Epilepsy Advocacy Outreach to DEA
The Epilepsy Foundation has asked the DEA to change their approval process for new epilepsy medications, so that it is a more efficient and transparent process.
|We have also asked the epilepsy community to join us in this and the response has been overwhelming. Below you will find links to the action alert that you can use to add your voice, our letter to the DEA, a press release we did on the topic, as well as some of comments that have been sent in personal messages to the DEA.
After the Food and Drug Administration (FDA) approves a drug for use, the Drug Enforcement Administration (DEA) must then evaluate the drug and label it with the controlled substance schedule.While the FDA has a standardized and fairly predictable process for drug approval, the DEA's
approval process has not been made public and the time it takes can vary significantly. These delays negatively impact the epilepsy community as they must wait for DEA approval before being able to purchase drugs already approved by the FDA, and every second they wait is another second some must continue to live with intractable or uncontrolled seizures.
Take Action Here: DEA Action alert
A sample from the DEA alert of personalized comments added to the DEA letter
- My friend's child has epilepsy, and this would help her child.
- My son has epilepsy that is not controlled completely even with 4 medications.
- I have lived with Epilepsy for 47 years, am a mother to someone who could possibly struggle with it for the rest of her life, and have many friends with Epilepsy.I have seen friends lose their lives way too young due to Epilepsy, and have cried, at the loss of several who should still be here today.For the millions of Americans that suffer silently, or right alongside of others who are the only ones who understand, we ask for your help! Don't our loved ones deserve the same quality of life as others? Please don't delay anything that could possibly help make our lives better. I for one, have been waiting too long for a cure, and know others have as well.You never know when it could happen to someone you love!
- My 9 Year old Granddaughter cannot wait for help.....Do not obstruct ANY medications that can help her and others!
- My daughter has been suffering from seizures for the past 28 years and still cannot find a medication to help her.Please speed up this process.We desperately need new treatment options!! PLEASE HELP US!!
- I have epilepsy due to TBI, & I am needing to try new therapies to lessen the severity of my seizures. I need to try new therapies but am concerned about the time the DEA takes with scheduling.
- I am writing to you on behalf of my 28 yr old daughter you has multiple disabilities, among them seizures. I am concern that the DEA scheduling to approval new therapies may interfere with the treatments she needs. This timeline puts a smaller pool of therapies her doctor may have for her in controlling her seizures.
- As for me, I am an epileptic that is also on blood thinners. The effects of the three medication that I have been on have taken a ton on my body. The meds must blend with blood thinners. I need help NOW.
- My son has been on a single rx therapy for 10 yrs, successfully. This is sad and worrisome condition, even when treated. Access to new FDA approved treatments may prevent further brain injuries. They may even be able to maintain steady employment and have some normal family life.
- Living with epilepsy can be a crippling condition that dulls the function of the patient. I was fortunate to be a health care professional with worsening epilepsy and successfully pursued epilepsy surgery successfully. I am no longer dependent on drugs and no longer see a neurologist and am in an excellent health condition.
- My daughter, who is now 35, has been living with uncontrolled seizures since birth. She currently has 6-8 tonic-clonic generalized (grand mal) seizures per week. You cannot imagine the challenges this has posed to maintaining any degree of quality of life for the past three and a half decades. I urge you to address the concerns brought to you by the Epilepsy Foundation on behalf of the hundreds of thousands of families like ours.
- My child has Epilepsy and more specifically Dravet's syndrome. We can't get our hands on good treatment fast enough!!! Please help.
- I have had Epilepsy for a long time. The following is a list of medications that were not successful in treating my seizures. Depakote, Serzone, Neuronten, Dilantin, Topamax, Kepra, Tripleptal. I was miserable I prayed everyday for a miracle. Finally a mixture of brand Name only Lamictal and Felbatol worked and I am living and enjoying life. If there is an FDA approval of new therapies,please don't let DEA make a patient whose going through a horror go through it more than a minute. Having been there I know. EVERY MINUTE COUNTS TOWARD FEELING WELL AND LIVING WELL!
