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Bill would reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market
“It is critical that we don’t allow regulatory burdens to get in the way of delivering lifesaving products to the patients who need them,” Klobuchar said. “This legislation will help ensure that we have processes that promote safe, pioneering technologies that help save lives and create good jobs in Minnesota.”
“In order to provide American patients access to the most cutting-edge medical therapies and advances, we need to fix what is broken at the FDA by restoring regulatory certainty and predictability,” Senator Burr said. “By streamlining and ensuring the least burdensome approach to FDA’s regulation of medical devices, we not only take a key step toward restoring America’s leadership in the research and development of life-saving products, but uphold our promise to patients in North Carolina and around our nation to continue innovating on their behalf.”
“Colorado is a hub of the life science industry and innovation, and we need to work with the FDA to ensure that it modernizes its regulatory system to foster innovation and drive the economy,” said Bennet. “This bill would help provide our nation’s medical device developers and manufacturers with the regulatory clarity and predictability that would give our patients the greatest access to lifesaving products and boost our national economic competitiveness.”
Over the past few years the FDA’s regulation has become increasingly longer and more difficult, delaying, and in some cases preventing, new and innovative devices from reaching the market. Recent studies showed that the average time to approve a 510(k) application has increased 43% from the 2003-2007 period to 2010, and the average time to approve a premarket approval (PMA) application has increased 75%. A recent survey of venture capitalist life sciences investors showed that almost 40% of investors are more likely to shift their operations and investments overseas because of FDA’s regulatory challenges.
The senators’ legislation would help streamline the FDA’s regulation of medical devices by clarifying FDA’s current least burdensome requirements.
These provisions will ensure that when making regulatory decisions on medical devices, FDA focuses only on the relevant information during the decision-making process, considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions, and uses all reasonable mechanisms to reduce review times when making these decisions.
Because current conflicts of interest restrictions are overly stringent, the FDA is having difficulty finding qualified experts to serve on advisory committees, which can contribute to unnecessary delays for patients. In response to this problem, the legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government. Finally, the legislation would also direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA’s Center for Devices and Radiological Health, including the impact on medical device innovation.
Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and has been a leader in the effort to cut red tape that threatens innovation in the medical device industry. After a December 2010 report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar pushed the Food and Drug Administration (FDA) to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar also founded the bipartisan Senate Medical Technology Caucus to increase awareness about issues facing the industry.
Bennet, a member of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to FDA Commissioner Margaret Hamburg in August pushing for reformed FDA regulations that foster innovation and competitiveness and position the FDA to serve as a driver of the global economy. Following the letter, Hamburg joined Bennet to hear about innovation and advances in the bioscience industry in Colorado while touring the Colorado Science and Technology Park at Anschutz Medical Campus.
If you think the FDA is dragging its feet on all matters social media, consider what’s happening across the pond.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has declared that it is satisfied (at least so far) with the work of the European Commission on the issue of information-to-patients (ItP). It did, however, suggest that future discussions should examine ways to ensure that high-quality information is accessible to patients in their own language.
What is really lacking in the proposals is any guidance on how companies can address social media - such as Facebook and Twitter - Efpia Director General Richard Bergstrom says.
But Bergstrom is not looking for another directive on this issue, as it may take "years to formulate." He says he hopes that within the framework of the current proposals, some members of the European Parliament will look to address the social media aspect.
"The reason why this has not come up before is that in the first review people were obsessed with the fundamental aspects of whether industry should be permitted to provide information in the first place," he says.
In the meantime, the Commission's proposals regarding information to patients must now be debated once more by both the European Parliament and the Council of ministers, although no timetable for these activities is as yet available.
Vaccines cause neither autism nor mental retardation.
Vaccines have delivered us from a plethora of public health afflictions from polio to pertussis, measles, mumps, rubella and most recently HPV.
Dr. Paul Offit is Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. In addition, Dr. Offit is the Maurice R. Hilleman Professor of Vaccinology and a Professor of Pediatrics at the University of Pennsylvania School of Medicine. He is also the recipient of the Center for Medicine in the Public Interest’s 2011 Odyssey Award for his courageous leadership against the dangerous idiots vaccine denial.
Shortly we will post Dr. Offit’s remarks at the recent Odyssey Awards dinner. But, as a teaser, here’s how he addressed the issue that Representative Michele Bachmann threw at Governor Rick Perry:
“If $5000 can buy a state vaccine mandate – I’m in for $10,000.”
Bravo.
