On Wednesday, November 14, 2018, Friends of Cancer Research (Friends) and Prevision Policy hosted the fourth annual BioPharma Congress. This year’s event focused on drug pricing, approval standards, patient input, and the future of the U.S. Food & Drug Administration (FDA). Featured speakers included HHS Deputy Secretary Eric Hargan and CMS Administrator Seema Verma. The event brought together regulators, industry, patient advocacy groups, and congressional staff as well as payment and reimbursement organizations.
This year’s BioPharma Congress was split into 10 sessions covering a diverse range of vital health policy topics. Friends’ Founder & Chairperson, Ellen Sigal, moderated a morning panel with FDA center directors including Dr. Janet Woodcock (CDER), Dr. Peter Marks (CBER), and Dr. Richard Pazdur (OCE). The directors covered a wide breadth of topics including gene therapy, how the FDA Oncology Center of Excellence has instigated a cultural change at FDA, and the need to fix the clinical trial system in the U.S.
CMS Administrator Seema Verma presented the lunch keynote at this year’s BioPharma Congress with Friends Vice President of Public Affairs, Ryan Hohman, introducing her. Verma discussed the Administration’s drug pricing blueprint, the need to transform how Medicare pays for drugs in the Part B program, adding more generic competition, and value-based care arrangements with drug makers.
In the afternoon, Friends President & CEO, Dr. Jeff Allen, participated on the panel “The Blueprint: Impact on Manufacturers, Providers & Patients.” There was a large focus on the cost to patients and the need to fix the specific problem of financial toxicity to patients. The issue between lowering drug spending versus lowering drug cost also came up and how manufacturers have a responsibility to find a solution to these issues too, but that it is difficult since they are unable to negotiate with CMS in a meaningful way.
Other sessions were moderated by Prevision Policy principles and included a keynote address by HHS Deputy Secretary Eric Hargan, the Administration’s drug pricing blueprint, the midterm election impact on 2019, OMB outlook for 2019, how to save antibiotics, the FDA’s new Office of New Drugs, and FDA’s rising stars. Key issues such as drug pricing, approval standards, patient input, and the future of FDA were discussed and analyzed throughout the day.
Media Coverage of BioPharma Congress IV
Four Rules For Being A Consistent US FDA Reviewer From Peter Stein – Pink Sheet (12/9)
A Call To Action On Antibiotic Development – Pink Sheet (12/5)
“Lame Duck” Congress Has High Stakes For Pharma Companies – Pink Sheet (11/29)
LPAD Approval Pathway Is Not Saving Antimicrobial Development – Pink Sheet (11/28)
CDER Recruitment Wins Begin Outnumbering Losses – Pink Sheet (11/26)
Keeping Up With “The Energizer Bunny”: US FDA Commissioner Gottlieb As A Boss – Pink Sheet (11/25)
Unlicensed Stem Cell Clinics Are ‘Surrogate’ For Right To Try, US FDA’s Marks Says – Pink Sheet (11/21)
US FDA Office Of New Drugs Likely To Be Headed By Deputy Director Stein – Pink Sheet (11/20)
Trump’s Part B demo getting less pushback than Obama’s – POLITICO (11/19)
Gene Therapy Guidance From US FDA Likely Needs Updating Sooner Rather Than Later – Pink Sheet (11/19)
Woodcock: High Drug Prices Changing Drug Development Debate – Inside Health Policy (11/15)
Verma: CMS ready to roll on new Part B plan – POLITICO PRO (11/15)
HHS Moves Ahead on Drug Prices, Regardless of House Shake-Up – CQ Roll Call (11/14)
Verma Says HHS Committed To Reforming Part D Protected Drug Classes – Inside Health Policy (11/14)
CMS Lets Michigan Use Outcome-Based Medicaid Rx Drug Contracts – Inside Health Policy (11/14)
