Latest Drugwonks' Blog
It is written in the Talmud that "The highest form of wisdom is kindess."
Our friend and colleague John Vernon, who passed away suddenly on June 19th, was very wise.
The health policy community is well aware of John's brilliance as an economist and his contribution to the literature on thevalue of biomedical
innovation. That legacy will endure. And we are honored to have worked alongside him on several publications, particularly in the area of comparative
effectiveness research, which he pursued with passion and intellectual precision.
But we knew John best for his gentle determination in the face of incredible personal tragedy, his genorosity and dedication, his open heart and devotion to his friends, his family and his son.
His death is truly tragic. He was to begin a new position and a new health policy program at Purdue, close to his son. We had talked at length about Indiana being a great place to live and raise a family. It seemed that the one person who deserved a blessed existence was getting his due, plus interest.
Now we can only remember by continuing his work and following his example of kindness, courage and unconditional love.
The Talmud also observes:
“There are stars who's light only reaches the earth long after they have fallen apart. There are people who's remembrance gives light in this world, long after they have passed away. This light shines in our darkest nights on the road we must follow.”
So too will our friend John Vernon's kindess light the way for us, now and in the the future, no matter how dark the days ahead. We will miss him greatly but will honor him even more.
The channel -- not the mayor.
Biosimilar Drug Development is a Challenging Proposition
Insights from a Bloomberg Panel Discussion
On June 12th, inThought co-hosted a Bloomberg Industries Biosimilars Panel Discussion with Owen Fields, vice president of Worldwide Regulatory Strategy at Pfizer and Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest.
Discussion centered on the commercial viability of biosimilars, focusing on pricing, the increasing influence of payors, and various life cycle management strategies being implemented as barriers to biosimilar adoption.
Panelists also debated key issues of interchangeability, extrapolation, naming, and use of foreign reference data.
The panel discussion continually highlighted the uncertainties and difficulties facing companies seeking to develop biosimilars, whether through the FDA biosimilar pathway or the traditional BLA approval process.
With the requirement for significant upfront investment, uncertain regulations, potential for huge litigation costs, and an uncertain degree of acceptance by physicians and patients, the development of differentiated biosimilars (“biobetters”) may ultimately be the more compelling business model for companies wishing to participate in the biosimilar market.
A more detailed review of the panel discussion can be found here.
Almost home.
Here is a final summary of the House/Senate conference report.
No REMS nonsense either.
Onwards.
Here is a final summary of the House/Senate conference report.
No REMS nonsense either.
Onwards.
In an interview with The Guardian, former CMS administrator Donald Berwick told a reporter:
"When you invite entrepreneurial private sector investors into the delivery of care, under most payment systems, they will be very interested in volume. They will be very interested in doing more things to people and you may find that you lose control of that level of discipline to the disadvantage of patients. When more things are done, more unnecessary things get done and more hazard enters the system – not just cost.
"You want hospitals that seek to be empty, doctors that seek to be idle, machines that are few. In healthcare you want to find the way to help that is the least invasive of the person's life and body. A volume-based system does not have that incentive structure."
Berwick misunderstands of the motivations of entrepreneurs and investors in health care and the role that government plays in skewing incentives. He also ignores how Moore's Law is remaking medicine, a subject I write about in the just released Scientific American Worldview (My article begins on page 88.) The rapid decline in the cost of the even more rapid digitization of health information is being combined with genomic knowledge to create low cost point of care diagnostics, accelerate the shift to same day surgery, permit the development of targeted oral therapies for illnesses that once required transplants or infusions, create treatments tailored to specific groups of individuals so as to avoid miss and hit type medicine. All the things Berwick claims he believes entrepreneurs are against.
One obstacle is reimbursement. That's shaped by government and private insurers who follow the government's lead. So Medicare will pay more for injectible drugs than oral treatments for MS or cancer and more for treating congestive heart failure than preventing it. Health plans will pay less for same day surgery for hip replacements if the surgeon is out of network than it will for the traditional form of the procedure even though it costs as much and the recovery time is twice as long. Both want to use CER to determine whether or not to pay for a product based on cost, not the "least invasive of the person's life and body." Otherwise, why would have Medicare rejected gene testing for warfarin? Is it better to keep sending people to hemotologists to have blood drawn?
