Tag Archives: package insert

FDA To Further Study Standardized Risk/Benefit Labeling for Drugs

The Patient Protection and Affordable Care Act requires the Food and Drug Administration (FDA) to determine whether adding quantitative summaries of the risks and benefits of a prescription drug medication in a standardized format would help healthcare providers and consumers make better decisions about using the drug.  For the better part of the last decade, FDA has been discussing whether the types of information now provided are sufficient to advise these decisions.  Currently, a patient package insert (PPI) is required for some classes of drugs, or if there is a risk evaluation and mitigation strategy (REMS) in place for a high-risk drug; otherwise it is voluntarily submitted by manufacturers for other products.  A medication guide is usually required to be distributed with the drug if there is a REMS in place.

While the PPI and the Medication Guide are often required to be distributed, consumers may also be given consumer medication information (CMI). CMI is developed by drug manufacturers according to general guidelines provided by FDA, but is not subject to the same distribution requirements or oversight when used in association with products.

For most of the last decade, FDA has been evaluating the effectiveness of these types of written prescription drug information, and the agency has held several public meanings to discuss the matter with the industry.  Among the issues being looked at is the report that most patients prefer written information rather than numerical data; and numbers, percentages and statistics might be difficult for the consumer to understand unless they are presented in a simple, straightforward organization.  Patients most prefer verbal communication about a drug’s risks and benefits, but relying on this as a primary means of communication could increase the risk of inaccurate medication compliance. 

At the last meeting in 2009, FDA concluded that there are too many forms of written patient information, and that more study is needed to come up with a user-friendly format that would be sufficiently educational to the patient.  The healthcare reform statute supports this conclusion. Section 3507 of the statute directs FDA to continue studying whether providing quantitative summaries of the risks and benefits of each prescription drug in a standard format would be helpful to the process of making individual healthcare decisions.

Baxam Law Group, LLC