Exemplary quotes regarding FDA, CMS, and tensions between them as revealed by aducanumab
| Due to how it handled aducanumab, FDA is viewed ... | |
| … unfavorably. | • ‘Unfortunately this decision throws into doubt the discretion of the FDA, an agency that was historically trusted to make good medical decisions.’ (Academic (including researchers)) • ‘The FDA’s reputation has been hurt in recent years, and this decision compounds that problem.’ (Medicare beneficiary) • ‘This rushed approval only highlights there are serious questions as to motivation for drug approval at the FDA. This rush to approve Aduhelm did manage to underscore the unwholesome connection between the developer of the drug, Biogen, and the FDA in their after-the-fact marginalized analyses of the phase 3 trials, which had already shown the drug as ineffectual.’ (Not specified) |
| … favorably. | • ‘With the approval of Aduhelm, Biogen and the FDA have lit a bright candle of hope for our entire community.’ (Person living with Alzheimer’s disease; Alzheimer’s patient advocacy organization) • This FDA approval offered new hope for Alzheimer’s patients and their loved ones since Aduhelm is the first and only treatment that targets the pathology of the disease: amyloid beta plaques in the brain. (Clinical society/organization) |
| Due to how it handled aducanumab, CMS is viewed … | |
| … unfavorably. | • ‘The NCD proposed by CMS is an unprecedented and capricious effort to regulate drugs in a manner that invades the FDA’s jurisdiction, violates CMS’s own regulations and long-standing practices, and denies more than a million potential patients’ coverage to label for the first approved therapy for AD in 20 years.’ (Alzheimer’s patient advocacy organization) • ‘Medicare/Medicaid should absolutely continue covering this medication to treat Alzheimer’s Disease. To do otherwise is morally irresponsible and would deny folks the potential benefits being offered from this specific treatment.’ (Not specified) |
| … favorably. | • ‘Your decision on restricting the use of anucanumab to research and the select people who might benefit from it shows you value good science over political pressure (from the Alzheimer’s Association). I understand the frustration people have about having such limited pharmaceutical options, but a questionably beneficial drug is worse than no drug.’ (Not specified) • ‘Bravo for our good colleagues at CMS for denying approval of Aduhelm—and Big Pharma’s corporate patient-exploitive products whose side-effects outweigh their benefits—and for preserving best standards of evidence-based patient-centered care and practices.’ (Clinician or other health care worker) |
| FDA and CMS are in tension because … | |
| … CMS is correcting FDA’s mistakes. | • ‘Professionally I believe FDA’s approval of this drug was a travesty, and frankly was enormously relieved when CMS imposed appropriate constraints on Aducanumab’s use and re-imbursements.’ (Clinician or other health care worker) • ‘Thank you for putting some brakes on the FDA’s ill-considered approval of Aduhelm by requiring evidence Aduhelm provides clinically meaningful benefit before agreeing to pay for it.’ (Family member/caregiver of person living with Alzheimer’s disease) |
| … CMS is undermining FDA. | • `The draft NCD sends a signal that the CMS can effectively set aside the FDA’s approval of a new therapy and require a duplicative system for its own re-evaluation of the evidence upon which an approval is based. This proposed approach disregards the primacy of the FDA’s jurisdiction as therapy regulator, its critical role in overseeing trial design (endpoint selection, methodology, target product profile, and biomarker selection, to name a few areas), and its benefit/risk determination based on significant scientific expertise in the relevant disease state.' (Other advocacy organization) • ‘[T]he current proposal inappropriately undermines FDA’s Accelerated Approval pathway. This pathway enables therapies for serious, life limiting conditions to be approved and available to patients more expeditiously and relies on scientifically validated surrogate endpoints.’ (Pharmaceutical company/industry association) |
| Due to how it handled aducanumab, FDA is viewed ... | |
| … unfavorably. | • ‘Unfortunately this decision throws into doubt the discretion of the FDA, an agency that was historically trusted to make good medical decisions.’ (Academic (including researchers)) • ‘The FDA’s reputation has been hurt in recent years, and this decision compounds that problem.’ (Medicare beneficiary) • ‘This rushed approval only highlights there are serious questions as to motivation for drug approval at the FDA. This rush to approve Aduhelm did manage to underscore the unwholesome connection between the developer of the drug, Biogen, and the FDA in their after-the-fact marginalized analyses of the phase 3 trials, which had already shown the drug as ineffectual.’ (Not specified) |
| … favorably. | • ‘With the approval of Aduhelm, Biogen and the FDA have lit a bright candle of hope for our entire community.’ (Person living with Alzheimer’s disease; Alzheimer’s patient advocacy organization) • This FDA approval offered new hope for Alzheimer’s patients and their loved ones since Aduhelm is the first and only treatment that targets the pathology of the disease: amyloid beta plaques in the brain. (Clinical society/organization) |
| Due to how it handled aducanumab, CMS is viewed … | |
