Conversation with The Cancer Letter

The Cancer Letter invited Jedd Wolchok, associate attending physician and chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center, to describe the workings of the just-announced Parker Institute for Cancer Immunotherapy.

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.

Devices aren't tracked with the same rigor as drugs, because FDA does not have a data system that can reliably track medical devices and identify potential safety problems, according to Gregory Daniel, fellow and managing director of the Center for Health Policy at Brookings Institution.

Patients are being harmed because FDA doesn't commit sufficient resources to enforce federal requirements for hospitals and manufacturers to report adverse outcomes caused by medical devices, according to Larry Pilot, one of the original authors of FDA's 510(k) device clearance process.

FDA's Class II 510(k) clearance process for medium-risk devices—a category that includes the power morcellator—is inadequate, because it does not focus on risk assessment, according to Bill Vodra, a former associate chief counsel for drugs at FDA.

The Cancer Letter invited Richard Wender, chief cancer control officer of the American Cancer Society, to describe the rationale for the society’s new guideline for breast cancer screening.