The Prescription Drug User Fee Act (PDUFA), passed by the FDA in 1992 and renewed for the fifth time this year, aims to better utilize patient input to inform the drug research and approval process. Patients provide an essential perspective on the severity of a disease and insight into the implications that available treatments (or lack thereof) have on their condition. Within the PDUFA, the Patient-Focused Drug Development initiative plans to explore 20 disease areas by featuring each one in an FDA public meeting. The disease areas chosen will have the attention of the pharmacological community, as well as a public forum to advocate for the research and development of treatment options. Because there is currently no drug treatment on the market designed specifically for temporomandibular disorders (TMD), a public meeting at the FDA would be a great opportunity to express the needs of sufferers of TMD. In addition, it could lead to a critical break-through in treatment of TMD.
We need your help! TMD are not currently on the list of disease areas to be considered for a public meeting. TMD affects over 35 million people nationwide; with our strength in numbers, we CAN be heard by the FDA. We strongly urge you to submit a comment via the FDA docket that explains why TMD should be chosen for future public meetings by the FDA. The deadline to submit a comment is THIS THURSDAY, NOVEMBER 1st, so you must act quickly.
Wondering where to start? As a reference, you can find the comment submitted by The TMJ Association here. We have addressed the five criteria (listed below) that the disease area must meet in order to be considered. Because submissions must not exceed 2000 typed characters, do not feel like you must speak to all of the criteria. We have included TMD statistics and information for you to incorporate if you wish.
- The disease area must be chronic, symptomatic, and affect the function and activities of daily life (TMD are ill-defined, painful, and debilitating disorders. Feel free to share how TMD impact your daily life, but keep in mind the 2000-character limit!)
- The disease area must reflect a range of severity (Symptoms of TMD range from mild discomfort to severe and intractable pain, and can also include debilitating jaw dysfunction.)
- The disease area must contain aspects that are not formally captured in clinical trials (The safety and efficacy of TMD treatments have not been demonstrated in clinical trials. The results of a recently published study indicate that in spite of the widespread impact of TMD and the plethora of TMD treatments, those treating TMD problems have given little attention to systematically carrying out clinical trial methods that would improve the validity and reliability of outcome measures. The authors state, "With some 20 years of knowledge of evidence-based healthcare, the meager attention to these issues begins to raise ethical issues about TMJD trial conduct and clinical care.")
- The disease area must have a severe impact on identifiable subpopulations (Although both men and women are affected, the majority of those seeking treatment are women in their childbearing years.)
- The disease area must represent a broad range in terms of size of the affect population (Over 35 million people in the United States suffer from TMD at any given time.)
- On current available treatments: A 2008 survey of 1,511 TMD patients conducted by The TMJ Association found that 75% of patients were prescribed anti-inflammatory agents, 50% were prescribed opioids, 50% were prescribed antidepressants, and 41% were prescribed anti-anxiety medications. Currently no prescription drug is labeled for temporomandibular disorders. Yet, over-the-counter and prescription medications continue to be prescribed to TMD patients−medications with a significant number of side effects and unknown risks of long-term use.