Latest Drugwonks' Blog
And at the top of the list should be the growing and worrisome EU/US medtech gap.
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.
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.
From The Voice of San Diego:
My Grandmother Out-Tweets Your Biotech
By DAVID WASHBURN
Wednesday, Sept. 23, 2009 | Very few industries are as willing to take risks on new technologies as the biotech industry. Companies will spend millions, and even billions, developing a drug that has a chance to cure a cancer or a device that could change the face of heart surgery.
Yet when it comes to social media, the industry has proven to be risk adverse. In fact, your grandmother is probably more likely to be active on Twitter or Facebook these days than a pharmaceutical, medical device or contract research company.
"What we've got is the social media Maginot Line," said Peter Pitts, director of global health care for the public relations firm Porter Novelli, referring to the French army's strategy of fortifying its borders during World War II.
"If they avoid social media they are safe. But what is happening is that important discussions about the medications and how they affect patients are happening minus the participation of companies," Pitts said after a panel discussion hosted Wednesday by Biocom, the local biotech industry association.
The FDA has scheduled a two-day public meeting in November to solicit views regarding how it should deal with social media. Among other things, the agency wants to discuss how companies will fulfill their fair balance obligations in social media, how they will deal with inaccurate information posted about their products as well as adverse event reporting.
The meeting, Pitts said, is an acknowledgement by FDA officials that the agency is "behind the curve," and needs to address the issue. FDA officials involved in the planning of the meeting could not be reached for comment today.
Pitts and others hope a larger embrace of social media emerges from the FDA meetings, and that the industry realizes that it is "irresponsible not to use social media." They raised the issue of benefits that a drug may have that are not officially recognized by the FDA.
Say, for example, that a clinical trial shows that a drug has an effectiveness against a certain type of cancer tumor that was not thought possible when the drug was submitted for FDA approval, and therefore isn't on the FDA label for the drug.
"If they choose not to share that information in the best way possible -- which is social media -- is that the ethical and moral thing to do?" Pitts said.
An even more vexing issue facing both the companies and the regulators is how they deal with adverse event reporting. Suppose, Pitts said, that someone taking a cancer drug develops numbness in their fingers, and then writes about it in a blog or on a Facebook wall.
"This is an opportunity in real time to understand adverse reporting issues," Pitts said.
"Rather than avoid it from a legal and regulatory standpoint, they should pursue it from a public health perspective. That, however, is a very contentious proposition."
The complete story can be found here.
My Grandmother Out-Tweets Your Biotech
By DAVID WASHBURN
Wednesday, Sept. 23, 2009 | Very few industries are as willing to take risks on new technologies as the biotech industry. Companies will spend millions, and even billions, developing a drug that has a chance to cure a cancer or a device that could change the face of heart surgery.
Yet when it comes to social media, the industry has proven to be risk adverse. In fact, your grandmother is probably more likely to be active on Twitter or Facebook these days than a pharmaceutical, medical device or contract research company.
"What we've got is the social media Maginot Line," said Peter Pitts, director of global health care for the public relations firm Porter Novelli, referring to the French army's strategy of fortifying its borders during World War II.
"If they avoid social media they are safe. But what is happening is that important discussions about the medications and how they affect patients are happening minus the participation of companies," Pitts said after a panel discussion hosted Wednesday by Biocom, the local biotech industry association.
The FDA has scheduled a two-day public meeting in November to solicit views regarding how it should deal with social media. Among other things, the agency wants to discuss how companies will fulfill their fair balance obligations in social media, how they will deal with inaccurate information posted about their products as well as adverse event reporting.
The meeting, Pitts said, is an acknowledgement by FDA officials that the agency is "behind the curve," and needs to address the issue. FDA officials involved in the planning of the meeting could not be reached for comment today.
Pitts and others hope a larger embrace of social media emerges from the FDA meetings, and that the industry realizes that it is "irresponsible not to use social media." They raised the issue of benefits that a drug may have that are not officially recognized by the FDA.
Say, for example, that a clinical trial shows that a drug has an effectiveness against a certain type of cancer tumor that was not thought possible when the drug was submitted for FDA approval, and therefore isn't on the FDA label for the drug.
"If they choose not to share that information in the best way possible -- which is social media -- is that the ethical and moral thing to do?" Pitts said.
An even more vexing issue facing both the companies and the regulators is how they deal with adverse event reporting. Suppose, Pitts said, that someone taking a cancer drug develops numbness in their fingers, and then writes about it in a blog or on a Facebook wall.
