Three tips for covering FDA advisory committee meetings

By Kerry Dooley Young

It’s crucial to understand what’s at stake when the Food and Drug Administration (FDA) seeks expert advice on medicines and medical devices.

For that reason, we’re offering three tips on how to cover FDA advisory committee meetings. Here’s a summary of our suggestions, which we’ll explain in more detail below after providing some background.

1. Explain study results in the simplest terms possible. Make sure to detail potential risks discovered during testing.

2. Use good quotes from experts on the advisory committees. Address key questions about the treatment under review.

3. Help readers understand the financial and emotional connections of people quoted in your reporting to the product under review.

Background on FDA Advisory Committees

There’s inherent drama in FDA advisory committee meetings. Some of these meetings deal with broad policy questions, but the most closely watched gatherings tend to address concerns about the approval or expanded use of drugs and medical devices.

The FDA usually follows the recommendations of its advisory panels, but it is not obliged to do so. A recent exception was the FDA’s 2021 decision to reject the recommendation of an advisory panel and approve Biogen’s Aduhelm drug for Alzheimer’s disease, as earlier discussed in this AHCJ article.

Most drugs and devices win approval without the FDA holding an advisory committee meeting. Companies often present strong applications for approvals of their products, with adequate evidence from studies to demonstrate a favorable balance of risks and harms.

Sometimes the FDA wants to better understand a drug that represents an advance in medicine, and it will hold an advisory committee meeting for feedback on a new approach to treatment.

But more often the FDA schedules advisory committee meetings because of significant questions about the safety or effectiveness of the drug or device under review.

The FDA has standing panels of experts in cardiology, oncology and other fields of medicine. The panels also include statisticians and people who represent the views of patients, consumers and medical industries. There often are changes made to the composition of a panel for a meeting. Here’s the link to the FDA’s website for its advisory committees.

Many FDA advisory committee members are active researchers. They sometimes have financial conflicts that prevent them from serving at meetings about specific applications. So, the FDA will add other experts as temporary members to make up for missing panelists. In some cases, FDA advisers can get waivers, allowing them to serve despite financial conflicts.

The FDA posts these waivers on its website along with agency staff reviews and other background information. The agency generally posts these materials about two business days ahead of the meeting.

You should check with your editors ahead of time about whether they might want stories about the FDA staff’s take on the product under review. The agency’s medical reviewers often make their opinions clear in these postings, and they sometimes have a substantial disagreement with the views of companies seeking approvals of products. This brings us to our first tip.

Tip 1. Explain medical data in the simplest terms possible. Make sure to detail potential risks.

In writing on the data presented, think about what patients want to know about drugs and medical devices — their chances of being helped by drugs and devices and their potential risk of being harmed by them.

Try to summarize the key data about a product under review in simple terms before the meeting starts. You can use the FDA and company briefing materials for this work.

Be careful about using relative risk calculations. In a widely cited example, Gary Schwitzer’s HealthNewsReview.org article explained how a 1% difference in study results for the cholesterol pill Lipitor could be touted as a 36% relative reduction in heart risk.

Coronary events, including heart attacks, in each group, occurred in 1.9% of the Lipitor group and 3% of the placebo group, a difference of about 1.1 %, according to the label for Lipitor posted on the FDA’s Drugs@FDA website.

That “1% difference is the number that people care about,” HealthNewsReview.org noted. The 36% refers to taking that 1.1% difference and dividing it by the placebo group rate of 3%, HealthNewsReview explained.

Try to describe the results in terms of raw numbers, showing what happened to each group of patients. Those Lipitor figures, for example, are from a study of 10,305 patients. There were a total of 154 coronary events in the placebo group and 100 in the Lipitor group.

If you are new to covering medical research, read this primer on clinical significance. This is just one of the many resources Tara Haelle, AHCJ’s core topic leader on medical studies, has posted in the section of AHCJ’s website dedicated to covering research.

When writing about side effects and complications, try to use language to describe the side effects of drugs and medical devices that a student in junior high school would understand.

Fainting, for example, is a more widely known word than syncope. The word vomiting will be clearer to your readers, listeners, and viewers than the medical term for it, emesis.

2. Use good quotes from the experts on the advisory committees. Make sure to address important questions about the treatment under review.