Entrepreneurs should have a passion for achieving what Berwick envisions: less intensive and complex care and better health. But the obstacles to achieving that are not the entrepreneur's vision nor the technology. They are the design of the products, the resistance of physicians and 'stakeholders' to adoption and a reimbursement system that discourages innovation in favor of stepwise incrementalism. I bet Berwick would agree on that score...
CMPI pulled together entrepreneurs who have a passionate capacity for change, a record of accomplishment and a commitment to accelerating the commercialization of personalized medicine. The result was The Personalized Medicine Acceleration Working Group and a report: From Promise to Performance: Commercializing Personalized Medicine.
I think you will find the report and it's recommendations timely. PPACA is -- whether it's ruled unconstitutional or not -- constructed as if current trends in health and health care delivery will continue for decades with nothing changing. Nothing will be further from reality. The design of new products that embody technological progress will create value for millions of people around the world. The problems of health care seem large because the tools we currently have for solving them are inadequate. As the tools get better, the tasks will become simpler and perhaps many will disappear. I's the entrepreneurs and companies who made up our working group -- and the Kauffman Foundation who supported it's efforts -- that is making it possible.
"When you invite entrepreneurial private sector investors into the delivery of care, under most payment systems, they will be very interested in volume. They will be very interested in doing more things to people and you may find that you lose control of that level of discipline to the disadvantage of patients. When more things are done, more unnecessary things get done and more hazard enters the system – not just cost.
"You want hospitals that seek to be empty, doctors that seek to be idle, machines that are few. In healthcare you want to find the way to help that is the least invasive of the person's life and body. A volume-based system does not have that incentive structure."
Berwick misunderstands of the motivations of entrepreneurs and investors in health care and the role that government plays in skewing incentives. He also ignores how Moore's Law is remaking medicine, a subject I write about in the just released Scientific American Worldview (My article begins on page 88.) The rapid decline in the cost of the even more rapid digitization of health information is being combined with genomic knowledge to create low cost point of care diagnostics, accelerate the shift to same day surgery, permit the development of targeted oral therapies for illnesses that once required transplants or infusions, create treatments tailored to specific groups of individuals so as to avoid miss and hit type medicine. All the things Berwick claims he believes entrepreneurs are against.
One obstacle is reimbursement. That's shaped by government and private insurers who follow the government's lead. So Medicare will pay more for injectible drugs than oral treatments for MS or cancer and more for treating congestive heart failure than preventing it. Health plans will pay less for same day surgery for hip replacements if the surgeon is out of network than it will for the traditional form of the procedure even though it costs as much and the recovery time is twice as long. Both want to use CER to determine whether or not to pay for a product based on cost, not the "least invasive of the person's life and body." Otherwise, why would have Medicare rejected gene testing for warfarin? Is it better to keep sending people to hemotologists to have blood drawn?
Entrepreneurs should have a passion for achieving what Berwick envisions: less intensive and complex care and better health. But the obstacles to achieving that are not the entrepreneur's vision nor the technology. They are the design of the products, the resistance of physicians and 'stakeholders' to adoption and a reimbursement system that discourages innovation in favor of stepwise incrementalism. I bet Berwick would agree on that score...
CMPI pulled together entrepreneurs who have a passionate capacity for change, a record of accomplishment and a commitment to accelerating the commercialization of personalized medicine. The result was The Personalized Medicine Acceleration Working Group and a report: From Promise to Performance: Commercializing Personalized Medicine.
I think you will find the report and it's recommendations timely. PPACA is -- whether it's ruled unconstitutional or not -- constructed as if current trends in health and health care delivery will continue for decades with nothing changing. Nothing will be further from reality. The design of new products that embody technological progress will create value for millions of people around the world. The problems of health care seem large because the tools we currently have for solving them are inadequate. As the tools get better, the tasks will become simpler and perhaps many will disappear. I's the entrepreneurs and companies who made up our working group -- and the Kauffman Foundation who supported it's efforts -- that is making it possible.
In a 5-4 decision the Supreme Court has ruled that pharmaceutical sales reps are not entitled to overtime pay because their job is to … sell drugs.
Yes folks, it took our nation’s highest court to decide that the job of a rep is “not merely to make physicians aware of the medically appropriate uses of a particular drug. Rather, it was to convince physicians actually to prescribe the drug in appropriate cases.”
And now back to our regularly scheduled programming.
The obscure we see eventually. The completely obvious, it seems, takes longer.
