Latest Drugwonks' Blog
For those of you out there (yes, that means you Marcia Angell) who think we have "too many me-too drugs," consider yesterday's FDA adcomm vote on Avalide.
FDA advisers voted 7-0 in favor of approving the drug for use in controlling high blood pressure. (Avalide was initially approved only for hypertension patients who have failed other types of treatment.)
You've heard of hypertension, right? It's one of those made-up lifestyle diseases.
If the Me-Tooers were running the show, would Avalide have been approved in the first place? After all, do we really need another drug that treats hypertension?
Indeed we do -- and now physicians have a new, valuable, and on-label weapon in their fight against a major public health enemy -- high blood pressure.
FDA advisers voted 7-0 in favor of approving the drug for use in controlling high blood pressure. (Avalide was initially approved only for hypertension patients who have failed other types of treatment.)
You've heard of hypertension, right? It's one of those made-up lifestyle diseases.
If the Me-Tooers were running the show, would Avalide have been approved in the first place? After all, do we really need another drug that treats hypertension?
Indeed we do -- and now physicians have a new, valuable, and on-label weapon in their fight against a major public health enemy -- high blood pressure.
From the FBI.... I might be wrong but I don't see "taking an SSRI" on the list
1. A history of violence and/or being victimized
2. Threats of violence
3. An obsessive interest in weapons
4. A tendency to be isolated
5. The inability to get along with others
6. Excessive anger
7. Job loss
8. Breakup of a relationship
9. Alcohol and drug usage
10. Intolerance of differences
11. Gang affiliation
12. Poor attachment to school
13. Exhibiting impulsive behavior
14. Making violent drawings or writings
1. A history of violence and/or being victimized
2. Threats of violence
3. An obsessive interest in weapons
4. A tendency to be isolated
5. The inability to get along with others
6. Excessive anger
7. Job loss
8. Breakup of a relationship
9. Alcohol and drug usage
10. Intolerance of differences
11. Gang affiliation
12. Poor attachment to school
13. Exhibiting impulsive behavior
14. Making violent drawings or writings
As this story unfolds drugwonks will highlight what appears to be the critical factor in this tragedy in order to stave off the j'accuse from the anti-medication mob who are quick to blame ever senseless act of adolescent violence on the use of drugs to treat mental illness. Now in this case it would appear that the killer was psychotic -- not depressed -- and had been through the entire judicial-mental health system before being allowed go "outpatient" where he completely lost contact with any systematic care.
So we will be interested to see how that squares with efforts by the mob and the media to draw a direct link between a single medication that may or may not have been in his system at the time he carried out his plot and the massacre.
The lunatic fringe, led by Scientologists and quacks peddling 'natural cures' for everything from Alzheimer's to schizophrenia, are already polluting the blogosphere with lies and half truths claiming that Cho Seung-Hui was on SSRIs.
http://vitalvotes.com/blogs/public_blog/Could-Antidepressants-Explain-the-Virginia-Tech-Massacre--10928.aspx
http://winnipeg.indymedia.org/item.php?5048S
As countless studies show, such medications will make people with tendencies towards violence, less not more so.
So we will be interested to see how that squares with efforts by the mob and the media to draw a direct link between a single medication that may or may not have been in his system at the time he carried out his plot and the massacre.
The lunatic fringe, led by Scientologists and quacks peddling 'natural cures' for everything from Alzheimer's to schizophrenia, are already polluting the blogosphere with lies and half truths claiming that Cho Seung-Hui was on SSRIs.
http://vitalvotes.com/blogs/public_blog/Could-Antidepressants-Explain-the-Virginia-Tech-Massacre--10928.aspx
http://winnipeg.indymedia.org/item.php?5048S
As countless studies show, such medications will make people with tendencies towards violence, less not more so.
Our colleague Ed Silverman generated a lot of controversy with his post that rumors that the VA Tech killer was on medication at some point might trigger another attack on drug companies about the alleged dangers of SSRIs.
Here's my take:
While I pin the blame on the media for over-hyping and misrepresenting the risks of SSRI's -- particularly the clinical trials involving children who have co-morbidities, misdiagnoses, etc. -- the fact is tha fear sells paper just as violence sells video games. The fact is, that as horrible as this campus shooting is, school related shootings are rare and violence on college campuses has declined because of increased security, increased counseling, etc., etc. And moreover, according to FBI crime stats, a college campus is ten times safer than than the US as a whole.