"This is an opportunity in real time to understand adverse reporting issues," Pitts said.
"Rather than avoid it from a legal and regulatory standpoint, they should pursue it from a public health perspective. That, however, is a very contentious proposition."
The complete story can be found here.
On Fox News Newt explains why Congress refuses to make the same 365 choices available to members of Congress as part of health care reform: "Because it doesn't increase the control government has over health care."
Which is also one reason why insurance under the health care proposals are 3 times more expensive than are available in the marketplace.
The other reason: legislation is nothing but a huge subsidy to large corporations, most union benefits and the liberal imagination. Heaven forbid, people choose health plans with higher deductibles, lower premiums, less coverage than the micromanagers want us to have.
On a related note: Here's President Obama's OMB director on what is really happening to health care costs:
"On the consumer side, and despite media portrayals to the contrary, the share of health care expenditures paid out of pocket, which is the relevant factor for evaluating the degree to which consumers are faced with cost sharing, has plummeted over the past few decades, from about 33% in 1975 to 15% today. All available evidence suggests that lower cost sharing increases health care spending overall. The result is that collectively we all pay a higher burden, although the evidence is somewhat mixed on the precise magnitude of the effect."
Rather than allowing people to choose plans that allow for cost sharing and accumulate cash (especially important for people who are chronically ill) and include health insurance premiums to lock in rates and pay for one time costs Orszag endorses the current solution: using an expert panel to determine what doctors should do and how much they should get paid for it:
"The real traction, though, will come from building the results of that research into financial incentives for providers. In other words, if we move from a “fee-for-service” to a “fee-for-value” system, where higher-value care is awarded with stronger financial incentives and low- or negative-value health care is penalized with smaller incentives or perhaps even penalties, the effects would be maximized."
All of which is at the heart of the Baucus bill and every other piece of legislation. Well since CER has been implemented elsewhere and costs have gone up, what has been the result on patients? Dr. Orszag let's it slip:
"... if all one did was, say, reduce payment rates under Medicare and Medicaid, and then tried to perpetuate that over time without a slowing of overall health care cost growth, the result would probably be that fewer doctors would accept Medicare and Medicaid patients, creating an access problem that would be inconsistent with the underlying premise and public understanding of these programs."
www.issues.org/24.3/orszag.html
Which brings us back to Newt. All of this happens because of government control. The unintended consequences of government run health care.
Which is also one reason why insurance under the health care proposals are 3 times more expensive than are available in the marketplace.
The other reason: legislation is nothing but a huge subsidy to large corporations, most union benefits and the liberal imagination. Heaven forbid, people choose health plans with higher deductibles, lower premiums, less coverage than the micromanagers want us to have.
On a related note: Here's President Obama's OMB director on what is really happening to health care costs:
"On the consumer side, and despite media portrayals to the contrary, the share of health care expenditures paid out of pocket, which is the relevant factor for evaluating the degree to which consumers are faced with cost sharing, has plummeted over the past few decades, from about 33% in 1975 to 15% today. All available evidence suggests that lower cost sharing increases health care spending overall. The result is that collectively we all pay a higher burden, although the evidence is somewhat mixed on the precise magnitude of the effect."
Rather than allowing people to choose plans that allow for cost sharing and accumulate cash (especially important for people who are chronically ill) and include health insurance premiums to lock in rates and pay for one time costs Orszag endorses the current solution: using an expert panel to determine what doctors should do and how much they should get paid for it:
"The real traction, though, will come from building the results of that research into financial incentives for providers. In other words, if we move from a “fee-for-service” to a “fee-for-value” system, where higher-value care is awarded with stronger financial incentives and low- or negative-value health care is penalized with smaller incentives or perhaps even penalties, the effects would be maximized."
All of which is at the heart of the Baucus bill and every other piece of legislation. Well since CER has been implemented elsewhere and costs have gone up, what has been the result on patients? Dr. Orszag let's it slip:
"... if all one did was, say, reduce payment rates under Medicare and Medicaid, and then tried to perpetuate that over time without a slowing of overall health care cost growth, the result would probably be that fewer doctors would accept Medicare and Medicaid patients, creating an access problem that would be inconsistent with the underlying premise and public understanding of these programs."
www.issues.org/24.3/orszag.html
Which brings us back to Newt. All of this happens because of government control. The unintended consequences of government run health care.
If you have not heard or read FDA commissioner's speech on regulatory science -- namely the Critical Path to promote personalized medicine in product review and post market management -- you should. It lays out vibrant vision of how the FDA can continue to adapt to and encourage companies to adopt genomics, biomarkers and other 21st century tools to make products safer and more effective.
