Latest Drugwonks' Blog
Here is the link to the relevant documents:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01591.html
If you are conflicted (either existentially or actually), I grant you a waiver to view these materials.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01591.html
If you are conflicted (either existentially or actually), I grant you a waiver to view these materials.
I am currently listening to an FDA stakeholder call on a new draft guidance for FDA advisory committee conflict of interest.
Rather than "in" or "out," the agency is suggesting three options:
(1) If an adcomm member has "some" conflicts, they can sit on the committee and participate in the meeting -- but cannot vote.
The FDA did not define what "some" means.
(2) If an adcomm member receives more than $50,000 compensation from a firm in front of an adcomm, they may not sit on the panal, participate in the debate, or vote.
It isn't clear (at least to me) in what period of time this money can be accrued (i.e., $50,000 in a calendar year, or in 12 months prior to the meeting, etc.).
(3) If a panel member has the "appearance" of a conflict they may be recused.
No definition of what "appearance" means. Perhaps this will be clarified in the actual draft guidance.
More as more develops.
Rather than "in" or "out," the agency is suggesting three options:
(1) If an adcomm member has "some" conflicts, they can sit on the committee and participate in the meeting -- but cannot vote.
The FDA did not define what "some" means.
(2) If an adcomm member receives more than $50,000 compensation from a firm in front of an adcomm, they may not sit on the panal, participate in the debate, or vote.
It isn't clear (at least to me) in what period of time this money can be accrued (i.e., $50,000 in a calendar year, or in 12 months prior to the meeting, etc.).
(3) If a panel member has the "appearance" of a conflict they may be recused.
No definition of what "appearance" means. Perhaps this will be clarified in the actual draft guidance.
More as more develops.
Want the facts and nothing but the facts on Medicare Advantage?
Of course you do, you're a drugwonk!
Have a look at this document:
Download file
CMPI is glad to have assisted in putting this fact sheet together.
Of course you do, you're a drugwonk!
Have a look at this document:
Download file
CMPI is glad to have assisted in putting this fact sheet together.
Here's a link to the complete BioCentury feature, "Deconstructing FDAMA."
Download file
Many thanks to Bard Steve and BioCentury for the permission to share.
Download file
Many thanks to Bard Steve and BioCentury for the permission to share.
Steve Usdin certainly has a way with words. Consider these pearls from the recent edition of BioCentury:
"Part of the lesson from FDAMA is that the road to regulatory perdition is paved with the best legislative intentions.
The fact is the Congress did not accompany its 1997 mandate for new treatments with any risks for FDA's failure to perform, and hasn't followed through with the resources to bring regulatory science into the 21st century.
Lawmakers also lost interest in the outcome, and now have turned their attention to raising political capital by easy grandstanding about safety.
The truth is that neither Vioxx nor anti-depressants, nor Ketek rise to the level of thalidomide. If it were so, then there would be a groundswell of calls to roll back FDAMA's mandate to being new treatments to patients who need them.
But even if there is no return to the pre-1997 era de jure, a de facto rollback is a real possibility unless Congress, regulators, patients and industry again are willing to do the hard work required to build the sophisticated systems to improve the risk-benefit calculus. This revived collaboration is necessary to make palatable the regulatory risk that everyone must accept if the new science is to make its way to the bedside."
We hereby dub Sir Steve the "Bard of BioCentury."
"Part of the lesson from FDAMA is that the road to regulatory perdition is paved with the best legislative intentions.
The fact is the Congress did not accompany its 1997 mandate for new treatments with any risks for FDA's failure to perform, and hasn't followed through with the resources to bring regulatory science into the 21st century.
Lawmakers also lost interest in the outcome, and now have turned their attention to raising political capital by easy grandstanding about safety.
The truth is that neither Vioxx nor anti-depressants, nor Ketek rise to the level of thalidomide. If it were so, then there would be a groundswell of calls to roll back FDAMA's mandate to being new treatments to patients who need them.
But even if there is no return to the pre-1997 era de jure, a de facto rollback is a real possibility unless Congress, regulators, patients and industry again are willing to do the hard work required to build the sophisticated systems to improve the risk-benefit calculus. This revived collaboration is necessary to make palatable the regulatory risk that everyone must accept if the new science is to make its way to the bedside."
We hereby dub Sir Steve the "Bard of BioCentury."
Henry Waxman supports a bill that would limit the FDA's control over the distribution of pot for medical purposes less than it would limit a doctor's use of new medicines that undergo FDA approval.
Here is the relevant portion of the States Right to Medical Marijuana Act
FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) In General- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict--
(1) the prescription or recommendation of marijuana by a physician for medical use,
(2) an individual from obtaining and using marijuana from a prescription or recommendation of marijuana by a physician for medical use by such individual, or
(3) a pharmacy from obtaining and holding marijuana for the prescription or recommendation of marijuana by a physician for medical use,
in a State in which marijuana may be prescribed or recommended by a physician for medical use under applicable State law.
