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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!
I just wrote (http://spectator.org/archives/2011/09/12/rick-perry-on-science) about how Rick Perry’s position on vaccines was science-based. Sadly, tonight Republican presidential candidate Michele Bachmann (followed by Congressman Ron Paul and former Senator Rick Santorum) tore into Rick Perry about his executive order mandating that girls entering the 6th grade receive a vaccine to prevent against human papilloma virus (HPV), the leading cause of cervical cancer as well as mouth cancer, tongue cancer and other cancers of the vagina, penis and anus.
Yes, HPV is a sexually transmittable disease and the transmission rates for these illnesses have been climbing rapidly. So too have both the prevalence and incidence of these cancers among young adults. Which means they are contracting them at around age 12.
Bachmann, Santorum and Ron Paul accused Perry of ordering mandatory immunizations in exchange for a $5000 campaign contribution from a former lobbyist for Merck, the developer of one version of the HPV vaccine called Gardasil. IN particular, Bachmann alleged that Perry’s decision exposed “little girls” to a dangerous drug. In doing so, Bachmann – and - by extension Santorum and Paul – gave credence to the canard pushed by the anti-vaccine movement that Merck conspired to market a product that was causing girls to go blind, become paralyzed and die.
First, the science and statistics:
- The most prominent argument against the HPV vaccine Gardasil is that it has been linked to 53 deaths (as of June 2009). These reports were made to the Vaccine Adverse Event Reporting System (VAERS). Of these, 30 reported deaths were confirmed to have occurred, but no causal link to the vaccine was found after investigation. Based on the evidence available, therefore, it does not appear that the vaccine causes death. More recent evidence demonstrates the same result.
- A post-market surveillance study by the CDC found that the rate of reported deaths (including anaphylaxis) was 0.1 per 100,000 doses distributed. Their conclusion was that reported adverse events did not differ significantly from vaccines in general.
- Further arguments against Gardasil mention fainting after immunization. This is a known possible side effect of some vaccines and is included in the package insert. The insert also includes recommendations to observe the patient for at least 15 minutes after injection to ensure the patient does not fall or suffer injury.
Then there is the claim – promoted by an anti-vaccine group claiming that Gardasil contains recombinant HPV DNA that can replicate on it’s own and go haywire on the bodies of young girls. SANE Vax Inc. Announces the Discovery of Viral HPV DNA Contaminant in Gardasil. As Respectful Insolence blog points out:
This is utter nonsense. First off…it's not a trivial matter to get recombinant DNA into human cells and expressing the protein that its sequence codes for. It's worth repeating what I described when I first encountered this idiocy in a different context. For rDNA to do what Dr. Lee worries about, the minute amount of rDNA in the HPV vaccine would have to:
- Find its way into human cells in significant quantities, which is highly unlikely given the tiny amount that, even in the worst case, is there.
- Express the protein that it codes for, which would require that the DNA be intact, complete with its promoter and regulatory regions. Again, this is incredibly unlikely, given the amount of DNA we're talking about unlikely.
Finally, there is the objection to the vaccination based on the assertion that it promotes sexual activity among pre-teens. But let’s assume – and hope – that one day a vaccine that prevents HIV is developed. Would Congresswoman Bachmann also object to requiring immunization in that case because it would similarly encourage boys and girls to engage in sexual activity?
Meanwhile Congressman Paul has indulged in the vaccine-autism conspiracy. Congressman Paul, along with Congresswoman Carolyn Maloney (D-NY) and Rep. Maurice Hinchey (D-NY) introduce the "Comprehensive Comparative Study of Vaccinated and Unvaccinated Population Act of 2006," or H.R. 2832. The bill would have required the National Institutes of Health to complete a study to examine the link between autism and thimerasol. The bill has never gone anywhere though it did prove that anti-vaccine stupidity is bipartisan.
http://www.informationliberation.com/?id=22711
Bachmann, Paul and Santorum (to a lesser extent) are spreading vaccine panic with unscientific and untruthful allegations about Gardasil and Merck. The willingness to foment fear in order to score some political points in the short term is depressing by itself. I don’t know what’s more demoralizing: that the fear mongering comes at a time when vaccination rates are dropping because parents believe the same things the candidates espouse or that the media is once again failing to do it’s job and let people know that all vaccines are highly safe and effective. But I guess that would get in the way of focusing on the catfight between Governor Perry and three politicians who have undermined the public health with misinformed and politically motivated assaults on an important tool in preventing cancer.
www.sciencemag.org/content/333/6047/1216.summary
www.biocenturytv.com/fullplayer.aspx#/BC+Show+52%3A+Biodefense/BioCentury+09.11.11+-+[3]+10+Years+After/608459720001/1150255534001/1153307594001
The need for a commercial application of products is critical to making the nation safer. The government drains value from bio-defense, it does not create it.
Nature Biotechnology opines on BIO’s proposal for a renewing and revitalizing the FDA:
Keeping innovation on American soil may also prove a Sisyphean task. BIO states that in 2009, 35% of pharma companies outsourced to Asia, primarily China and India, and almost a third of small US biotech firms have been tapped to move their R&D operations abroad of biochemical, genomic, imaging, metabolite, cellular, physiological and clinical scoring-scale information gathered from clinical trial reports, scientific conferences and public literature.
The complete article can be found here.
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.