-- Edward R. Murrow
I want to continue my discussion of Section 1131 of the Senate version of PDUFA (S. 3187) that would compel an innovator company that has a REMS in place to sell "samples" of their product to potential generic competitors. PDUFA POLITICS: GENERICS SEEK PROFITS AND FORSAKE SAFETY
My colleague and tireless crusader for free market healthcare Grace Marie Turner has a concise post at NRO's Critical Condition health blog that raises an important point I did not address:
"This provision also faces a potential constitutional challenge. Such FDA intrusion into the marketplace would be unprecedented because the government would be compelling a commercial transaction between companies that does not involve a willing seller and willing buyer."
Grace-Marie's point is grounded in both the FDA statutory authority and previous Supreme Court rulings that anti-trust claims are not grounds for forcing a company to share it's intellectual property with it's competitors. In the past, when Congress enacted statutes requiring innovator companies to share IP or data absent an exclusivity period or protections they did so in stand-alone bills (Hatch-Waxman and biosimilars) and not as amendments that, as Grace Marie notes, are "tucked" into another bill. (Though the biosimilars measure was folded into PPACA)
Further, the exclusivity granted to innovator companies extends, in particular cases, to REMS programs. Specifically 10 percent of all REMS require elements to assure safe use (ETASU) that include training, websites, track and trace technology to link companies, wholesalers, pharmacists, physicians and patients, software systems that integrate prescribing information with data collected to monitor safe use. These are proprietary systems without which a drug is considered unsafe. It's a criminal activity to sell knowingly sell unsafe drugs. Companies can incur criminal and civil liability even for selling such drugs with the understanding that they will be used in a 'safe' manner if the drug winds up being mis-used or harming someone. Will generic companies assume the cost of litigation and damages? What safeguards are in place to assure that both the administration of a REMS and product testing are done overseas where Congress has raised concerns about FDA's oversight?
Grace Marie also notes that the "REMS provision is expected to save the government at least $100 million over ten years (for reasons that are unclear even to careful observers). The risks to innovation and patient safety are incalculably larger."
That's an understatement. Just as the original estimates of the savings from biosimilars were vastly overstated and unreliable, so too are the estimates of hundreds of millions of dollars in savings from generic versions of drug with REMS. REMS, especially those with hard-wired systems to assure safe use, are expensive to develop, maintain and update. The cost of REMS will be passed on to consumers in the form of higher prices. My guess is CBO and the sources it relied on to develop the cost-saving estimates did not take into account the requirement that generic companies will need to create a REMS for the drugs they want to get outside of REMS.
And I also bet they did not look at the impact this amendment might have on drug shortages. Maintaining an ETASU program is an expensive proposition. Most of them are required of cancer drugs or drugs used in treating cancer patients. What's the point of accelerating generic development of products only to create shortages of the drugs down the road? The PDUFA bill has a whole section on addressing drug shortages. Not a word on how the cost of REMS might affect that problem.
Finally, In a previous post I wrote: "And now, because the Supreme Court ruled that innovator companies are liable for harms done to patients by the administration of a generic version of their drug (Wyeth v. Levine) any screw up because of a sloppy REMS or the purchase of a product outside the REMS or even an adverse event could be grounds for suing an innovator. "
I failed to also note that a more recent Supreme Court ruling could also put innovator companies in more legal danger. In PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011) "the Court ruled that FDA’s regulations preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name, Reference Listed Drug (“RLD”) manufacturer (whose drug product is approved under an NDA) preempt state-law failure-to-warn claims against generic drug manufacturers, because generic drug manufacturers are unable to comply with both federal and state duties to warn. Since the Court issued its decision, scores of court decisions have been issued dismissing litigation against generic drug manufacturers on Mensing grounds. "
So that might mean innovator companies will still be on the hook for updating REMS well after it stops manufacturing a drug. It's one reason Roche has pulled out of making Accutane and the iPLEDGE program.
There's another wrinkle to the liability issue. As the FDA Law Blog notes: Two months ago, Senator Leahy noted that the Mensing decision “creates a troubling inconsistency in the law with respect to prescription drugs.” This is a reference to the U.S. Supreme Court’s March 2009 decision in Wyeth v. Levine, 555 U.S. 555 (2009), in which the Court held that state-law tort actions against a brand-name drug manufacturers for failure to provide an adequate warning label are not preempted.
