New leadership needed at the FDA

The “times are changing,” but has the FDA remained in the past? Aduhelm, the failed Bioigen drug, should never have been approved, and the FDA’s guidance on DTC needs to be revised. The FDA needs new leadership and a visionary to lead the agency.

This week, I sat on an interesting call between a client and their agency. The topic was the fair balance in the TV spot. Was it too long, too short, or just right? The opinions were all over the place, but our research indicated that people paid little attention to the fair balance at the end of the spots.

The FDA requires fair balance, but have they really studied how patients make treatment decisions? Research has consistently shown that patients trust their doctors to make treatment decisions and use the Internet to research medications. The number of people who see a TV spot for a new drug and ask their doctor for/about it without doing research has been shrinking.

The one area where more regulation is needed is online, but the FDA can’t regulate social media posts by influencers.  Tools for curbing the ads that go too far are limited — especially regarding social media. Regulatory systems are most interested in pharma’s claims, not necessarily those of doctors or their enthused patients.

The FDA oversees ads from the pharmaceutical industry, which must acknowledge drug risks and side effects. But ads from people who write prescriptions don’t necessarily have the same restrictions. FDA regulations apply if the prescriber works for a regulated entity, like a pharma manufacturer or distributor.

But is the FDA restricted when it comes to non-pharma-based ads and influencers? Not really. The FDA could, for example, require pharma brands to put call-outs on product homepages, dispelling any hype around certain drugs. For instance, if a diabetes drug does not indicate weight loss, it should be required to say so on its homepage.

For TV spots, the FDA must ask consumers whether fair balance impacts how they choose treatments. I would do in-depth research on how patients make treatment decisions when exposed to DTC ads and websites. The FDA needs to hire an agency specializing in consumer research, not a scientific study, as patient behavior isn’t scientific.

Then there are advisory committees. The primary role of the FDA advisory committee is to: provide independent expert advice to the Agency in evaluating these regulated products. They help the agency make sound decisions based on practical application of sound scientific principles. But when the FDA ignores an advisory committee, what message does that send to HCPs?

The FDA has 49 technical and scientific advisory committees and panels that include scientific experts and members of the public. Members are selected by their expertise to meet the needs of each specific committee’s function and topic area. Science-oriented professionals – such as physician researchers, statisticians, engineers, medical faculty, chemists, and biologists – are represented on the committees. So what happened with Aduhelm?

Controversy erupted after the FDA’s 2021 approval of the Alzheimer’s disease drug aducanumab over an almost unanimously negative advisory committee vote. Some drugs are turned down initially for FDA approval based on the advisory committee’s negative vote but receive agency approval eventually. It is possible the agency later obtained additional data that justified approval. Members might have voted for approval if those additional data were brought to the advisory committee.

There was a dramatic decline in advisory committee review of approved drugs, from 55% to 6% annually. In 2010, half of the drugs approved by the FDA were first reviewed by an advisory committee. “But by 2021, advisory review of approved drugs was pretty unusual.

Of 482 new drugs and biologics, 114 underwent an advisory committee review before FDA approval. Drugs were FDA-approved despite receiving a negative vote from an advisory committee at a median of one drug per year. In six cases, advisory committees voted negatively due to safety and efficacy concerns. In three points, the committee voted negatively due to a lack of evidence for a surrogate measure leading to clinical benefit. “Advisory committees can support public trust in the FDA if they’re used consistently.

There is no doubt that the way patients are making treatment decisions has changed since the pandemic. The FDA needs to better understand that process and the impact of the Internet, especially people and organizations that are not subject to FDA guidelines.

Even when new drugs are approved, the number of doctors asking drug companies for more data has increased substantially. Is this an indicator of a lack of trust in the FDA? It could be, and that’s a problem.