Author name: PCeditor

Comments Re: “Questions for Stakeholders Regarding Appropriate Regulation of Pharmacy Compounding”

We welcome the opportunity to provide our views regarding pharmacy compounding. Stronger regulations are clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.  Current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk.

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Letter to Congressman Edward J. Markey on the VALID Compounding Act of 2012

The Patient, Consumer, and Public Health Coalition thanks Congressman Markey on his commitment to the health of patients and consumers by introducing the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012.  This bill would strengthen FDA oversight of compounding pharmacies in several essential ways, and is clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.

Letter to Congressman Edward J. Markey on the VALID Compounding Act of 2012 Read More »

Statement of NCHR On Behalf of Members of the Patient, Consumer and Public Health Coalition on Bumper Pads

We strongly oppose the use of ASTM International Standard (F1917-12) as a safety standard for baby bumper pads.  The standard is not a useful alternative to the Department of Health and Mental Hygiene’s (DHMH) proposed ban. As we stated in our July 19, 2012 letter to DHMH, we agree with DHMH that “the pads pose a risk of suffocation, strangulations, and death.”

Statement of NCHR On Behalf of Members of the Patient, Consumer and Public Health Coalition on Bumper Pads Read More »

Comments of Patient and Consumer Coalition On proposed rule “Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses” [Docket No. FDA-2012-N-0378]

We oppose FDA’s proposal to allow a Product Development Protocol (PDP) instead of a PMA for this device because PDPs are for devices where a sponsor comes to an “early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.” FDA has stated unequivocally that SWD devices “have not been shown to be safe and effective” therefore, the devices have no public health benefits, and that also rules out the use of a PDP.

Comments of Patient and Consumer Coalition On proposed rule “Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses” [Docket No. FDA-2012-N-0378] Read More »

Comments to the U.S. Consumer Product Safety Commission on Children’s Toys and Child Care Articles Containing Phthalates

We support most of the proposed guidance because it will help to protect the public, especially children, from the adverse effects of phthalates. Nevertheless, it would be better to explicitly protect children by not assuming fabric covers are adequate protection against phthalates.

Comments to the U.S. Consumer Product Safety Commission on Children’s Toys and Child Care Articles Containing Phthalates Read More »

Letter to Maryland Department of Health and Mental Hygiene opposing the use of ASTM International Standard as a safety standard for baby bumper pads

The Patient, Consumer, and Public Health Coalition writes to strongly oppose the use of ASTM International Standard (F1917-12) as a safety standard for baby bumper pads.  The standard is not a useful alternative to the Department of Health and Mental Hygiene’s (DHMH) proposed ban. 

Letter to Maryland Department of Health and Mental Hygiene opposing the use of ASTM International Standard as a safety standard for baby bumper pads Read More »

Comments to the FDA Regarding Representative Edward J. Markey’s filing of a Food Additive Petition

Congressman Markey’s petition would provide extra safeguards to protect all babies and children.  We know the focus of this “Notice of petition” is on amending regulations because BPA use has been abandoned in packaging for infant formula, but we encourage the FDA to release its separate assessment of the safety of BPA.

Comments to the FDA Regarding Representative Edward J. Markey’s filing of a Food Additive Petition Read More »

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.

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

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.

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