Impact of New FDA Labeling Rule for Pregnancy and Lactation Information on Medical Information Teams 

Mar 06, 2016


On December 3, 2014, the United States Food and Drug Administration (FDA) published a rule regarding the labeling and presentation of medication information about pregnancy or lactation. The goal of the new approach is to improve the safe and effective use of drugs during pregnancy or lactation. The new rule requires more information to be published about risks and benefits associated with prescription medication use while pregnant or breastfeeding. It replaces the current pregnancy risk classification system that is confusing and does not provide enough information for providers and patients to make the best decision.  This rule will take effect on June 30, 2015. Here are the details of the Pregnancy and Lactation Labeling Final Rule.

How will this change impact Medical Information Teams?

Whenever there is an important label change Medical Information teams have to initiate certain actions.

  1. All impacted medical information letters, FAQs, slides, and other affected response documents may require updating if there is new information available.
  2. Since this is related to safety all response documents that discuss the safety of the product or include safety statements may need to be revised. Since the changes relate to pregnancy and lactation all Medical Information Letters and other content about pregnancy and lactation will require revision if there are important changes.
  3. Medical Information teams should also update the version of the prescribing information that is provided to patients and providers in response to inquiries.
  4. All team members should learn the new rule, what has changed in product labeling, and which response documents have been modified.
  5. If new data is introduced team members should also learn the new data and be prepared to answer questions from HCPs or consumers.
  6. New Medical Information letters may need to be written to address any new pregnancy or lactation data that is introduced.

These are just a few general activities that may occur because of a significant label change. The impact of a label change on Medical Information teams depends on the extent and nature of the change, how many Medical Information response documents are impacted and in how many countries, and whether new response documents are required.

Medical Information business practices and the Medical Information Software solution will greatly impact the effort it takes to make required changes. For example, teams with complex content creation and review steps may have more challenges than small teams with a less complex approval and review process. Teams that use a modern Medical Information System, such as agInquirer, that enables global collaboration in creating, approving, and sharing content will find it easier to make changes and create new content than teams with less sophisticated solutions. In agInquirer, content that is ubiquitous to all Medical information letters (e.g., Safety statements or disclaimers) is placed in a template. When there is new information only the template needs updating and not every Medical Information letter. The template is merged with the Medical Information letter before it is sent to the HCP. If multiple templates contain the same information then Components can be inserted in each template. In case of a change only the Component needs to be updated and the new content is propagated to all the impacted templates.

The new FDA labeling rule for pregnancy and lactation information may significantly impact Medical Information teams. Teams should plan ahead so they are ready in case there is a significant labeling change for their drug.