While I am on the subject, and excuse me for saying it and maybe I have a little more leeway for saying this because of my own family experience, but I am tired of the press using perpetually enraged parents who blame the death of their kid's on prescription drugs. There are thousands of children who take their own lives who who never get medication and thousands more who have pulled themselves from the abyss because of such drugs. Who are they to lecture the rest of us about the motives of drug companies and science of medicine. I am sorry for their loss but I have been through hell too. They have no monopoly on sorrow and portraying them as victims of antidepressants is inaccurate and unfair. Give it a rest!
You don't want your kids to be on anti-depressants. Fine. But stop pouring gasoline on a subject with ignorance and fear. And don't exploit a tragedy by using it to scare other parents into seeking appropriate care for their kids. As for the media, you have the facts now. Use them.
Here's my take:
While I pin the blame on the media for over-hyping and misrepresenting the risks of SSRI's -- particularly the clinical trials involving children who have co-morbidities, misdiagnoses, etc. -- the fact is tha fear sells paper just as violence sells video games. The fact is, that as horrible as this campus shooting is, school related shootings are rare and violence on college campuses has declined because of increased security, increased counseling, etc., etc. And moreover, according to FBI crime stats, a college campus is ten times safer than than the US as a whole.
While I am on the subject, and excuse me for saying it and maybe I have a little more leeway for saying this because of my own family experience, but I am tired of the press using perpetually enraged parents who blame the death of their kid's on prescription drugs. There are thousands of children who take their own lives who who never get medication and thousands more who have pulled themselves from the abyss because of such drugs. Who are they to lecture the rest of us about the motives of drug companies and science of medicine. I am sorry for their loss but I have been through hell too. They have no monopoly on sorrow and portraying them as victims of antidepressants is inaccurate and unfair. Give it a rest!
You don't want your kids to be on anti-depressants. Fine. But stop pouring gasoline on a subject with ignorance and fear. And don't exploit a tragedy by using it to scare other parents into seeking appropriate care for their kids. As for the media, you have the facts now. Use them.
What if fewer people find out about important new medicines while at the same time critics pan new products and scaremongers push panic about side effects leading to those quacks who sell to good to be true cures to rake in profits at the expense of the sick and scared?
Power abhors a vacuum. So does information.
Power abhors a vacuum. So does information.
In the wake of the terrible tragedy at Virginia Tech comes yet another study demonstrating that the use of anti-depressants in adolescents -- carefully monitored -- are useful in treating various forms of depression, anxiety, panic disorder, etc. No major paper or media outlet which gave David Graham or others front page coverage of the threats or the misrepresentation of the dangers of SSRIs are now giving the benefits of these medications the same top of the fold treatment.
For those of you who want to see how such fear mongering can lead to a decline in the use of effective treatment and therefore an increase in violent behavior that in fact leads to suicide and tragic death, we now present one Graham's typical statements on SSRI's
"With the SSRIs [Selective Serotonin Re-Uptake Inhibitors, the class of antidepressants including Prozac and Paxil], I think FDA pulled a fast one on the American people. Because they said, �we are using our most powerful labeling, our most powerful medicine: we�re putting a black box around it.� But it doesn�t change physician behavior. People are as unsafe after the labeling goes into effect as they were before.
With the SSRI labeling, people are actually more deceived. Because the labeling says that the risk of suicidal thoughts and behavior in children is 1-2 percent. But FDA�s own senior managers admitted at an open public advisory committee meeting that our clinical trials don�t capture suicidal thoughts and behavior. So what we know about it is what has been voluntarily reported. There are lots more out there, we just didn�t measure them. They have evidence from an NIH clinical trial that the risk is more like 8 percent. "
http://multinationalmonitor.org/mm2004/122004/interview-graham.html
Members of Congress and senior officials of the FDA should be ashamed of themselves for giving Graham the chance to not only rant on about Vioxx and SSRIs but to make the same claims about Ketek and drugs for schizophrenia.
For those of you who want to see how such fear mongering can lead to a decline in the use of effective treatment and therefore an increase in violent behavior that in fact leads to suicide and tragic death, we now present one Graham's typical statements on SSRI's
"With the SSRIs [Selective Serotonin Re-Uptake Inhibitors, the class of antidepressants including Prozac and Paxil], I think FDA pulled a fast one on the American people. Because they said, �we are using our most powerful labeling, our most powerful medicine: we�re putting a black box around it.� But it doesn�t change physician behavior. People are as unsafe after the labeling goes into effect as they were before.
