Uncategorized – Page 3 – Patient, Consumer, and Public Health Coalition

Comments on “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications”

December 15, 2015 April 26, 2022

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.

Comments on Classification of Medical Cribs

December 7, 2015 April 26, 2022

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.

Comments on the Establishment of the Patient Engagement Advisory Committee

November 20, 2015 April 26, 2022

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.

Comments of members of the Patient, Consumer, and Public Health Coalition on Medical Device Patient Labeling

October 30, 2015 April 26, 2022

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.

Comments on Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age

August 7, 2015 April 26, 2022

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.

Comments on Standardization of Risk Evaluation and Mitigation Strategies

November 24, 2014 April 28, 2022

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.”

Members of the Patient, Consumer, and Public Health Coalition strongly support the Research for All Act of 2014

June 5, 2014 April 15, 2022

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 …

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Letter to the Center for Devices and Radiological Health on the Implementation of the Unique Device Identification (UDI) System

August 18, 2011 April 15, 2022

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 …

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