Latest Drugwonks' Blog
In May, I opined on giving Americans a tax deduction based on a healthy BMI (Body Mass Index).
My article can be found here.
Yesterday, Brian Sullivan of Fox Business News blogged on a similar idea. His blog can be found here.
Today, Brian and Degan McDowell and I discussed the idea on air. My point is that, when it comes to healthcare reform, we seem to be discussing everything except diet and exercise ... and personal responsibility.
We talked about tax incentives (the "carrot") as well as the political time bomb of a fat VAT (the "stick").
All things considered -- a very timely conversation.
The complete video interview can be found here.
As Julia Child would say: "Bon Appetit!"
My article can be found here.
Yesterday, Brian Sullivan of Fox Business News blogged on a similar idea. His blog can be found here.
Today, Brian and Degan McDowell and I discussed the idea on air. My point is that, when it comes to healthcare reform, we seem to be discussing everything except diet and exercise ... and personal responsibility.
We talked about tax incentives (the "carrot") as well as the political time bomb of a fat VAT (the "stick").
All things considered -- a very timely conversation.
The complete video interview can be found here.
As Julia Child would say: "Bon Appetit!"
My guess is that this story below about how imperfectly the HER2 test for breast cancer is used captures the “real world” experience of personalized medicine: Even when a predictive tool is available, many doctors will not use it. The reasons can vary. Not trusting the accuracy of the test itself (of which there are different types) unwillingness or hassle in getting the test paid for by insurance companies. Prior studies have found that access to HER2 test varies with type of insurance coverage. They key to consistent and effective use of predictive tests is analysis of real world application to improve validity and impact on outcome. To demand large scale clinical trials prior to use in real world settings will only delay the ability of people to find out how to use next generation medicine wisely and well.
LONDON, Sept 14 (Reuters) - A genetic test to determine if women should receive Roche's (ROG.VX) breast cancer drug is frequently not given, U.S. researchers said on Monday.
Up to two thirds of patients with aggressive breast cancer had no documentation of the test in their health insurance records, according to a study published online by the journal Cancer.
The research also found that one in five genetic test results may be incorrect.
Herceptin, a blockbuster product for Roche, can save lives. But it only works for about 20 percent of women whose tumours overproduce a protein called HER2, and identifying these HER2-positive patients requires a genetic test.
The researchers said their findings suggested many breast cancer patients who might benefit from Herceptin, also known as trastuzumab, were not receiving it, while some women on the drug had never been properly tested.
"Our review of the literature suggests that there are important knowledge gaps regarding the real world use of HER2 testing and trastuzumab," Elena Elkin, a researcher at Memorial Sloan-Kettering Cancer Center in New York and one of the study's authors, said in a statement.
"Filling these gaps may help optimise limited healthcare resources and improve care for women with breast cancer."
GlaxoSmithKline (GSK.L) also has a newer medicine for HER2-positive breast cancer called Tykerb.
Read full article here.
Read full article here.
Sure looks that way:
"Section 3105 of the Kennedy bill says American health Benefit Gateways would be created in every state, serving as a health insurance exchange. A "Navigators" program would award grants to public and private entities to "conduct public education; distribute fair and impartial information regarding health plans; [and] assist with enrollment and provide information that is culturally and linguistically appropriate for the population." The bill stipulates that both health insurance issuers and current independent insurance agents would be prohibited from participating in the Navigators program."
Read more here.
And here is what ACORN is already doing:
"Moving toward maximum eligible participation in federal and state benefits programs is one of ACORN’s key national priorities. ACORN will begin transitioning many of its offices to the Nets2Ladders screening platform (Nets2Ladders is also a key strategic partner with H&R Block). Nets2Ladders offers a powerful, automated benefits enrollment platform that will increase the efficiency and effectiveness of enrolling low-income families in federal and state benefits programs. This software integrates tax return and benefit information so that the information that is collected while filing the tax return is automatically updated into the benefits screening tools, reducing the amount of time needed to add a benefit screening component. Beginning in January 2008, ACORN will conduct benefits screening and enrollment in approximately 26 states, meaning that anyone visiting an ACORN Tax and Benefits Access Center in these states can also quickly be screened for up to 15 federal, state, and local assistance programs, including:
Insurance Program (SCHIP)
ACORN’s new screening platform will generate complete applications that are then printed out for clients, saving them countless hours of trouble and heartache and more importantly dramatically increasing their chances for actually qualifying for these important programs. By January 2010, all 50 states will be covered by the ACORN screening and enrollment platform"
Read more here
Will Congress ban ACORN and other politically-motivated groups from grabbing control of health care at the grass roots level with federal funding?