Leahy has introduced The “Patient Safety and Generic Labeling Improvement Act.” The bill would amend the FDC Act to add new section 505(w): "Notwithstanding any other provision of this chapter, the holder of an application approved under subsection (j) may change the ‘Warnings’ section of the labeling of a drug so approved in the same manner as the holder of an approved new drug application under subsection (b), unless the Secretary prescribes by rule another manner.
Section 1131 could open up another double standard of tort liability. At the very least, it complicates Leahy's effort to develop a stand-alone bill.
It is an ill-considered amendment that was rejected once before because it was considered extreme to force a company to sell a product to a competitor who wants to make money by copying it. Because it also threatens patient safety, exposes innovator companies to unknown liability and may contribute to drug shortages, another approach to reconciling REMS with generic drug approvals is needed.
My colleague and tireless crusader for free market healthcare Grace Marie Turner has a concise post at NRO's Critical Condition health blog that raises an important point I did not address:
"This provision also faces a potential constitutional challenge. Such FDA intrusion into the marketplace would be unprecedented because the government would be compelling a commercial transaction between companies that does not involve a willing seller and willing buyer."
Grace-Marie's point is grounded in both the FDA statutory authority and previous Supreme Court rulings that anti-trust claims are not grounds for forcing a company to share it's intellectual property with it's competitors. In the past, when Congress enacted statutes requiring innovator companies to share IP or data absent an exclusivity period or protections they did so in stand-alone bills (Hatch-Waxman and biosimilars) and not as amendments that, as Grace Marie notes, are "tucked" into another bill. (Though the biosimilars measure was folded into PPACA)
Further, the exclusivity granted to innovator companies extends, in particular cases, to REMS programs. Specifically 10 percent of all REMS require elements to assure safe use (ETASU) that include training, websites, track and trace technology to link companies, wholesalers, pharmacists, physicians and patients, software systems that integrate prescribing information with data collected to monitor safe use. These are proprietary systems without which a drug is considered unsafe. It's a criminal activity to sell knowingly sell unsafe drugs. Companies can incur criminal and civil liability even for selling such drugs with the understanding that they will be used in a 'safe' manner if the drug winds up being mis-used or harming someone. Will generic companies assume the cost of litigation and damages? What safeguards are in place to assure that both the administration of a REMS and product testing are done overseas where Congress has raised concerns about FDA's oversight?
Grace Marie also notes that the "REMS provision is expected to save the government at least $100 million over ten years (for reasons that are unclear even to careful observers). The risks to innovation and patient safety are incalculably larger."
That's an understatement. Just as the original estimates of the savings from biosimilars were vastly overstated and unreliable, so too are the estimates of hundreds of millions of dollars in savings from generic versions of drug with REMS. REMS, especially those with hard-wired systems to assure safe use, are expensive to develop, maintain and update. The cost of REMS will be passed on to consumers in the form of higher prices. My guess is CBO and the sources it relied on to develop the cost-saving estimates did not take into account the requirement that generic companies will need to create a REMS for the drugs they want to get outside of REMS.
And I also bet they did not look at the impact this amendment might have on drug shortages. Maintaining an ETASU program is an expensive proposition. Most of them are required of cancer drugs or drugs used in treating cancer patients. What's the point of accelerating generic development of products only to create shortages of the drugs down the road? The PDUFA bill has a whole section on addressing drug shortages. Not a word on how the cost of REMS might affect that problem.
Finally, In a previous post I wrote: "And now, because the Supreme Court ruled that innovator companies are liable for harms done to patients by the administration of a generic version of their drug (Wyeth v. Levine) any screw up because of a sloppy REMS or the purchase of a product outside the REMS or even an adverse event could be grounds for suing an innovator. "
I failed to also note that a more recent Supreme Court ruling could also put innovator companies in more legal danger. In PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011) "the Court ruled that FDA’s regulations preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name, Reference Listed Drug (“RLD”) manufacturer (whose drug product is approved under an NDA) preempt state-law failure-to-warn claims against generic drug manufacturers, because generic drug manufacturers are unable to comply with both federal and state duties to warn. Since the Court issued its decision, scores of court decisions have been issued dismissing litigation against generic drug manufacturers on Mensing grounds. "
So that might mean innovator companies will still be on the hook for updating REMS well after it stops manufacturing a drug. It's one reason Roche has pulled out of making Accutane and the iPLEDGE program.