| … unfavorably. | • ‘The NCD proposed by CMS is an unprecedented and capricious effort to regulate drugs in a manner that invades the FDA’s jurisdiction, violates CMS’s own regulations and long-standing practices, and denies more than a million potential patients’ coverage to label for the first approved therapy for AD in 20 years.’ (Alzheimer’s patient advocacy organization) • ‘Medicare/Medicaid should absolutely continue covering this medication to treat Alzheimer’s Disease. To do otherwise is morally irresponsible and would deny folks the potential benefits being offered from this specific treatment.’ (Not specified) |
| … favorably. | • ‘Your decision on restricting the use of anucanumab to research and the select people who might benefit from it shows you value good science over political pressure (from the Alzheimer’s Association). I understand the frustration people have about having such limited pharmaceutical options, but a questionably beneficial drug is worse than no drug.’ (Not specified) • ‘Bravo for our good colleagues at CMS for denying approval of Aduhelm—and Big Pharma’s corporate patient-exploitive products whose side-effects outweigh their benefits—and for preserving best standards of evidence-based patient-centered care and practices.’ (Clinician or other health care worker) |
| FDA and CMS are in tension because … | |
| … CMS is correcting FDA’s mistakes. | • ‘Professionally I believe FDA’s approval of this drug was a travesty, and frankly was enormously relieved when CMS imposed appropriate constraints on Aducanumab’s use and re-imbursements.’ (Clinician or other health care worker) • ‘Thank you for putting some brakes on the FDA’s ill-considered approval of Aduhelm by requiring evidence Aduhelm provides clinically meaningful benefit before agreeing to pay for it.’ (Family member/caregiver of person living with Alzheimer’s disease) |
| … CMS is undermining FDA. | • `The draft NCD sends a signal that the CMS can effectively set aside the FDA’s approval of a new therapy and require a duplicative system for its own re-evaluation of the evidence upon which an approval is based. This proposed approach disregards the primacy of the FDA’s jurisdiction as therapy regulator, its critical role in overseeing trial design (endpoint selection, methodology, target product profile, and biomarker selection, to name a few areas), and its benefit/risk determination based on significant scientific expertise in the relevant disease state.' (Other advocacy organization) • ‘[T]he current proposal inappropriately undermines FDA’s Accelerated Approval pathway. This pathway enables therapies for serious, life limiting conditions to be approved and available to patients more expeditiously and relies on scientifically validated surrogate endpoints.’ (Pharmaceutical company/industry association) |
Exemplary quotes regarding FDA, CMS, and tensions between them as revealed by aducanumab
| Due to how it handled aducanumab, FDA is viewed ... | |
| … unfavorably. | • ‘Unfortunately this decision throws into doubt the discretion of the FDA, an agency that was historically trusted to make good medical decisions.’ (Academic (including researchers)) • ‘The FDA’s reputation has been hurt in recent years, and this decision compounds that problem.’ (Medicare beneficiary) • ‘This rushed approval only highlights there are serious questions as to motivation for drug approval at the FDA. This rush to approve Aduhelm did manage to underscore the unwholesome connection between the developer of the drug, Biogen, and the FDA in their after-the-fact marginalized analyses of the phase 3 trials, which had already shown the drug as ineffectual.’ (Not specified) |
| … favorably. | • ‘With the approval of Aduhelm, Biogen and the FDA have lit a bright candle of hope for our entire community.’ (Person living with Alzheimer’s disease; Alzheimer’s patient advocacy organization) • This FDA approval offered new hope for Alzheimer’s patients and their loved ones since Aduhelm is the first and only treatment that targets the pathology of the disease: amyloid beta plaques in the brain. (Clinical society/organization) |
| Due to how it handled aducanumab, CMS is viewed … | |
| … unfavorably. | • ‘The NCD proposed by CMS is an unprecedented and capricious effort to regulate drugs in a manner that invades the FDA’s jurisdiction, violates CMS’s own regulations and long-standing practices, and denies more than a million potential patients’ coverage to label for the first approved therapy for AD in 20 years.’ (Alzheimer’s patient advocacy organization) • ‘Medicare/Medicaid should absolutely continue covering this medication to treat Alzheimer’s Disease. To do otherwise is morally irresponsible and would deny folks the potential benefits being offered from this specific treatment.’ (Not specified) |
| … favorably. | • ‘Your decision on restricting the use of anucanumab to research and the select people who might benefit from it shows you value good science over political pressure (from the Alzheimer’s Association). I understand the frustration people have about having such limited pharmaceutical options, but a questionably beneficial drug is worse than no drug.’ (Not specified) • ‘Bravo for our good colleagues at CMS for denying approval of Aduhelm—and Big Pharma’s corporate patient-exploitive products whose side-effects outweigh their benefits—and for preserving best standards of evidence-based patient-centered care and practices.’ (Clinician or other health care worker) |
| FDA and CMS are in tension because … | |
