Latest Drugwonks' Blog
Last Wednesday I chaired the Fourth National FDA Regulatory Symposium. Being the chair gave me the privilege to introduce the event’s keynote speaker, FDA Commissioner Peggy Hamburg.
By way of introduction, I pointed out that everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible.
Every specific action the agency takes is an opportunity to speak to a larger public health issue. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. The FDA must be seen as leading rather than simply participating in the process.
As a former New York City Health Commissioner, Dr. Hamburg has the opportunity to bring to the FDA the ability to view regulatory issues from the viewpoint of the man on the street, the patient -- the consumer. And there are issues aplenty:
• There’s the question of REMS plans.
• And complete response letters.
• And the transparency of complete response letters.
• And biomarkers.
• And guidance on off-label promotion.
• And “net impressions” of DTC materials
• And oversight of social media.
• And of clinical trials.
• And of adaptive clinical trials.
• And follow-on biologics.
• And bioequivalence for generics.
• And GMPs
• And drug importation.
• And counterfeiting.
• And companion diagnostics.
• And the regulation of diagnostics.
• And 510(k) reform.
• And food safety and security.
• And dietary supplements.
• And nutritional health claims.
• And tobacco.
• And early safety signal communications.
• And pandemic preparedness.
• And greater international harmonization.
• And the balance of predictability vs. ambiguity.
• And food from the progeny of cloned animals.
• And the FDA’s working relationships with industry and academia.
• And the Reagan/Udall Foundation – wither the agency’s Critical Path program?
As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”
The Commissioner began her remarks by commenting, “It’s a lot easier to ask the questions then to answer them.” Zing,
Some additional thoughts from Dr. Hamburg:
* Concerned that the agency “is under-appreciated by the public” (a recent poll shows that, among government agencies, the FDA ranks just one notch above the IRS) “and under-resourced.” In fact, she mentioned that she was going to OMB on Friday (October 2) to defend the FDA’s budget proposal for the coming fiscal year. I promised to pray for her.
* The FDA’s most valuable assets are the “extraordinary public servants” who work at the FDA. Can’t repeat that too many times.
* That to be FDA Commissioner requires “wisdom, common sense, and a sense of humor.” Well said.
* The urgency of the FDA’s Critical Path program and “the urgency to fund robust 21st century regulatory science. “ She aptly defined the agency’s role as “Reviewer, Approver – and Catalyst. And, “We must advocate for it.”
* “Success is not measured in warning letters.” Amen – and courageous of her to say so.
* Similarly, and relative to foreign drug manufacture, “The FDA will never be able to assure safety all on our own.” And that there must be “shared responsibility for global drug inspections.”
* During the Q&A she was asked whether or not the FDA would add comparative effectiveness as a third leg to the approvals process. Her smart response was that the FDA should find ways to share its data with researchers in order to “enrich understanding.” Short answer to direct question – no third leg.
* Per the FDA’s initiative on transparency (led by Deputy Commissioner Josh Sharfstein), Dr. Hamburg said she hoped to have some initial (“incremental”) recommendations by November. Stand by on that one.
Thank you Commissioner.
By way of introduction, I pointed out that everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible.
Every specific action the agency takes is an opportunity to speak to a larger public health issue. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. The FDA must be seen as leading rather than simply participating in the process.
As a former New York City Health Commissioner, Dr. Hamburg has the opportunity to bring to the FDA the ability to view regulatory issues from the viewpoint of the man on the street, the patient -- the consumer. And there are issues aplenty:
• There’s the question of REMS plans.
• And complete response letters.
• And the transparency of complete response letters.
• And biomarkers.
• And guidance on off-label promotion.
• And “net impressions” of DTC materials
• And oversight of social media.
• And of clinical trials.
• And of adaptive clinical trials.
• And follow-on biologics.
• And bioequivalence for generics.
• And GMPs
• And drug importation.
• And counterfeiting.
• And companion diagnostics.
• And the regulation of diagnostics.
• And 510(k) reform.
• And food safety and security.
• And dietary supplements.