Exchanges we can believe in....
"Section 3105 of the Kennedy bill says American health Benefit Gateways would be created in every state, serving as a health insurance exchange. A "Navigators" program would award grants to public and private entities to "conduct public education; distribute fair and impartial information regarding health plans; [and] assist with enrollment and provide information that is culturally and linguistically appropriate for the population." The bill stipulates that both health insurance issuers and current independent insurance agents would be prohibited from participating in the Navigators program."
Read more here.
And here is what ACORN is already doing:
"Moving toward maximum eligible participation in federal and state benefits programs is one of ACORN’s key national priorities. ACORN will begin transitioning many of its offices to the Nets2Ladders screening platform (Nets2Ladders is also a key strategic partner with H&R Block). Nets2Ladders offers a powerful, automated benefits enrollment platform that will increase the efficiency and effectiveness of enrolling low-income families in federal and state benefits programs. This software integrates tax return and benefit information so that the information that is collected while filing the tax return is automatically updated into the benefits screening tools, reducing the amount of time needed to add a benefit screening component. Beginning in January 2008, ACORN will conduct benefits screening and enrollment in approximately 26 states, meaning that anyone visiting an ACORN Tax and Benefits Access Center in these states can also quickly be screened for up to 15 federal, state, and local assistance programs, including:
• Food Stamps
• Medicaid
Insurance Program (SCHIP)
ACORN’s new screening platform will generate complete applications that are then printed out for clients, saving them countless hours of trouble and heartache and more importantly dramatically increasing their chances for actually qualifying for these important programs. By January 2010, all 50 states will be covered by the ACORN screening and enrollment platform"
Read more here
Will Congress ban ACORN and other politically-motivated groups from grabbing control of health care at the grass roots level with federal funding?
Exchanges we can believe in....
Health reform, that is. Or it could be.
President Obama's effots to sell lawmakers and the American public on the merits of his proposals have been hamstrung by his preference for a big-government solution to the nation’s healthcare woes. While it’s true that reform is needed, there’s no need to completely remake the health sector. Instead, the president should borrow from more hands-off reforms, like Medicare Part D, which have been both successful and popular in the past.
A recent survey revealed that 92 percent of beneficiaries were satisfied with their drug coverage in 2008. And, at last tally, Part D was costing about 30 percent less than initial budget projections. The program’s popularity as well as its cost-effectiveness can be attributed in large part to its use of the private-sector competition.
Part D allows Medicare participants to choose from a variety of government-subsidized yet privately-administered drug plans. Seniors get to choose from a number of plans and decide for themselves which one best suits them. Meanwhile, insurers must compete to offer high-quality plans at reasonable prices.
But does Part D really work? The numbers speak for themselves: in 2004 nearly one in four seniors lacked drug coverage. By 2006, when Part D took effect, that statistic dropped to seven percent.
Democratic lawmakers could use this success as a roadmap for expanding coverage while avoiding the kind of drastic government intervention that inspired such rancor in opponents of the public option.
In other words, create a program that allows insurers to compete to offer those 8-16 million chronically uninsured Americans the best plan. The government could then provide subsidies to make that plan even more affordable. This would by no means be easy to implement. But it wouldn’t be revolutionary either, since the policy’s basic framework has already proven to work well.
President Obama is in desperate need of fiscally responsible healthcare reform ideas. A Part D-like insurance program might be exactly what he’s looking for.
For more on this, see a new article in Reuters' "Great Debate" series here.
President Obama's effots to sell lawmakers and the American public on the merits of his proposals have been hamstrung by his preference for a big-government solution to the nation’s healthcare woes. While it’s true that reform is needed, there’s no need to completely remake the health sector. Instead, the president should borrow from more hands-off reforms, like Medicare Part D, which have been both successful and popular in the past.
A recent survey revealed that 92 percent of beneficiaries were satisfied with their drug coverage in 2008. And, at last tally, Part D was costing about 30 percent less than initial budget projections. The program’s popularity as well as its cost-effectiveness can be attributed in large part to its use of the private-sector competition.
Part D allows Medicare participants to choose from a variety of government-subsidized yet privately-administered drug plans. Seniors get to choose from a number of plans and decide for themselves which one best suits them. Meanwhile, insurers must compete to offer high-quality plans at reasonable prices.