With the SSRI labeling, people are actually more deceived. Because the labeling says that the risk of suicidal thoughts and behavior in children is 1-2 percent. But FDA�s own senior managers admitted at an open public advisory committee meeting that our clinical trials don�t capture suicidal thoughts and behavior. So what we know about it is what has been voluntarily reported. There are lots more out there, we just didn�t measure them. They have evidence from an NIH clinical trial that the risk is more like 8 percent. "
http://multinationalmonitor.org/mm2004/122004/interview-graham.html
Members of Congress and senior officials of the FDA should be ashamed of themselves for giving Graham the chance to not only rant on about Vioxx and SSRIs but to make the same claims about Ketek and drugs for schizophrenia.
My latest oped on how Democrats (mostly, but not all) -- led by the incredibly clueless Debbie Stabenow -- are subverting medical science (and proper spelling) for the sake of ideology in the area of pharmaceutical regulation. And it's going to get worse this week and the next when the same Jacobins seek to destroy what is now sensible drug safety legislation with amendments on drug importation and other nonsense. Maybe AARP will offer me another pedometer for calling my Congressman on these important issues.
Or maybe not.
http://washingtontimes.com/op-ed/20070417-091721-8233r.htm
Or maybe not.
http://washingtontimes.com/op-ed/20070417-091721-8233r.htm
A new IMS Health report posits that, “The billions of dollars thrown at global health problems by the Bill & Melinda Gates Foundation are changing the game in drug discovery, posing big challenges to the world's top drug makers.â€
"Pharma companies need to develop an explicit strategy to deal with this phenomenon," IMS said in its annual Intelligence.360 report on factors shaping the industry.
According to the report, the foundation’s $60 billion gives it plentiful resources to compete in the medical research arena with both government-funded institutions and commercial pharmaceutical firms.
IMS believes that, even if drug companies succeed in making key discoveries first, they may still find it attractive to partner with the Gates Foundations, from a practical and public relations point of view.
Well, that’s all to the good – but what the report doesn’t mention is that discovery and development is still a very difficult proposition.
Drugwonks challenges the Gates Foundation to become a major player in the FDA’s Critical Path program – because the best way to get new cures to market faster is to develop the 21st tools required to expedite discovery and development.
Here’s the link to the Reuters story on the IMS report:
http://news.yahoo.com/s/nm/20070417/hl_nm/gates_pharmaceuticals_dc_1
"Pharma companies need to develop an explicit strategy to deal with this phenomenon," IMS said in its annual Intelligence.360 report on factors shaping the industry.
According to the report, the foundation’s $60 billion gives it plentiful resources to compete in the medical research arena with both government-funded institutions and commercial pharmaceutical firms.
IMS believes that, even if drug companies succeed in making key discoveries first, they may still find it attractive to partner with the Gates Foundations, from a practical and public relations point of view.
Well, that’s all to the good – but what the report doesn’t mention is that discovery and development is still a very difficult proposition.
Drugwonks challenges the Gates Foundation to become a major player in the FDA’s Critical Path program – because the best way to get new cures to market faster is to develop the 21st tools required to expedite discovery and development.
Here’s the link to the Reuters story on the IMS report:
http://news.yahoo.com/s/nm/20070417/hl_nm/gates_pharmaceuticals_dc_1
Late last month, an important study in JAMA showed that patients in a high LDL cholesterol group from 130 to 160 did not show a progression of carotid plaque when receiving rosuvastatin compared with control. This study was a breakthrough in terms of primary prevention though the results are not surprising, and many internists, myself included, were already treating many of the members of this group with statins. Carotid plaque is predictive of coronary plaque, and previous studies have shown plaque stabilization with atorvastatin in patients with heart disease leading to a diminishing of subsequent cardiac events. (secondary prevention)
Here is the new JAMA study on rosuvastatin - it would be interesting to follow this up with a study that looked at whether bringing down LDL to less than 80 with diet alone, gave the same results in terms of plaque as when a statin is used.
http://jama.ama-assn.org/cgi/content/full/297/12/1376
Here is the new JAMA study on rosuvastatin - it would be interesting to follow this up with a study that looked at whether bringing down LDL to less than 80 with diet alone, gave the same results in terms of plaque as when a statin is used.
http://jama.ama-assn.org/cgi/content/full/297/12/1376
Markup tomorrow for the Food and Drug Administration Revitalization Act. No importation codicil – but, unfortunately, it may yet appear as a floor amendment.
