May 5, 2017
Sharnell Ligon Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
RE: Public Comments on Docket No. FDA–2017–N–0455 for “Enhancing Patient Engagement Efforts Across FDA; Establishment of a Public Docket; Request for Comments.”
Dear Ms. Ligon,
The following are the comments of the Protecting Access to Pain Relief (PAPR) Coalition on the request for comments entitled “Enhancing Patient Engagement Efforts Across FDA; Establishment of a Public Docket; Request for Comments” published in the Federal Register on Tuesday, March 14, 2017 [Docket No. FDA–2017–N–0455]. The PAPR Coalition is a multi-stakeholder group whose mission is to advocate for public policy that supports access to and choice of appropriate over-the-counter (OTC) pain relief, while educating the public about responsible use of acetaminophen. Our members include public health organizations, medical professional societies, consumers living with pain, and concerned citizens. Collectively, our organizations can reach millions of patients and health care providers with public health messages.
The PAPR Coalition was created to engage patients, providers and public health advocates in developing the best public policy to support access to and choice of pain relief. We recognize the unique perspective patients can offer in policy-making.
We commend the FDA for its proposal to engage patients through its proposed Office of Patient Affairs, an effort designed to help ensure the patient voice and patient concerns are more fully represented in the regulatory process. The FDA Office of Professional Affairs and Stakeholder Engagement lead by Dr. John Whyte has been a valuable asset to the FDA and in its engagement to stakeholders. The creation of this Office would build on Dr. Whyte’s success and provide an important opportunity to work with patients and patient organizations in the development of FDA policy and agency education efforts. The PAPR Coalition believes that by working together, the FDA and stakeholders can develop strategies that address the full spectrum of interests surrounding a policy decision, including the patients who use the FDA-regulated products. We urge the FDA to use the PAPR Coalition as a resource in its patient engagement efforts, as Coalition members have the resources and communication tools to engage millions of Americans. Members of the PAPR Coalition are in the unique position to be able to clearly and effectivity communicate complex regulatory information to consumers.
We are eager to work collaboratively with the FDA to ensure patients have a voice in regulatory and other decision-making processes through the proposed Office of Patient Affairs. We look forward to future dialogue with the Agency to ensure that the importance of engaging with patients, caregivers, and their advocates remains a strong consideration in agency decisions.