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To date no one has kept track of the total impact on patients. In part that's because until 2007 generic companies were not require by the FDA to monitor the effect of their products in the marketplace and only then it was limited to opioid based painkillers. The increased use of generic lamotrigine is strongly associated with increased physician visits and hospitalizations. The same goes for switching patients to a generic version of other anti-convulsants, anti-depressants, etc.
The key question of the conference is what can companies do to assure that all medicines affect us in more or less the same way. As I have written before, one step in the right direction is to hold drugs that are supposed to have the same benefit and same risks to the same standards of post market evaluation. Another approach, to be discussed by Gerard Sanderink of Sanofi will be how to use biomarkers to more precisely predict dose response and absorption of products in the earliest stages of development and periodically in the post market.
The conference may seem mundane. However the fact that Bob Temple is showing up indicates just how serious the FDA is about this issue. And more generally, it underscores the fact that the public at large is unaware of the importance of how a drug is delivered. Discovering a medicine is half the battle. Making sure it is delivered safely and effectively is as important.
Accordingly, CMPI will be covering the AAPS conference "live" with bloggers and a video crew in a effort to "deliver" the modified release message in a way that it interesting and timely.
The long-awaited and much anticipated draft guidance on REMS can be found here.
Also now available (and worth a careful read or two) is the FDA's strategic plan for risk communications. Here's the press release, along with a link to the complete document.
FDA NEWS RELEASE
For Immediate Release: Sept.30, 2009
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Strategic Plan for Risk Communication
Establishes framework for communicating with public about FDA-regulated products
The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information. The plan also lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it, and for how the agency oversees industry communications.
“We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”
The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year. They include:
- Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
- Producing a research agenda for public dissemination
- Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
- Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
- Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes
- Posting pictures of FDA- regulated products affected by Class I or high-priority Class II recalls as part of recall notices/information
- Developing detailed action plans at the agency and center levels for implementing and achieving the proposed action steps, including timelines, responsibilities and resource needs
The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations, and focuses on policies that affect areas of high public health impact.
For more information:
FDA’s Strategic Plan for Risk Communication
“The leading proposal in the Finance Committee would apply to family insurance plans that cost roughly $21,000 and up starting in 2013. For the sake of fairness, the threshold would vary based on geography and the average age of a company’s work force. In all, something like 10 percent of plans would be subject to the tax in 2013, according to the Center on Budget and Policy Priorities, a research group."
(The complete New York Times story can be found here.)
60% of the American public gets their health benefits through their jobs -- and they’re not “free.” According to the Kaiser Family Foundation, the average American worker with “employer-provided” healthcare pays about 41% of the cost.
So – will benefits be taxed before or after the 41%? Clearly the answer is – before.
And as everyone’s favorite economist, Robert Reich, opines, "According to the Congressional Budget Office, taxing all employee health benefits would yield a whopping $246 billion every year. Even limiting the tax to higher-income employees would go a long way to funding universal health care. Employer-provided health insurance is the biggest tax break in the whole federal income tax system.”
The AFL-CIO’s Gerald Shea, the union’s top healthcare lobbyist, sees the definition of “Cadillac” shifting with time, “People are going to see this as a huge middle-class tax hit.”
The New York Times agrees:
“ … the number of affected plans would grow over time. The Senate has been talking about having the threshold rise each year by the inflation rate plus one percentage point. Since medical spending has been rising much faster than inflation, more and more plans would probably cross the threshold in the years after 2013. Over the next decade, the Congressional Budget Office has estimated that the tax would pay as much as 25 percent of the cost of extending coverage to the uninsured.”
And so does Robert Reich. “So a sensible and politically feasible alternative is to limit tax-free employer-provided health benefits to workers whose incomes are under, say, $100,000 a year, and subject those with higher incomes to progressively higher taxes on them."
Can you say, “mission creep?”
"...recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do. Those critics, though, are up against a large European health study, sponsored by Bayer, the German pharmaceutical giant, that reported the opposite conclusion. The Bayer-financed study said that cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth control pills."
www.nytimes.com/2009/09/26/health/26contracept.html
Hmm...
Here's a blog from a law firm leading the litigation against Bayer, the company that makes Yaz:
"The risks associated with this popular birth control pill are severe; many women who took Yaz or Yasmin have died or been seriously injured because of the serious health risks associated with the drug. In fact, the FDA received over fifty reports of Yaz and Yasmin-related deaths between 2004 and 2008, most involving increased levels of potassium and occurring in women as young as 17 years old. Imagine how many went unreported! A growing number of lawsuits have been filed by or on behalf of these women, charging the drug manufacturer with inadequately warning them of the increased risks Yaz and Yasmin pose to those women who use the oral contraceptive.
While the public-at-large and many physicians may not recognize an adverse reaction to drospirenone, the health risks have been known for longer than many realize. In 2002, the British Medical Journal reported some practitioners’ concern about the drug as a result of 40 cases of venous thrombosis among women taking it. Also, in 2003, the Journal published a paper that detailed reports of thromboembolism deaths and injuries thought to be caused by Yaz and Yasmin.
www.nolan-law.com/yasmin-yaz-ocella-birth-control-injuries/#side%20effects
The FDA has been reprimanding Yaz and Yasmin manufacturers for misleading and inadequate television advertising for the drug for quite some time."