Some topline highlights:
Title I -- Prescription Drug User Fees
Title I establishes an overall amount for user fees of nearly $393 million for 2008 (which will be adjusted upward based on 2007 workload). It includes the expansion of use of drug user fees by nearly $30 million for post-approval drug safety programs.
Title I also includes the FDA-industry proposal to create a voluntary user fee program under which drug companies can submit direct-to-consumer television advertisements to the agency for review before they are distributed.
Title II -- Drug Safety
Subtitle A -- Risk Evaluation and Mitigation Strategies (REMS)
This subtitle establishes a system of routine active surveillance for post-market drug safety through a public-private partnership. The partnership will aggregate data from Federal and private health databases containing information for at least 100,000,000 covered lives and support the analysis of utilization and safety data from these databases. The establishment of this system will be supported with up to $30 million in appropriations.
Given the ability of this active surveillance system to identify and assess drug risks, most drugs and biologics will not need anything further than this system and the drug label to appropriately manage risk. However, some drugs and biologics will need additional tools to manage serious risks, and these products will be approved with risk evaluation and mitigation strategies (REMS). Sponsors would propose a REMS and FDA would approve it after structured negotiations, if necessary. The REMS will be reviewed at 18 months and three years, as well as in labeling supplements and when FDA requests a review.
Additional Elements —When more is needed, a REMS may include tools to assess, communicate about, or manage risks. The bill contains clear standards detailing the appropriate application of each tool. These standards ensure that new FDA authorities are applied narrowly, and only as necessary.
A REMS would be assessed in response to new information about a serious risk, and could be modified, including by reducing the stringency of elements, in response to new information.
Resources -- Increased drug user fees would be used to review REMS and for FDA’s general drug safety surveillance. This subtitle increases user fee revenue by $50 million over the agreement between industry and the FDA to fund drug safety activities.
Subtitle B -- Reagan-Udall Foundation for the Food and Drug Administration
Subtitle B establishes a foundation to lead collaborations amongst the FDA, academic research institutions, and industry directed to supporting the FDA’s mission. Collaborative research projects will be selected that are designed to bolster R & D productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make regulated product development and safety more predictable and manageable. The Foundation will be financially supported by industry and philanthropic donated funds.
Subtitle C -- Clinical Trials
To enhance patient enrollment and provide a mechanism to track subsequent progress of trials, the data bank at www.clinicaltrials.gov will be expanded to include all phase II and later trials, and to include devices. Currently, only clinical trials of drugs for serious and life threatening conditions are required to register in the data bank.
In addition, to ensure that results of trials are made public, and that patients and providers have the most up-to-date information, results information would be added to this database. Information would be added only after the product in question has been approved or cleared for marketing. Results information would first come from existing FDA and NIH documents, as well as peer-reviewed scientific publications. A negotiated rulemaking process would be used to determine when and how to add results information not captured under those conditions.
Subtitle D -- Conflicts of Interest
Subtitle D requires disclosure of conflicts of interest of advisory committee members prior to an advisory committee meeting, and greater efforts by FDA to identify and recruit members of advisory committees.
Title III -- Medical Device User Fees
Title III is reflective of the agreement between FDA and industry regarding the total list of issues within their agreement from the time of the publication of the Federal Register notice. Given that some of the submitted language does not track the intent of the agreement, we expect to provide further improvements to the language at a later date. Those improvements will be agreed to by both FDA and industry.
Per the agreement between FDA and industry, it establishes an overall amount of $287 M of user fees over five years, with $48 M in 2008. This is coupled with a fixed 8.5% annual increase (with no other adjustors) and a further reduction of fees for small business.
Title III also includes the FDA-industry proposal on third party inspection improvements to ensure that the program works more efficiently and clarifying that entities can register and list electronically.
Title IV -- Pediatric Medical Products
Subtitle A -- Best Pharmaceuticals for Children
Subtitle A would reauthorize the Best Pharmaceuticals for Children Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations. BPCA generally provides six months of additional exclusivity to drug manufactures to encourage the determination of safety and efficacy of drugs in pediatric populations. The bill contains an incentive of three months of additional exclusivity if US sales of the active moiety by the innovator and its affiliates exceed $1 billion annually at the time written request for study is issued. The bill is a five-year authorization and will expire in 2012. No PDUFA funds can be used for BPCA studies. The Secretary may send declined requests for study to the NIH Foundation if funds are available.