Indiana Governor Mitch Daniels
Montel Williams
Dr. Paul Offit
There’s only one thing you need to know about the most recent decision of the United States Preventative Services Task Force claim the PSA set for prostate cancer is useless and the Institute of Medicine’s recommendation that all medical services now and forever should be covered under Obamacare only if they are cost-effective: They both rely on one-size fits all information that ignores racial, gender, cultural and genetic variations that doctors rely on to personalize care and developers of medical technology now use to develop more targeted treatment.
http://www.uspreventiveservicestaskforce.org/uspstf12/prostate/prostateart.htm
http://www.kaiserhealthnews.org/Stories/2011/October/06/iom-essential-health-benefits-package.aspx
The one size fits all approach is tailored to the goal of Obamacare of reducing the cost of government run health care by rationing the use and creation of medical services and products. And the cost-effectiveness benchmark is designed to delay and discourage adoption of new treatments. So for instance, the USPSTF hasn’t considered research showing that certain women should get mammograms as a early as 25 to reduce the risk of breast cancer. And it neglects discussion of next-gen PSA tests called pro-PSA that measures at least three forms of free PSA (called B-PSA, I-PSA, and pro-PSA. These first two forms are decreased in the blood of prostate cancer patients and pro-PSA is increased. ) This test can predict prostate cancer more accurately and earlier.
Pro-PSA will have to go through testing before it is approved by the Food and Drug Administration. But under Obamacare the cost of proving it is cost-effective even for specific groups of patients. This will add millions of dollars to the cost of development and extra years before it’s available. If at all.
Multiply this exercise countless times and before you know it, fewer new drugs, devices and tests will come to market. Since these products often reduce other treatment costs, save lives and increase productive, hindering their development will not save money or make healthcare cost effective or humane. But that is not the goal of Obamacare. The goal is to give government – or rather thousands of bureaucrats and second-rate health economists who do not practice medicine, who never developed a drug or device, who rarely accept responsibility for the damage they cause with their monstrous regulatory certainty – control over decisions our more enlightened overseers believe we are too stupid and greedy to make on our own.
This breathtaking assault on freedom will not stand. But before it falls, people will die. Those who profit from this enterprise in the form of consulting contracts from Health and Human Services and the Agency for Healthcare Quality and Research are and will be to blame. Shame on them. And shame on us for not doing and say more to stop this sick slide into rationing.
Are Politics Driving the CDC’s Pending Decision on an Infant Meningitis Vaccine?
For decades, the Centers for Disease Control and Prevention has championed immunization against a host of deadly diseases. But, now, in a sudden reversal, CDC is signaling it may not recommend the routine administration of a proven new vaccine to prevent infant meningitis, an often fatal disease.
This briefing will feature the release of brand new research evaluating the disparities in how government programs place economic value on human life, as well as testimonies from health care and FDA experts.
Please join us as we examine how and why the CDC may be restricting access to a new meningitis vaccine for infants, and the impact this may have on patient care.
Special Remarks By
The Honorable Michael C. Burgess, M.D.
US House of Representatives (TX-26)
Panelists:
Christopher Stomberg, Ph.D., Partner, Bates White Economic Consulting
Gretchen Moen, RN, MS, CPNP-Pediatric Nurse Practitioner, Eagan Child and Family Care
Richard G. Judelsohn, MD, FAAP-Medical Director, Erie County Department of Health
Peter Pitts, President & Co-Founder, Center for Medicine in the Public Interest
Moderated by Merrill Matthews, Ph.D., Institute for Policy Innovation
Event Details:
Friday, October 14, 2011
10:00 am to Noon
Rayburn 2325
Rayburn House Office Building
Capitol Hill, Washington DC
Complimentary refreshments will be served
*This event is widely attended
RSVP to Erin Humiston
erin@ipi.org or (972) 874-5139
Are Politics Driving the CDC’s Pending Decision on an Infant Meningitis Vaccine?
For decades, the Centers for Disease Control and Prevention has championed immunization against a host of deadly diseases. But, now, in a sudden reversal, CDC is signaling it may not recommend the routine administration of a proven new vaccine to prevent infant meningitis, an often fatal disease.
This briefing will feature the release of brand new research evaluating the disparities in how government programs place economic value on human life, as well as testimonies from health care and FDA experts.
Please join us as we examine how and why the CDC may be restricting access to a new meningitis vaccine for infants, and the impact this may have on patient care.
Special Remarks By
The Honorable Michael C. Burgess, M.D.
