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.
These are the issues that cross cut over all the other ones, such as the importance of patients’ access to accurate information about medical products, improving communications between doctors and patients, decreasing discrimination and disparities in health care, and ensuring appropriate gender, racial, ethnic, and age diversity in clinical trials.
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.
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.
We support efforts to improve the safety and effectiveness of drugs and medical devices for ALL patients that are likely to use them. Women, people of color, and patients over the age of 65 have often been under-represented in clinical trials. Just as that was improving in recent years, efforts to speed drug approval have resulted in smaller clinical trials. So, the number of patients in those groups are again shrinking, making it impossible to do meaningful analysis of safety or effectiveness.
We are writing to respond to the FDA’s draft guidance for comments on appearances of conflicts of interest.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.
We are concerned about the establishment of a stand-alone Patient Engagement Advisory Committee for medical devices. It is not clear whether this committee will isolate rather than integrate the voices of patients into CDRH decision-making. We support both patient representatives and consumer representatives becoming voting members on the current medical device advisory committee with its 18 panels.
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.
There has been growing interest in learning how vitamin D can affect various chronic diseases, such as cardiovascular disease and diabetes, 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.
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.
The FDA needs to make sure that the information available on the Internet is as accurate and balanced as possible, and should not rely on companies who make the medical products to voluntarily correct flattering or promotional material about the products they are selling. FDA should require companies to correct this information to the greatest extent possible in order to ensure that consumers are not influenced by misinformation that may harm their health.