- FDA Commissioner Scott Gottlieb issued two statements reaffirming the agency's commitment to patient-centered care, medication access, and value-based care.
- FDA aims to support those efforts by guiding communication between payers and drug manufacturers about the value of certain drugs.
The FDA is continuing its efforts for patient-centered care, releasing two separate statements focused on incorporating patient voice into medical product development and improving patient access to affordable drugs.
The first statement outlined FDA’s commitment to consulting patients about drug and medical device development. As much as FDA is able to learn about medical advances through scientific trials and experiments, it can glean equally valuable insights when communicating with patients about their needs and values.
“Our work demands that we must continue to reflect on how we can make the science of drug development and review more modern and more patient-centered, so that approved products impact the metrics that real-world patients and families value most,” FDA Commissioner Scott Gottlieb wrote in a statement.
“Done well, the result is more and more of our review of new medical products benefits from a better understanding of the patient’s experience, providing our reviewers with the critically-important context of a disease, and helping them to understand what’s most important to patients related to treatment benefits, risks and disease burden,” Gottlieb continued.
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To that end, FDA published a new guide, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input. This guide aims to outline how stakeholders can interact with patients and family caregivers to understand their needs and values in medical treatment.
Specifically, the guide outlines mechanisms for collecting patient input, store and analyze that information, disseminate it to relevant stakeholders, and integrate it into the development process.
The guidance was informed by previous meetings FDA has held to discuss patient input in product development, especially the Patient Focused Drug Development meetings held in 2017. These meetings focused on treatments for HIV, Parkinson’s disease, opioid use disorder, and autism.
“As the nature of drug development becomes more targeted and as more of the new treatments address specific aspects of disease, our approach to development and regulation must also become more patient focused,” Gottlieb wrote. “Through the input we receive from the patient community we can bridge this critical opportunity between the science and needs of patients.”
FDA also released a second statement related to the rising cost of medications and how those costs hinder patient access to care. Although the medical industry has seen considerable drug innovation in recent years, these advancements are of little value when patients cannot afford them.
“But to realize the potential of these scientific advances, American patients must be able to gain access to these innovations,” Gottlieb said. “That means they must be able to afford the resulting medicines. And the rising list prices of drugs can create an obstacle to access. This is especially true for patients who find themselves underinsured or uninsured for medicines.”
Last month, HHS released a blueprint addressing the rising cost of drugs for patients. The blueprint proposed tying drug costs to the value the drug puts forth. Additionally, the blueprint called on payers to alleviate some of the obstacles to value-based purchasing for medications.
FDA aims to support those efforts by guiding communication between payers and drug manufacturers about the value of certain drugs. Better discourse about the value of certain drugs and medical products will ideally inform how much the product costs and expand patient access to the product.
“In this way, we can help ensure patients have more timely access to cutting-edge medical technologies,” Gottlieb said. “We can facilitate access by helping to reduce the overall cost of providing these benefits to patients. And in promoting access, we will advance important public health goals.”
FDA also issued guidance about critical drug information that is not included on the required FDA labeling. This will allow payers and other stakeholders to fully understand the medical product and make more informed patient access decisions.
Ideally, these efforts will reduce the cost of drugs and influence the judicious use of those drugs for patients. As FDA sees more innovation across the board, it is important that those innovations are accessible for patients. Issues related to costs are particularly burdensome, but FDA’s other efforts may also address appropriate and effective product use. The bedrock of those efforts will be better communication amongst stakeholders.
“The ultimate goal is to help facilitate a market that is more competitive, based on the outcomes that matter most the benefit to patients,” Gottlieb concluded. “Helping facilitate appropriate company communications with these audiences may help foster these outcomes, and enable better access to medical products and possibly more affordable options for Americans.”
Date: June 14, 2018