Public Comments at the FDA’s Safe Use Symposium: A Focus on Outpatient Preventable Adverse Drug Effects

Megan Polanin, PhD, National Center for Health Research: June 15, 2017

Thank you to the FDA and the Safe Use Team for hosting this meeting and for the opportunity to share our perspective. I’m Dr. Megan Polanin, and I am a Senior Fellow at the National Center for Health Research.

Our focus is patient-centered comparative effectiveness research. With support from PCORI (the Patient-Centered Outcomes Research Institute), we’ve trained about 120 patient advocates to understand the value as well as the limitations of clinical trials.

Some of the patients we’ve trained are desperate for new cures, and others have been harmed by medical products and believe that the FDA needs to require better evidence of safety before approving new drugs or devices.

But the one thing they all agree on is that patients aren’t really getting informed consent about the drugs they are taking. Most doctors aren’t talking to most patients about potential side effects, or even about how good the evidence is that the treatment will work. Most patients blindly fill prescriptions because they assume that the drugs are proven safe and effective for patients just like them.

A big problem is that doctors rarely tell patients if their prescriptions are off-label. Most patients who are prescribed a drug off-label don’t realize that the drug they are prescribed has not been approved for the particular indication they need. Research shows that off-label uses are often ineffective and have more adverse side effects than on label use. Patients deserve to know if a doctor recommends a use that hasn’t been proven to have benefits that outweigh the risks.

Reducing the chances of adverse drug events requires a discussion between the doctor and patient about any evidence that the drug really will do more harm than good.  Unfortunately, doctors often have limited information – most of which they got from drug reps, not from the FDA. Drug labels have gotten so long that most doctors and patients don’t read them. I ask you: Why include the chemical composition of the drug on those labels? Why not focus on the risks and benefits in simple language instead?

And, as we all know, many doctors don’t have a lot of time to discuss these kinds of issues with their patients, and many doctors are not skilled in having these kinds of conversations.

In addition, FDA rarely provides information to patients or doctors about adverse events for specific major demographic groups, such as women, men, people of color, or for older patients. Having that information clearly on the label would help reduce adverse drug effects.

Doctors and patients should be clearly told when a drug is approved on the basis of biomarkers, and whether there are other drugs for the same indication that are proven to improve survival or clinically meaningful health measures, such as fewer heart attacks or better quality of life.

Bottom line: An important way for the FDA to help prevent adverse drug events is to make sure that patients know in advance what kind of choices they have for prescription drugs, and which ones are likely to be safer for them as women, people of color, patients over 65, and people with a particular illness. Patients deserve to know this information before filling their prescription.