Latest Drugwonks' Blog
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.
Nice article by Matthew Arnold in the December edition of Medical Marketing & Media. “Eye of the Storm,” provides a nice overview of what we might expect in 2011 on a range of issues.
Here’s the section discussing the future of PCORI (the Patient Centered Outcomes Research Institute):
Healthcare reform rematch
Ex-FDA communications chief Peter Pitts says the board “provides the grease on the slippery slope towards formularies.” Three of its 21 seats are dedicated to pharmas, with execs from Pfizer, J&J and Medtronic among the initial appointees. Congress could also pull the $1.1 billion allocated to the Agency for Healthcare Research and Quality for comparative effectiveness research by the law.
“That money will be radically reduced if not eliminated altogether,” predicts Pitts. Pitts also expects “a very colorful season for healthcare hearings on the hidden codicils of healthcare reform.”
The full article can be found here.
Talk about a doc fix!
News from the AMA. But not really “news,” in the sense that everyone knew this already. Nevertheless …
New AMA Survey Finds Insurer Preauthorization Policies Impact Patient Care
Chicago – Policies that require physicians to ask permission from a patient's insurance company before performing a treatment negatively impact patient care, according to a new survey released today by the American Medical Association (AMA). This is the first national physician survey by the AMA to quantify the burden of insurers' preauthorization requirements for a growing list of routine tests, procedures and drugs.
"Intrusive managed care oversight programs that substitute corporate policy for physicians' clinical judgment can delay patient access to medically necessary care," said AMA Immediate Past President J. James Rohack, M.D. "According to the AMA survey, 78 percent of physicians believe insurers use preauthorization requirements for an unreasonable list of tests, procedures and drugs."
The AMA survey of approximately 2,400 physicians indicates that health insurer requirements to preauthorize care has delayed or interrupted patient care, consumed significant amounts of time, and complicated medical decisions. Highlights from the AMA survey include:
· More than one-third (37%) of physicians experience a 20 percent rejection rate from insurers on first-time preauthorization requests for tests and procedures. More than half (57%) of physicians experience a 20 percent rejection rate from insurers on first-time preauthorization requests for drugs.
· Nearly half (46%) of physicians experience difficulty obtaining approval from insurers on 25 percent or more of preauthorization requests for tests and procedures. More than half (58%) of physicians experience difficulty obtaining approval from insurers on 25 percent or more of preauthorization requests for drugs.
· Nearly two-thirds (63%) of physicians typically wait several days to receive preauthorization from an insurer for tests and procedures, while one in eight (13%) wait more than a week. More than two-thirds (69%) of physicians typically wait several days to receive preauthorization from an insurer for drugs, while one in ten (10%) wait more than a week.
· Nearly two-thirds (64%) of physicians report it is difficult to determine which test and procedures require preauthorization by insurers. More than two-thirds (67%) of physicians report it is difficult to determine which drugs require preauthorization by insurers.
Preauthorization policies deliver costly bureaucratic hassles that take time from patient care. Physicians spend 20 hours per week on average just dealing with preauthorizations. Studies show that navigating the managed care maze costs physicians $23.2 to $31 billion a year.
"Nearly all physicians surveyed said that streamlining the preauthorization process is important and 75 percent believe an automated process would increase efficiency," said Dr. Rohack. "The AMA is urging health insurers to automate and streamline the current cumbersome preauthorization process so physicians can manage patient care more efficiently."
See these two new papers from Health Affairs:
What Does It Cost Physician Practices To Interact With Health Insurance Plans?
Peering Into The Black Box: Billing And Insurance Activities In A Medical Group
Strombeek-Bever, Belgium, November 30, 2010 – Reliable Cancer Therapies (RCT) is a Swiss non-profit organization that provides research-based information on cancer therapies and selectively funds the development of promising therapies.
RCT today launched a global online database (www.reliablecancertherapies.com) that provides scientifically checked information on cancer treatments. With this online database, RCT hopes to broaden the reliable treatment options for cancer for patients.
“Our online database provides patients and medical professionals with free and qualitative information on cancer treatments, guidelines and clinical trials s” states Lydie Meheus, PhD, executive director of RCT: “This website is an answer to the growing need for a comprehensive repository of reliable, trustworthy information on cancer treatments and investigational drugs. We give specific, verified information on as well conventional as non-conventional cancer therapies, and we want to focus on the resulting patient outcomes. We hope that this database will help people find their way through overwhelming, confusing and way too often unverified information. However, it should be emphasized that RCT does not provide medical advice and that our website does not replace a medical consultation.”
Executives at 50 medical companies think FDA has improved it relationships with them, but say the agency is not keeping up with advances in technology, the survey by PricewaterhouseCoopers LLP and Biocom, an association of 550 California life sciences companies, found.
PwC and Biocom interviewed 1,000 adults and executives at 50 drug, device and diagnostics companies of varying sizes for the report, available at www.pwc.com/us/fdasurvey.
Among the companies, 80 percent said FDA is providing better guidance about its expectations but just 38 percent said the overall working relationship with FDA has improved over the past two years.
Only 8 percent of drug and device makers said FDA is doing enough to advance personalized medicine.
While 93 percent of U.S. consumers are confident about the safety and effectiveness of drugs and medical devices approved by the FDA, 56 percent said they would be willing to use drugs and devices approved outside the United States.
More than 50 percent of consumers said they think FDA does a good job, but 36 percent said they have lost confidence in the FDA over the past two years as a result of high profile safety concerns and product recalls.
"Consumers want safer, more effective drugs and devices and access to the latest medical innovation. Industry wants fast and efficient product approvals," PWC's Michael Mentesana said in a statement.
"But the promise of faster product development has yet to be realized and the quality and productivity of the FDA-industry relationship would be better on both sides if there was more collaboration and clarity around expectations."
One of the most misunderstood areas is the Prescription Drug User Fee Act or PDUFA, which requires companies that make drugs pay up to $1.25 million per drug application.
FDA says this cash has helped speed up drug approvals but the survey found that 46 percent of company executives do not believe approvals are any faster.
And 70 percent of consumers disapprove of having companies help pay for FDA's work. Only 36 percent knew that industry helps pay for FDA and just 68 percent fully understood the agency is paid for by taxes.
“Defensive REMS” May Be Needed To Appease Advisory Committees
Sponsors facing an FDA advisory committee should be prepared to discuss Risk Evaluation and Mitigation Strategies, even if FDA tells a company that a REMS need only have minimal elements or is not necessary, to avoid a negative vote, industry experts say.
Egrifta Approval Suggests Evolution In FDA Thinking On Role Of REMS
FDA’s decision not to require a Risk Evaluation and Mitigation Strategy for Theratechnologies’ HIV lipodystrophy drug Egrifta (tesamorelin) suggests the agency is becoming more circumspect in how it applies its drug safety powers under the FDA Amendments Act more than two-and-a-half years after they took effect.
Wither predictability?
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.
