Today, we’re examining how and what biopharmaceutical companies communicate with payers about a medicine prior to its approval by the U.S. Food and Drug Administration (FDA).
MYTH: Biopharmaceutical companies can freely communicate with payers about a medicine ahead of the medicine’s approval by the FDA or about unapproved indications for approved medicines.
FACT: Outdated FDA regulations may inhibit biopharmaceutical companies from communicating scientifically sound, truthful and non-misleading information about medicines with payers prior to FDA approval. In addition, once a medicine is approved, current rules can stand as an obstacle to timely dissemination of important efficacy information about a medicine that is not included in the labeling. The FDA has not provided a clear regulatory safe harbor to facilitate companies’ timely information sharing with payers.
Prompt access to information about new medicines, or about approved medicines with new indications, can be critical to patient care. This is particularly true when the new medicine or indication is a breakthrough in treating a life-threatening disease or where the new drug is safer or more effective than existing treatment.
Under current FDA policy, biopharmaceutical companies may be constrained in sharing safety and efficacy information about medicines in development with payers. Until a medicine is approved, there is no clear safe harbor permitting proactive sharing of accurate, data-driven information to payers, including data on expected indications and expected effects on a patient population. These limitations can lead to suboptimal patient care and payer budgeting.
For example, a company should be able to describe to payers in a truthful, non-misleading way its:
- Research and development pipeline;
- Status of FDA applications;
- Anticipated use of products in the pipeline;
- Relevant data from clinical trials;
- Applicable treatment guidelines; and
- Pharmacoeconomic information.
Modernizing FDA policy to allow biopharmaceutical companies to share accurate, science-based information with payers about approved and unapproved uses of medicines will benefit patient care. Stakeholders participating in a recent event, featuring representatives from biopharmaceutical companies, insurers, patient groups and payers, endorsed these principles. We further applaud Congress’ focus on this issue as seen in the 21st Century Cures Act and look forward to continued work on this important matter.
Read more about PhRMA’s policy solutions regarding responsible communications with payers here.