Focus on the key issue or issues that led the FDA to call the advisory committee meeting. Then find the best quote from members to describe these issues.

There’s often a lot of discussion at these meetings about how people lack good options for treatment. During the public hearing session, patients and their families often give moving accounts about the devastation caused by conditions like amyotrophic lateral sclerosis, or ALS. You will want to include some of the public hearing discussion in your story.

But it’s not the lack of treatment options itself that leads the FDA to schedule a meeting on a specific application for approval of a drug or a device.

The FDA tends to hold advisory committee meetings when it has doubts about how effective or how safe a drug or medical device is for the intended group of patients.

So, the best quotes for your story will come from a discussion about these issues among the experts serving on the advisory committee.

Sometimes experts state their views in nice, clear terms that the public can understand.

Members of an FDA advisory committee in March, for example, voted 6-4 to say that a single study from Amylyx Pharmaceuticals failed to establish the drug’s effectiveness in treating ALS.

A transcript of the meeting shows FDA panelist Kenneth Fischbeck, M.D., of the National Institute of Neurological Disorders and Stroke, for example, explaining the difficulty with deciding on the drug by saying he had taken care of people with ALS. He noted the testimony provided by people with ALS and their families in support of the AMX0035, reflecting “the burdensome nature of the disease and the huge unmet need” for treatments.

But Fischbeck stressed that it would be “a disservice to the patients and their families to move ahead and approve a treatment that is an uncertain benefit.” Such an approval also could get a truly effective drug, he said.

Often, though, specialists and statisticians speak in the language of their fields during advisory committee meetings.

To follow the discussion, you may need to quickly adapt to a new set of medical jargon and acronyms. Again, those FDA briefing materials will be a great help in preparing to translate these terms for your audience.

3. Help your readers understand the financial and emotional connections of people quoted in your reporting to the product under review.

Keep in mind that the speakers heard during the public comment sessions skew heavily toward people who want the product under review approved, Matthew McCoy, Ph.D., an expert in medical ethics at the University of Pennsylvania, told AHCJ in an interview.

“This is nothing like a representative sample of the patients” who would take the drug or use the medical device under review if approved, McCoy said.

During advisory committee meetings, it’s rare to hear, for example, from people who suffered complications from investigational products or simply didn’t benefit much from them.

McCoy is among the researchers who in recent years have studied the issue of undisclosed conflicts among speakers at public hearings. He and co-authors published a 2018 research letter in JAMA Internal Medicine, focused on the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee meetings.

Looking at meetings of this committee held from 2009 to 2017, McCoy and co-authors found 91 people had made a total of 112 combined speaking appearances. They reported that in 21, or 19% of these cases, the speakers had not disclosed what McCoy and colleagues considered relevant financial associations.

The FDA encourages members of the public to disclose relevant ties to companies but does not require it. “If you prefer not to address financial interests, you can still give your comments,” the FDA said in its guidance document on open public hearings at advisory committee meetings.

During the COVID pandemic, FDA advisory committees have been held via webcast.

If the FDA returns to in-person meetings, it will be critical to ask people speaking in favor of products about who paid for their travel to the agency’s White Oak, Maryland, headquarters. And, of course, it’s also important to try to determine whether people speaking via webcast during the public comment session have potential conflicts of interest.

Logistics and resources

You’ll want to record the meetings to make sure you have the exact quotes, as the discussion can involve many technical terms and phrases. AHCJ’s Barbara Mantel last year did a review of popular transcription services.

And Twitter can be a great help in following meetings, especially when you have not covered the drug or device under study before.

The FDA has several web pages with information about reaching its campus in White Oak, Maryland, where advisory committee meetings were held before the pandemic. There are directions for taking public transportation and driving and parking.

It’s a good idea to get in touch before the meeting with the FDA press office and with the company that is seeking approval for the product under review. Get the email addresses of the FDA and company representatives who will field questions from the press during the meeting.

Also, check in with nonprofit groups that watch the FDA closely to see if they will be speaking at the meeting. These include Public Citizen, the National Center for Health Research and the Center for Science in the Public Interest.

Below are suggestions for handles of journalists on the FDA beat. These are good reporters to follow if you have an interest in the agency, even if they are not covering the advisory committee you are watching. Please feel free to send me suggestions for other handles at patientsafety@healthjournalism.org.