U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Prescription Drug User Fee Amendments
  5. FDA-led Patient-Focused Drug Development (PFDD) Public Meetings
  1. Prescription Drug User Fee Amendments

FDA-led Patient-Focused Drug Development (PFDD) Public Meetings

Patient Focused Drug Development

People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focused Drug Development (PFDD) initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. PFDD meetings are unique among FDA public meetings, with a format designed to engage patients and elicit their perspectives on two topic areas: (1) the most significant symptoms of their condition and the impact of the condition on daily life; and, (2) their current approaches to treatment. 

From 2012 to 2017, under the fifth authorization of PDUFA (PDUFA V), FDA conducted 24 disease-specific patient-focused drug development (PFDD) meetings to more systematically obtain the patient perspective on specific diseases and their treatments. PFDD meetings provide key stakeholders, including FDA, patient advocates, researchers, drug developers, healthcare providers, and others, an opportunity to hear the patient’s voice. The lessons learned include but are not limited to specific experiences that matter most to patients, patient perspectives on meaningful treatment benefits and how patients want to be engaged in the drug development process.

The list of the 24 disease-area PFDD meetings conducted under PDUFA V can be found below, along with links to meeting materials, including transcripts, webcast recordings and presentation slides that are publicly available. Following each PFDD meeting, FDA summarized the input shared by patients and patient representatives in a Voice of the Patient report. The links to these summary reports can also be found below.

More information on the selection of disease areas for fiscal years 2013-2015 can be found in the Federal Register Notice (PDF - 111KB) published on April 11, 2013. More information on the selection of disease areas for fiscal years 2016-2017 can be found in the Federal Register Notice published on July 2, 2015.

FDA recognizes the value of gathering patient input through PFDD meetings and continues to host disease-specific PFDD meetings. More information on FDA-led PFDD meetings hosted after PDUFA V and any upcoming FDA-led PFDD meetings can also be found below.

Click Below to Browse Disease Areas for FDA-Led PFDD Meetings

Upcoming FDA-led PFDD Meetings

FDA-led PFDD Meetings Hosted After PDUFA V (Fiscal Year 2018 onwards)

FDA-led PFDD Meetings Hosted Under PDUFA V (Fiscal Years 2013-2017)

 

Upcoming FDA-led PFDD Meetings

 

There are currently no upcoming FDA-led PFDD meetings.

 

 

FDA-led PFDD Meetings Hosted After PDUFA V (Fiscal Year 2018 onwards)

 

 

Chronic Pain

On July 9, 2018, FDA conducted a public meeting on Patient-Focused Drug Development for Chronic Pain. FDA was interested in hearing patients’ perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain. FDA was particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies.

 

 

Opioid Use Disorder

On April 17, 2018, FDA conducted a public meeting on Patient-Focused Drug Development for Opioid Use Disorder (OUD).In particular, FDA was interested in learning patients’ perspectives on OUD, including the effects on their health and well-being that have the greatest impact on daily life, their experience using prescription medical treatments and other treatments or therapies for OUD, and challenges or barriers to accessing or using medical treatments for OUD.

The audio recording of this meeting is publicly available using the links below. Because of the sensitive nature of the meeting topic, and the importance of gathering candid, meaningful input from individuals who have come forward to speak about living with opioid use disorder, there is no video recording of the meeting.

 

 

FDA-led PFDD Meetings Hosted Under PDUFA V (Fiscal Years 2013-2017)

 

 

Alopecia Areata

On September 11, 2017, FDA conducted a public meeting on Patient-Focused Drug Development for Alopecia Areata. FDA was interested in obtaining patient perspectives on the impact of alopecia areata on daily life and patient views on treatment approaches.

 

 

Alpha-1 Antitrypsin

On September 29, 2015, FDA conducted a public meeting on Patient-Focused Drug Development for Alpha-1 Antitrypsin. FDA was interested in obtaining patient perspectives on the impact of Alpha-1 Antitrypsin on daily life and patient views on treatment approaches.

 

 

Autism

On May 4, 2017, FDA conducted a public meeting on Patient-Focused Drug Development for Autism. FDA was interested in obtaining patient perspectives on the impact of autism on daily life and patient views on treatment approaches.

 

 

Breast Cancer

On April 2, 2015, FDA conducted a public meeting on Patient-Focused Drug Development for Breast Cancer. FDA was interested in obtaining patient perspectives on the impact of Breast Cancer on daily life and patient views on treatment approaches.

 

 

Chagas Disease

On April 28, 2015, FDA conducted a public meeting on Patient-Focused Drug Development for Chagas Disease. FDA was interested in obtaining patient perspectives on the impact of Chagas Disease on daily life and patient views on treatment approaches.

 

 

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

On April 25, 2013, FDA conducted a public meeting on Patient-Focused Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis. FDA was interested in obtaining patient perspectives on the impact of Chronic Fatigue Syndrome and Myalgic Encephalomyelitis on daily life and patient views on treatment approaches.

 

 

Female Sexual Dysfunction

On October 27, 2014, FDA conducted a public meeting on Patient-Focused Drug Development for Female Sexual Dysfunction. FDA was interested in obtaining patient perspectives on the impact of Female Sexual Dysfunction on daily life and patient views on treatment approaches.

 

 

Fibromyalgia

On March 26, 2014, FDA conducted a public meeting on Patient-Focused Drug Development for Fibromyalgia. FDA was interested in obtaining patient perspectives on the impact of Fibromyalgia on daily life and patient views on treatment approaches.

