We have reviewed the vaccine information statement and we have suggested revisions for the wording and content of the Vaccine Information Statement. It is important that the statement concisely describe the benefits and risks associated with the vaccine. But it is equally important that the statement provide all the essential information about the vaccine.
We support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling.
FDA should test drop-rail cribs for safety, since there are well-established and serious risks. We oppose the FDA proposed rule as currently written because it would not require any safety testing data be reviewed by the FDA. However, even if that part of the proposed rule were revised, the proposed rule would still create an enormous loophole that would allow widespread use of cribs outside of healthcare settings, as noted above.
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We are concerned about the establishment of a stand-alone Patient Engagement Advisory Committee for medical devices. It is not clear whether this committee will isolate rather than integrate the voices of patients into CDRH decision-making. We support both patient representatives and consumer representatives becoming voting members on the current medical device advisory committee with its 18 panels.
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We strongly support the FDA’s use of objective usability evidence and requiring labels to be written at an appropriate reading level that is easy and interesting to read. However, FDA should focus more on key issues around “advancing development” of labels such as noting on the label if risks and benefits were determined with surrogate endpoints, whether clinical trials were conducted, and whether the device was analyzed on subpopulations.
We believe that pregnant women’s daily exposures to phthalates since 2005-6 are likely to be similar to other women of reproductive age (WORA). The new report indicates that some of those exposures have increased and others have decreased, presumably reflecting changes in products more than changes in women’s habits. It is alarming that the daily intake of DINP has increased. We strongly support the plan to make the interim ban on DINP a permanent one.
The Patient, Consumer, and Public Health Coalition presented this comment on the draft report Standardization of Risk Evaluation and Mitigation Strategies. As part of its PDUFA V commitments, the Food and Drug Administration agreed in closed door meetings with industry “to explore greater standardization of REMS…with the aim of reducing the implementation burden of REMS for practitioners, patients, and others in various health care settings.”
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The Honorable Jim Cooper 1536 Longworth HOB Washington, DC 20515 Re: Members of the Patient, Consumer, and Public Health Coalition strongly support the Research for All Act of 2014. Dear Congressman Cooper, As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Research for All Act. It would require the FDA
Jeffrey Shuren, Director Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD 20993 Dear Dr. Shuren, The Patient, Consumer, and Public Health Coalition strongly supports the implementation of the Unique Device Identification (UDI) system, which was part of the Center for Devices and Radiological Health’s (CDRH) 510(k) and Science Report Recommendations