(b) Production- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict an entity established by a State, in which marijuana may be prescribed or recommended by a physician for medical use, for the purpose of producing marijuana for prescription or recommendation by a physician for medical use from producing and distributing marijuana for such purpose.
Compare that to the civil penalties handed out to anyone violating any aspect of any risk management plan doled out by the FDA under Waxman's watchful eye,
Waxman said of those who opposed a bill to give states the right to regulate the use of marijuana for medical purposes: They "think we should just say no to sick and dying patients because it looks like we're getting tough on drugs."
Is that like saying no to sick and dying patients because it looks like we are getting tough on drug safety?
PS. See the following article
High School Students Getting Medical Marijuana Cards In California
Some California teens are giving a new meaning to "high" school.
Students are finding easy access to medical marijuana cards and presenting those cards to school authorities as a legitimate excuse for getting high.
Advertisement
But, where are the cards coming from?
A letter was sent home to parents of students in the Grossmont Union High School District.
"It's not a get out of jail free card at all." Catherine Martin says even though medical marijuana is legal in California, the law doesn't apply to schools which are subject to federal law. The district also says the students most recently suspended for being high with cards in hand - didn't have major illnesses.
"Students are getting them for things like sleeplessness and stress - it just draws into question how easy is it for people to get their hands on these cards."
Well, at least they are not promoting off-label drug use....
http://www.ksdk.com/news/news_article.aspx?storyid=114394
Here is the relevant portion of the States Right to Medical Marijuana Act
FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) In General- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict--
(1) the prescription or recommendation of marijuana by a physician for medical use,
(2) an individual from obtaining and using marijuana from a prescription or recommendation of marijuana by a physician for medical use by such individual, or
(3) a pharmacy from obtaining and holding marijuana for the prescription or recommendation of marijuana by a physician for medical use,
in a State in which marijuana may be prescribed or recommended by a physician for medical use under applicable State law.
(b) Production- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict an entity established by a State, in which marijuana may be prescribed or recommended by a physician for medical use, for the purpose of producing marijuana for prescription or recommendation by a physician for medical use from producing and distributing marijuana for such purpose.
Compare that to the civil penalties handed out to anyone violating any aspect of any risk management plan doled out by the FDA under Waxman's watchful eye,
Waxman said of those who opposed a bill to give states the right to regulate the use of marijuana for medical purposes: They "think we should just say no to sick and dying patients because it looks like we're getting tough on drugs."
Is that like saying no to sick and dying patients because it looks like we are getting tough on drug safety?
PS. See the following article
High School Students Getting Medical Marijuana Cards In California
Some California teens are giving a new meaning to "high" school.
Students are finding easy access to medical marijuana cards and presenting those cards to school authorities as a legitimate excuse for getting high.
Advertisement
But, where are the cards coming from?
A letter was sent home to parents of students in the Grossmont Union High School District.
"It's not a get out of jail free card at all." Catherine Martin says even though medical marijuana is legal in California, the law doesn't apply to schools which are subject to federal law. The district also says the students most recently suspended for being high with cards in hand - didn't have major illnesses.
"Students are getting them for things like sleeplessness and stress - it just draws into question how easy is it for people to get their hands on these cards."
Well, at least they are not promoting off-label drug use....
http://www.ksdk.com/news/news_article.aspx?storyid=114394
Mark McClellan in this week's BioCentury:
"When you have an adverse event reporting system that only captures about 10% of events, that does it with variable time lags, and with inconsistentely collected information, and isn't linked to an adequate infrastructure at the FDA to analyze the information, no wonder there is real public concern."
"When you have an adverse event reporting system that only captures about 10% of events, that does it with variable time lags, and with inconsistentely collected information, and isn't linked to an adequate infrastructure at the FDA to analyze the information, no wonder there is real public concern."
After reading Daniel Costello's article in the LA Times "Setting a Price for Putting Off Death," I fired off an angry letter to him basically accusing him of favoring rationing and of being heartless.
He called me back and let me have it. I deserved it and he deserved better.
The article is excellent. And it raises an important question about whether our health care system is designed to invest in life or not. More important, I might be upset that some people might think about putting a price on life but I was way out of line.
http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?page=2&track=rss
He called me back and let me have it. I deserved it and he deserved better.
The article is excellent. And it raises an important question about whether our health care system is designed to invest in life or not. More important, I might be upset that some people might think about putting a price on life but I was way out of line.
http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?page=2&track=rss
Frank Burroughs that is, of the Abigail Alliance.
Frank called me yesterday to discuss an article in the March issue of Medical Marketing & Media entitled, "Are NDA Laws Constitutional." He felt that my comments were used to undercut the policy position of the Abigail Alliance.
So I went back to the article and, although I stand by every single one of my quotes, Frank is right in pointing out that the context in which they were used could lead you to think I fundamentally disagree with his position on the issue.
