Author name: PCeditor

Letter to Ranking Member Waxmen of Opposition to H.R. 3303, the SOFTWARE Act of 2013

We strongly oppose H.R. 3303, the SOFTWARE Act of 2013. 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 lawmakers on this very issue.

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Comments on the Food and Drug Administration’s Draft Guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act”

The Patient, Consumer, and Public Health Coalition conditionally supports the draft guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (FD&C) because it clarifies FDA enforcement actions that can be taken against individuals or firms that illegally make drugs under the banner of traditional compounding.

Comments on the Food and Drug Administration’s Draft Guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” Read More »

Letter to Congresswoman DeLauro Thanking Her for Her Dedication to Patients and Consumers

We are writing to thank you for your dedication to patients and consumers through your work to strengthen safeguards for all medical products sold in the United States.  Your continued efforts through the years, including your recent letter to the FDA Commissioner, is needed now more than ever to help preserve the public health mission of the FDA.

Letter to Congresswoman DeLauro Thanking Her for Her Dedication to Patients and Consumers Read More »

Comments on the Food and Drug Administration’s Proposed Rule “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”

The proposed rule is needed to help safeguard the health and safety of patients and consumers. In addition to the specific provisions of the rule, legal accountability is a powerful incentive for generic drug manufacturers to take post-market monitoring more seriously.  We strongly urge the FDA to adopt the proposed rule in its current form as soon as possible.

Comments on the Food and Drug Administration’s Proposed Rule “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” Read More »

Members of the Patient, Consumer, and Public Health Coalition strongly support FDA’s ban on the imports of Ranbaxy medical products

We strongly support the FDA’s ban on importing drugs manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The company’s facility is not complying with current good manufacturing practices (cGMP), which are the main regulatory safeguard to ensure drug manufacturing quality.

Members of the Patient, Consumer, and Public Health Coalition strongly support FDA’s ban on the imports of Ranbaxy medical products Read More »

Comments on Proposed Order “Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses”

We strongly support the FDA’s proposed order for Intra-Aortic Balloon and Control Systems (IABP) devices used to treat septic shock or pulsatile flow generation (Other Specific Intended Uses) to remain in Class IIIwith Premarket Approval applications (PMA) required. The evidence of safety and effectiveness forthese indications has not been established.  As the FDA noted in its assessment of the device, there is no “theoretical or demonstrated benefit to using the intra-aortic balloon and control systems for this clinical syndrome.”

Comments on Proposed Order “Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses” Read More »

Comments on Proposed Order “Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs”

We oppose the FDA proposed order that will reclassify stair-climbing wheelchairs (a preamendment Class III device, indicating high risk) into Class II (moderate risk).  This change in classification would result in greater risk for some of our nation’s most vulnerable consumers.

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Comments on Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina and Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses

We are writing to express our concerns about the proposed down-classification from Class III to Class II of External Counter-Pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. We strongly support the proposed PMA for other indications for the same ECP devices.  Our coalition includes consumer groups, patient groups, public health experts, medical professionals, and scientists who are dedicated to ensuring that all medical products sold in the U.S. are safe and effective. 

Comments on Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina and Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses Read More »

Comments on Proposed Order “General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products”

We urge you to finally follow the recommendations made by FDA classification panels in 1977 and upclassify sunlamp products. All sunlamps should be reclassified as Class III devices because of their known risks, especially the increased likelihood of developing the most serious type of skin cancer. By law, high-risk devices that can cause substantial harm or even death are Class III. Clearly, sunlamps satisfy those criteria.

Comments on Proposed Order “General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products” Read More »