There's another wrinkle to the liability issue. As the FDA Law Blog notes: Two months ago, Senator Leahy noted that the Mensing decision “creates a troubling inconsistency in the law with respect to prescription drugs.” This is a reference to the U.S. Supreme Court’s March 2009 decision in Wyeth v. Levine, 555 U.S. 555 (2009), in which the Court held that state-law tort actions against a brand-name drug manufacturers for failure to provide an adequate warning label are not preempted.
Leahy has introduced The “Patient Safety and Generic Labeling Improvement Act.” The bill would amend the FDC Act to add new section 505(w): "Notwithstanding any other provision of this chapter, the holder of an application approved under subsection (j) may change the ‘Warnings’ section of the labeling of a drug so approved in the same manner as the holder of an approved new drug application under subsection (b), unless the Secretary prescribes by rule another manner.
Section 1131 could open up another double standard of tort liability. At the very least, it complicates Leahy's effort to develop a stand-alone bill.
It is an ill-considered amendment that was rejected once before because it was considered extreme to force a company to sell a product to a competitor who wants to make money by copying it. Because it also threatens patient safety, exposes innovator companies to unknown liability and may contribute to drug shortages, another approach to reconciling REMS with generic drug approvals is needed.
From the June edition of MedAd News:
Contraception, who cares?
By: Peter J. Pitts
During an episode of “Mad Men,” someone asks (apropos of an advertising campaign for pantyhose), “What do women want?” Strolling by, agency principal Roger Sterling quips, “Who cares?”
Who cares, indeed?
There’s been a lot of news lately about pharmacists not wanting to be forced to dispense medicines about which they have moral objections, specifically Plan B, “the morning after pill.” A thorny topic, to say the least. Yet, despite all the hoopla from the usual suspects, there has been total silence from an important voice in the debate – the pharmaceutical industry.
On the one hand, that’s not surprising. Why, after all, would anyone want to interject themself into such a no-win, high stakes, high profile battle? But doesn’t a manufacturer who makes a product have a responsibility to stand up and be counted when their product is under attack?
(And, let’s face it, contraceptives are under attack. No value judgment here – just a fact.)
What? Pharma take a stand? Not only is this not unheard of, it is regular and accepted practice when scientific questions are raised. It is regular and accepted practice when safety and efficacy are debated. It is regular and accepted practice when legislative questions arise.
Here’s a relevant example – pseudoephedrine. When many state and federal legislators wanted to ban (or severely restrict) the availability of many OTC products in order to address the scourge of methamphetamine (pseudoephedrine is a common ingredient, or “precursor,” in the manufacture of methamphetamine) both manufacturers and their trade association (the Consumer Health Products Association) went on the offensive.
But, then again, there’s no pro-meth lobby.
When it comes to pharmacists not wanting to dispense Plan B – there’s nothing but silence from the manufacturer. Has Planned Parenthood approached Teva (the maker of Plan B) to enlist its support? If so, what explains the company’s silence? And, if not – why not? Doesn’t Teva have the courage to speak out in favor of its own product? When the initial Rx-to-OTC switch debate was raging, Barr Labs (subsequently purchased by Teva) was quite vocal in its support of Plan B as an avatar for reproductive rights. Today – silence. Qui tacet consentire videtur? Not likely. So why is mums the word?
Could it be that leveraging reproductive rights at FDA was in Barr’s financial interest but that debating it “in the streets” isn’t? Is Teva afraid (should they side with Planned Parenthood and other such organizations) that there might be a boycott against many of its other products?
Mums the word? Consider this couplet from Piers Plowman:
Thou mightiest beter meten the myst on Malverne hulles
Then geten a mom of heore mouth til moneye weore schewed!
That translates as, “You may as well try to measure the mist on the Malvern Hills as to try and get her to speak without first offering payment,” or, in more modern parlance, “Show me the money.”
Why the silence from Teva?
It’s a shame and a sham that a principled stand on reproductive rights was silenced when it became associated with potential commercial risk – just as Secretary Sebelius’ recent reversal of FDA on further Plan B access was done to mitigate potential political repercussions. When politics and profit come before the public health – bad things happen.
As my father used to say, “A principle doesn’t count until it hurts.”
Ouch.