We may disagree with the Obama vision of health care but we also share his commissoner's vision of how to sustain medical innovation.
Watch Commissioner Hamburg's remarks here.
We may disagree with the Obama vision of health care but we also share his commissoner's vision of how to sustain medical innovation.
Watch Commissioner Hamburg's remarks here.
It's back.
According to Senate leadership aides, Senate Majority Leader Reid may bring a bill to the Senate floor in the next two weeks that would allow the importation of prescription drugs from Canada.
Wonder if Senator Reid has discussed this act of pharmaceutical imperialism with our neighbors to the North. Last conversation I had with Canadian officials left no doubt they are very concerned with how such an action would impact their domestic medicines supply.
And is this bill about drugs from Canada or drugs through Canada?
Here we go again.
According to Senate leadership aides, Senate Majority Leader Reid may bring a bill to the Senate floor in the next two weeks that would allow the importation of prescription drugs from Canada.
Wonder if Senator Reid has discussed this act of pharmaceutical imperialism with our neighbors to the North. Last conversation I had with Canadian officials left no doubt they are very concerned with how such an action would impact their domestic medicines supply.
And is this bill about drugs from Canada or drugs through Canada?
Here we go again.
AdvaMed’s Stephen J. Ubl, on Chairman Max’s Mark:
“Exempting Class I devices does not address the arbitrary nature of this tax. It will still cover scores of consumer products and medical devices used by millions of Americans every day. For instance, contact lenses and solution and battery powered breast pumps for nursing mothers will still be taxed.”
And, in a further feat of legislative legerdemain, maxi pads are not taxed, while scented maxi pads are.
“Exempting Class I devices does not address the arbitrary nature of this tax. It will still cover scores of consumer products and medical devices used by millions of Americans every day. For instance, contact lenses and solution and battery powered breast pumps for nursing mothers will still be taxed.”
And, in a further feat of legislative legerdemain, maxi pads are not taxed, while scented maxi pads are.
Time to get out and dust off your Part 15 mojo for the November 12-13 "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools" meeting.
It's about time.
According to the announcement:
"... FDA recognizes that the Internet possesses certain unique technological features and that some online tools that may be used for promotion offer novel presentation and content features. Another emerging issue involves the reporting of adverse event data because such information may initially be revealed using social media platforms in the context of Internet promotion for FDA-regulated medical products."
The complete announcement can be found here.
Groovy baby.
Writing in the Chicago-Sun Times Jesse Jackson claims that government healthcare is a proven success.
He starts off by saying of the VA, “Despite its many faults, it is very popular, as virtually any veteran will tell you.”
How many veterans do you suppose Jesse Jackson knows? Enough for him to assert that “virtually any veteran” will tell us that the VA is paradise on earth?
He goes on to list a litany of gratuitously partisan – not to mention fallacious - arguments in favor of the president’s health care overhaul.
Jackson then makes the following claims regarding the insurance reforms proposed:
“They can't refuse you insurance if you are already sick. They can't cut off your insurance if you get sick. They can't discriminate against women in health-care rates. These are big deals. And insurance companies have been ready to accept them so long as they could continue to ratchet up rates on millions of new customers. That's why they hate the public option so much. It would derail their gravy train.”
Scott Harrington argues in the Wall Street Journal that policy rescissions aren’t as widespread a problem as some would have us believe.
Equally absurd is the notion that discriminatory pricing is somehow “unfair” in the area of insurance. The potential medical risks are different for men compared to women. And, of course, insurance premiums are based on risks.
Several factors account for the price disparity in premiums for males and females:
1. Well, for one, males and females have different bodies, thus different reproductive systems.
2. Generally speaking, women tend to visit the doctor more often than men for check-ups and tests.
3. High use of oral contraceptives.
The good news is that women generally pay less for auto insurance, as young males are more likely to be reckless and irresponsible drivers.
On the issue of life insurance, males also tend to pay more than women.
And, if that’s not enough, you still have ladies’ night at bars and clubs, ladies!
You see, discriminatory pricing is all around us. It’s a function of that beautiful thing called a free market.
We need less commentators reducing the health care debate to this sort of childish thinking and more focused on advancing the best ideas for reform.
Reverend Jackson would be wise to focus on other issues and leave health care policy to the experts.
Can I get an Amen?
I thought I was hearing things this morning when I watched this video of President Obama speaking to college students at the University of Maryland yesterday and he said this:
“We are the only nation on Earth that leaves millions of people without health insurance.”