• And nutritional health claims.
• And tobacco.
• And early safety signal communications.
• And pandemic preparedness.
• And greater international harmonization.
• And the balance of predictability vs. ambiguity.
• And food from the progeny of cloned animals.
• And the FDA’s working relationships with industry and academia.
• And the Reagan/Udall Foundation – wither the agency’s Critical Path program?
As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”
The Commissioner began her remarks by commenting, “It’s a lot easier to ask the questions then to answer them.” Zing,
Some additional thoughts from Dr. Hamburg:
* Concerned that the agency “is under-appreciated by the public” (a recent poll shows that, among government agencies, the FDA ranks just one notch above the IRS) “and under-resourced.” In fact, she mentioned that she was going to OMB on Friday (October 2) to defend the FDA’s budget proposal for the coming fiscal year. I promised to pray for her.
* The FDA’s most valuable assets are the “extraordinary public servants” who work at the FDA. Can’t repeat that too many times.
* That to be FDA Commissioner requires “wisdom, common sense, and a sense of humor.” Well said.
* The urgency of the FDA’s Critical Path program and “the urgency to fund robust 21st century regulatory science. “ She aptly defined the agency’s role as “Reviewer, Approver – and Catalyst. And, “We must advocate for it.”
* “Success is not measured in warning letters.” Amen – and courageous of her to say so.
* Similarly, and relative to foreign drug manufacture, “The FDA will never be able to assure safety all on our own.” And that there must be “shared responsibility for global drug inspections.”
* During the Q&A she was asked whether or not the FDA would add comparative effectiveness as a third leg to the approvals process. Her smart response was that the FDA should find ways to share its data with researchers in order to “enrich understanding.” Short answer to direct question – no third leg.
* Per the FDA’s initiative on transparency (led by Deputy Commissioner Josh Sharfstein), Dr. Hamburg said she hoped to have some initial (“incremental”) recommendations by November. Stand by on that one.
Thank you Commissioner.
The AAPS conference regarding extended or modified release formulations of drugs and therapeutic equivalence raised many important public policy questions. The AAPS conference material noted that:
"Demonstration of bioequivalence (BE) between drug products can be made using blood level measurements, pharmacodynamic studies, clinical trials, and/or in
vitro studies. The US regulations deem drug products therapeutic equivalents (TE) if they are both pharmaceutically equivalent and bioequivalent."
But it became clear that current standards of BE do not add up to TE because we know more about the impact of individual variation in how we absorb and process drugs now than when the generic drug reforms were enacted in 1984. So the question is, as Kamal Midha, Ph.D. of University of Saskatchewa, who spoke about existing standards for TE of sustained release products: are current regulations for measuring BE enough?
More to the point: if the public and the FDA are demanding more evidence about the safety and reliability of new products pre and post market (including more information the pharmacodynamics and phamacokinetics of such products), why shouldn't such information be used to establish TE of generic products, particularly those where the amount of a drug released and when is essential to a drug's safety and effectiveness. While it may be true that this issue only affects a handful of drugs, it is also true that these drugs are not only widely prescribed, they are also mostly prescribed in generic form. And post market oversight of this growing market share is not a top FDA priority even as safety has become an critical (path) FDA concern,
So at the end of the day (and the conference) it became clear that better standards for tracking the impact of modified release products with new tools is not to be ignored. Rather than being a way for innovators to escape generic competition, the collection and monitoring of better measures of TE can improve the overall quality of medicines without significant costs to either part of the industry. That is the goal and essence of the Critical Path. To ignore or dismiss concerns about toxicity or adverse events of sustained release products because they are made by generic companies is to suggest that the financial interests of that industry is more important than the public health.
This issue can, as the AAPS meeting demonstrated, can be explored in a way that uses science to clarify issues and stratify risk so that the most important public health issues relative to this product class can be addressed.
"Demonstration of bioequivalence (BE) between drug products can be made using blood level measurements, pharmacodynamic studies, clinical trials, and/or in
vitro studies. The US regulations deem drug products therapeutic equivalents (TE) if they are both pharmaceutically equivalent and bioequivalent."