| … CMS is correcting FDA’s mistakes. | • ‘Professionally I believe FDA’s approval of this drug was a travesty, and frankly was enormously relieved when CMS imposed appropriate constraints on Aducanumab’s use and re-imbursements.’ (Clinician or other health care worker) • ‘Thank you for putting some brakes on the FDA’s ill-considered approval of Aduhelm by requiring evidence Aduhelm provides clinically meaningful benefit before agreeing to pay for it.’ (Family member/caregiver of person living with Alzheimer’s disease) |
| … CMS is undermining FDA. | • `The draft NCD sends a signal that the CMS can effectively set aside the FDA’s approval of a new therapy and require a duplicative system for its own re-evaluation of the evidence upon which an approval is based. This proposed approach disregards the primacy of the FDA’s jurisdiction as therapy regulator, its critical role in overseeing trial design (endpoint selection, methodology, target product profile, and biomarker selection, to name a few areas), and its benefit/risk determination based on significant scientific expertise in the relevant disease state.' (Other advocacy organization) • ‘[T]he current proposal inappropriately undermines FDA’s Accelerated Approval pathway. This pathway enables therapies for serious, life limiting conditions to be approved and available to patients more expeditiously and relies on scientifically validated surrogate endpoints.’ (Pharmaceutical company/industry association) |
| Due to how it handled aducanumab, FDA is viewed ... | |
| … unfavorably. | • ‘Unfortunately this decision throws into doubt the discretion of the FDA, an agency that was historically trusted to make good medical decisions.’ (Academic (including researchers)) • ‘The FDA’s reputation has been hurt in recent years, and this decision compounds that problem.’ (Medicare beneficiary) • ‘This rushed approval only highlights there are serious questions as to motivation for drug approval at the FDA. This rush to approve Aduhelm did manage to underscore the unwholesome connection between the developer of the drug, Biogen, and the FDA in their after-the-fact marginalized analyses of the phase 3 trials, which had already shown the drug as ineffectual.’ (Not specified) |
| … favorably. | • ‘With the approval of Aduhelm, Biogen and the FDA have lit a bright candle of hope for our entire community.’ (Person living with Alzheimer’s disease; Alzheimer’s patient advocacy organization) • This FDA approval offered new hope for Alzheimer’s patients and their loved ones since Aduhelm is the first and only treatment that targets the pathology of the disease: amyloid beta plaques in the brain. (Clinical society/organization) |
| Due to how it handled aducanumab, CMS is viewed … | |
| … unfavorably. | • ‘The NCD proposed by CMS is an unprecedented and capricious effort to regulate drugs in a manner that invades the FDA’s jurisdiction, violates CMS’s own regulations and long-standing practices, and denies more than a million potential patients’ coverage to label for the first approved therapy for AD in 20 years.’ (Alzheimer’s patient advocacy organization) • ‘Medicare/Medicaid should absolutely continue covering this medication to treat Alzheimer’s Disease. To do otherwise is morally irresponsible and would deny folks the potential benefits being offered from this specific treatment.’ (Not specified) |
| … favorably. | • ‘Your decision on restricting the use of anucanumab to research and the select people who might benefit from it shows you value good science over political pressure (from the Alzheimer’s Association). I understand the frustration people have about having such limited pharmaceutical options, but a questionably beneficial drug is worse than no drug.’ (Not specified) • ‘Bravo for our good colleagues at CMS for denying approval of Aduhelm—and Big Pharma’s corporate patient-exploitive products whose side-effects outweigh their benefits—and for preserving best standards of evidence-based patient-centered care and practices.’ (Clinician or other health care worker) |
| FDA and CMS are in tension because … | |
| … CMS is correcting FDA’s mistakes. | • ‘Professionally I believe FDA’s approval of this drug was a travesty, and frankly was enormously relieved when CMS imposed appropriate constraints on Aducanumab’s use and re-imbursements.’ (Clinician or other health care worker) • ‘Thank you for putting some brakes on the FDA’s ill-considered approval of Aduhelm by requiring evidence Aduhelm provides clinically meaningful benefit before agreeing to pay for it.’ (Family member/caregiver of person living with Alzheimer’s disease) |
| … CMS is undermining FDA. | • `The draft NCD sends a signal that the CMS can effectively set aside the FDA’s approval of a new therapy and require a duplicative system for its own re-evaluation of the evidence upon which an approval is based. This proposed approach disregards the primacy of the FDA’s jurisdiction as therapy regulator, its critical role in overseeing trial design (endpoint selection, methodology, target product profile, and biomarker selection, to name a few areas), and its benefit/risk determination based on significant scientific expertise in the relevant disease state.' (Other advocacy organization) • ‘[T]he current proposal inappropriately undermines FDA’s Accelerated Approval pathway. This pathway enables therapies for serious, life limiting conditions to be approved and available to patients more expeditiously and relies on scientifically validated surrogate endpoints.’ (Pharmaceutical company/industry association) |
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