But does Part D really work? The numbers speak for themselves: in 2004 nearly one in four seniors lacked drug coverage. By 2006, when Part D took effect, that statistic dropped to seven percent.
Democratic lawmakers could use this success as a roadmap for expanding coverage while avoiding the kind of drastic government intervention that inspired such rancor in opponents of the public option.
In other words, create a program that allows insurers to compete to offer those 8-16 million chronically uninsured Americans the best plan. The government could then provide subsidies to make that plan even more affordable. This would by no means be easy to implement. But it wouldn’t be revolutionary either, since the policy’s basic framework has already proven to work well.
President Obama is in desperate need of fiscally responsible healthcare reform ideas. A Part D-like insurance program might be exactly what he’s looking for.
For more on this, see a new article in Reuters' "Great Debate" series here.
Yesterday evening, President Obama was faced with a daunting task.
To the chagrin of many Americans who tuned in for President Obama's remarks to Congress last night, the speech was long on rhetoric and purely partisan accusations and short on sound solutions for reform.
Beyond that, the president's speech was regrettably replete with contradictions that will only cause further confusion among the public.
There are certain parts of the President Obama's speech that deserve a response. Below are excerpts from his speech in bold with my responses.
President Obama: We are the only democracy -- the only advanced democracy on Earth -- the only wealthy nation -- that allows such hardship for millions of its people. There are now more than 30 million American citizens who cannot get coverage. In just a two-year period, one in every three Americans goes without health care coverage at some point. And every day, 14,000 Americans lose their coverage. In other words, it can happen to anyone.
A few points here.
First, notice how for the last few months this Administration has repeatedly used the “47 million” uninsured figure. That number suddenly disappeared in the president’s address last night. Surely with “14,000 Americans” losing their coverage every day, it’s a mathematical impossibility for 17 million Americans supposedly uninsured prior to the president’s remarks before Congress to now have insurance coverage.
Furthermore, if the president’s figure is correct regarding the number of Americans losing their coverage every day, would it not make more sense for his Administration and Congress to focus all their efforts primarily on getting the economy back on track so that Americans with health insurance through their employer don’t lose their jobs?
Secondly, for President Obama to claim that the United States is the only advanced nation in the world that allows “such hardship” for millions of Americans is simply stunning.
The majority Americans are satisfied with their current health coverage. We lead the world in cancer treatment and medical innovation. Any country can pass a law mandating “universal coverage.” While countries like Canada, Britain, and Japan have universal healthcare in theory, in practice it’s a different story.
President Obama made it sound as if the government mandating universal healthcare tomorrow would solve all our problems and impose no sacrifices on us. He did not once mention waiting lists, doctor shortages, or the cost to taxpayers. We need look no further than Massachusetts – the state with the most physicians in the country – for proof of what universal healthcare would look like on a national scale. Waiting times and costs alike have skyrocketed in Massachusetts since that state implemented its universal health program. What good is “universal coverage” for purposes of preventative care if said coverage means longer waiting lines to see a physician?
President Obama: But the problem that plagues the health care system is not just a problem for the uninsured. Those who do have insurance have never had less security and stability than they do today. More and more Americans worry that if you move, lose your job, or change your job, you'll lose your health insurance too. More and more Americans pay their premiums, only to discover that their insurance company has dropped their coverage when they get sick, or won't pay the full cost of care. It happens every day.
The president’s criticisms of the system become more inconsistent with each passing day. He has repeatedly maintained that we spend far too much on healthcare in this country. But last night he complained about insurance companies not financing the “full cost of care.” He failed to expand on this point.
Many of us on the free-market side of this issue have long advocated for health insurance portability. This can be achieved in a number of ways. Sadly, the president did not mention anything last night about treating individuals and employers equally in terms of tax treatment and health insurance.
President Obama: One man from Illinois lost his coverage in the middle of chemotherapy because his insurer found that he hadn't reported gallstones that he didn't even know about. They delayed his treatment, and he died because of it. Another woman from Texas was about to get a double mastectomy when her insurance company canceled her policy because she forgot to declare a case of acne. By the time she had her insurance reinstated, her breast cancer had more than doubled in size. That is heart-breaking, it is wrong, and no one should be treated that way in the United States of America.
The president didn’t name names when he invoked these stories last night. But if true these stories are heartbreaking and these persons and their families would have legal recourse.
But it bears mentioning once more that most Americans are currently satisfied with their coverage. Is there room for improvement? Of course.
