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Inside Health Policy - FOCR To DeGette, Upton: Include MODERN Labeling Act In Cures 2.0

A major cancer research advocacy organization wants key House lawmakers to include in their upcoming Cures 2.0 package a policy that would give FDA authority to require generic drug labels be updated to reflect new information about the drug and its use.


The request is one of several proposals Friends of Cancer Research (FOCR) includes in a letter to House Energy & Commerce oversight subcommittee Chair Diana DeGette (D-CO) and Rep. Fred Upton (R-MI) on areas to include in the second installment of the 21st Century Cures Act, dubbed Cures 2.0.


Pink Sheet - 'The Pazdur Effect': A Tale Of Three US FDA Oncology Advisory Committee Meetings

Executive Summary

ODAC meetings are usually few and far between – and rarely come with good news for the sponsor. Below are some lessons learned from the bounty (three!) held this week.


The US Food and Drug Administration's Oncologic Drugs Advisory Committee is always fodder for interesting discussion, given that any application that Oncology Center of Excellence Director Rick Pazdur brings to committee comes with valuable “lessons learned” – not only for the sponsor under the spotlight, but for anyone else that follows.


GenomeWeb - DNAnexus PrecisionFDA Platform Expansion Will Add Support for Multi-Omics Data, Interactive Review

Armed with a recently awarded five-year $20 million contract from the US Food and Drug Administration to support its work on the PrecisionFDA platform, DNAnexus is working with Deloitte to enhance the platform's capabilities for sponsor-reviewer interaction, add support for multi-omics, and provide a library of analytical, statistical, and machine-learning applications.


Change Together - The Breakthrough Therapy Designation: How a best practice campaign can shift the lines in patient access to medicines

In little over seven years, FDA Breakthrough Therapy Designation has been given to almost 200 drugs, resulting in more than 70 treatments being approved approximately two years earlier than would otherwise have been expected, according to Dr. Jeff Allen, CEO at Friends of Cancer Research (FoCR).


First passed by Congress in 2012, the designation was the brainchild of the Friends of Cancer Research (FoCR), according to Jeff, who credits effective collaboration with FDA with the program’s success.


Health Affairs - Access For 21st Century Cures: Updating Medicare’s Approach To Coverage And Payment

In recent years, considerable bipartisan Congressional action, leadership from both Democratic and Republican administrations, and broad-based multistakeholder collaborations have focused on improving the tools and regulatory processes at the Food and Drug Administration (FDA), other government agencies, and public-private collaborations to support more efficient and timely development of new medical technologies.

PMLive - UPDATED: Senate officially confirms Stephen Hahn as FDA commissioner

The Senate Committee on Health, Education, Labor and Pensions voted 18-5 in favour of advancing Hahn's nomination to the full Senate last week, after he was put forward for the job by President Donald Trump.


Following the final confirmation, Hahn will now go on to head the FDA and become a pivotal figure on a number of key issues the agency is currently facing.


This includes the ongoing opioid crisis and litigation, drug contaminations in major products and the outbreak of a lung illness thought to be caused by certain electronic vaping products.


Pink Sheet - New US FDA Commissioner Stephen Hahn Heads to White Oak Under Vaping Cloud

Executive Summary

Bipartisan Senate confirmation vote comes despite concerns about Stephen Hahn's non-answers to e-cigarette regulation questions.

Stephen Hahn cruised to confirmation as the next US Food and Drug Administration commissioner 12 December, but not without another warning that his yet-to-be articulated stance on vaping will be closely scrutinized.


Hahn was confirmed by the Senate 72-18 after 37 days, the shortest of time from nomination to confirmation since Mark McClellan needed less than a month in 2002. (See chart below.)


Scientific American - Speeding Access To New And Innovative Cancer Treatments

When Yelak Biru was diagnosed with stage 3 multiple myeloma in 1995, his prospects looked grim. The antibody-producing immune cells in his bone marrow were growing out of control and had lodged in several of his bones. He was a newly married graduate student, just 25 years old. The disease was considered incurable, and freshly diagnosed patients, such as Biru, lived an average of just two or three years.


Food Safety News - Senate ready for confirmation vote on Hahn as next FDA commissioner

The Senate committee charged with reviewing the nomination of Dr. Stephen Hahn as the next FDA Commissioner has approved his appointment by an 18-to-5 vote, sending the nomination to a Senator floor vote.  If confirmed by the full Senate, Hahn will succeed Scott Gottlieb to become the 24th FDA Commissioner in the history of the United States.