PCeditor

Letter to Department of Health and Mental Hygiene in Support of Ban on Crib Bumpers

We strongly support the proposed ban. The risks of bumper pads in cribs are real (suffocation, strangulations, and entrapment) while the benefits are essentially nonexistent. The four doctors on Maryland’s expert advisory panel regarding crib baby bumpers concluded that there was no evidence for meaningful benefits of bumper pads to infants. This ban will help to protect more than 70,000 babies born in Maryland each year.

Comments on Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose

We have concerns about clearing a group of devices through the 510(K) process for one use and through a more rigorous process for a different use.  In addition, the Food and Drug Administration’s (FDA’s) proposal for these devices raises fundamental questions about whether the Center for Devices and Radiological Health is following the law regarding the regulation of devices that are life-sustaining or life-supporting.

Comments Regarding the Medical Device User Fee Act

The coalition advocates with Congress for increased funding for the FDA to ensure the agency has the resources it needs to carry out its mission of protecting and promoting the public health.

Letter to the House of Representatives Energy and Commerce Committee and Health Subcommittee about the Generating Antibiotic Incentives Now (GAIN) Bill

The nonprofit Patient, Consumer, and Public Health Coalition shares concerns about the need for new antibiotics. The Generating Antibiotic Incentives Now (GAIN) bill focuses on providing incentives to pharmaceutical companies, which is important. However, some antibiotics are much more important than others, and the bill may have unintended consequences for increasing AMR.

Comments to the Centers for Medicare and Medicaid Services on Transparency Reports and Reporting of Physician Ownership or Investment Interests

We agree with the Institute of Medicine and the Medicare Payment Advisory Commission (MedPAC) that “enhanced disclosure and transparency [is needed] to discourage the inappropriate use of financial incentives and lessen the risk of such incentives interfering with medical judgment and patient care.” While we strongly support the proposed rule overall, there are several major loopholes that need to be fixed.

Letter to the House Committee on Energy and Commerce in Support for the Safety of Untested and New Devices (SOUND Devices) Act of 2012

As members of the Patient, Consumer, and Public Health Coalition, we want to express our strong support for H.R. 3847, the Safety of Untested and New Devices (SOUND Devices) Act of 2012.  This legislation will protect the public from avoidable harms caused by unsafe devices that should never have been cleared for sale in the first place.  It will also help to ensure that decisions on device safety are based on more reliable information.

​​Comments on Proposed Rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices).  These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices.

Letter to the FDA and Commissioner Hamburg in Support of the Filing of Premarket Approval for the Implantable Pacemaker Pulse Generator

We strongly support the FDA’s proposal to require the filing of a premarket approval application (PMA) for the implantable pacemaker pulse generator, a class III pre-amendments device. We agree with report on the 510(k) process’s recommendations 7-8, which state that the FDA should promptly call for PMA applications or reclassify the Class III devices that are still cleared by the 510(k) process.  The implantable pacemaker pulse generator is one of those Class III devices alluded to by GAO and IOM.

Comments of Members of the Patient, Consumer, and Public Health Coalition FDA’s Center for Devices and Radiological Health 510(k) Clearance Process: Recommendations Proposed in Institute of Medicine

We support the Institute of Medicine’s (IOM) efforts to strengthen the 510(k) clearance process for medical devices, but believe that the concerns expressed by the IOM regarding the lack of proof of safety and efficacy can be addressed by substantially improving 510(k) criteria, policies, and implementation. We strongly encourage CDRH to incorporate the concerns of the IOM report into substantial efforts to improve the 510(k) process, and to better ensure the safety and effectiveness of implanted medical devices by requiring that they all be reviewed through the PMA process instead.