FDA Considers Faster Approval Process for Obesity Drugs

Bloomberg News:  By Anna Edney on October 11, 2012

Obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit despite their risks may get speedier U.S. approvals under plans being discussed to better balance innovation and safety.

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Patient-Focused Drug Development – Oct. 25th FDA Public Meeting

As part of the performance commitments of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), FDA has published a notice in the Federal Register related to Patient-Focused Drug Development, an initiative that provides for a more systematic approach to obtaining the patient perspective on certain disease areas in PDUFA V.

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Time=Lives: A New Social Media Campaign from FasterCures

Saving time in medical research means saving lives. That’s the theme of a new social media campaign by FasterCures, designed to elevate the profile of medical research on the national agenda and underscore the toll of a slow, inefficient research system on every life. Through personal stories and compelling graphics, Time=Lives explains why medical research matters.

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Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 (H.R. 6502)

Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourage the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing exclusivity.

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My Experience on Capitol Hill: Rare Disease Lobby Day

By Laura Welch

 I am a 33-year-old mother of a 2-year-old boy and wife to a wonderful US Soldier.  In July 2011 we moved from Seattle to DC. Hello sunshine!

On August 18, 2011,  I was diagnosed with Epitheliod Sarcoma (ES), a rare and aggressive form of cancer.  I did what anyone in this day and age would do; I consulted the bible that is Google!  The prognosis was bleak, to put it mildly. However, I am of the mindset that if this disease is so rare that it has little data available, I will make my own data and try not to dwell on the figures in front of me.

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Opportunity to Learn From AIDS Activists – Documentary Screenings

ACT UP and their colleagues fought for nine years before winning life-saving medications. They organized a mass movement, they took to the streets, they made art, they made noise, they made a difference. Their tools included clear demands, arresting graphics, media savvy, and an ability to learn from their mistakes and refine their strategies. And a sense of humor, when appropriate, in combination with their urgent and ethical message.

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POLITICO Pro’s Deep Dive: The Future of the FDA

The POLITICO Pro Health care team takes an in-depth look at the future and policies of the FDA.  Special guests include: Friends of Cancer Research’s Dr. Jeff Allen; The Pew Charitable Health Group’s Allan Coukell; Biotechnology Industry Organization’s Sara Radcliffe and the FDA’s Dr. Janet Woodcock.

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Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation

On September 25, 2012, the President’s Council of Advisors on Science and Technology (“PCAST”) released a report entitled “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.”

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NIH: National Center for Advancing Translational Sciences (NCATS)

Christopher P. Austin, M.D.,  named director of NCATS

The mission of the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

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PDUFA V: Accelerated Approval Expansion May Outshine Rare Disease Improvements

Rare disease advocate says the focus should be on ensuring the accelerated approval expansion and surrogate endpoint guidances become FDA priorities as the rare disease drug program is set to grow under PDUFA V.

By Derrick Gingery / Email the Author / “The Pink Sheet” Sep. 17, 2012, Vol. 74, No. 38

Regulatory Update / Article # 00120917013

Congress mandated specific upgrades to FDA’s rare disease program in the new user fee legislation, but the largest impact may come through the expected changes to the accelerated approval pathway.

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