Subtitle B -- Pediatric Research Improvement
Subtitle B would reauthorize the Pediatric Research Equity Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations.
In order to improve coordination with the pediatric exclusivity provisions of the Best Pharmaceuticals for Children Act (BPCA), PRIA would consolidate an internal FDA committee to review all issues of pediatric-related labeling and assessments. Doing so ensures that a drug that falls under PRIA or BPCA is reviewed not only by experts for that particular drug, but experts with pediatric expertise. PRIA will sunset in tandem with BPCA in 2012. If a company chooses not to pursue pediatric exclusivity for an already marketed drug under the Best Pharmaceuticals for Children Act, and no study is performed through NIH, then the Secretary has the authority to require the submission of pediatric data for such drug. PRIA streamlines this process and helps get essential pediatric data for important drugs, while preserving the ability of companies to meet and discuss testing with the agency.
The bill would require two reports – one from the Institute of Medicine and one from the GAO – that would allow us to have better data on the number and ways in which the pediatric rule is used, and evaluate its contributions to ensuring overall pediatric drug safety.
Subtitle C -- Pediatric Medical Devices
Subtitle C modifies the existing humanitarian device exemption (HDE) for medical devices to allow profit for HDE-approved devices specifically designed to meet a pediatric need. Maintains existing requirement that a humanitarian use device is limited to one that treats and diagnoses diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year. No profit will be allowed for a device used in more than 4,000 individuals. The HDE exemption expansion sunsets in 2013 and a GAO report assessing the HDE exemption expansion and its impact on patients and manufacturers is required.
The FDA’s Office of Pediatric Therapeutics will acquire enhanced authority to collaborate with NIH, AHRQ, and subject matter experts in order to assess pediatric device R&D needs.
Demonstration grants, with tracked results, will be established for non-profit consortia to promote pediatric device development, manufacture and distribution. The bill grants explicit authority to the FDA’s Pediatric Advisory Committee to monitor pediatric devices and make recommendations for improving their availability and safety. This approach incorporates several recommendations of the Institute of Medicine including improving the postmarket surveillance of medical devices used in children and expanding public access to postmarket studies of pediatric medical devices.
Still plowing through the details – more to follow.
FDA package posted here:
http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf
Have a look and let the debate begin!
Some topline highlights:
Title I -- Prescription Drug User Fees
Title I establishes an overall amount for user fees of nearly $393 million for 2008 (which will be adjusted upward based on 2007 workload). It includes the expansion of use of drug user fees by nearly $30 million for post-approval drug safety programs.
Title I also includes the FDA-industry proposal to create a voluntary user fee program under which drug companies can submit direct-to-consumer television advertisements to the agency for review before they are distributed.
Title II -- Drug Safety
Subtitle A -- Risk Evaluation and Mitigation Strategies (REMS)
This subtitle establishes a system of routine active surveillance for post-market drug safety through a public-private partnership. The partnership will aggregate data from Federal and private health databases containing information for at least 100,000,000 covered lives and support the analysis of utilization and safety data from these databases. The establishment of this system will be supported with up to $30 million in appropriations.
Given the ability of this active surveillance system to identify and assess drug risks, most drugs and biologics will not need anything further than this system and the drug label to appropriately manage risk. However, some drugs and biologics will need additional tools to manage serious risks, and these products will be approved with risk evaluation and mitigation strategies (REMS). Sponsors would propose a REMS and FDA would approve it after structured negotiations, if necessary. The REMS will be reviewed at 18 months and three years, as well as in labeling supplements and when FDA requests a review.
Additional Elements —When more is needed, a REMS may include tools to assess, communicate about, or manage risks. The bill contains clear standards detailing the appropriate application of each tool. These standards ensure that new FDA authorities are applied narrowly, and only as necessary.
A REMS would be assessed in response to new information about a serious risk, and could be modified, including by reducing the stringency of elements, in response to new information.
Resources -- Increased drug user fees would be used to review REMS and for FDA’s general drug safety surveillance. This subtitle increases user fee revenue by $50 million over the agreement between industry and the FDA to fund drug safety activities.
Subtitle B -- Reagan-Udall Foundation for the Food and Drug Administration
Subtitle B establishes a foundation to lead collaborations amongst the FDA, academic research institutions, and industry directed to supporting the FDA’s mission. Collaborative research projects will be selected that are designed to bolster R & D productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make regulated product development and safety more predictable and manageable. The Foundation will be financially supported by industry and philanthropic donated funds.
