House Energy & Commerce Chair Greg Walden (R-OR) told Inside Health Policy Tuesday (Feb. 6) he does not believe House leadership will heed calls from sponsors of a pending Right to Try bill to bypass the E&C committee and send the Senate-passed bill directly to the House floor. Walden and his staff are currently working…
President Trump rightly congratulated the Food and Drug Administration Tuesday night for approving more new and generic drugs and medical devices than ever during his first year in office. The accomplishment should help “fix the injustice” of high drug prices, which Trump said will be one of his top priorities for the year. …
Executive Summary Concept mentioned during Gottlieb’s ‘star’ turn at Davos may sound similar to now-withdrawn generic labeling rule, but actually appears based on a proposal from the Friends of Cancer Research to get current clinical guidelines reflected on labels. The US FDA is interested in establishing a system where it can more easily drive generic…
Congress’s inability to pass a long-term spending bill has major ramifications for public health, advocates and former agency officials warn. The short-term measures hinder efforts to play ahead and recruit staff even as they keep the government open, the advocates say. They have left public health agencies “treading water,” said Ellie Dehoney, vice president…
Executive Summary ‘Better informed patients,’ ‘drug competition,’ ‘biosimilar innovation’ – as well as nutrition and tobacco goals will be achieved through guidances, promotional plans and other items FDA will develop over the next year. FDA’s 2018 Strategic Policy Roadmap Opioid Policy Work Plan Re-examine and modernize FDA’s framework for evaluating pre- and post-market safety of…
One year ago, Jan. 19, 2017, FDA officially launched the Oncology Center of Excellence to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices (including diagnostics). Dr. Richard PazdurIn doing so, we hoped to help expedite the development of oncology and hematology medical products and support an…
Executive Summary US FDA’s revised draft guidance spelling out its policy on ‘refuse-to-file’ decisions differs little in substance compared to predecessor issued in 1993. But difference in style is telling sign of the times. The US FDA is replacing its 25 year-old guidance on “Refuse to File” (RTF) decisions for NDA/BLA submissions with a…
When can patients sue drugmakers for failure to issue safety warnings? The Supreme Court hears arguments this morning in a case that could affect state consumer protection laws and the FDA’s drug labeling process. The financial stakes are high for drug companies. — FDA will run out of carryover drug user fees in a…
Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in clinical trial designs for this purpose were discussed by a…
As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food and Drug Administration…