But it became clear that current standards of BE do not add up to TE because we know more about the impact of individual variation in how we absorb and process drugs now than when the generic drug reforms were enacted in 1984. So the question is, as Kamal Midha, Ph.D. of University of Saskatchewa, who spoke about existing standards for TE of sustained release products: are current regulations for measuring BE enough?
More to the point: if the public and the FDA are demanding more evidence about the safety and reliability of new products pre and post market (including more information the pharmacodynamics and phamacokinetics of such products), why shouldn't such information be used to establish TE of generic products, particularly those where the amount of a drug released and when is essential to a drug's safety and effectiveness. While it may be true that this issue only affects a handful of drugs, it is also true that these drugs are not only widely prescribed, they are also mostly prescribed in generic form. And post market oversight of this growing market share is not a top FDA priority even as safety has become an critical (path) FDA concern,
So at the end of the day (and the conference) it became clear that better standards for tracking the impact of modified release products with new tools is not to be ignored. Rather than being a way for innovators to escape generic competition, the collection and monitoring of better measures of TE can improve the overall quality of medicines without significant costs to either part of the industry. That is the goal and essence of the Critical Path. To ignore or dismiss concerns about toxicity or adverse events of sustained release products because they are made by generic companies is to suggest that the financial interests of that industry is more important than the public health.
This issue can, as the AAPS meeting demonstrated, can be explored in a way that uses science to clarify issues and stratify risk so that the most important public health issues relative to this product class can be addressed.
BioCentury reports that late Thursday ...
The Senate Finance Committee night passed an amendment to healthcare reform legislation that would create a $1 billion temporary tax credit over two years for investments in drug R&D by companies with 250 or fewer employees.
The measure, sponsored by Sen. Robert Menendez (D-N.J.) and backed by the Biotechnology Industry Organization (BIO), would cover expenditures made in 2009 and 2010. Companies that don't have a tax liability would have the option to receive the credit in the form of a grant.
In allocating the credits and grants, the amendment instructs the U.S. Treasury to consider only projects that: "show reasonable potential" to "result in new therapies to treat areas of unmet medical need or to prevent, detect, or treat chronic or acute disease and conditions;" or to "reduce long-term health costs in the United States; or to "significantly advance the goal of curing cancer within a 30-year period."
In addition, the Treasury would consider which projects have the greatest potential to create and sustain high quality, high-paying jobs in the U.S. and to advance U.S. biomedical competitiveness.
Projects that received a credit or grant would not qualify for existing R&D or Orphan tax credits, or for bonus depreciation.
The legislation still is subject to modification as it moves through Congress. The Finance Committee is expected to approve America's Healthy Future Act early next week. It will then be merged with legislation passed by the Health, Education, Labor and Pensions (HELP) Committee and sent to the full Senate for a vote. The final Senate bill would have to be reconciled with healthcare reform legislation coming out of the House.
The Senate Finance Committee night passed an amendment to healthcare reform legislation that would create a $1 billion temporary tax credit over two years for investments in drug R&D by companies with 250 or fewer employees.
The measure, sponsored by Sen. Robert Menendez (D-N.J.) and backed by the Biotechnology Industry Organization (BIO), would cover expenditures made in 2009 and 2010. Companies that don't have a tax liability would have the option to receive the credit in the form of a grant.
In allocating the credits and grants, the amendment instructs the U.S. Treasury to consider only projects that: "show reasonable potential" to "result in new therapies to treat areas of unmet medical need or to prevent, detect, or treat chronic or acute disease and conditions;" or to "reduce long-term health costs in the United States; or to "significantly advance the goal of curing cancer within a 30-year period."
In addition, the Treasury would consider which projects have the greatest potential to create and sustain high quality, high-paying jobs in the U.S. and to advance U.S. biomedical competitiveness.
Projects that received a credit or grant would not qualify for existing R&D or Orphan tax credits, or for bonus depreciation.
