Latest Drugwonks' Blog
Here are the links to the two performances.. I think I look better on radio than I do on TV.. But you decide.
minnesota.publicradio.org/display/web/2011/09/19/midmorning1/
www.nbc.com/the-tonight-show/video/michele-bachmann-part-2-91611/1355953/
www.nbc.com/the-tonight-show/video/michele-bachmann-part-1-91611/1355952/
A: When it's a super office.
FR: Janet Woodcock
TO: CDER Staff:
The Office of Medical Policy (OMP) has been reorganized into a Super Office. Within its organizational structure are the Office of Medical Policy Initiatives and the Office of Prescription Drug Promotion. Led by Rachel Sherman and her Deputy, Kathleen Uhl, OMP plays a critical role in directing medical policy programs and strategic initiatives.
This includes directing regulation of prescription drug promotion and advertising, providing leadership and scientific advice on clinical trial design, providing consultation and direction in policy issues related to human subject protection and good clinical practices, supporting the recent Health Care Reform Act that provides new legislation for Biosimilars, and developing regulation, guidance documents, and procedures related to medical policy issues.
· Rachel Sherman, Director, Office of Medical Policy
· Kathleen Uhl, Deputy Director, Office of Medical Policy
· Janet Norden, Associate Director for Regulatory Affairs
The Office of Prescription Drug Promotion
The Division of Drug Marketing, Advertising, and Communications has been reorganized and elevated into the Office of Prescription Drug Promotion (OPDP).
This reorganization will leverage OPDP’s resources and processes to provide for the highly effective oversight of prescription drug promotion.
ODPD consists of an Immediate Office, the Division of Professional Promotion (DPP), and the Division of Direct-to-Consumer Promotion (DDTCP). The new structure will help prevent misleading promotion about prescription drugs and enhance the quality of communications about prescription drugs and other health information developed by companies.
Thomas Abrams, Director, Office of Prescription Drug Promotion
Mark Askine, Associate Director, Office of Prescription Drug Promotion
Marci Kiester, Associate Director of Operations, Office of Prescription Drug Promotion
Catherine Gray, Acting Director, Division of Professional Promotion
Robert Dean, Acting Director, Division of Direct-to-Consumer Promotion
The Office of Medical Policy Initiatives
A newly created Office of Medical Policy Initiatives (OMPI) consists of an Immediate Office, the Division of Medical Policy Programs (DMPP), and the Division of Medical Policy Development (DMPD).
This office will develop and coordinate medical policy regulations and guidances that address the policy and program areas covered by the Super Office. The organization of the divisions supports the continued implementation and successful advancement of the Sentinel Initiative, the Clinical Trials Transformation Initiative (CTTI), and the Patient Medication Information (PMI) Initiative.
Within this reorganization, the Patient Labeling Team (PLT) will be moving from the Office of Surveillance and Epidemiology (OSE), Division of Risk Management (DRISK) to OMPI, Division of Medical Policy Programs. The goal of the Patient Labeling Team is to promote the safe and effective use of prescription medications by providing accurate and easily understood patient medication information. OMPI will reach out to affected offices with procedural details on the PLT's transfer.
Denise Hinton, Director, Office of Medical Policy Initiatives
Richardae Araojo, Deputy Director, Office of Medical Policy Initiatives & Acting Division Director, Division of Medical Policy Programs
Paula McKeever, Division Director, Division of Medical Policy Development
It seems that the FDA has decided that biosimilar sponsors will not be required to meet with the agency at specific times or for specific reasons during the IND phase of development, allowing them more flexibility early in the process.
Product development fees would be collected when a biosimilar sponsor files an IND. It is expected to be about 10% of the cost to file for a marketing application review and be charged annually as long as the product remains in active development stages.
FDA wants the earlier infusion of funding to support agency activities during the biosimilar IND stage, which are expected to be more extensive than those for other applications. The agency agreed to discount all product development fee payments from the marketing application fee once it is filed
FDA and the brand and generic industry representatives also may have ended their dispute over whether the biosimilar user fee program should be independent of the other user fee programs.
