Latest Drugwonks' Blog
A new report from the President's Council of Advisors on Science and Technology (PCAST) has recommended the Agency for Healthcare Research and Quality (AHRQ) receive funds above and beyond the $1.1 billion earmarked in the President’s initial stimulus package to develop a test network for comparative effectiveness research.
The report notes that if patient progress and outcomes are routinely captured in data and made available in near real time, "partial data can be used in sophisticated ways to assign treatments to new patients in optimal ways. These data also could be used to personalize treatment for patients already enrolled in a study."
“Assign treatment?” Perhaps “help a physician decide” or “provide important clinical information” -- but … “assign?” Sounds rather top-down, don’t you think? Alas, as this report was drafted by experts who understand the importance of precise language, we have to assume what they wrote is what they meant.
And that’s frightening.
Sounds like a good topic for a Congressional hearing.
The Council’s report can be found here.
This Sunday on "BioCentury This Week" TV
Broadcast on WUSA Channel 9 in Washington, D.C.
and Fox affiliate WFXT Channel 25 Boston
8:30 - 9:00 a.m. EST
Dec. 12 broadcast investigates
POLITICAL COMMUNICATIONS
Finding Biotech's Voice in a Divided Washington
continuous webcast at
www.biocenturytv.com
Biotech avoided the eye of the storm during the bruising healthcare reform debate. In the newly divided Washington, the question is whether the industry can afford to stay under the radar on its hot button issues, such as PDUFA, as other interest groups join the fray. On Sunday, Dec. 12, BioCentury This Week examines this political communications landscape.
Policom Basics -- Gene Grabowski, SVP at Levick Strategic Communications, and Wayne Pines, President of Regulatory Services and Health Care at APCO Worldwide, warn that biotech must make its voice heard. |
Enjoy!
I spent the last two days chairing the Social Media for Pharma conference and boy are my arms tired.
Actually, it’s my brain that’s tired – because it got a lot of exercise.
Some speaker comments that resonated:
Julie Zawisza (CDER’s Director of Communications): “If we don’t tell our own story – others will.”
So true. And not just for the FDA. The same is equally relevant for pharmaceutical and medical technology companies. Perhaps even more so. In fact, definitely more so.
Paul Buckman, the FDA’s new Dean of Digital, revealed that there is an FDA employee who is (in real time) posting responses to queries generated on the agency’s FaceBook page. This is surprising considering that such a thing would certainly constitute an FDA “written response.” More on this as it develops.
Ambre Morley and Alpesh Patel (product communications and regulatory affairs at Novo Nordisk respectively) discussed their much-ballyhooed Twitter campaign (for Levemir) with IndyCar driver Charlie Kimball. At the beginning of the presentation, Alpesh said that when Ambre first discussed the idea with him, he said, “Let me think about it.” To which Ambre replied, “Actually, you said no.” Success, as they say, has many fathers.
J&J’s always-insightful Marc Monseau shared some gems, discussing the need for well-developed social media “policy, process and guardrails.” The most important pharmaceutical company asset for success in social media? “A cultural willingness to try.” Amen.
Shwen Gwee and Zach Barber (Vertex) discussed their company’s foray into Twitter – and the interesting correlation between number of tweets and number of followers. Shwen also shared their concern over “proactive following.” Add that one to things that make you go hmm. (FYI – current Vertex Twitter guidelines can be found here.)
Both the Novo Nordisk and the Vertex presentations raised questions about retweets – especially those with a hotlink. All present agreed that all links should be carefully vetted before being retweeted. (Here’s a brainteaser – what about retweeting an FDA tweet with a product-specific hotlink that doesn’t one-click to the P.I.? Once again – hmm.)
Relative to FDA tweets and the aforementioned FDA FaceBook – and as if things weren’t ambiguous enough – what happens when you have the federal agency in charge saying (for all intents and purposes) “do as I say, not as I do.” And, of course, this is made even worse since the FDA isn’t saying much.
But I digress.
During one of the breaks, I participated in a very entertaining conversation with three regulatory types from three different companies. We decided there is an unmet need for “regulatory emoticons.” The consensus opinion was for an emoticon representing arms crossed across the chest. We felt that a more, shall we say, digit-based representation was overly confrontational.