US House of Representatives (TX-26)
Panelists:
Christopher Stomberg, Ph.D., Partner, Bates White Economic Consulting
Gretchen Moen, RN, MS, CPNP-Pediatric Nurse Practitioner, Eagan Child and Family Care
Richard G. Judelsohn, MD, FAAP-Medical Director, Erie County Department of Health
Peter Pitts, President & Co-Founder, Center for Medicine in the Public Interest
Moderated by Merrill Matthews, Ph.D., Institute for Policy Innovation
Event Details:
Friday, October 14, 2011
10:00 am to Noon
Rayburn 2325
Rayburn House Office Building
Capitol Hill, Washington DC
Complimentary refreshments will be served
*This event is widely attended
RSVP to Erin Humiston
erin@ipi.org or (972) 874-5139
It is no use to blame the looking glass if your face is awry. -- Nikolai Gogol
The survey found that FDA regulatory challenges were most frequently cited as having a significant effect on investment trends.
Blame the FDA? It’s a convenient excuse when sponsors aren’t transparent (I hesitate to say “honest”) about their interactions and communications with the agency.
For example, upon receipt of a Complete Response Letter, many companies issue public statements to the effect of, “We were shocked! The FDA never said there were any problems. We were most definitely expecting product approval.”
Some companies will blame the FDA with excuses like, “The FDA won’t allow us to discuss the letter” or “The FDA will be upset if we release the letter.” Hogwash.
And when you read the CR, all of a sudden it seems there is often blame to be shared. But, since CRs (and all FDA-sponsor communications) are commercial confidential, sponsors rarely (if ever) offer them with the media or, for that matter (and germane to the NVCA survey), the investment community. Why is that?
Might it be that sponsors make mistakes and that there is (de minimus) blame to be shared? Might it be that companies sometimes try to game the system (accelerated approval issues come to mind) – and fail? Blaming the FDA when corporate strategy flounders is convenient when the agency cannot release (in its own defense) any information.
Might Complete Response Letters be made public? Consider this statement by FDA Commissioner Hamburg when asked whether FDA is discussing unilateral disclosure of information about drug development programs even if a sponsor objects, “It’s a discussion that we’re having, and I think it’s a partnership working with industry. We need to move in directions that make sense, that will have value added, and where everyone understands the expectations and the opportunities.”
Here it is straight from the Bob Temple:
“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’ That’s what I would say.”
Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency.
Blame the FDA? Perhaps. But the fault, dear Brutus …
Take your life in your own hand and what happens? A terrible thing: No one to blame. -- Erica Jong
The NVCA also noted that, after FDA issues, the most potent challenge to investors are reimbursement issues.
And that’s another story.
But frankly it reads like a publication edited, rewritten and vetted by the FDA's political minders and not the work of scientists. The glossy document spends half it's pages extolling the virtues of activities that have nothing to do with accelerating the development of new products through cheap and easy to use tools and metrics. Rather, we get a roll call of Obama administration initiatives such as Startup! America, the FDA Small Business Liaison Program, Young Entrepreneurs, Partnering with the Small Business Administration and programs with one time funding from the stimulus bill. Taken together they are a Potemkin Village to divert attention to the increasing regulatory uncertainty flowing from comparative effectiveness research requirements, projected cuts in reimbursements and other features of the new health care law that undermine innovation.
When the report discusses activity that the FDA will undertake to 'drive innovation' it largely restates work already underway. To be fair, efforts to integrate the use of biomarkers, adaptive trial designs, etc., that could accelerate development of drugs and devices takes time. Often companies, fearing it could actually doom a product by using new approaches, simply load up on old ones. But by the same token when you have the FDA demanding more safety data on the back and front end of the regulatory process and certain divisions change endpoints, revoke approvals and raise the bar so high as to make approval unlikely -- think drugs for obesity and diabetes and Avastin -- a 37 page brochure celebrating 'regulatory science' and 'partnerships' should make anyone who follows the FDA highly skeptical of real progress. Which means that specific initiatives to accelerate targeted treatments and combination products -- initiatives that were launched in 2004 under the Critical Path Initiative -- will need it's own targeted effort to be adopted.
And even here driving innovation is undermined by the stealth effort to turn the FDA into an accomplice of those seeking to use comparative effectiveness research as rationing tool:
"FDA has launched the Partnerships in Comparative Effectiveness Science (PACES) program to support the development of new mathematical methods to support patient-centered outcomes research. PACES provides funds to pilot out the technical, infrastructure, scientific and legal constructs that will be used as foundations for science computing communities involving FDA scientists and data. These activities will support scientifically sound assessments of medical interventions consistent with FDA’s public health responsibilities."
The PACES program is nothing but the mathematical manipulation of claims data -- data that tells you nothing about differences in patients -- to create the illusion that you are truly measuring differences in patients. The FDA's solicitation for the PACES program begins:
"CER could extend beyond the application of specific intervention methods to controlled clinical trials or within specific health care settings. For example CER could be used to better understand what interventions work best for individuals and subgroups within populations."