The legislation still is subject to modification as it moves through Congress. The Finance Committee is expected to approve America's Healthy Future Act early next week. It will then be merged with legislation passed by the Health, Education, Labor and Pensions (HELP) Committee and sent to the full Senate for a vote. The final Senate bill would have to be reconciled with healthcare reform legislation coming out of the House.
With generic drugs now making up nearly 70 percent of all medications prescribed in the US it is no surprise that the issues of bioequivalency and interchangeability of branded drugs and generics remained front and center this morning at the second day of the AAPS meeting.
The FDA has come in for a fair amount of criticism from companies and consumers alike. We wrote yesterday about the concerns about bupropion/Wellbutrin and Ambien but these are only two of the cases in which it has been questioned whether drugs certified by the FDA as bioequivalent are indeed therapeutically equivalent.
For a fairly comprehensive treatment of the alleged problems of non-bioequivalent generics , check out Glenn Lammi’s legal brief.
This morning, we had a chance to hear from the FDA and an explanation of when the agency believes there may be grounds to modify the current procedure for approving generics as bioequivalent.
Dr. Robert Temple, Director of the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research and Acting Director of the Office of Drug Evaluation I, argued that for the large majority of drugs bioequivalency is relatively straight forward but also walked through where differences between two drugs might or might not be indications of the potential for therapeutic efficacy differences.
He opined that for two drugs that meet FDA bioequivalency standards, interchangeability depends on two factors: the sensitivity of the drug effects to differences in concentration and where one is on the dose response curve.
On the first point, it matters a lot whether a drug takes effect slowly or quickly, both in terms of the intended effect and the potential for side effects. When the drug is specially created to take effect quickly or to have high concentrations at certain times, testing the concentration at more time points is an important part of demonstrating that the two drugs really can be substituted for one another without big changes in the effects. Ambien is an example. Another is ADHD drugs which are designed to have high concentrations at some times and lower concentrations at others.
But Dr. Temple indicated that in the case of drugs that may take hours, days, or weeks to work completely, for instance antidepressants, beta-blockers, and coumadin, he felt it is highly unlikely that small deviations in concentration and release would have much of an impact on therapeutic effect. The shape of the curve, arguably, is not as critical.
That speaks against the complaints about Wellbutrin (bupropion) that we heard about, and wrote about, yesterday since the drug’s effects develop over weeks. Indeed, Dr. Temple attributed the complaints about the generic bupropion at least partially to patients blaming reoccurrence of symptoms to the drug change even though they would have returned whichever drug the patient was on. He made a similar argument about patients on anti-seizure medications who say that their seizures came back after they moved to a generic.
On the second consideration in determining whether existing bioequivalence standards are adequate, placement on the curve, Dr. Temple identified cases where the closeness of the pharmacokinetic profiles are important, generally where one is on the steep part of the curve. However, few drugs fall in this area, usually oncology drugs. He suggested that when one is on the plateau, differences in release rate are not very important, offering the example of drugs such as fluoxetine where the drug is equally effective at 20, 40, and 80mg doses and can be taken once a week with little difference in effect from taking it once a day.
When patients are faced with the choice between a branded drug and a generic one – or find themselves put on a generic because their insurer is trying to save money – they are often reassured that the two medications are the same.
But the remarks this afternoon at the AAPS conference in Baltimore of Gerard Sanderink, Director of Metabolism and Pharmacokinetics at Sanofi-Aventis, brought into relief the question of exactly how different drugs can be and still pass the FDA’s current standards for bioequivalence.
And it’s a troubling picture.
Dr. Sanderink described how when Sanofi-Aventis decided to create an extended release version of Ambien that would work for an additional 3 to 5 hours in order to help patients remain asleep, the company tested 8 bi-layer formulations, comprising different proportions of the two included medications and different total doses.
Critical to Sanofi-Aventis was that the new pill would have three essential properties. It would offer patients the same quick absorption to help them get to sleep, it would offer medication to keep them asleep, and it would not leave any residual impairment in the morning.
One of the eight formulas “won” the aptly named Scheherzade trial and became what we now know as Ambien CR but what is interesting is what the other seven variations can tell us about the inadequacy of the FDA’s present procedure for approving generics as bioequivalent.