The government finances nearly 50% if health care expenditures in this country and the president believes more government is the solution? He cites these two stories with a nary a mention about the pitfalls of moving to a system with even greater government control of the health care sector.
President Obama may have missed the 2005 landmark Canadian Supreme Court ruling on government-run healthcare.
The Wall Street Journal reported at the time:
Call it the hip that changed health-care history. When George Zeliotis of Quebec was told in 1997 that he would have to wait a year for a replacement for his painful, arthritic hip, he did what every Canadian who's been put on a waiting list does: He got mad. He got even madder when he learned it was against the law to pay for a replacement privately. But instead of heading south to a hospital in Boston or Cleveland, as many Canadians already do, he teamed up to file a lawsuit with Jacques Chaoulli, a Montreal doctor. The duo lost in two provincial courts before their win last week.
The court's decision strikes down a Quebec law banning private medical insurance and is bound to upend similar laws in other provinces. Canada is the only nation other than Cuba and North Korea that bans private health insurance, according to Sally Pipes, head of the Pacific Research Institute in San Francisco and author of a recent book on Canada's health-care system.
Chief Justice Beverly McLachlin went on to declare, “Access to a waiting list is not access to health care.”
Is Canada one of the advanced democracies to which President Obama was referring in his speech? Again – having to wait in pain for one year for a hip replacement is neither compassionate nor moral.
President Obama: Then there's the problem of rising cost. We spend one and a half times more per person on health care than any other country, but we aren't any healthier for it. This is one of the reasons that insurance premiums have gone up three times faster than wages. It's why so many employers -- especially small businesses -- are forcing their employees to pay more for insurance, or are dropping their coverage entirely. It's why so many aspiring entrepreneurs cannot afford to open a business in the first place, and why American businesses that compete internationally -- like our automakers -- are at a huge disadvantage. And it's why those of us with health insurance are also paying a hidden and growing tax for those without it -- about $1,000 per year that pays for somebody else's emergency room and charitable care.
How does the president arrive at the conclusion that we spend more than people in other countries “but we aren’t any healthier for it”? Could it be that this assertion is based on one statistic alone – life expectancy? Forget that we are a profoundly more diverse nation than most others and that life expectancy is determined by a whole host of factors.
The president misrepresents the burden imposed on our businesses by providing employees with health insurance. As Shikha Dalmia points out, “whatever else universal coverage might bring, there is no evidence that it will bring economic nirvana. If anything, contrary to what the president suggests, the correlation runs the other way for countries with universal coverage such as Canada, England, France, Germany, and Japan. On nearly every economic front, their performance has been worse than America's—even, surprisingly, in controlling health care costs.”
If the president and Congressional democrats were to have their way, the financial burden would shift from employers to taxpayers and the result would undoubtedly be lower quality medical treatment and more government control of health decisions.
President Obama claimed that we are all paying about a $1,000 per year for someone else’s emergency room care. Okay, but he did not explain how much we would be paying if his plans were to be enacted.
Does anybody honestly believe that a new public plan will not be heavily subsidized by taxpayers?
President Obama: Finally, our health care system is placing an unsustainable burden on taxpayers. When health care costs grow at the rate they have, it puts greater pressure on programs like Medicare and Medicaid. If we do nothing to slow these skyrocketing costs, we will eventually be spending more on Medicare and Medicaid than every other government program combined.
So the way to mitigate pressure on government health care spending is to create yet another government plan modeled after Medicare?
Is that right?
President Obama: Here are the details that every American needs to know about this plan. First, if you are among the hundreds of millions of Americans who already have health insurance through your job, or Medicare, or Medicaid, or the VA, nothing in this plan will require you or your employer to change the coverage or the doctor you have. Let me repeat this: Nothing in our plan requires you to change what you have.
Notwithstanding President Obama’s powers of clairvoyance, this claim is not exactly true.
President Obama: And that's why under my plan, individuals will be required to carry basic health insurance -- just as most states require you to carry auto insurance. Likewise -- likewise, businesses will be required to either offer their workers health care, or chip in to help cover the cost of their workers. There will be a hardship waiver for those individuals who still can't afford coverage, and 95 percent of all small businesses, because of their size and narrow profit margin, would be exempt from these requirements. But we can't have large businesses and individuals who can afford coverage game the system by avoiding responsibility to themselves or their employees.
Wait. Did the president not say that American businesses are at unfair advantage in terms of international competition because of health care costs? So his plan is to improve their advantage by imposing an even larger financial burden on them?
What am I missing here?
