Author name: PCeditor

Comments from the Coalition on research entitled “Disclosure Regarding Additional Risks in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements”

We applaud FDA’s efforts to clearly and effectively communicate risks and benefits to consumers in direct-to-consumer (DTC) advertisements.  However, we are concerned about this study’s definition of “serious and actionable” risks, the diversity of the population being studied, the administration of the study in an online setting only, and the timing of the major statement in the ad (at the end of the ad instead of the beginning or middle).

Comments from the Coalition on research entitled “Disclosure Regarding Additional Risks in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements” Read More »

Letter to FDA Commissioner Margaret Hamburg Re: Microbiology Medical Devices Panel on Cobas HPV Test Premarket Approval Application

This proposed indication for the HPV test would represent an unprecedented and significant shift in clinical practice that would affect millions of women for the majority of their adult lives.  With the health of so many at stake, we strongly urge the FDA to reject the application for this expanded indication, until evidence clearly indicates that this will not reduce the effectiveness of screening for cervical cancer.

Letter to FDA Commissioner Margaret Hamburg Re: Microbiology Medical Devices Panel on Cobas HPV Test Premarket Approval Application Read More »

Comments on Proposed Order That Splits Cardiovascular Device into Two Classifications

We strongly support the FDA’s proposed order for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support devices to remain in Class III with Premarket Approval applications (PMA) required. The evidence of safety and effectiveness for these indications has not been established, and the benefit/risk profile for these devices is “unknown.”

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Letter to the Accredited Standards Committee X12 Chair Margaret Weiker in Strong Support for Updated Standards for the New Unique Device Identifier (UDI) System

The Patient, Consumer, and Public Health Coalition, which includes groups representing physicians, scientists, consumers, and patients, writes to express our strong support for updated standards that will enable the capture and transmission of the new unique device identifier(UDI) system in the claims transaction.

Letter to the Accredited Standards Committee X12 Chair Margaret Weiker in Strong Support for Updated Standards for the New Unique Device Identifier (UDI) System Read More »

Letter to Representative Slaughter in strong support of H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act

The Patient, Consumer, and Public Health Coalition, we strongly support H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act.  The Act would help to preserve the effectiveness of antimicrobials used to treat diseases in both animals and humans.

Letter to Representative Slaughter in strong support of H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act Read More »

Letter of Opposition for the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014

The Patient, Consumer, and Public Health Coalition strongly opposes the Preventing Regulatory Overreach To Enhance Care Technology (PROECT) Act of 2014.  The Act, as drafted, would have the harmful consequence of exempting so-called “health software” and “clinical software” devices from FDA oversight.  Also, the Act is premature.  Congress is awaiting a study commissioned in 2012 to guide policymakers on this very issue.

Letter of Opposition for the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014 Read More »

Letter to Chairman Harkin on Opposition on the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014

As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the Preventing Regulatory Overrreach To Enhance Care Technology (PROTECT) Act of 2014.  The Act, as drafted, would have the harmful consequence of exempting so-called “health software” and “clinical software” devices from FDA oversight.  Also, the Act is premature.  Congress is awaiting a study commissioned in 2012 to guide policymakers on this very issue.

Letter to Chairman Harkin on Opposition on the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014 Read More »