At an August 8th meeting the agency circulated draft statutory language authorizing creation of the program independent of other user fees. The minutes did not indicate opposition by GPhA on any portions of the proposal. There also was no mention in the minutes of further discussion of the appropriations trigger.
The agency agreed to write a draft commitment letter for discussion at another negotiating session, another indication both sides have moved beyond the issue.
The biosimilar user fee program is expected to be included in an omnibus bill that also will include the Medical Device User Fee and Modernization Act and PDUFA reauthorizations, as well as the new generic drug user fee program.
On Wednesday I attended the Washington Post’s event on non-communicable diseases (NCDs), “Sharing the Responsibility.” The event was co-sponsored by Eli Lilly & Co.
(Video clips of this event can be found at www.washingtonpostlive.com)
The title of the conference was crucial as world-class speaker after speaker spoke to the need for cooperation between (as Ann Keeling, the CEO of the International Diabetes Federation and Chair of the NCD Alliance put it) “the three P’s – public, private, and people.”
For a change, the discussion of NCDs wasn’t framed as a battle between “good guys” (generally portrayed in the mainstream media as “civil society”) and “bad guys” (private industry). Rather than being about placing the blame, it was about developing solutions. This position was stated early and eloquently by the event’s opening speaker, Dr. Julio Frank (Dean of the Faculty, Harvard School of Public Health and the key founding father of the Mexican healthcare system). Dr. Frank warned that we must avoid and beware of “reductionist solutions.”
When asked about the role of intellectual property rights and their role in addressing the NCD issue, Dr. Frank said that protecting IPRs is crucial to developing new and innovative global healthcare solutions. While he was answering this question, Ms. Keeling had no comment on the question of IPRs but did comment that, “there are no magic bullets.”
This concept of “shared responsibility” issues many challenges – not the least of which goes out to the “Uncivil Society” movement led by (among others) Jamie Love. Uncivil Society demonizes any role for industry -- except maybe writing checks (which brings to mind Abba Eban’s famous quote about the give-and-take between Israel and the PLO –“We give and they take.”)
As H.L. Mencken famously quipped, “For every complex problem there is an answer that is clear, simple, and wrong.”
Uncivil Society was called out at this event. “Shared responsibility,” means they must cease repeating and repeating and repeating their incessant falsehood that the majority of the Developing World’s healthcare problems could be solved if only we would do away with patents and intellectual property protection.
The petty agenda of Uncivil Society must not be allowed to hijack the important global mission of combating NCDs.
During the panel on “Public & Private Partnerships,” Herb Riband (VP, External Affairs for Medtronic) spoke about a “confluence of interests.” And John Lechleiter (President and CEO, Eli Lilly & Co.) commented that, “There is no substitute for the power of partnership.” And Lilly is putting its money where its mouth is. A day before the Post event they announced the Lilly NCD Partnership, a five-year $30 million commitment to fight the rising burden of non-communicable diseases in developing nations. And it’s not about writing a check, but rather combines the company’s resources with the expertise of leading global health organizations, to identify new models of patient care that increase treatment access and improve outcomes for underserved people.
As Mark Kramer (Senior Fellow, Harvard Kennedy School of Business) said, a key role for private industry is to “broker partnerships that propel progress.”
David Brown (a Washington Post journalist and a physician) commented that we must avoid the “false dichotomies” of NCDs (infectious vs. non-infectious, cure vs. prevention, rich vs. poor). So too must we avoid the false dichotomy of “hero vs. villain.”
The Washington Post conference, held in advance of next week’s historic United Nation’s High Level Meeting on NCDs, made it abundantly clear that, to actively, aggressively, and creatively fight NCDs in the Developing World (and, for that matter, the whole world), there must be partnerships rather than partisanship.
The common ground is shared responsibility.
Hm.
Please have a look at this short PSA on why, when it comes to vaccines, celebrity trumps science.
And please, pass this along. Let's make it a YouTube sensation.
