Week in Review: The Latest from PhRMA

As a physician and chief medical officer at PhRMA, I know how important it is to ensure that patients have access to safe, innovative medicines to help them live longer, healthier lives. But equally important is appreciating when a medicine’s risks have the potential to outweigh its benefits. In such cases, both the U.S. Food and Drug Administration (FDA) and biopharmaceutical manufacturers agree that extra steps have to be taken to help ensure safe use of those therapies.

America’s biopharmaceutical research companies play an important role in supporting patient health and post-market surveillance of medicines. In instances where medicines may pose more serious potential side effects, the FDA may require a biopharmaceutical company to implement additional procedures, called Risk Evaluation & Mitigation Strategies (REMS), to facilitate safe use.

The procedures can take many different forms and vary by medicine. They can also be established when a new medicine is first approved, or after a medicine has been prescribed by physicians for some time.

So what can a REMS program look like? Here are a few examples of common REMS components the FDA may require:

• Medication Guide: the FDA may require this additional, in-depth patient guidance for safe use be distributed with medicines if it believes that information is necessary to avoid potential adverse events. Written in non-technical language, medication guides go beyond the standard packaging and labeling required of all medicines.

• Healthcare Provider (HCP) Communication Plan: as part of an HCP communication plan, the FDA may require companies to send letters informing HCPs about increased risks from medicines, share information to highlight the role HCPs can play in implementing REMS or to explain certain safety measures they must take, such as monitoring their patients during treatment. Alternatively, the FDA may require companies to work with relevant professional societies to inform HCPs about these additional safety measures. 

• Elements to Assure Safe Use (ETASU): this term typically refers to medical interventions or actions HCPs must take before prescribing or dispensing the medicine. These may include a requirement for the provider to receive special training or certification to prescribe or administer the medicine, or that the medicine is administered in a specialized treatment center, physician’s office or hospital setting. For example, ETASUs may require that patients undergo regular monitoring for things like liver function while receiving the medicine. In addition, for a handful of medicines, an FDA-approved REMS may require that certain drugs with very high risks be available only through limited distribution channels or pharmacies in order to protect patient safety.

Working with patients, I’ve seen how implementation of REMS programs can help maximize patient benefits while minimizing risks. The current REMS program helps ensure physicians are equipped with the information needed to prescribe medicines safely and provide the best possible care. 

REMS represent one of the many ways through which biopharmaceutical companies and the FDA are collaborating to bring cutting-edge therapies to patients in need, while ensuring patient safety is always at the forefront.

Learn more about FDA’s REMS process.