Let it be noted that there is already a lot of this sort of analysis included in clinical trials already. So why do we need another initiative of this nature? The solicitation explains:
"Both pre- and post-approval data collected and housed at the FDA can be combined with other datasets on long term health outcomes that reside in other agencies or the private sector. As personalized medicine develops, FDA expects an increase in the need for comparisons across products (and associated delivery mechanisms) to define how these products should be used in combination for individualized health care before and after FDA approval."
Does this sound like an requirement that will speed up product development. Why should clinical trials to compare response across products (CER) be a requirement for FDA approval? Why should it be a requirement after FDA approval? The additional cost and time of such trials will be hugely expensive. At least $100-$200 million per product. And by requiring the use of algorithms derived from claims data, the FDA guarantees that detection of no differences when in fact they exist in the real world.
Worse, the FDA's Janus project, an effort to standardized the submission of patient-level data to expedite biomarker development and promote smaller trial designs is being hijacked for CER purposes (from the PACES solicitation):
• Component 1- The Contractor shall plan and organize the CER project with FDA stakeholders, including participation in annual FDA-hosted planning workshops (three workshops, two days each) to define candidate CER questions and priorities, analyses strategies and datasets to be utilized.
• Component 2- The Contractor shall provide training on methodologies developed to FDA staff during two of the FDA-hosted planning workshops.
• Component 3 - The Contractor shall identify or develop appropriate analytic methodologies for CER and apply them to FDA and/or other data; develop new scientific computing strategies and hone existing computational strategies to perform these CER analyses. The Contractor shall prepare reports and manuscripts of the results suitable for publication in scientific journals.
• Component 4- The Contractor shall develop innovative clinical trial design strategies for prospective CER clinical trials and analyses of healthcare data including providing formal recommendations for best practices for submission of studies to the FDA when they involve product comparisons. These strategies and recommendations shall be documented in reports and manuscripts suitable for publication in scientific journals.
Even if all the happy talk about driving innovation was real, it could all be undermined by this effort to use FDA's most significant data program into a tool for rationing. It will drive innovation all right, off a cliff.
I believe that senior leadership at the FDA from Commissioner Hamburg on down have the best of intentions. And I know for a fact that Janus and other activities undertaken in response to the Critical Path were to be used to bring new and better products to market with greater speed and at less expense. It's those who want to slow down the development and adoption of innovation and who have politicized the FDA with CER claptrap that are at fault. They think they know better and their monstrous certainty will kill innovation for decades to come.
The FDA has released a new “blueprint” document, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients,” containing immediate steps that can be taken to drive biomedical innovation.
Addressing the sustainability of the medical product development pipeline, which is slowing down despite record investments in research and development, FDA Commissioner Peggy Hamburg comments, “America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public. Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”
The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups.
The blueprint focuses on implementing the following major actions:
• rebuilding FDA’s small business outreach services
• building the infrastructure to drive and support personalized medicine
• creating a rapid drug development pathway for important targeted therapies
• harnessing the potential of data mining and information sharing while protecting patient privacy
• improving consistency and clarity in the medical device review process
• training the next generation of innovators
• streamlining and reforming FDA regulations.
The complete report can be found here.
An important read. But it’s got to be more than rhetoric.But then again, The Shink probably has insights we cannot share. He was the ace reporter of Marijuana Business Reporter, a job he was recruited for. Actually he found the job on Craigslist. Which is fitting in so many ways. Nothing like finding a job while checking out garage sales and massage parlors. But I digress. In addition, The Shink broke new journalist ground with his Irony Supplement blog. Get it? Irony (as in iron) Supplement? If Twain were alive he would be jealous. Here is a sample of The Shink's writing skills and prophetic reporting gifts:
Why Bernard Madoff Should Face The Death Penalty
A rational discussion as to why disgraced financier Bernard Madoff should face capital punishment.
Father Limbaugh?
A comparison of Rush Limbaugh and Charles Coughlin's political tactics.
And my favorite..
Hurry Up And...@*&%# WAIT?!?!?
An examination of the media's dementia in covering the stimulus package. (This is where The Shink attacks the media for doubting the benefit of the stimuls and not believing the recession was over in 2009 when The Shink said it was.)
Why do I bother with such a bottom-feeding paranoid? Because he writes for what once was and should be a respectable online publication that cares about the mindset and journalistic stability of it's editors.
I hope The Shink has to hit Craigslist for work real soon. He shouldn't have a problem getting another job. After all, the recession is over, isn't it? Or maybe BIG PHARMA is cooking up that crisis too.
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.