Nancy Buono Cartwright (Kaiser Permanente) discussed using social media as an internal communications tool. Much smart thinking and nifty program elements. Her suggestion for engagement --“Play in traffic.” Not the best way to encourage an already skittish audience. Auto de fé indeed!
The omega presenter was Dennis Urbaniak (sanofi-aventis) and he had a keen observation about pharma and social media, “It’s not if anymore – it’s when and how.”
He also pointed out that social media (as part of an integrated marketing strategy) is unlike other, more traditional component – such as advertising. Social media programs are the gift that (properly understood and harvested) is the gift that keeps on giving.
What does that mean? Well, a DTC television commercial doesn’t generate anything once it’s been aired. Social media, on the other hand, generates awareness, interaction, a call to action (when appropriate), and robust metrics that supply real-time competitive intelligence.
Need I say more?
There were many excellent presenters who I have not mentioned. The complete program agenda can be found here.
Joe Pitts (R,PA) on American Healthcare Reform from CMPI on Vimeo.
Fascinating and informative BioCenutury cover story on a 21t century regulatory pathway for diagnostics. Penned by the always informed Steve Usdin, here are some snippets:
FDA and members of Congress are putting the finishing touches on different proposals to create a new regulatory pathway for diagnostics, making it almost certain that major changes will be unveiled in 2011. The question is which approach will prevail — and whether either approach solves the problem of value-based reimbursement.
Top FDA officials and lawmakers have concluded that the current oversight system for diagnostics, which imposes premarket review requirements for in vitro diagnostics (IVDs) but not for the vast majority of laboratory-developed tests (LDTs), is not sufficient to protect the public or to support the development of innovative tests that are at the heart of hopes for widespread adoption of personalized medicine.
The only option that is off the table is the status quo.
Senator Orrin Hatch (R-UT) is lining up bipartisan support — and his staff is trying to build consensus among labs, diagnostics companies and investors — on draft legislation that would preempt FDA’s efforts. His approach would create a new regulatory category encompassing both LDTs and IVD tests.
Under the Hatch bill, IVDs would no longer be regulated as medical devices. Also, FDA would for the first time routinely regulate tests performed in labs, although lab services and operations would continue to be regulated by the Centers for Medicaid and Medicare Services (CMS) under the Clinical Laboratory Amendments (CLIA) (see “BETTER at a Glance”).
Hatch hopes to use a new regulatory system to go even farther, as a platform for launching reform of diagnostics reimbursement policies, and shifting Medicare from a payment system based on the complexity of test procedures to one based on the value of tests, according to diagnostics.
FDA has clearly signaled that in the absence of legislation, it intends to regulate LDTs, fitting them into a structure that many labs and IVD manufacturers argue is ill-suited for diagnostics.
Indeed, according to Alberto Gutierrez, director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OVID), laboratory directors who hope FDA will back off from its plans to regulate their tests are like “ostriches which have their heads in the sand.” Gutierrez, who made the comment at a Nov. 22 meeting organized by ACLA, said the agency is writing a guidance document outlining a proposed diagnostics oversight framework. While he declined to say when the guidance will be released, FDA has already begun recruiting staff to implement it. At the same time, FDA has indicated that it will move slowly, leaving room for Congress to intervene before the agency implements any major changes.
“The success of personalized medicine depends on having accurate diagnostic tests that identify patients who can benefit from targeted therapies.”
(From July NEJM commentary jointly authored by FDA Commissioner Peggy Hamburg and NIH Director Francis Collins.)
The complete BioCentury article can be found here.
Pfizer Board of Directors Names Ian C. Read President and Chief Executive Officer
Read Succeeds Jeffrey B. Kindler, who has Retired from the Company
New York – December 5, 2010 – Pfizer Inc. (NYSE: PFE) today announced that its Board of Directors has elected Ian C. Read, 57, currently head of the Company’s global biopharmaceutical operations, as President, Chief Executive Officer and Director. Mr. Read succeeds Jeffrey B. Kindler, who has retired from the Company.