The winning formula took the crown in part because it left no lingering effects in the morning when compared to placebo. This was not true of some of the other formulas, which in some cases continued to have a residual impact long after the subject had woken up. As Dr. Sanderink’s presentation today showed, the pharmacodynamic profiles of the eight versions differed quite widely.
Yet, under the current FDA rules, all of the alternative Ambien formulations would pass a bioequivalence test against the chosen version. Right now, the agency only tests drug concentrations at 1.5 hours and then 1.5 hours to infinity.
That means that drugs that leave a lot more impairment in the morning can be sold as if they are identical to the original. And so can drugs that lack the properties of sleep initiation and sleep maintenance that make physicians and patients alike turn to Ambien CR.
Instead, Sanofi-Aventis wants the FDA to look at 0-3 hours, 3-6 hours, and 6 hours plus, covering the three important phases of the drug’s operation, initiation, maintenance, and wake-up.
I must agree with Dr. Sanderink: Classical bioequivalence criteria are insufficient, at least for this type of drugs, and the FDA should move to a more nuanced and tailored approach to evaluating whether generic drugs are sufficiently similar to the originals. To do otherwise is to do harm to patients, the companies that made the innovator drugs, and the agency’s own reputation.
It seems pretty clear that when patients who take Ambien CR to both fall and stay asleep are told their new generic will do the same thing, they won’t be satisfied with a pill that fulfills only half of that promise.
But that’s just what they may get with generic zolpidem. Ambien CR is specially formulated so that the medication it contains is dispensed so that patients both drop off and remain asleep so any variation in these concentrations can mean patients may wake up long before they want to.
Yet, the FDA only tests the concentration of generic zolpidem at 1.5 hours and then 1.5 hours to when the drugs stops being measurable in the system, which does very little to ensure that the drug concentrations match those of the branded drug over course of the 7 or 8 hours that it is patients’ systems. Especially since 90 percent of the drug enters the body after 1.5 hours.
Who thinks this is acceptable?
Similar concentrations at one single point is hardly strong evidence that the two drugs are actually bioequivalent.
What’s more, generics that dispense their contents in a different way can actually be dangerous since the drug may linger in patients’ systems longer than it should. That can mean day time sleepiness and reduced coordination.
Sanofi-aventis, which makes Ambien CR, has a simple solution and a reasonable request: test generics for the concentration during 0-3 hours, 3-6 hours, and more than 6 hours. As Gerard Sanderink of sanofi-aventis explained this afternoon, this would assure that the generic was bioequivalent on all of the main dimensions of Ambien CR, sleep initiation, sleep maintenance, and residual effects.
It’s a proposal that’s good for patients – and innovator companies. Why is the FDA dragging its feet?
The first sessions this afternoon at the AAPS Meeting focus on bupropion, otherwise known, in its branded form, as Wellbutrin. With the introduction three years ago of a generic for the antidepressant, patient switched to generic bupropion began to complain that the new drug was not working as well as the branded version had. They reported reduced control of their depression or even suicidal symptoms.
Theoretically at least, the two drugs were the same for all intents and purposes. The FDA had evaluated the data on the generic before approving it and certified that the branded and generic drugs were bioequivalent.
Yet, patients were reporting in increasing numbers, particularly online via patient advocacy sites, that this was not so. Now drugwonks and the Center for Medicine in the Public Interest are both on the record discussing why the internet is not a reliable source of data on medical information, and calculating prevalence of side effects is no exception to this.
However, the internet was not the only place that complaints were accumulating about generic bupropion. And an in vitro study done by one of the sites receiving these complaints revealed that 34 percent of the contents of the generic was being released in the initial two hours. That percentage was only 8 percent for the branded drug. Despite concerns about the bioequivalence of the two versions, the FDA reiterated that the two were the same.
Since then, this line has been maintained. One of this afternoon’s speakers, Dr. Paul Fackler, Vice President of Biopharmaceutics in Global Generic R&D at Teva Pharmaceutical, one of the companies making the drug and the first to produce a generic of bupropion, argued that the data does show that the release pattern of the drugs is indeed very similar.
