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 strongly support the CMS proposed decision to limit the coverage of these drugs to patients participating in clinical trials, because it will provide the evidence needed regarding safety and effectiveness for the Medicare population. We agree with CMS that this will enable patients and family members to make informed decisions based on unbiased information pertaining to the known risks and as yet unproven benefits.
Patients deserve access to smoking cessation treatments, but they also deserve warnings about the risks. There remains considerable credible evidence that some patients are severely harmed by Chantix and Zyban, and those patients’ lives depend on warnings about the risks, so they will recognize that sudden suicidal, paranoid, or violent thoughts are side effects of the drugs.
In November 2013, the Food and Drug Administration (FDA) proposed to revise its regulations to allow generic drug manufacturers to initiate safety updates to their products’ labeling.[1] We strongly support the FDA’s proposal.
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.
We applaud the FDA for providing guidance to industry to advance the regulatory science behind abuse-deterrent oral opioid formulations. We agree with many of the recommendations in the guidance and urge the FDA to consider our recommendations regarding the use of the term “abuse-deterrent”.
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 However, we believe that the draft guidance is not sufficient.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.
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.