Not so. Not at all. And I feel it's important that I make this point without any ambiguity.
Here is a link to the article:
http://www.mmm-online.com/content/index.php?id=77&no_cache=1&tx_magissue_pi1[pointer]=0&tx_magissue_pi1[showUid]=428
That's good for Frank. And it's good sense.
Frank called me yesterday to discuss an article in the March issue of Medical Marketing & Media entitled, "Are NDA Laws Constitutional." He felt that my comments were used to undercut the policy position of the Abigail Alliance.
So I went back to the article and, although I stand by every single one of my quotes, Frank is right in pointing out that the context in which they were used could lead you to think I fundamentally disagree with his position on the issue.
Not so. Not at all. And I feel it's important that I make this point without any ambiguity.
Here is a link to the article:
http://www.mmm-online.com/content/index.php?id=77&no_cache=1&tx_magissue_pi1[pointer]=0&tx_magissue_pi1[showUid]=428
That's good for Frank. And it's good sense.
http://news.yahoo.com/s/ap/20070320/ap_on_he_me/alzheimer_s
Latest estimate of people living with Alzheimer's is up to 5 million. Meanwhile as Steve Usdin's excellent piece in Biocentury demonstrates, the FDA Modernization Act of 1997 has done nothing to accelerate the pace of bringing new drugs to people.
Which is why the FDA pushed for Critical Path
Meanwhile Congress ignores the growing Alzheimer problem. Indeed, it seems determined to make it worse. It fiddles with making the FDA decision making process longer and more expensive and so-called medical experts flush with money from junk science litigation about silicone breast implants (defendscience.org) claim that user fees have made more people less safe. (Without any evidence to back it up, but what else is new?) These same people also want follow on biologics to flow like tap water free from the same safety standards they would impose on old medicines.
On a related subject,even if a new drug for Alzheimer's was approved and it cost $10000 a year to stave off onset by 1-3 years, my guess is that the media would question whether medicines that don't cure such a disease are worth it. Don't believe me? Just look at the piece of garbage Daniel Costello of the LA Times wrote about cancer drugs this past Sunday. He basically asked if 3 months of life is worth $40k?
Let him cut short his own life and family to save some cash before he makes that decision for society.
http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?track=rss
By LAURAN NEERGAARD, AP Medical Writer Tue Mar 20, 6:51 AM ET
WASHINGTON - More than 5 million Americans are living with
Alzheimer's disease, a 10 percent increase since the last Alzheimer's Association estimate five years ago — and a count that supports the long-forecast dementia epidemic as the population grays.
Age is the biggest risk factor, and the report to be released Tuesday shows the nation is on track for skyrocketing Alzheimer's once the baby boomers start turning 65 in 2011. Already, one in eight people 65 and older have the mind-destroying illness, and nearly one in two people over 85.
Unless scientists discover a way to delay Alzheimer's brain attack, some 7.7 million people are expected to have the disease by 2030, the report says. By 2050, that toll could reach 16 million.
Latest estimate of people living with Alzheimer's is up to 5 million. Meanwhile as Steve Usdin's excellent piece in Biocentury demonstrates, the FDA Modernization Act of 1997 has done nothing to accelerate the pace of bringing new drugs to people.
Which is why the FDA pushed for Critical Path
Meanwhile Congress ignores the growing Alzheimer problem. Indeed, it seems determined to make it worse. It fiddles with making the FDA decision making process longer and more expensive and so-called medical experts flush with money from junk science litigation about silicone breast implants (defendscience.org) claim that user fees have made more people less safe. (Without any evidence to back it up, but what else is new?) These same people also want follow on biologics to flow like tap water free from the same safety standards they would impose on old medicines.
On a related subject,even if a new drug for Alzheimer's was approved and it cost $10000 a year to stave off onset by 1-3 years, my guess is that the media would question whether medicines that don't cure such a disease are worth it. Don't believe me? Just look at the piece of garbage Daniel Costello of the LA Times wrote about cancer drugs this past Sunday. He basically asked if 3 months of life is worth $40k?
Let him cut short his own life and family to save some cash before he makes that decision for society.
http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?track=rss
By LAURAN NEERGAARD, AP Medical Writer Tue Mar 20, 6:51 AM ET
WASHINGTON - More than 5 million Americans are living with
Alzheimer's disease, a 10 percent increase since the last Alzheimer's Association estimate five years ago — and a count that supports the long-forecast dementia epidemic as the population grays.
Age is the biggest risk factor, and the report to be released Tuesday shows the nation is on track for skyrocketing Alzheimer's once the baby boomers start turning 65 in 2011. Already, one in eight people 65 and older have the mind-destroying illness, and nearly one in two people over 85.
Unless scientists discover a way to delay Alzheimer's brain attack, some 7.7 million people are expected to have the disease by 2030, the report says. By 2050, that toll could reach 16 million.
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.
