Letter to Congressman Cooper strongly supporting the Research for All Act of 2014

June 5, 2014. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Research for All Act. It would require the FDA to develop policies to ensure that clinical trials for medical products granted expedited approval are sufficient in design and size to determine the safety and effectiveness for men and women, using subgroup analysis. Continue reading

Letter to Majority Leader Reid Supporting the repeal of the Excise Tax on Medical Devices

June 4, 2014. As members of the Patient, Consumer, and Public Health Coalition, we thank you for being an outstanding champion of the Affordable Care Act (ACA), and we strongly support your position that a repeal of the 2.3% excise tax on medical devices should not be included in the Tax Extenders Act. Continue reading

Comments of the National Center for Health Research On proposed order “Physical Medicine Devices: Reclassification and Renaming of Shortwave Diathermy of All Other Uses”

To view as PDF, click here.   Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852   May 21, 2014 Comments of the National Center for Health Research On proposed order “Physical Medicine … Continue reading

Letter to FDA Commissioner Hamburg About Approving Cobas HPV Test Alone (Without Pap Smear) and FDA Response, April 2014

April 11, 2014. We are writing as members of the Patient, Consumer, and Public Health Coalition and other interested experts to express our grave concerns about the March 12, 2014 FDA meeting of the Microbiology Medical Devices Panel of the Medical Devices Advisory Committee. Under consideration was the premarket approval of a new indication for the Cobas HPV test, as a first-line primary screening tool for cervical cancer in women aged 25 and older.
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Statement of Laurén Doamekpor on the Importance of Including Women, Minorities, and the Elderly in Studies of the Safety and Effectiveness of New Drugs and Devices (FDASIA Section 907 Hearing)

The responsibility of collecting sufficiently representative demographic subgroup data sits solely on the shoulders of device and drug companies. The companies know how to persuade – they do it everyday in commercials. Similarly, if they identify persuasive incentives for patients to participate in studies, and minimize disincentives, patients will participate and be available for follow-up. Continue reading