Prescription and over-the-counter drugs can be life-saving or harmful. Our goal is to improve the safety and effectiveness of drugs sold in the U.S. and educate healthcare professionals and patients about known and unknown benefits and risks.
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 However, we believe that the draft guidance is not sufficient.
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 »
We have reviewed the vaccine information statement and we have suggested revisions for the wording and content of the Vaccine Information Statement. It is important that the statement concisely describe the benefits and risks associated with the vaccine. But it is equally important that the statement provide all the essential information about the vaccine.
We support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling.
We strongly support the use of generic drugs and find it disturbing that generic drug manufacturers are putting their financial interests before the health and safety of patients. Members of the coalition strongly urge the FDA to adopt the proposed rule in its current form as soon as possible.
Testimony on Generic Labeling at FDA Read More »
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).
Letter to FDA Commissioner Hamburg on New Antibiotic Product (CAZ-AVI) Read More »
We strongly urge you to recommend that the FDA keep a strongly worded black box warning and delete the misleading conclusions regarding the meta-analyses from the Chantix label.
Testimony of Dr. Laurén Doamekpor Before the FDA Advisory Panel on Chantix Read More »
We strongly urge the Food and Drug Administration (FDA) to withdraw its draft guidance proposing to allow pharmaceutical firms to distribute to health care providers and facilities scientific medical literature suggesting that the risk information for prescription drugs and biological products are less than what is stated in the FDA-approved product labeling. The guidance has the potential to cause confusion and greatly harm patients.
We are writing to comment on various aspects of the proposed rule to extend FDA’s jurisdiction to tobacco (including made or derived from tobacco) products other than cigarettes, including e-cigarettes. It is essential that the proposed rule be strengthened, since nicotine is highly addictive.
Comments on proposed rule to allow FDA to regulate all tobacco products Read More »