Wow. I’ll let the absurdity of that statement speak for itself.
Now, for a politician who advocates big government, college students probably represent the optimal target audience. Many are still living with their parents, receiving government loans or other entitlements, and have yet to face the realities of life. In other words, they’re heavily insulated from the costs of big government due to their minimal experience in life.
There is another point President Obama made in his concluding remarks that needs some clarification.
“Health care is about more than the details of a policy. It’s about what kind of country you want to be. Young people, it's about what kind of country you want to be. We are the only nation on Earth that leaves millions of people without health insurance. We spend more than any country on Earth, and we're not any healthier for it. So this is about what kind of country you want your children to grow up in.”
When the president says we are not any healthier for our higher level of spending on health care, will somebody please ask him what exactly he means by that?
Aside from that, this debate is very much about what kind of country we want our children to grow up in.
Medicare is on an unsustainable financial path. Not too far into the future, there will be only two workers for every Social Security recipient.
And now the geniuses in Washington want to turn even more control of the health sector over to the government. Make no mistake about it, the quality of our medical care will undoubtedly diminish. The overall quality of life, standard of living and opportunities for many of the young people in attendance at the University of Maryland will diminish.
Over at State House Call, Greg Scandlen explains the irony of young Americans’ support for President Obama’s health care agenda:
Oddly, the key population to be hit with the effect of mandatory coverage are young adults, which are also the biggest supporters of Obama and health reform generally. The recent Census Bureau survey notes that 28.6% of young adults from 18 to 24 years old are uninsured, as are 26.5% of those from 25 to 34. That is double the rate of those of age 45 to 64.
Many of these people are in very good health, so don't feel a strong need for coverage, but in the proposals before Congress, they will not be allowed to benefit from their good health and will pay the same premium as people who are very sick.
These young people often have other priorities for their money. They are looking for a mate or starting a family. They are setting up their household from scratch and need to buy furniture, or save for the down payment on their first house. They are getting rid of the beat-up Toyota they used in college and buying a decent car to get to their new jobs. They are buying clothing that is suitable for the workplace.
Many of these people are in very good health, so don't feel a strong need for coverage, but in the proposals before Congress, they will not be allowed to benefit from their good health and will pay the same premium as people who are very sick.
These young people often have other priorities for their money. They are looking for a mate or starting a family. They are setting up their household from scratch and need to buy furniture, or save for the down payment on their first house. They are getting rid of the beat-up Toyota they used in college and buying a decent car to get to their new jobs. They are buying clothing that is suitable for the workplace.
Scandlen concludes:
Man, if this thing passes, these folks are in for a rude awakening. But, I guess growing up involves a whole series of disillusionments. This will be just one of many for the new generation.
Indeed.
Opposition to Health Care Plan Hits New High of 56%
Friday, September 18, 2009
Fifty-six percent (56%) of voters nationwide now oppose the health care reform proposed by President Obama and congressional Democrats. That’s the highest level of opposition yet measured and includes 44% who are Strongly Opposed.
Just 43% now favor the proposal, including 24% who Strongly Favor it.
Friday, September 18, 2009
Fifty-six percent (56%) of voters nationwide now oppose the health care reform proposed by President Obama and congressional Democrats. That’s the highest level of opposition yet measured and includes 44% who are Strongly Opposed.
Just 43% now favor the proposal, including 24% who Strongly Favor it.
Date | Approve | Disapprove |
Sep 16-17 | 43% | 56% |
44% | 53% | |
42% | 55% | |
45% | 52% | |
51% | 46% | |
48% | 48% | |
47% | 49% | |
46% | 51% | |
44% | 53% | |
43% | 53% | |
42% | 53% | |
47% | 49% | |
44% | 53% | |
46% | 49% | |
50% | 45% |
But the overall picture remains one of stability. While the numbers have bounced a bit following nationally televised appearances by the president to promote the plan, opposition has generally stayed above 50% since early July. Support has been in the low to mid 40s.
The number who Strongly Oppose the plan has remained above 40% and the Strongly Favor totals have been in the mid-20s. This suggests public opinion is hardening when it comes to the plan that is currently working its way through Congress.
However, now just 48% say that health care reform plan is at least somewhat likely to pass this year, a figure that has been trending down in recent days. That figure includes 17% who say passage is Very Likely.
Rasmussen Reports has been tracking support for the health care plan on a daily basis since the president's speech to Congress last week intended to revitalize the troubled initiative.
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.