 

 

Functional Gastrointestinal Disorders

On May 11, 2015, FDA conducted a public meeting on Patient-Focused Drug Development for Functional Gastrointestinal Disorders. FDA was interested in obtaining patient perspectives on the impact of Functional Gastrointestinal Disorders on daily life and patient views on treatment approaches.

 

 

Hemophilia A, B, and Other Heritable Bleeding Disorders

On September 22, 2014, FDA conducted a public meeting on Patient-Focused Drug Development for Hemophilia A, B, and Other Heritable Bleeding Disorders. FDA was interested in obtaining patient perspectives on the impact of Hemophilia A, B, and Other Heritable Bleeding Disorders on daily life and patient views on treatment approaches.

 

 

Hereditary Angioedema

On September 25, 2017, FDA is conducting a public meeting on Patient-Focused Drug Development for Hereditary Angioedema. FDA is interested in obtaining patient and caregiver perspectives on the on the impact of Hereditary Angioedema on daily life and patient views on treatment approaches.

 

 

Human Immunodeficiency Virus (HIV)

On June 14, 2013, FDA conducted a public meeting on Patient-Focused Drug Development for Human Immunodeficiency Virus (HIV). FDA was interested in obtaining patient perspectives on the impact of Human Immunodeficiency Virus (HIV) on daily life and patient views on treatment approaches.

 

 

Huntington’s disease

On September 22, 2015, FDA conducted a public meeting on Patient-Focused Drug Development for Huntington’s Disease. FDA was interested in obtaining patient perspectives on the impact of Huntington’s Disease on daily life and patient views on treatment approaches.

 

 

Idiopathic Pulmonary Fibrosis

On September 26, 2014, FDA conducted a public meeting on Patient-Focused Drug Development for Idiopathic Pulmonary Fibrosis. FDA was interested in obtaining patient perspectives on the impact of Idiopathic Pulmonary Fibrosis on daily life and patient views on treatment approaches.

 

 

Inborn Errors of Metabolism

On June 10, 2014, FDA conducted a public meeting on Patient-Focused Drug Development for Inborn Errors of Metabolism. FDA was interested in obtaining patient perspectives on the impact of Inborn Errors of Metabolism on daily life and patient views on treatment approaches.

 

 

Lung Cancer

On June 28, 2013, FDA conducted a public meeting on Patient-Focused Drug Development for Lung Cancer. FDA was interested in obtaining patient perspectives on the impact of Lung Cancer on daily life and patient views on treatment approaches.

 

 

Narcolepsy

On September 24, 2013, FDA conducted a public meeting on Patient-Focused Drug Development for Narcolepsy. FDA was interested in obtaining patient perspectives on the impact of Narcolepsy on daily life and patient views on treatment approaches.

 

 

Neuropathic Pain Associated with Peripheral Neuropathy

On June 10, 2016, FDA conducted a public meeting on Patient-Focused Drug Development for Neuropathic Pain Associated with Peripheral Neuropathy. FDA is interested in obtaining patient input on the impact of neuropathic pain associated with peripheral neuropathy on daily life and patients’ views on currently available therapies to treat the condition.

 

 

Non-tuberculous Mycobacterial Lung Infections

On October 15, 2015, FDA conducted a public meeting on Patient-Focused Drug Development for Non-tuberculous Mycobacterial Lung Infections. FDA was interested in obtaining patient perspectives on the impact of Non-tuberculous Mycobacterial Lung Infections on daily life and patient views on treatment approaches.

 

 

Patients Who Have Received an Organ Transplant

On September 27, 2016, FDA conducted a public meeting on Patients Who Have Received an Organ Transplant. FDA was interested in obtaining patient input on the impact of receiving an organ transplant on daily life and patients’ views on currently available therapies to manage organ transplantation.

 

 

Parkinson’s Disease

On September 22, 2015, FDA conducted a public meeting on Patient-Focused Drug Development for Parkinson’s Disease. FDA was interested in obtaining patient perspectives on the impact of Parkinson’s Disease on daily life and patient views on treatment approaches.

 

 

Psoriasis

On March 17, 2016, FDA conducted a public meeting on Patient-Focused Drug Development for Psoriasis. FDA was interested in obtaining patient perspectives on the impact of psoriasis on daily life, patient views on treatment approaches, and decision factors taken into account when selecting a treatment. FDA was interested in patient's perspectives for the types of psoriasis with primarily skin symptoms (such as plaque psoriasis, nail psoriasis, guttate psoriasis, etc.).

 

 

Pulmonary Arterial Hypertension

On May 13, 2014, FDA conducted a public meeting on Patient-Focused Drug Development for Pulmonary Arterial Hypertension. FDA was interested in obtaining patient perspectives on the impact of Pulmonary Arterial Hypertension on daily life and patient views on treatment approaches.

 

 

Sarcopenia

On April 6, 2017, FDA conducted a public meeting on Patient-Focused Drug Development for Sarcopenia. FDA was interested in obtaining patient perspectives on the on the impact of sarcopenia on daily life and patient views on treatment approaches.

 

 

 

Sickle Cell Disease

On February 7, 2014, FDA conducted a public meeting on Patient-Focused Drug Development for Sickle Cell Disease. FDA was interested in obtaining patient perspectives on the impact of Sickle Cell Disease on daily life and patient views on treatment approaches.

 

To contact FDA’s CDER Patient-Focused Drug Development Program Staff, please email patientfocused@fda.hhs.gov.

To get updates about CDER's Patient-Focused Drug Development programs, subscribe to our free email subscription service using the button at the top of the page.

Back to CDER Patient-Focused Drug Development Homepage

Patient Focused Drug Development

Get regular FDA email updates delivered on this topic to your inbox.