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

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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Coalition Concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013

As members of the Patient, Consumer, and Public Health Coalition, which includes groups representing physicians, scientists, consumers, and patients, we are writing to express our concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 Continue reading