There is one obvious source of doubt of this, despite Dr. Fackler’s lovely graphs, is that they are simulations, not creations of actual data. The argument for this is that only so much blood can be drawn from volunteer subjects so producing a full graph over the drug’s 20 hour half life is unfeasible. Yet, the simple fact that they are simulations leaves the numbers very open to questions.
The second issue, and one that has existed since the beginning of the controversy over the bioequivalence of branded and generic bupropion, is that the FDA tested only the 150mg dose, not the 300mg dose. As Dr. Fackler explained this afternoon, an in vivo waiver was granted on 300mg. With the larger dose being the target of many of the reports of therapeutic inequivalence, it seems short sighted of the FDA not have asked for data on 300mg after complaints began to stream in, if not during approval.
Well, the actual title of the conference is "Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products". But the core issue of the conference is whether the generic version of extended release drugs -- used widely to treat pain, mental illness, Parkinson's, and bacterial infections -- deliver the medicine to the right place at the right time in the right amount. Too much can be painful, even deadly. Too little can cause setbacks. The drug might be cheaper but the outcome is costly.
To date no one has kept track of the total impact on patients. In part that's because until 2007 generic companies were not require by the FDA to monitor the effect of their products in the marketplace and only then it was limited to opioid based painkillers. The increased use of generic lamotrigine is strongly associated with increased physician visits and hospitalizations. The same goes for switching patients to a generic version of other anti-convulsants, anti-depressants, etc.
The key question of the conference is what can companies do to assure that all medicines affect us in more or less the same way. As I have written before, one step in the right direction is to hold drugs that are supposed to have the same benefit and same risks to the same standards of post market evaluation. Another approach, to be discussed by Gerard Sanderink of Sanofi will be how to use biomarkers to more precisely predict dose response and absorption of products in the earliest stages of development and periodically in the post market.
The conference may seem mundane. However the fact that Bob Temple is showing up indicates just how serious the FDA is about this issue. And more generally, it underscores the fact that the public at large is unaware of the importance of how a drug is delivered. Discovering a medicine is half the battle. Making sure it is delivered safely and effectively is as important.
Accordingly, CMPI will be covering the AAPS conference "live" with bloggers and a video crew in a effort to "deliver" the modified release message in a way that it interesting and timely.
To date no one has kept track of the total impact on patients. In part that's because until 2007 generic companies were not require by the FDA to monitor the effect of their products in the marketplace and only then it was limited to opioid based painkillers. The increased use of generic lamotrigine is strongly associated with increased physician visits and hospitalizations. The same goes for switching patients to a generic version of other anti-convulsants, anti-depressants, etc.
The key question of the conference is what can companies do to assure that all medicines affect us in more or less the same way. As I have written before, one step in the right direction is to hold drugs that are supposed to have the same benefit and same risks to the same standards of post market evaluation. Another approach, to be discussed by Gerard Sanderink of Sanofi will be how to use biomarkers to more precisely predict dose response and absorption of products in the earliest stages of development and periodically in the post market.
The conference may seem mundane. However the fact that Bob Temple is showing up indicates just how serious the FDA is about this issue. And more generally, it underscores the fact that the public at large is unaware of the importance of how a drug is delivered. Discovering a medicine is half the battle. Making sure it is delivered safely and effectively is as important.
Accordingly, CMPI will be covering the AAPS conference "live" with bloggers and a video crew in a effort to "deliver" the modified release message in a way that it interesting and timely.
The long-awaited and much anticipated draft guidance on REMS can be found here.
Also now available (and worth a careful read or two) is the FDA's strategic plan for risk communications. Here's the press release, along with a link to the complete document.
FDA NEWS RELEASE
For Immediate Release: Sept.30, 2009
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Strategic Plan for Risk Communication
Establishes framework for communicating with public about FDA-regulated products
The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information. The plan also lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it, and for how the agency oversees industry communications.