Jim Pinkerton sums up President Obama’s speech nicely writing, “And in the meantime, completely absent from the speech were the words ‘cure’ and ‘research.’ Obama mentioned medicine just twice, and in a routine fashion. Like the Clintons before him, Obama is more focused on the redistribution of health, not the creation of health.”
There are a number of other points President Obama made last night that warrant a response and I will address those points in the next few blogs.
Congressman Charles Boustany (R-LA) was chosen last night to give the Republican response to President Obama’s remarks.
Congressman Boustany has more than 20 years experience as a Cardiovascular surgeon.
CMPI did a video interview with Congressman Boustany last year as a lead up to the Presidential election.
Congressman Boustany has an insightful take on health care reform and explained some of his ideas to us in this video interview.
Congressman Boustany has an insightful take on health care reform and explained some of his ideas to us in this video interview.
Last night the President summoned “the character of our country.”
But his attempt to create an atmosphere of bipartisan support evaporated with the turn of a single phrase:
“I will not stand by while the special interests use the same old tactics to keep things exactly the way they are. If you misrepresent what’s in the plan, we will call you out.”
Threats to those who honestly oppose his ideas? Or does that also apply to those (such as Speaker Pelosi) who accused our fellow citizens of being “anti-American” for venting their honest frustrations at town hall meetings?
No question this speech was largely an exercise about reasserting the President’s leadership. Did that happen? Will, for example, Henry Waxman decide that he is now obligated to the agreements the President reached with, among others, PhRMA? If Mr. Waxman remains unobligated, will the President “stand by” or will he “call him out.”
“If you like your healthcare plan, you can keep it.” But “your healthcare plan” could be more expensive – or your employer may cease to offer it at all. As the old Yiddish proverb goes, “A half-truth is a whole lie.”
And as far as the tax on “gold-plated” insurance policies, here’s what Robert Pear wrote in the New York Times, “Proponents say the idea … would encourage employers to buy cheaper, less generous coverage for employees, thereby reducing excessive use of medical services.”
“Excessive use?” According to whom? And what does “gold-plated” mean? No details offered.
Pear continues, “But many House Democrats and labor union leaders have resisted those proposals, saying the tax would often be passed on to employers and to workers in the form of higher premiums” and “that could be seen as violating a campaign promise not to raise taxes on anyone making less than $250,000 a year."
The President’s for a “not for profit” public plan – but “We should remain open to other ideas that accomplish our ultimate goal.” Translation: “I’ll sign a bill without a public plan.”
And the left cringes.
Welcome news that the President supports a yet-to-be written initiative to create pilot projects intended to curb medical malpractice lawsuits. But who will co-pilot this idea in Congress. That’ll be interesting to see -- or to see if it really happens.
Strangely lacking – a timeline, or even a call for one.
As Senator John McCain commented post-speech on the Larry King Show, “Facts are stubborn things.”
But his attempt to create an atmosphere of bipartisan support evaporated with the turn of a single phrase:
“I will not stand by while the special interests use the same old tactics to keep things exactly the way they are. If you misrepresent what’s in the plan, we will call you out.”
Threats to those who honestly oppose his ideas? Or does that also apply to those (such as Speaker Pelosi) who accused our fellow citizens of being “anti-American” for venting their honest frustrations at town hall meetings?
No question this speech was largely an exercise about reasserting the President’s leadership. Did that happen? Will, for example, Henry Waxman decide that he is now obligated to the agreements the President reached with, among others, PhRMA? If Mr. Waxman remains unobligated, will the President “stand by” or will he “call him out.”
“If you like your healthcare plan, you can keep it.” But “your healthcare plan” could be more expensive – or your employer may cease to offer it at all. As the old Yiddish proverb goes, “A half-truth is a whole lie.”
And as far as the tax on “gold-plated” insurance policies, here’s what Robert Pear wrote in the New York Times, “Proponents say the idea … would encourage employers to buy cheaper, less generous coverage for employees, thereby reducing excessive use of medical services.”
“Excessive use?” According to whom? And what does “gold-plated” mean? No details offered.
Pear continues, “But many House Democrats and labor union leaders have resisted those proposals, saying the tax would often be passed on to employers and to workers in the form of higher premiums” and “that could be seen as violating a campaign promise not to raise taxes on anyone making less than $250,000 a year."
The President’s for a “not for profit” public plan – but “We should remain open to other ideas that accomplish our ultimate goal.” Translation: “I’ll sign a bill without a public plan.”
And the left cringes.
