Rebuilding trust in FDA through labeling clarity and transparency

Regulatory agency must be proactive in fighting the surge in skepticism about the drugs and vaccines it regulates

The decline in the public’s trust in FDA is due in no small part to the agency’s perceived lack of “data transparency” — the provision of accurate information clearly understandable by the average citizen. And nowhere is this more obvious than when it comes to vaccines.

FDA has long recognized truthful, accurate and non-misleading labeling is foundational to healthcare decision-making because it is the primary tool for educating healthcare professionals about the benefits and risks associated with a particular product, thereby helping safeguard public health.

Given the rising public skepticism about vaccines, data transparency is particularly important in labeling for vaccines.

Successful immunization programs rest entirely on healthcare provider understanding of what vaccines do and, most importantly, in the public’s trust of regulators and public health agencies providing clear and complete information.

Today, the greatest threat in the U.S. to the entire vaccine program is the public’s loss of confidence in the overall process and, as a result, in the products the agency regulates. Not all the factors colliding to create this surge in skepticism are under FDA’s control, but some are. Given the magnitude of the threat to the public health, the agency can and should take proactive steps to combat this trend.

Shoring up several weak points in product labeling — from overly technical language to available but missing pieces of information — and then communicating these “new and improved” labels to the public would be a good place to start.

For vaccines and other FDA-regulated products, the agency requires product labeling to not only summarize the safety and effectiveness data supporting approval, but also to describe limitations of the existing evidence to help ensure safe and effective use. Yet, it does not always enforce that requirement. For example, in the labeling of Seqirus’ Fluad adjuvanted influenza vaccine, the agency omitted an important explanation of the failed absolute efficacy confirmatory study required as part of its accelerated approval pathway requirements.

Without a clear understanding of the limitations of the evidence, it can be difficult for healthcare professionals, patients and caregivers to make informed decisions. Sins of omission are often the most pernicious.

FDA must also develop methods to explain such information that are understandable to both healthcare professionals and the average citizen. No one said it was going to be easy, but it is possible.

A look at how the European Medicines Agency (EMA) addresses the issue of both clarity and brevity through its public assessment reports (EPARs) could offer valuable insight. Presented in a public-friendly, question-and-answer format, EPARs provide public information on medicines, including how they were assessed by EMA, in a usable, transparent and appropriately detailed manner. Importantly, EPARs are updated periodically to reflect the latest regulatory information on medicines. When the original terms and conditions of a marketing authorization change, the EPAR is updated to reflect such changes with an appropriate level of detail.

EMA does a good job educating the public, and FDA can do even better, but only if it makes this a high priority. The agency should aspire to be not only the gold standard when it comes to 21st century regulatory science, but also in clearly communicating the benefits and risks of medical products.

One way FDA can augment transparency and clarity is through more aggressive labeling updates. Agency programs such as Prior Approval Supplements (regulatory submissions that request approval for a significant change to an approved drug product, such as a generic drug) could be a good starting place. Publicly posting summaries from PAS reviews would take a step toward building more regular, user-friendly and timely information sharing. FDA must put equal weight behind what happens post-approval, as it does in addressing the much more controlled premarket clinical trial environment. This also raises important questions relative to the current strengths and weaknesses of the agency’s post-market surveillance programs.

An important aspect of transparency is regulatory reproducibility. Labels for similar products should provide similar information in a clear manner. Healthcare professionals and average Americans should be able to do side-by-side comparisons so they can be more engaged in the process of making smart healthcare decisions. FDA should consider developing consumer-friendly product one-sheets, listing the “five most important things to know” about a drug or a vaccine. Transparency must also mean clarity — and clarity drives both trust and compliance.

To help restore the overall public health ecosystem, including the development and deployment of critical products for this mission, FDA and its intramural partners should design a “Trust through Transparency” campaign that:

1.      Enhances regulatory predictability and reproducibility

2.      Delivers labeling transparency and product understanding

3.      Drives up vaccination rates through increased trust in the system

Blaming the purveyors of misinformation and disinformation for low trust in vaccines specifically and diminishing faith in FDA more generally only goes so far. For FDA, it has to start with an honest mea culpa. Healing can only begin once the agency admits that it owns a share of the problem. A good place to start is with an honest appraisal process that embraces the basic premise of trust through transparency.

More complete, accurate and comprehensible product labeling will go a long way to help restore public trust in the FDA process and in the products it regulates.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris School of Medicine.

Signed commentaries do not necessarily reflect the views of BioCentury.