Author name: PCeditor

Public Comments to CMS on Aduhelm for the Treatment of Alzheimer’s Disease

We strongly support the CMS proposed decision to limit the coverage of these drugs to patients participating in clinical trials, because it will provide the evidence needed regarding safety and effectiveness for the Medicare population. We agree with CMS that this will enable patients and family members to make informed decisions based on unbiased information pertaining to the known risks and as yet unproven benefits. 

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Public Comments on FDA’s Generic Drugs Commitment Letter

We believe that the proposed recommendations must do more to ensure that generic drugs are providing an equally beneficial treatment for patients and consumers. We appreciate the efforts of the agency to work toward those ends, but as long as patients and consumers are excluded from the GDUFA negotiations, the concerns and priorities of these principal stakeholders will also be excluded.

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Patient and Consumer Stakeholder Consultation Meeting, MDUFA V Reauthorization

It is vitally important that the treatments approved by the FDA are proven to be both safe and effective for all patients. The only way this can be accomplished is through increased diversity and improved equity. There also is a need to improve overall accessibility to information related to medical device development and approval.

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Letter to Congresswoman DeGette Expressing Concerns About 21st Century Cures

At the recent E&C Subcommittee on Health markup of the 21st Century Cures Act, Committee Ranking Member Frank Pallone stated that the Act was “far from a finished product,” and the Health Subcommittee Ranking Member Gene Green said there is “still work to do.”  We agree. Several sections of the Act would lower standards for the approval of antibiotics, medical devices, and most prescription drugs – putting patients at unnecessary risk of injury or death. 

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Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent

FDA has been slow to recognize the full impact of BIA-ACL and needs to do more to protect women from it. The delayed intervention of the FDA and surgeons everywhere on this matter is too serious to ignore.  For those women who were barely informed of these severe risks, it has had terrible and sometimes fatal consequences.

Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent Read More »

Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Vaginal Mesh

Our Coalition strongly supports FDA’s decision to require a pre-market approval review, including clinical trials, to determine the long-term safety and effectiveness of trans-vaginal mesh for pelvic organ prolapse repair. These products were initially allowed on to the market as substantially equivalent to mesh used in other parts of the body, under the 510(k) approval pathway that does not usually require clinical trials or direct scientific evidence of safety or effectiveness.

Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Vaginal Mesh Read More »

Comments to FDA against removal of the black box warning for Chantix

Patients deserve access to smoking cessation treatments, but they also deserve warnings about the risks.  There remains considerable credible evidence that some patients are severely harmed by Chantix and Zyban, and those patients’ lives depend on warnings about the risks, so they will recognize that sudden suicidal, paranoid, or violent thoughts are side effects of the drugs.

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Testimony Before Maryland Senate Regarding the Dangers of Artificial Turf

We strongly support SB 0763, which would prohibit the use of state funds for artificial turf fields and playgrounds. At the House hearing on the companion bill, HB 505, I heard testimony from individuals who misrepresented the evidence regarding the safety of recycled tire material, other synthetic rubber, and other synthetic materials on playing fields and playgrounds. 

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