The Board’s Lead Independent Director, Constance J. Horner, said, “In 2006, Jeff Kindler took on the challenge of transforming Pfizer in the face of enormous changes in the global health care marketplace and significant patent expirations of major products, including Lipitor. Acting with the highest level of ethics and professionalism, he moved aggressively to drive change at the Company, including putting new, more focused and agile business units in place, building and enhancing world class compliance systems, recruiting talented new leaders, and refocusing and streamlining operations in every part of the world. He also led the acquisition of Wyeth, which brought the Company valuable in-line and pipeline products and capabilities in attractive growth areas, including vaccines and biologics. Due to the efforts of Jeff, the executive leadership team and Pfizer’s talented employees around the world, the Company is now a stronger, more diversified and more focused company.”Mr. Kindler commented, “My nearly nine years at Pfizer and, particularly the last four and a half as CEO, have been extremely exciting and rewarding. I feel our team can proudly boast of some transformational accomplishments. However, the combination of meeting the requirements of our many stakeholders around the world and the 24/7 nature of my responsibilities, has made this period extremely demanding on me personally. Now that we are about to complete a full year of operating Pfizer and Wyeth together, with our world-class team fully in place, I have concluded the time is right to turn the leadership of the company over to Ian Read. Ian is an outstanding and experienced pharmaceutical executive who I know will make the next phase of the company’s future a successful one. He is more than ready to take on these responsibilities and I am excited at the opportunity to recharge my batteries, spend some rare time with my family, and prepare for the next challenge in my career.
Ms. Horner added, “In the last four years as President of Pfizer’s pharmaceutical businesses, Ian has redefined our go to market approach with the creation of global business units and has brought to product development a focus and commitment to advance only medicines that have clear value to our customers. Today’s business leaders need to understand global markets, drive change and innovation, and move quickly to adapt to competitive pressures. Ian’s track record throughout his career has demonstrated these exact strengths.”
Mr. Read said, “I am honored to lead an organization with outstanding and dedicated colleagues on the front lines of medical innovation. We have a broad portfolio that spans the entire spectrum of human and animal health, from vaccines to biologics to primary care, specialty care, oncology, consumer products, nutritionals and beyond. I have great confidence in the strength of our company and our leaders and will be looking at the performance and potential of all of our businesses to ensure we are delivering value to our customers and shareholders. We have all the elements for success -- financial strength, global reach, a disciplined focus on the therapeutic areas with the strongest growth potential and a talented and dedicated workforce.”
Since 2006, Mr. Read has led Pfizer’s Worldwide Biopharmaceutical Businesses which now comprises five global business units – Primary Care, Specialty Care, Oncology, Established Products and Emerging Markets – and accounts for approximately 85 percent of Pfizer’s annual revenues. He was responsible for more than 40,000 Pfizer colleagues. His leadership team consisted of senior executives directing Pfizer development and commercial operations in 180 nations.
Mr. Read joined Pfizer in 1978 and quickly assumed positions of increasing responsibility in Latin America. In 1996, he was appointed President of Pfizer’s International Pharmaceuticals Group, with responsibility for Latin America and Canada. He was named Corporate Vice President in 2001, and assumed responsibility for Europe in addition to Canada. Mr. Read later added the Africa/Middle East and Latin American regions to his leadership responsibility.
The Board will elect a non-executive Chairman from its current membership at its next regularly scheduled meeting that will take place within the next two weeks.
The saga continues …
NEW YORK (AP) - Momenta Pharmaceuticals Inc. said Thursday it is suing rival Teva Pharmaceutical Industries Ltd. in a patent dispute over generic versions of the anti-clotting drug Lovenox.
The Cambridge, Mass., company said it filed a patent infringement lawsuit against Teva, alleging the Israeli company violated two patents held by Momenta that are related to its generic version of the drug. Lovenox, or enoxaparin, is used to prevent dangerous blood clots, including clots in the veins of the thigh or leg, or in patients who are having a heart attack or chest pain. The original version of the drug is made by Sanofi-Aventis SA, and it was approved in the U.S. in 1993..
More 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.
