Latest Drugwonks' Blog
Pharmaceutical sponsors across therapeutic categories may have breathed a sigh of relief when FDA’s Cardiovascular and Renal Drugs Advisory Committee said that Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) need not show it is “as effective” as Boehringer Ingelheim GmbH’s anticoagulant Pradaxa (dabigatran) in atrial fibrillation patients.
At the September 8th meeting focused on efficacy data from the pivotal ROCKET AF study and whether the Factor Xa inhibitor was studied against an appropriate comparator. FDA sought the advisory committee’s input on whether warfarin or dabigatran was the appropriate comparator for rivaroxaban in light of a 1995 agency policy that requires new therapies be “as effective” as approved treatments when the disease at issue is life-threatening or capable of causing irreversible morbidity.
At a Sept. 8 meeting, the majority of panel members said Xarelto’s sponsors should not be required to directly show comparable efficacy to dabigatran, a drug approved 11 months ago.
According to the Pink Sheet, panelists commented that requiring drugs for serious or life-threatening diseases to be compared head-to-head against the newest treatment on the block could “throw a wrench in long-planned and ongoing clinical development programs that use a well-established standard of care as a comparator agent.”
Office of Drug Evaluation I Director Bob Temple on the question as to whether or not the ROCKET AF study population represented a sufficiently different group of patients from those in RE-LY as to render the “as effective” policy inapplicable to rivaroxaban:
“This was not my favorite question.” Dr, Temple then proceeded to point out the bigger issue inherent in applying FDA’s “as effective” policy in a dynamic development and regulatory environment.
“There is an interesting and provocative issue here. Suppose in the course of the study, something new and really hot comes along. Do we ever say, ‘I’m sorry, you compared it to a dog, we have something better now?’ We don’t usually do that, but I wouldn’t rule out the possibility. And this is a little bit about that possibility, but I don’t think we really meant to get too much into that discussion.”
PCORI Executive Director Joe Selby wants to be clear that while the institute's main focus will be on patient-centered activities, it will wants participation from all interested parties.
"We want a director of stakeholder engagement to engage providers, caregivers, employers, health plans, health systems, health services researchers and other researchers, government and industry," Selby said September 19th during the PCORI Board of Governors meeting in Seattle.
Good idea. And the selection process (and the selected candidate) should be carefully watched to see how Dr. Selby and the PCORI board defines “interested parties.”
Barak Obama is quickly becoming the anti-innovation President.
On Monday, the White House released its deficit reduction plan. Part of the President’s strategy is to impose new rebates on Medicare drugs, strengthen the Independent Payment Advisory Board, and reduce the exclusivity period for innovator biologic drugs.
It’s not class warfare – it’s no-class warfare. And it’s deleterious to the public health.
As the Old Perfessor used to say, let’s look at the record.
First, on the topic of Medicare rebates, why don’t we just call it what it is – a tax. More precisely, an excise tax imposed by Uncle Sam on drug sales.
But wait, it gets worse. The revenues from this tax don’t lower costs for a single patient. Not one. The cash would go into the general fund. It’s not a “rebate” – it’s a tax, plain and simple. A levy imposed on price.
And, hiding behind “deficit reduction,” it’s a tax with a hidden purpose – the introduction of backdoor price controls. And price controls equal cost controls – with or without IPAB.
Speaking of IPAB, the President's plan seeks to lower the threshold at which IPAB would impose Medicare spending cuts; however, the plan doesn't specify what the savings would be. So much for “specifics.” But, specifically speaking, a stronger IPAB further ices the slippery slope towards government price controls and (ultimately) a single payer system.
There’s already the very real risk that IPAB will be insensitive to the needs of Medicare patients. After all, board members are unelected appointees with an incredible amount of power. The IPAB is liable to enact cost-cutting measures that might sound good in the boardroom, but actually lead to worse health outcomes for Medicare patients and strap them with unbearable costs. The President’s proposal makes this twice as bad.
And then there’s the anti-innovation codicil. The President wants to cut innovator biologics exclusivity to seven from the current 12 years.
It’s hugely disappointing that the same man who (as a United States Senator) once said that …
“Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."
… is now advocating a policy that would result in precisely the opposite.
After speaking (during the State of the Union and a widely quoted op-ed in the Wall Street Journal) about the need for America to embrace innovation – President Obama is trying to make it more difficult, specifically when it comes to the desire to invest in pharmaceutical innovation – a sure bet under no circumstances.
Patent exclusivity funds an innovator company’s research and development efforts. If the President’s proposal becomes law, the US would provide less data protection for innovative biologics than Europe.
12 years of exclusivity also gives hope to those suffering from rare diseases or conditions. If innovator companies think they will have a short time before a follow-on versions of their products hit on the market, they will likely only focus on drugs for major diseases and conditions -- potentially ignoring ailments that are less common, but equally as serious, to those suffering.
What’s next – an executive order instructing the FDA to approve biosimilars without clinical trials? Alas – this is unfortunately not a far-fetched idea considering the tone and substance of President’s speech on Wednesday.
If innovation is one of the key answers to our national economic recovery, then the President should abide by what he said, “Our economy is not a zero-sum game. Regulations do have costs; often, as a country, we have to make tough decisions about whether those costs are necessary. But what is clear is that we can strike the right balance. We can make our economy stronger and more competitive, while meeting our fundamental responsibilities to one another.”
As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted: "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."
L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning. Let’s keep our eye on the prize. No, not budget reduction – the real prize: better access to smarter healthcare for all Americans. Innovation that focuses on creating a chronic healthcare culture that embraces prevention and prophylactic care. Rather than wasting time on spin, let’s redouble our efforts on innovation. Then, when we succeed through brainpower and teamwork (and, hopefully some civil bipartisanship), the circus surrounding the President’s deficit reduction proposal will be but a footnote in the history of American healthcare.
According to the New York Times, “Hospira, based in Lake Forest, Ill., which has been selling cheaper versions of expensive biologic drugs in Europe for nearly four years, said on Monday that it would begin a final-stage clinical trial in the United States by the end of this year of its biosimilar version of Amgen’s brand-name Epogen in patients with renal dysfunction who have anemia.”
Good news, right? Well – yes. But ...
Yesterday at the 3rd annual Business of Biosimilars & Biobetters Conference in Boston, Naomi Pearce (Director of IP at Hospira) gave a brutally tactical presentation on how to move forward with biosimilars via the “3 C’s – Challenge, Circumvent, Create.” 99.9% of her remarks focused on how to challenge and circumvent patents. The remaining .1% (under the heading of “create”) was limited to “and create something new when it makes good commercial sense.”
Ms. Pearce is a patent attorney and, of course, when you have a hammer every problem looks like a nail. But it does point out many of those looking to enter the biosimilar space are looking at the opportunity as another “generics play.” It reminds me of the time that Israel Makov (the founder and “Big Abba” of Teva) said to me that “Teva isn’t in the pharmaceutical business, it is in the litigation business.”
That was then and this is now? Alas, not so fast.
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.
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.
