NEWS FROM THE FDA
In early July 2015, the FDA announced that Alopecia Areata was in a list of diseases for the fifth authorization of the Prescription Drug User Fee Act as part of its Patient-Focused Drug Development Initiative. (PDUFA V)
How Did We Get Here?
We asked. You rallied! When we asked our vibrant BGDL network to help us secure the alopecia areata disease onto the hearings list, you answered with intelligence and clarity. We compiled and submitted your verbatim comments to the FDA in a compelling document HERE.
With so many diseases and disease advocates across the country, the FDA set up a systematic process to narrow down the diseases they would discuss in future hearings. They set criteria to narrow the long list of diseases. We spelled it out to educate the Bald Girls Do Lunch network.
You Benefit with Alopecia Education
You need and deserve accurate information. Educating you is a core reason that Bald Girls Do Lunch was created.
We have seen far too many hyperbolic headlines with misleading words designed to excite the alopecia community into a frenzy of fund raising. Have you seen “FDA” and “more funding for alopecia” in the same sentence? We have too! Enough is enough. You need to know why such phrases are misleading. Our Myths and Facts below will get you started.
> Strung all together, PDUFA is the acronym for Prescription Drug User Fee Act.
> This Act is a law in the United States.
> This Act is a regulatory requirement created by Congress for the FDA, a federal agency named the Food and Drug Administration. The PDUFA was created as a way for pharmaceutical companies to pay fees to the FDA to facilitate the FDA’s drug evaluation process.
> One of the requirements for the renewal of the Act is that the FDA obtain patient
viewpoints on such things as the severity of diseases they live with on a daily basis.
Myths and Facts
Myth: The letter D in FDA stands for “Drug”. That means that the FDA will develop drugs for patients.
FACT: The FDA never develops drugs of any kind.
Myth: The letter P in the words “Prescription Drug User” stands for prescription because the FDA researches drugs and suggest who should receive them .
FACT: The FDA does not conduct research of any kind, let alone on drugs for alopecia patients.
Myth: The letter F in PDUFA stands for “Fee”. Fee means that the FDA is going to help reduce the cost of drugs that patients take.
FACT: The FDA has no role of any kind in the cost of drugs. Rather, the word “Fee” refers to the purpose of the PDUFA. The purpose of the PDUFA is to require pharmaceutical companies to pay fees to the FDA. Why? These fees are a source of revenue providing the FDA with increased funding. These fees enable the agency to speed up its evaluation of drugs.
More Myths and Facts ….
Myth: The word “Patient” means that the current renewal of the PDUFA with the FDA’s list of diseases earmarked for patient-focused meetings will result in more research on alopecia patients and drugs for alopecia patients.
FACT: The FDA does not conduct research on patients. The FDA does not administer drugs to patients. The FDA does not treat patients. The FDA does not actively promote drugs or research on drugs for patients, period.
Myth: Alopecia Areata ‘made the cut’ to be discussed in 2016-2017 to essentially fast-track research, research funding and new treatments for AA.
FACT: Listening to patients at Patient-Focused Drug Development meetings about diseases is a regulatory requirement for renewal of the PDUFA V. Soliciting feedback from patients is a benefit because it advances the FDA staff’s comprehensive understanding of disease impact. However, the FDA does not do research. The FDA does not suggest treatments. The FDA neither allocates nor recommends funding for research or treatments.
Myth: Future ‘Patient-Focused Drug Development’ discussions are going to focus on new drugs for diseases for alopecia areata because some of the public’s contacts for more information have job titles such as ‘analyst in the FDA Center for Drug Evaluation and Research.’
FACT: Try not to let job titles and department names with ‘Drug’ and ‘Research’ lead you to the false conclusion that ‘Patient-Focused Drug Development’ discussions will develop new drugs. They will not. See above.
Myth: Sixteen diseases have been chosen by the FDA for new drug development talks.
FACT: Sixteen diseases have been chosen to be the subject of public meetings for FY( fiscal year) 2016-2017 and alopecia areata is one of them. FDA established a systematic method to whittle down suggested disease areas from nearly 2,700 public comments. The majority of the comments concerned lewy body dementia, frontotemporal lobar degeneration, and neuropathies.
What Is the Role of Bald Girls Do Lunch?
Advocacy: To continue to provide you with accurate, user-friendly ways to understand and then talk about all things alopecia areata, especially medical updates.
Community: To continue to raise the voice of the patient in public forums and share your life experiences through the Bald Girls Do Lunch organization.
Education: To separate fact from fiction; so that when you see pitches asking you to give more money for research, you will read very carefully and determine if you are being misled in any way.
Alopecia Areata Made the Cut: Now What?
The FDA is required by PDUFA to listen to patients who live with the diseases that drug companies are developing treatments for. Patients’ perspectives help FDA staff understand which aspects of disease are most troublesome for patients and how specific kinds of treatments might improve patients’ lives. FDA does this “listening” by holding public meetings focused on a select few diseases each year. Alopecia Areata is on the list of diseases slated for one of these hearings in the 2016-2017 schedule.
We thank you! Based on the focused feedback such as comments we provided HERE, the FDA narrowed their long list of diseases to include the alopecia areata skin disease for the one-time, in-person public hearings schedule in FY 2016-2017.
We hope you have enjoyed learning a thing or two today about our role as advocates and educators.
Here at BGDL, we refer to patient comments and patient-focused hearings as ‘background information for FDA reviewers’ because that is what it is.
Does our educational blog give you some talking points today? Let us know in the comments below!