Author name: PCeditor

Coalition Letter to Senators regarding the Senate’s Biomedical Bills (21st Century Cures companion legislation)

We want all Americans to have the best possible medical treatments but we are concerned that the primary focus of 21st Century Cures is on getting medical products to market more quickly, instead of making sure they are safe and effective. Whether creating a new expedited pathway for devices (which already are approved based on much lower standards than drugs) or deregulating health IT software.

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Coalition’s comments to the FDA on User Fees for Over-the-Counter Drugs

We support providing FDA with additional resources through the implementation of OTC user fees, so the agency can fulfill its mission of protecting the public from dangerous and ineffective OTC products.  Additional funding will help FDA to finalize the remaining OTC monographs, and allow patients and consumers to have confidence in the OTC products they use every day.

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Coalition’s Comment the Black Box Warning and Patient Decision Checklist for Essure Birth Control System

We appreciate the efforts of the FDA to improve the information available to women and physicians considering the Essure System for Permanent Birth Control, through a “Boxed Warning” (black box warning) and a “Patient Decision Checklist” as part of the product labeling.  However, we believe that the draft guidance is not sufficient.

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Coalition’s Comments on FDA’s Efforts to Improve Diversity and Analyses in Clinical Trials

The FDA needs to make it clear to companies that if they want their drugs approved for women and men, whites and people of color, and adults of all ages (and especially Medicare beneficiaries), they need to study sufficient numbers of those patients in subgroup analyses to make sure the drugs are safe and effective for them in the short-term and long-term.

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Coalition’s Comments on FDA’s Direct-to-Consumer Advertising Survey

To truly protect consumers, and reduce unnecessary healthcare costs, Congress and the FDA need to do more than survey the public about DTC ads. They need to propose laws and rules to limit the persuasive power and unbalanced information provided in DTC ads, especially for drugs that have not been tested for long-term safety on a large population.

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Coalition Supports Proposal to Notify the Public About Emerging Safety Issues with Medical Devices

We support the draft guidance, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). The draft guidance addresses a serious problem: the delay between early signals that a device is less safe or less effective than expected, and the development of confirming evidence that the FDA would like to have before making recommendations. But in the months or even years during that delay, patients can be and too often have been seriously harmed.

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Comments in Support of FDA’s Proposed Updated Performance Standards for Tanning Devices

We strongly support the FDA’s proposed rule to update the performance standards for sunlamp products because much stronger standards are necessary to reduce “sunburn, photokeratitis, skin cancer, cataracts, and ocular melanoma” by limiting exposure to UV radiation. However, those standards should be merely a first step. The FDA should go even further to protect the public health by banning commercial sunlamp products entirely.

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