“We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”
The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year. They include:
- Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
- Producing a research agenda for public dissemination
- Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
- Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
- Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes
- Posting pictures of FDA- regulated products affected by Class I or high-priority Class II recalls as part of recall notices/information
- Developing detailed action plans at the agency and center levels for implementing and achieving the proposed action steps, including timelines, responsibilities and resource needs
The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations, and focuses on policies that affect areas of high public health impact.
For more information:
FDA’s Strategic Plan for Risk Communication
Speaking of taxing “Cadillac” health plans, today’s New York Times reports that:
“The leading proposal in the Finance Committee would apply to family insurance plans that cost roughly $21,000 and up starting in 2013. For the sake of fairness, the threshold would vary based on geography and the average age of a company’s work force. In all, something like 10 percent of plans would be subject to the tax in 2013, according to the Center on Budget and Policy Priorities, a research group."
(The complete New York Times story can be found here.)
60% of the American public gets their health benefits through their jobs -- and they’re not “free.” According to the Kaiser Family Foundation, the average American worker with “employer-provided” healthcare pays about 41% of the cost.
So – will benefits be taxed before or after the 41%? Clearly the answer is – before.
And as everyone’s favorite economist, Robert Reich, opines, "According to the Congressional Budget Office, taxing all employee health benefits would yield a whopping $246 billion every year. Even limiting the tax to higher-income employees would go a long way to funding universal health care. Employer-provided health insurance is the biggest tax break in the whole federal income tax system.”
The AFL-CIO’s Gerald Shea, the union’s top healthcare lobbyist, sees the definition of “Cadillac” shifting with time, “People are going to see this as a huge middle-class tax hit.”
The New York Times agrees:
“ … the number of affected plans would grow over time. The Senate has been talking about having the threshold rise each year by the inflation rate plus one percentage point. Since medical spending has been rising much faster than inflation, more and more plans would probably cross the threshold in the years after 2013. Over the next decade, the Congressional Budget Office has estimated that the tax would pay as much as 25 percent of the cost of extending coverage to the uninsured.”
And so does Robert Reich. “So a sensible and politically feasible alternative is to limit tax-free employer-provided health benefits to workers whose incomes are under, say, $100,000 a year, and subject those with higher incomes to progressively higher taxes on them."
Can you say, “mission creep?”
“The leading proposal in the Finance Committee would apply to family insurance plans that cost roughly $21,000 and up starting in 2013. For the sake of fairness, the threshold would vary based on geography and the average age of a company’s work force. In all, something like 10 percent of plans would be subject to the tax in 2013, according to the Center on Budget and Policy Priorities, a research group."
(The complete New York Times story can be found here.)
60% of the American public gets their health benefits through their jobs -- and they’re not “free.” According to the Kaiser Family Foundation, the average American worker with “employer-provided” healthcare pays about 41% of the cost.
So – will benefits be taxed before or after the 41%? Clearly the answer is – before.
And as everyone’s favorite economist, Robert Reich, opines, "According to the Congressional Budget Office, taxing all employee health benefits would yield a whopping $246 billion every year. Even limiting the tax to higher-income employees would go a long way to funding universal health care. Employer-provided health insurance is the biggest tax break in the whole federal income tax system.”
The AFL-CIO’s Gerald Shea, the union’s top healthcare lobbyist, sees the definition of “Cadillac” shifting with time, “People are going to see this as a huge middle-class tax hit.”
The New York Times agrees:
“ … the number of affected plans would grow over time. The Senate has been talking about having the threshold rise each year by the inflation rate plus one percentage point. Since medical spending has been rising much faster than inflation, more and more plans would probably cross the threshold in the years after 2013. Over the next decade, the Congressional Budget Office has estimated that the tax would pay as much as 25 percent of the cost of extending coverage to the uninsured.”
And so does Robert Reich. “So a sensible and politically feasible alternative is to limit tax-free employer-provided health benefits to workers whose incomes are under, say, $100,000 a year, and subject those with higher incomes to progressively higher taxes on them."
Can you say, “mission creep?”
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.
