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.
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.
Coalition’s Comments on FDA’s Direct-to-Consumer Advertising Survey Read More »
As members of the coalition, we strongly support the proposed rule (Federal Register Docket #2016-03722) based on President Obama’s Executive Order 13706, Establishing Paid Sick Leave for Federal Contractors, which requires that employees that work on federal contracts are entitled to earn at least seven days or 56 hours of paid sick leave per year.
Establishing Paid Sick Leave for Federal Contractors Read More »
We support the draft guidance, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). The draft guidance addresses a serious problem: the delay between early signals that a device is less safe or less effective than expected, and the development of confirming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.
We strongly support the proposed rule that bans minors (individuals under the age of 18) from using commercial tanning beds (sunlamp products). However, we think the age limit should be 21, as it is for alcohol, and as it is for cigarettes in more than 100 U.S. cities.
Comments in Support of FDA’s Proposed Age Restrictions on Tanning Beds Read More »
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.
Comments in Support of FDA’s Proposed Updated Performance Standards for Tanning Devices Read More »
We strongly support the safety and effectiveness clinical and nonclinical testing requirements to obtain generally recognized as safe and effective (GRASE) status, as they are articulated in the draft guidance. Americans are using sunscreens more frequently and on a more long-term basis than ever before. Our safety and efficacy standards must reflect that Americans of all ages rely on these products to protect them from skin cancer.
Coalition Strongly Supports FDA’s Proposal to Regulate Over-the-Counter Sunscreens Read More »
We are writing to respond to the FDA’s draft guidance for comments on appearances of conflicts of interest. In our view, there are troublesome inconsistencies in the way that the FDA considers financial conflicts of interest and how they consider appearances of conflicts of interest. Moreover, there are also troubling inconsistencies in how the FDA perceives such appearances for public health and consumer advocates and how they are considered for clinicians.
Coalition Comment on Conflicts of Interest Read More »
We are submitting these comments to express our strong concerns about the United States Preventive Services Task Force’s (USPSTF) draft recommendation statement. We strongly disagree with USPSTF’s two recommendations regarding adults aged 40 to 75.
We recommend that the FDA broaden the rule’s focus to be more consistent with the public health intent of the law, which is necessary because of numerous changes in tobacco products that have been introduced since the law passed.
Comments on Products made from Tobacco Rulemaking Read More »