Here's Singer again... stoking the fires, fanning the flames, leading the witness...
"The health questions and the lawsuits may rattle consumer confidence, but the warnings from federal health authorities about advertising and quality control raise larger questions about Bayer’s approach to complying with government rules, said Michael A. Santoro, an associate professor at the Rutgers Business School who has studied ethics in the pharmaceutical industry. "
False Claims Act anyone? That's the fulcrum which the trial lawyers use to leverage meager findings about safety into a conspiracy of silence and misrepresentation.
I see another Avandia in the making.
Via the Pink Sheet:
The potential for physicians to favor innovator biologics over follow-on biologics because of a reimbursement advantage would be eliminated under an amendment to health care reform legislation adopted by the Senate Finance Committee Sept. 23.
The amendment, offered by Sen. Charles Schumer, D-N.Y., says the goal is "to ensure that patients and the Medicare program utilize biosimilars appropriately" and "create parity between brand name biologics and biosimilars and save patients and Medicare money."
The basic problem the amendment is trying to solve is the fact that, under current law, each biological product must have a separate billing code for reimbursement by Medicare Part B. Since the reimbursement rate under Part B is the average sales price of the drug plus six percent, if a biosimilar were introduced at a lower price than the innovator, there would be no incentive for physicians to use the lower-priced drug, since the six percent administration payment would be higher for the innovator. As a result, there would be no downward pressure on prices.
To eliminate this disparity, the amendment would provide equal administration fees for both the innovator, or reference product, and the follow-on biologic. The description of the amendment says a biosimilar approved by FDA and assigned a separate billing code would be "reimbursed at the ASP of the biosimilar plus six percent of the ASP of the reference product."
Brand Pharma May Dodge A CBO Bullet
The committee adopted the amendment by unanimous voice vote, and brand pharma stalwarts Sens. Orrin Hatch, R-Utah, and Michael Enzi, R-Wyo., joined as co-sponsors.
Brands may be supportive of the idea of reimbursement parity for physicians because, if treated as the fix Medicare needs to accommodate FOBs, it would mean that brands avoided potentially much more consequential modifications to the program.
The Congressional Budget Office has previously suggested that there would be additional savings from follow-on biologics if they are put on equal footing with innovators in government health care programs, not just in terms of physician reimbursement, but product coding as well, which would mean that brands would be reimbursed at the FOB price.
In a December 2008 score of legislation options, CBO said that putting a biosimilar in the same reimbursement code as its brand-name counterpart would save the government $10.6 billion over 10 years, about 30 percent more than the $8.1 billion it would save if they were not in the same code.
Many observers believe that such a coding change would need to be made by statute, and that without it Medicare would never fully embrace FOBs. Indeed, while the Schumer amendment removes a disincentive to prescribing FOBs, it does not seem to create an incentive for their use either.
Dr. Alway concludes by boiling the entire debate down to two choices before us:
For the sake of future Americans, let us hope and pray that we take the first road.
"People have unique needs. I take Lipitor, they put me on the generic, Zocor, my cholesterol went up. They put me back on Lipitor, my cholesterol went down."
You mean that all statins aren't the same? That different people respond to different drugs in different ways. That generic substitution can have ... unintended consequences? Holy cow! And who is the mysterious "they" the Senator refers to? Probably not his Uncle Sam.
(PS, "Zocor" is not the "generic." Simvastatin is the generic. Not the same thing. But that's another story for another time.)
FDA NEWS RELEASE
For Immediate Release: Sept. 23, 2009
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.
The IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.
“Good government conducts periodic reviews and evaluations of its programs,” said Jeffrey Shuren, M.D., acting director of CDRH. “Our working group and the IOM’s independent evaluation will help us determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.”
The 510(k) process was established under the Medical Device Amendments of 1976 with two goals:
* Make safe and effective devices available to consumers
* Promote innovation in the medical device industry.
During the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for CDRH to review the adequacy of the premarket notification program in meeting these two goals.
Established by the National Academy of Sciences, the IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.
As part of the study, the IOM will convene a committee to answer two principal questions:
* Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
* If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?
The $1.3 million IOM review is slated for completion in 2011, and is one of six priorities Dr. Shuren has outlined for CDRH. Others include:
* Creating an internal task force on the use of science in regulatory decision-making
* Developing an effective compliance strategy
* Optimally integrating premarket and postmarket information
* Increasing transparency in decision-making
* Establishing clear procedures to resolve differences of opinion.
The IOM will hold two public workshops during the next nine months as part of its review, and will publish a final report in March 2011 containing its conclusions and recommendations.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.
Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can be marketed after submission of premarket notifications—also called 510(k) applications—that support their substantial equivalence to legally marketed devices that do not require premarket approval.
Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.
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.
