Author name: PCeditor

Comments on Proposed Order “Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System”

We strongly support the FDA proposed order that will require the premarket approval application (PMA) for Automated External Defibrillators systems (AEDs). A study of high-risk recalls of medical devices from 2005-2009, Medical Device Recalls and the FDA Approval Process, published in the Archives of Internal Medicine in 2011, noted that cardiovascular devices comprised the largest category of high-risk recalls. More than 350,000 Americans may need an AED this year, which is why we do not support the FDA exercising enforcement discretion for 15 months.

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Letter to Key U.S. Senators in Support of Funding for the Affordable Care Act

We re very supportive of the Patient Protection and Affordable Care Act (ACA).  We were extremely disappointed that the Hatch-Klobuchar amendment (S. Amdt. 297 to S. Con. Res. 8 ) to repeal the 2.3% excise tax on medical devices was overwhelmingly supported. Thank you very much for your important vote against the amendment.  We are writing to ask for a meeting with your staff to discuss this issue.

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Comments to the FDA on “Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need”

We recognize the need for new drugs to reach patients with serious or life-threatening diseases. However, based on our knowledge of existing accelerated approval strategies and the widespread off label use of prescription drugs, we have grave concerns about the creation of a new, vaguely defined pathway intended to approve drugs for limited populations.

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Letter to U.S. Senators in opposition of efforts to delay or repeal excise tax on medical devices

The Patient, Consumer, and Public Health Coalition, we strongly oppose efforts to delay or repeal the 2.3% excise tax on medical devices.  The excise tax was included in the Patient Protection and Affordable Care Act (ACA), so that it would help to pay for benefits such as affordable health insurance for currently uninsured and underinsured Americans.  The Affordable Care Act will greatly benefit medical device manufacturers because more patients and consumers will have coverage that will enable them to afford medical devices.

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Comments Re: FDA’s Recent HELP Committee testimony on pharmacy compounding

We generally support the VALID Act because it will give the FDA the clear regulatory authority it needs to prevent tragedies such as the contaminated steroid injections that have resulted in hundreds of cases of fungal meningitis and more than 30 deaths. However, Congress should absolutely clarify the legal status of section 503A, which should be revised to delete the unconstitutional advertising provision.

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