Contraception, who cares?
By: Peter J. Pitts
During an episode of “Mad Men,” someone asks (apropos of an advertising campaign for pantyhose), “What do women want?” Strolling by, agency principal Roger Sterling quips, “Who cares?”
Who cares, indeed?
There’s been a lot of news lately about pharmacists not wanting to be forced to dispense medicines about which they have moral objections, specifically Plan B, “the morning after pill.” A thorny topic, to say the least. Yet, despite all the hoopla from the usual suspects, there has been total silence from an important voice in the debate – the pharmaceutical industry.
On the one hand, that’s not surprising. Why, after all, would anyone want to interject themself into such a no-win, high stakes, high profile battle? But doesn’t a manufacturer who makes a product have a responsibility to stand up and be counted when their product is under attack?
(And, let’s face it, contraceptives are under attack. No value judgment here – just a fact.)
What? Pharma take a stand? Not only is this not unheard of, it is regular and accepted practice when scientific questions are raised. It is regular and accepted practice when safety and efficacy are debated. It is regular and accepted practice when legislative questions arise.
Here’s a relevant example – pseudoephedrine. When many state and federal legislators wanted to ban (or severely restrict) the availability of many OTC products in order to address the scourge of methamphetamine (pseudoephedrine is a common ingredient, or “precursor,” in the manufacture of methamphetamine) both manufacturers and their trade association (the Consumer Health Products Association) went on the offensive.
But, then again, there’s no pro-meth lobby.
When it comes to pharmacists not wanting to dispense Plan B – there’s nothing but silence from the manufacturer. Has Planned Parenthood approached Teva (the maker of Plan B) to enlist its support? If so, what explains the company’s silence? And, if not – why not? Doesn’t Teva have the courage to speak out in favor of its own product? When the initial Rx-to-OTC switch debate was raging, Barr Labs (subsequently purchased by Teva) was quite vocal in its support of Plan B as an avatar for reproductive rights. Today – silence. Qui tacet consentire videtur? Not likely. So why is mums the word?
Could it be that leveraging reproductive rights at FDA was in Barr’s financial interest but that debating it “in the streets” isn’t? Is Teva afraid (should they side with Planned Parenthood and other such organizations) that there might be a boycott against many of its other products?
Mums the word? Consider this couplet from Piers Plowman:
Thou mightiest beter meten the myst on Malverne hulles
Then geten a mom of heore mouth til moneye weore schewed!
That translates as, “You may as well try to measure the mist on the Malvern Hills as to try and get her to speak without first offering payment,” or, in more modern parlance, “Show me the money.”
Why the silence from Teva?
It’s a shame and a sham that a principled stand on reproductive rights was silenced when it became associated with potential commercial risk – just as Secretary Sebelius’ recent reversal of FDA on further Plan B access was done to mitigate potential political repercussions. When politics and profit come before the public health – bad things happen.
As my father used to say, “A principle doesn’t count until it hurts.”
Ouch.
The passage of the Prescription Drug User Fee Act (PDUFA) has stalled. The generic drug industry, along with AARP, trade unions and some other organizations support a provision that they claim would simply require " brand-name drugmakers to provide samples of their medicines, including biologics. Generic drugmakers and their allies, including some insurers and pharmacy benefit managers, complain that brand-name drugmakers have been using the strict distribution provisions of the Risk Evaluation and Mitigation Strategies ( REMS) regulation as an excuse not to provide samples for development and testing."
And the generic industy says that as a result drug companies are costing consumers and taxpayers billions.
That's the spin. It's not about the samples. It's about getting around REMS. Generic companies never guarantee that they will replicate the REMS system that an innovator comany uses. Anyone who has seen the citizen's petitions of the generic companies knows that. So does the FDA. Take the the case of Accutane (the acne drug that goes by the generic name of isotretinoin): Despite a program designed to limit fetal damage from the drug called iPLEDGE there were 122 pregnancies just in its first year. And that was with just one program.
By allowing "samples" the provision would force FDA to approval countless versions of REMS programs that were designed for a single drug for a single use for a specific group of patients. And now, because the Supreme ruled that innovator companies are liable for harms done to patients by the administration of a generic version of their drug (Wyeth v. Levine) any screw up because of a sloppy REMS or the purchase of a product outside the REMS or even an adverse event could be ground for suing an innovator.
