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FDA: Drug Development Transparency Key for Precision Medicine

Draft guidance from the FDA promotes transparency through the drug development process as a way to improve patient-centered care and foster precision medicine.

FDA reports that drug development transparency is the key for precision medicine

Source: Thinkstock

By Jessica Kent

- New guidance from the FDA urges drug development stakeholders to be transparent with their data as a way to maintain high quality and foster patient-centered precision medicine.  

Innovative, personalized treatments are being developed at an accelerated pace, offering patients targeted therapies based on their genetic responses to treatment pathways.

However, in order for patients to fully leverage the benefits of these new, targeted therapies, drug companies must ensure that they communicate with patients and other healthcare stakeholders.

“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,” said FDA Commissioner Scott Gottlieb, MD, in a recent statement.

“To that end, FDA has made it a priority to work with companies and other stakeholders on gathering information from patients about their views and needs.”

The draft guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, discusses methods of collecting representative data on patient experiences to assist with the development and evaluation of medical products.

The draft guidance also describes how to operationalize and standardize the collection, analysis, and dissemination of patient experience data, an important first step in using this data to help improve medical product development and regulatory decision-making.  

This guidance is the first of four documents that FDA will issue about patient experience data and drug development.

These documents will add to FDA’s previous work in gathering information on the needs and experiences of patients. The organization has held Patient Focused Drug Development (PFDD) meetings in more than 20 disease areas, where they have heard directly from patients affected by disease, including HIV, autism, and opioid abuse.

In addition to enhancing the role of the patient in drug development, FDA is working to increase drug companies’ communication with payers to improve patient access to cutting-edge treatments.

The rising prices of drugs can create a barrier to patient access, Gottlieb noted. The FDA will work with the Department of Health and Human Services (HHS) to  provide guidance to pharmaceutical companies about open communication with payers as a way to control spending and ensure access for patients.

Both FDA and HHS believe that drug prices should be adjustable to reflect their value and the outcomes they provide, which will help control the rising costs of medications for patients.

A second FDA draft guidance document, Drug and Device Manufacturer Communications with Payers, Formulary Committees, and Similar Entities – Questions and Answers, responds to common questions about drug companies’ communications to payers, including questions from payers about the effectiveness, safety and cost-effectiveness of approved drugs, to facilitate appropriate product selection or reimbursement decisions.

By increasing cost savings from coverage or reimbursement choices, FDA expects to allow patients to have timely access to precision therapies.

FDA also released guidance called Medical Product Communications that are Consistent with the FDA-Required Labeling, which offers the FDA’s views on drug manufacturers’ communication of information that is not included in FDA-required labeling, but is consistent with that labeling.

This information could help inform clinical decision-making, and it could also help payers establish value-based contracts where reimbursement may depend on information that isn’t included in the drug label.

With the release of these new documents, FDA expects to increase communication between patients, manufacturers and payers throughout the drug development process. Ensuring that drug companies understand the patient experience and that they communicate appropriate information with payers will help enhance patient-centered, quality care.

“We believe these guidances will provide clarity to companies as they develop communications about their medical products and help ensure that patients, providers and insurers have access to a range of relevant, truthful and non-misleading information from companies about medical products,” Gottlieb concluded.

“The aim of our policy is to help facilitate contracting for new medical products that are based on the value that these products are delivering to health systems, providers and especially patients.”


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