The Food and Drug Administration (FDA) needs to hear from you, and soon! Through the Patient-Focused Drug Development Initiative, the FDA is getting the patient perspective on selected diseases and their treatments. They are holding public meetings on different medical conditions to better understand what it is actually like to live with the condition and the real world impact of medication – how well your current medications work, the side effects, how your disease and your treatment affect your daily life.
The FDA is currently inviting public comment on what disease areas it should include in public meetings to be held in the next couple of years. Lupus is NOT on the FDA's preliminary list. But the FDA is asking for feedback before finalizing the list. So let’s get lupus included!
We're urging everyone to write to the FDA why lupus must be included.
Please hurry; you need to respond by December 5.
What You Need To Do:
1. Use the outline below as a guideline to write your own letter, in your own words
2. The FDA is using four criteria to determine what conditions it will hold meetings about. In your letter, please describe your own situation or that of a loved one to illustrate how lupus meets the following criteria:
- Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
- Disease areas for which aspects of the disease are not formally captured in clinical trials;
- Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives; and
- Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly).
3. Must include that you are responding to Docket No. FDA-2012-N-0967
4. Submit electronically using this link. Or, mail your letter to: Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
5. Send your letter by Friday, December 5, 2014
The FDA is receiving emails and letters about many diseases. We need to make sure the voice of lupus patients is included in the drug review process. So write your own letter and tell the FDA why lupus deserves their attention!
Let us know you wrote to the FDA, email us at firstname.lastname@example.org.
For More Information on the Patient-Focused Drug Development initiative:
FDA’s “Voice of the Patient:” Listening to Those Most Affected
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: DOCKET NO. FDA-2012-N-0967
I am writing to provide public comment regarding the Patient-Focused Drug Development initiative.
As a [LUPUS PATIENT/RELATIONSHIP TO A PERSON WITH LUPUS] I would like to strongly request inclusion of lupus as one of the disease areas for which the Food and Drug Administration will hold a public meeting.
For the body of the letter, the four criteria FDA will consider for selection should be addressed. Please include points that address the following:
1. TELL YOUR STORY OF HOW LUPUS IS CHRONIC, THE SYMPTOMS YOU EXPERIENCE AND HOW IT AFFECTS YOUR DAILY LIFE. GIVE EXAMPLES OF HOW UNPREDICTABLE LUPUS IS IN YOUR LIFE I.E. FLARES; DIFFERENCE IN HOW YOU FEEL FROM DAY TO DAY; VARYING COMPLICATIONS
2. MENTION IF YOU HAVE BEEN UNABLE TO PARTICIPATE IN A CLINICAL TRIAL BECAUSE YOU WEREN’T ELIGIBLE DUE TO LIMITED INCLUSION CRITERIA
3. NOTE THAT ONLY ONE DRUG HAS BEEN DEVELOPED SPECIFICALLY FOR LUPUS IN NEARLY 60 YEARS. HOW MANY DRUGS YOU TAKE, THE SYMPTOMS THEY DO AND DO NOT ADDRESS, MENTION THE SIDE EFFECTS YOU EXPERIENCE, DRUGS YOU TAKE TO COMBAT THE SIDE EFFECTS OF YOUR LUPUS MEDICATIONS
4. MENTION WHO YOU ARE, FOR EXAMPLE: ARE YOU A YOUNG WOMAN RECENTLY DIAGNOSED? OR HAVE YOU BEEN LIVING WITH LUPUS FOR MANY YEARS? ARE YOU A MALE WHO MAY HAVE A DIFFERENT EXPERIENCE WITH LUPUS? ARE YOU AFRICAN-AMERICAN, HISPANIC, ASIAN OR NATIVE-AMERICAN? ARE YOU WRITING ON BEHALF OF A CHILD OR SENIOR WITH LUPUS?
Thank you for considering the patient perspective in the drug review process. I hope that the 1.5 million Americans living with lupus will have the opportunity to be represented in the Patient-Focused Drug Development initiative.