Welcome news that the President supports a yet-to-be written initiative to create pilot projects intended to curb medical malpractice lawsuits. But who will co-pilot this idea in Congress. That’ll be interesting to see -- or to see if it really happens.
Strangely lacking – a timeline, or even a call for one.
As Senator John McCain commented post-speech on the Larry King Show, “Facts are stubborn things.”
Is innovation the problem or the solution? Well, it depends who you ask and what you’re talking about. The issue at hand is the future of medical technology innovation and the question is – are we willing to trade tomorrow for today? Or, put another way – are we willing to focus on short-term costs savings and jeopardize long-term patient outcomes?
Here’s what Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), had to say in response to the proposed $40 billion tax on medical devices and diagnostics that is included in a draft health care reform proposal from Senator Max Baucus, chairman of the Senate Finance Committee:
“This tax will raise the cost of care for all patients, especially those in greatest need of advanced treatments and diagnostics. It is a form of double taxation, since a portion of the hundreds of billions in cuts aimed at our customers, including hospitals, nursing homes, and home health care agencies will be passed on to us. Moreover, the tax will fall most heavily on the small and emerging companies that are the backbone of our industry, often driving development of cutting-edge treatments and cures, and are least able to pay new taxes. Additionally, the fee imposed on clinical labs raises serious concerns in view of other cuts to payments for lab services.”
“While AdvaMed supports broad-based health care reform and has been working to achieve that important goal, we cannot support a proposal that unfairly singles out the medical technology industry for a tax on innovation on top of the billions in cuts that the industry would already have to absorb within the health care reform proposal. We will continue to work with congressional leaders and the White House to further real health reform and to eliminate this counterproductive proposal from any reform package considered by the Congress.”
Real reform doesn't pay for itself by standing on the throat of innovation.
Here’s what Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), had to say in response to the proposed $40 billion tax on medical devices and diagnostics that is included in a draft health care reform proposal from Senator Max Baucus, chairman of the Senate Finance Committee:
“This tax will raise the cost of care for all patients, especially those in greatest need of advanced treatments and diagnostics. It is a form of double taxation, since a portion of the hundreds of billions in cuts aimed at our customers, including hospitals, nursing homes, and home health care agencies will be passed on to us. Moreover, the tax will fall most heavily on the small and emerging companies that are the backbone of our industry, often driving development of cutting-edge treatments and cures, and are least able to pay new taxes. Additionally, the fee imposed on clinical labs raises serious concerns in view of other cuts to payments for lab services.”
“While AdvaMed supports broad-based health care reform and has been working to achieve that important goal, we cannot support a proposal that unfairly singles out the medical technology industry for a tax on innovation on top of the billions in cuts that the industry would already have to absorb within the health care reform proposal. We will continue to work with congressional leaders and the White House to further real health reform and to eliminate this counterproductive proposal from any reform package considered by the Congress.”
Real reform doesn't pay for itself by standing on the throat of innovation.
From the Pink Sheet:
FDA may hold approval of supplemental indications to a higher standard of evidence than what can feasibly be obtained since the drugs are already available to treat patients in an off-label setting, FDA Office of Drug Oncology Products Director Richard Pazdur indicated at a Sept. 1 advisory committee meeting.
ODAC was convinced that clofarabine is active in getting elderly AML patients into remission, but ultimately voted 9-3 that the additional trial did need to be conducted prior to its approval - regardless of the enormous disease and patient population challenges that have stood in the way of conducting such trials thus far.
Hmm.
Jenkins blamed the lapses on "long-standing limitations in staffing and information technology resources," saying that "competing workload priorities prevented us from the level of oversight and review of the entire portfolio of [postmarketing requirements] and [postmarketing commitments] that we would have desired …With new resources and congressional directives, FDA is committed to ensuring proper drafting and review of the entire portfolio going forward.”
Among the changes, each Center for Drug Evaluation and Research division now has a designated postmarketing study coordinator and a postmarketing study tracking coordinator.
In general, the deputy division director for safety - a position established under the agency's Safety First initiative - has assumed the postmarketing study coordinator job, and the safety regulatory manager will handle postmarketing study tracking. "These people as their full-time job are managing the safety and postmarketing study portfolio for their division," Jenkins said.
According to Jenkins, new policies and procedures are in place to "improve consistency in developing" postmarket requirements and commitments and lead to "better designed studies and trials with effective and realistic time frames for initial completion.” He added that other changes have been made to improved tracking and reviewing, including standardizing policies and procedures across CDER review divisions and offices.
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.
