Author name: PCeditor

Comments from Members of the Patient, Consumer, and Public Health Coalition on Innovation for Healthier Americans

The aim of the white paper is “to examine the current process of drug and device development and identify inefficiencies” and examine what is and is not working at NIH and FDA (p vi). We strongly support that. However, we do not support the goal of “accelerating medical innovation and patient access to important medicines and medical technologies” (p. vii) because safety and effectiveness is not included in that goal.

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Letter to Congresswoman Rosa DeLauro Supporting “Helping Effective Antibiotics to Last” (HEAL) Act

We would like to express our strong and enthusiastic support for the “Helping Effective Antibiotics to Last” (HEAL) Act. The Centers for Disease Control and Prevention (CDC) points out that two major actions are urgently needed to address the threat posed by antibiotic resistance are: 1) stop the misuse of existing antibiotics, and 2) develop effective new antibiotics.  HEAL is the first bill to focus on both these necessary actions.

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Summary of Comments from Members of the Patient, Consumer, and Public Health Coalition on 21st Century Cures Discussion Draft

The purpose of federal regulations is to protect the U.S. public from harm by implementing reasonable safeguards.  The purpose of U.S. public health agencies is to support scientifically sound research and protect the integrity of the scientific enterprise.  Even our current regulatory oversight has failed to protect hundreds of thousands of patients from unsafe drugs and defective devices, as evidenced by the needless deaths linked to Vioxx and serious injuries from metal on metal hips. Voluntary safeguards are not sufficient, nor is reliance on public/private negotiations to develop research agendas or scientific research safeguards.

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Letter to Minority Leader Reid Thanking Him for Opposing the Repeal of the Medical Device Excise Tax

As enthusiastic supporters of the Affordable Care Act, we thank you for helping millions of Americans obtain health insurance. We are writing to ask you to vigorously defend the 2.3% excise tax on medical devices, a key provision in the law that provides a significant source of funding.

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Comments on the proposed order on Reclassification of Iontophoresis Devices Intended for Any Other Purposes

We strongly oppose the down classification of iontophoresis devices intended for any other purposes from Class III to Class II (special controls).  This down classification could needlessly expose patients to harm, and would eliminate essential safeguards.

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Letter to FDA Commissioner Hamburg on New Antibiotic Product (CAZ-AVI)

We are writing as members of the Patient, Consumer, and Public Health Coalition to express our strong concerns about the approval standards considered and the conflicts of interest apparent at the December 5, 2014 FDA meeting of the Anti-Infective Drugs Advisory Committee (AIDAC) regarding a new combination antibiotic product, ceftazidime-avibactam (CAZ-AVI).

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Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers

We strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. EPPGs are clearly life-sustaining devices and they should remain in Class III and be reviewed by the more rigorous Premarket Approval (PMA) process, which will better ensure that the devices are safe and effective.

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Comments in Favor of Draft Recommendation on Screening for Vitamin D Deficiency

There has been growing interest in learning how vitamin D can affect various chronic diseases, such as cardiovascular disease[1] and diabetes,[2] and whether screening for vitamin D deficiency can actually improve health.  However, we agree with the conclusions drawn by the USPSTF: There is insufficient evidence to propose recommendations for or against screening for vitamin D deficiency in adults who do not present with symptoms associated with such deficiency.

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Comments on Standardization of Risk Evaluation and Mitigation Strategies

The Patient, Consumer, and Public Health Coalition presented this comment on the draft report Standardization of Risk Evaluation and Mitigation Strategies. As part of its PDUFA V commitments, the Food and Drug Administration agreed in closed door meetings with industry “to explore greater standardization of REMS…with the aim of reducing the implementation burden of REMS for practitioners, patients, and others in various health care settings.”

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Comments on Internet/Social Media Platforms Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

The draft guidance notes, “The public health is best served when risk and effectiveness information about drug and device products is clearly and accurately communicated.” We agree. Unfortunately, social media platforms with character space limitations do not allow firms to provide “a balanced presentation of both risks and benefits of medical products.”   On the contrary, it is a classic case of cramming a round peg in a square hole. This medium was not designed to provide enough information for patients to adequately access a product’s benefits and risks.

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