If you have an interest and no pressing conflicts, two important briefings by the CME Coalition (www.cmecoalition.org) to consider attending:
CME Cancer Policy Briefing
On September 27, from 12:00 – 1:00 in the Rayburn House Office Building “Gold Room” (Room 2168), the Coalition will be presenting a program entitled “Continuing Medical Education: A Focus on Breast Cancer Breakthroughs.” This panel will comprise thought leaders in the fields of CME and breast cancer treatment, and will include:
Dr. Jonathan Sackier: Chief Medical Officer, Audax Health Solutions, Visiting Professor of Surgery, University of Virginia, Following positions at Cedars-Sinai and UCLA, he was named Professor of Surgery at George Washington University, in Washington, D.C. where he founded the Washington Institute of Surgical Endoscopy.
Dr. Charles Balch: Professor of Surgery and Oncology and Dermatology, Deputy Director, Johns Hopkins Institute for Clinical and Translational Research, Former CEO of American Society of Clinical Oncology
Dr. Dana Simpler: Primary Care Practitioner, Mercy Medical Center, Baltimore, MD, Has appeared in numerous print and broadcast media, locally, regionally and nationally as a health care thought leader.
And …
CME HIV Policy Briefing
On September 28, from 12:00 – 1:00 in the Senate Commerce Committee Hearing Room (Russell Senate Office Building Room 253), the Coalition will be presenting a program entitled “Continuing Medical Education: A Focus on HIV Breakthroughs.” This panel will comprise thought leaders in the fields of CME and HIV treatment, and will include:
Dr. Jonathan Sackier
Dr. John Bartlett: Professor and Chief of the Division of Infectious Diseases at Johns Hopkins, Internationally renowned authority on AIDS and other infectious diseases and recipient of the prestigious 2005 Maxwell Finland Award for scientific achievement from the National Foundation for Infectious Diseases.
Dr. Alan Wasserman: The Eugene Meyer Professor of Medicine and the Chairman of the Department of Medicine at The GWU School of Medicine and Health Sciences, Chairman of the Board of Trustees and President of The George Washington University Medical Faculty Associates.
Space is limited, however, so kindly RSVP at by September 16th to rsvp@cmecoalition.org or call Shea McCarthy at (202) 688-0225.
In advance of next week's UN meeting on non-communicable diseases in the developing world, tomorrow I will attend and participate at a Washington Post forum on this very topic.
Today, this relevant news crossed my desk.
Kismet? I don't think so.
Indianapolis, IN – Eli Lilly and Company (NYSE: LLY) announced today a $30 million commitment over five years to fight the rising burden of non-communicable diseases in developing nations. Lilly is launching The Lilly NCD Partnership, which combines the company’s unique resources with the expertise of leading global health organizations, to identify new models of patient care that increase treatment access and improve outcomes for underserved people. The partnership will initially focus on diabetes – a core business area in which Lilly has deep expertise.
Non-communicable diseases (NCDs), known as chronic diseases, include cardiovascular diseases, diabetes, cancer and chronic respiratory diseases. The first phase of The Lilly NCD Partnership will focus on improving diabetes care in targeted communities in Brazil, India, Mexico and South Africa.
“Non-communicable diseases are afflicting nations, communities and families around the world, with the most vulnerable bearing most of the burden,” said John C. Lechleiter, Ph.D., Lilly chairman, president, and chief executive officer. “We believe we have a responsibility – and are uniquely positioned – to assist in the global fight against these diseases. In partnership with leading health organizations, Lilly will contribute its deep expertise and the company’s broad research capabilities to help find solutions for these pressing societal needs.”
Lilly and its partners continue to develop country-specific programs that will launch in early 2012. Lilly and its partners will develop country-specific milestones that, if achieved, will trigger future investments.
Partners include:
• Brazil: Hospital Israelita Albert Einstein – Diagnostic & Preventive
Medicine and Research Institute
• India: The Public Health Foundation of India, Project HOPE, Population
Services International
• Mexico: The Carlos Slim Health Institute – Casalud
• South Africa: The Donald Woods Foundation, Project HOPE
Congratulations to my friends at Eli Lilly & Co. Good luck and good karma.
Now if only Peyton Manning was healthy!
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