Subtitle C -- Clinical Trials
To enhance patient enrollment and provide a mechanism to track subsequent progress of trials, the data bank at www.clinicaltrials.gov will be expanded to include all phase II and later trials, and to include devices. Currently, only clinical trials of drugs for serious and life threatening conditions are required to register in the data bank.
In addition, to ensure that results of trials are made public, and that patients and providers have the most up-to-date information, results information would be added to this database. Information would be added only after the product in question has been approved or cleared for marketing. Results information would first come from existing FDA and NIH documents, as well as peer-reviewed scientific publications. A negotiated rulemaking process would be used to determine when and how to add results information not captured under those conditions.
Subtitle D -- Conflicts of Interest
Subtitle D requires disclosure of conflicts of interest of advisory committee members prior to an advisory committee meeting, and greater efforts by FDA to identify and recruit members of advisory committees.
Title III -- Medical Device User Fees
Title III is reflective of the agreement between FDA and industry regarding the total list of issues within their agreement from the time of the publication of the Federal Register notice. Given that some of the submitted language does not track the intent of the agreement, we expect to provide further improvements to the language at a later date. Those improvements will be agreed to by both FDA and industry.
Per the agreement between FDA and industry, it establishes an overall amount of $287 M of user fees over five years, with $48 M in 2008. This is coupled with a fixed 8.5% annual increase (with no other adjustors) and a further reduction of fees for small business.
Title III also includes the FDA-industry proposal on third party inspection improvements to ensure that the program works more efficiently and clarifying that entities can register and list electronically.
Title IV -- Pediatric Medical Products
Subtitle A -- Best Pharmaceuticals for Children
Subtitle A would reauthorize the Best Pharmaceuticals for Children Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations. BPCA generally provides six months of additional exclusivity to drug manufactures to encourage the determination of safety and efficacy of drugs in pediatric populations. The bill contains an incentive of three months of additional exclusivity if US sales of the active moiety by the innovator and its affiliates exceed $1 billion annually at the time written request for study is issued. The bill is a five-year authorization and will expire in 2012. No PDUFA funds can be used for BPCA studies. The Secretary may send declined requests for study to the NIH Foundation if funds are available.
Subtitle B -- Pediatric Research Improvement
Subtitle B would reauthorize the Pediatric Research Equity Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations.
In order to improve coordination with the pediatric exclusivity provisions of the Best Pharmaceuticals for Children Act (BPCA), PRIA would consolidate an internal FDA committee to review all issues of pediatric-related labeling and assessments. Doing so ensures that a drug that falls under PRIA or BPCA is reviewed not only by experts for that particular drug, but experts with pediatric expertise. PRIA will sunset in tandem with BPCA in 2012. If a company chooses not to pursue pediatric exclusivity for an already marketed drug under the Best Pharmaceuticals for Children Act, and no study is performed through NIH, then the Secretary has the authority to require the submission of pediatric data for such drug. PRIA streamlines this process and helps get essential pediatric data for important drugs, while preserving the ability of companies to meet and discuss testing with the agency.
The bill would require two reports – one from the Institute of Medicine and one from the GAO – that would allow us to have better data on the number and ways in which the pediatric rule is used, and evaluate its contributions to ensuring overall pediatric drug safety.
Subtitle C -- Pediatric Medical Devices
Subtitle C modifies the existing humanitarian device exemption (HDE) for medical devices to allow profit for HDE-approved devices specifically designed to meet a pediatric need. Maintains existing requirement that a humanitarian use device is limited to one that treats and diagnoses diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year. No profit will be allowed for a device used in more than 4,000 individuals. The HDE exemption expansion sunsets in 2013 and a GAO report assessing the HDE exemption expansion and its impact on patients and manufacturers is required.
The FDA’s Office of Pediatric Therapeutics will acquire enhanced authority to collaborate with NIH, AHRQ, and subject matter experts in order to assess pediatric device R&D needs.
Demonstration grants, with tracked results, will be established for non-profit consortia to promote pediatric device development, manufacture and distribution. The bill grants explicit authority to the FDA’s Pediatric Advisory Committee to monitor pediatric devices and make recommendations for improving their availability and safety. This approach incorporates several recommendations of the Institute of Medicine including improving the postmarket surveillance of medical devices used in children and expanding public access to postmarket studies of pediatric medical devices.
Still plowing through the details – more to follow.
FDA package posted here:
http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf
Have a look and let the debate begin!
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.
