The U.S. Food and Drug Administration (FDA) is one of the most respected regulatory authorities in the world. Owing to its strict evidence-based approach, its decisions and guidelines have always been carefully examined by other national regulators, and not only during the global covid pandemic. This may be the reason why FDA faces misinterpretation, at home as well as globally, more often than similar institutions in other countries. It is constant combat, says FDA’s Principal Deputy Commissioner Janet Woodcock. We also asked about the opioid crisis and regulation of modified risk tobacco products.
In Europe, anti-vaxxers and protesters against measures limiting the spread of covid-19 distribute “secret” documents which are said to prove that vaccination does not work and/or lead to numerous serious adverse events and even death. Often, official FDA documents are presented in this context which are, however, misinterpreted. In what way does FDA fight against such misinterpretation?
The FDA has taken significant steps to combat misinformation that is being perpetuated online and by high-profile public officials, celebrities and certain news organizations. The agency’s efforts have included working with news media and other organizations to do countless fact-checks of misinformation, responding to comments on social media to correct inaccuracies, creating numerous resources for our website and social media to address common questions about the products we regulate or combat dangerous misinformation, posting videos with subject matter experts on social media, livestreaming our media and stakeholder calls, arming public health stakeholders with toolkits of resources and accurate information on myths versus facts; and posting the memos and other regulatory documents that outline the agency’s decision-making.
Unfortunately, despite the FDA’s aggressive efforts, there continues to be an army of people both in the U.S. and abroad, that have continued to aggressively push misinformation that is inflicting significant harm and delaying prevention or treatment for real people, particularly as it relates to the COVID-19 pandemic. As we started to do in 2021, the agency will continue to look for opportunities to combat misinformation head-on in ways that are easy for consumers to understand and communicate the potential for real harm.
Similarly, the VAERS (Vaccine Adverse Event Reporting System) safety surveillance program is misused. The public does not understand that it collects suspicions which need yet to be confirmed. Can FDA provide official figures showing how many of these suspicions have been confirmed and what is the actual incidence of adverse events, or even deaths, caused by vaccination in common clinical practice (i.e. not only in clinical studies)?
The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system that receives unverified reports of adverse events following immunization with both licensed (approved) vaccines and those that are FDA-authorized for use. The FDA and CDC place a high priority on vaccine safety and are committed to the integrity and credibility of our vaccine safety monitoring efforts. Anyone can report an adverse event to VAERS. Patients, parents, caregivers and healthcare providers are encouraged to report adverse events after vaccination even if it is not clear that the vaccine caused the adverse event. In addition, healthcare providers are required to report certain adverse events (such as a severe allergic reaction) after vaccination, and vaccine manufacturers are required to report all adverse events brought to their attention. Accurate and honest reporting play an important role in this process.
Timely updates on all adverse events of interest following COVID-19 vaccination can be found on the CDC website.
Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. More than 550 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through February 22, 2022. During this time, VAERS received 12,612 preliminary reports of death (0.0023%) among people who received a COVID-19 vaccine. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines. However, a review of reports indicates a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and TTS, a rare and serious adverse event—blood clots with low platelets—which has caused deaths.
FDA continues to find the three authorized and approved COVID-19 vaccinations meet the agency’s rigorous standards for safety, effectiveness, and manufacturing quality. These vaccines have proven to be an important tool for fighting the COVID-19 pandemic.
The USA faced the opioid overdose epidemic. Therefore, the FDA have taken steps to support the development of non-opioid analgesics for acute pain lasting more than 30 days, e.g. after an injury or a surgery. In which areas remain the analgesics irreplaceable and what rules or measures protect against their misuse?
The FDA recently issued draft guidance that is intended to assist sponsors in the development of alternatives to opioids for the management of acute pain. Accordingly, the guidance addresses FDA’s current thinking about three specific topics: development of non-opioid analgesic products for acute pain (e.g., clinical trial design and establishment of clinical trial efficacy endpoints), labeling claims, and expedited programs as they pertain to this purpose.
The FDA continues to respond to the opioid crisis that has devastated families and communities across the nation and has taken critical steps to address this crisis, including supporting development of new and effective pain treatment therapies, creating better safety communication and prescriber education policies, and working to prevent the illegal sale of opioids online.
Based on your „modified risk tobacco products“ pathway, can we say that there is already enough scientific evidence to say that these products are effective harm reduction tools?
Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes.
To market a product as a modified risk tobacco product (MRTP), tobacco companies must now first demonstrate to FDA that a proposed MRTP will, or is expected to, benefit the health of the U.S. population as a whole – including adults and children, tobacco users and nonusers. As a general example, an MRTP can benefit population health when data show consumers who currently use a more harmful product like cigarettes are likely to completely replace their cigarette use with the MRTP, and the marketing of the MRTP would not make non-users of tobacco products more likely to start using them.
It is important to note that each individual product application will be considered on its own merits with the agency thoughtfully and appropriately considering the content of each individual submission.
Once the FDA authorizes the marketing of a product as a „modified risk tobacco product,“ this allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance.
Helena Sedláčková