Finally, it's not just giving samples. Especially when it comes to the little things, like say, permanent birth defects, maybe we want to be a bit more careful. Perhaps we want to be extra cautious about passing around samples without having a good reason to go outside a tightly controlled method of distributing and administering a specific group of drugs that has protected infants from damage up till now? REMS are not one size fits all to be sure. But take a look at this video about the effects of thalidomide before assuming that there's no risk in giving generic companies every sample of every drug they want. I find it ironic that the same interests who demand more regulation of innovator companies for the sake of safety are willing to let safety slide for the sake of generic industry profits...
http://www.youtube.com/watch?v=FK-RuOqdZ1M
And the generic industy says that as a result drug companies are costing consumers and taxpayers billions.
That's the spin. It's not about the samples. It's about getting around REMS. Generic companies never guarantee that they will replicate the REMS system that an innovator comany uses. Anyone who has seen the citizen's petitions of the generic companies knows that. So does the FDA. Take the the case of Accutane (the acne drug that goes by the generic name of isotretinoin): Despite a program designed to limit fetal damage from the drug called iPLEDGE there were 122 pregnancies just in its first year. And that was with just one program.
By allowing "samples" the provision would force FDA to approval countless versions of REMS programs that were designed for a single drug for a single use for a specific group of patients. And now, because the Supreme ruled that innovator companies are liable for harms done to patients by the administration of a generic version of their drug (Wyeth v. Levine) any screw up because of a sloppy REMS or the purchase of a product outside the REMS or even an adverse event could be ground for suing an innovator.
Finally, it's not just giving samples. Especially when it comes to the little things, like say, permanent birth defects, maybe we want to be a bit more careful. Perhaps we want to be extra cautious about passing around samples without having a good reason to go outside a tightly controlled method of distributing and administering a specific group of drugs that has protected infants from damage up till now? REMS are not one size fits all to be sure. But take a look at this video about the effects of thalidomide before assuming that there's no risk in giving generic companies every sample of every drug they want. I find it ironic that the same interests who demand more regulation of innovator companies for the sake of safety are willing to let safety slide for the sake of generic industry profits...
http://www.youtube.com/watch?v=FK-RuOqdZ1M
Let’s give credit where credit is due – Mayor Bloomberg’s heart is in the right place. Obesity (especially of the childhood variety) is an epidemic that is going to sink us all unless we can address it immediately and aggressively.
But we have to address it smartly.
The media circus surrounding the Mayor’s call to ban large sodas is just silly. It reeks of nanny statism and diverts attention away from the issue. Plainly speaking, it trivializes the problem.
Prohibition doesn’t work. How many times do we have to learn this lesson? What works is personal responsibility and adherence to the Aristotelian Mean (aka – moderation).
In the immortal words of Nucky Thompson, “First rule of politics, kiddo: Never let the truth get in the way of a good story.”
It’s time to put headlines behind us and move on to addressing the real story.
And we start right here with a short video -- “Big Gulp Empire.” Have a look and pass it on.
Not content to stop at keeping people from 20 oz bottles of Mountain Dew (but unlimited refills are fine) the Board of Health started coming up with other food items that it should portion control:
“The popcorn isn’t a whole lot better than the soda,” said Bruce Vladeck, a senior adviser at Nexera Consulting and one of the mayor’s appointees to the 11-member board. The board yesterday agreed to put Bloomberg’s big-soda ban up for a public hearing July 24, but also talked about the merits of limiting other high-calorie treats. A large tub of movie-theater popcorn has up to 1,650 calories.
Bruce Vladeck (center in photo)
But why stop at regulating popcorn?
“There are certainly milkshakes and milk-coffee beverages that have monstrous amounts of calories . . . and I’m not so sure what the rationale is not to include those,” said member Dr. Joel Forman, a pediatrics professor at Mount Sinai. (Milkshakes have calories? Coffee coolattas too? Shocking.)
So wait.. I thought the enemy was sugar. Or is it calories? Or is it portions? Or is it food?
Perhaps we should just wait until the Board of Health comes out with a government approved menu that we all have to buy from. Scary thing is, as this poll shows, there are enough social control freaks out there who would agree the government should regulate what we eat and drink:
And here's an enthusiastic defense of the nutritional police state by someone that calls herself "the portion teller." (Oy)
http://portionteller.com/size-matters-at-least-in-nyc/
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