- As a mother of an adult son who has epilepsy since 6th grade, I am well aware that new medications are needed as soon as possible to make lives safer.
- Having epilepsy for the last 13 years, and having changed several drugs to control my seizures, I know how important is for me to have new treatments available without unnecessary delays.
- I have had epilepsy all of my life and currently have been seizure-free for 3 years thanks to medications recently introduced.Others should have the same experience as I without a long wait.
- We, at the LGS Foundation (Lennox-Gastuat Syndrome) are requesting a review of the policies of the DEA which have allowed FDA approved medication to wait in limbo. Having access to a variety of therapies including different types of medication is important for patients with epilepsy. The lack of transparency and uncertain timelines the DEA has exhibited have left physicians unable to properly inform their patients. Access to new medication or information on the availability of new medication is especially important for individuals living with Lennox-Gastuat Syndrome and their caregivers. Children with this syndrome can have hundreds of seizures a day and with no cure available, medications and therapies offer an improvement in the quality of life. Unclear delays hinder this process. Furthermore, some individuals who have LGS respond adversely to current medications and additional treatments options are especially important in these scenarios.
- I've had epilepsy for 41 yrs. gone through 2 brain surgeries to help to reduce and stop the epileptic seizures and I've tried over 11 different seizure meds but nothing has worked and I have had over 300 seizures a yr. some days I will have 3-9 seizures in a day.
- I am one of the many people who acquired epilepsy through head injury from a head-on collision with a drunk driver. I was a first year teacher when the accident happened & my head broke the windshield. A few years later the seizures began... due to the scar tissue that grew in my brain. At first my medications worked well. Later, they had less control of returning seizures and I had to switch meds every few years.Sometimes I got injuries from falls due to sudden seizures. I lost many years of work but with help from my husband, I was able to care for our children & work as a visual artist.Finally I agreed to pre-surgery testing, qualified for corrective brain surgery, and got it done. Then I needed to go through lengthy recovery & rehab. My return to teaching worked out and I earned my teacher pension. If my epilepsy ever returns I will need to have contemporary meds. All the earlier types were unable to continue full control for my condition. Please conclude approval for anti-seizure meds for people who need it. Rather than abusing meds illegally, epilepsy patients need them as treatment to save their lives.
- My epilepsy controlled my life for a number of years. Seizures tried to rule my life while I was a small child. Mistakenly, I understood that my seizures were a thing of the past when my seizures were controlled. I became careless and once again triggered my seizures when I was in college. The seizures continued as I was trying to participate in the working world. When my husband and I wanted to start a family, seizures interfered in our plans.
- After years of seizures, I was blessed to have had a successful brain surgery in 1991, My seizures are controlled at this time because of my surgery. I am now the mother of a 20-year old son and a wife. I have a part-time job so that I can help my mother when she needs me. I will take medicine for the rest of my life. If I fail to do as my neurologist says and quit taking my medicine, I will start having seizures again. I learned as a young adult that I will always have epilepsy; my seizures are controlled at this time.
- I have several friends who still have seizures. I am blessed to have controlled seizures. I drive my friends to doctor's appointments, etc. I like to advocate for people with epilepsy. Please help us help more people get their seizures controlled!
- My husband has epilepsy and meds are really an ISSUE. We can't be late on them or he has a seizure. For those who need control and new drugs are waiting in the wings. The WAIT NEEDS TO BE EXPEDITED. You need some kind of temporary allowance. Even copying a driver's license or id card of some kind. it is really important.
- I've had epilepsy for five years, and finding the right medication has been difficult. Even though my current regimen seems to work, it is far from perfect. There are so many side effects, and there is no guarantee that it will keep working. I'm fortunate enough to have meds that prevent seizures. So many seizure patients do not have the same fortune as myself.
- I have always suffered from epilepsy since my day of birth, 51 years ago.After receiving a successful treatment from middle school through high school, my seizures resumed during my freshman year (1980 - '81) at Tufts University, and have continued ever since.Nevertheless, I was able to complete my double major (in International Relations and in Economics) and receive my BA (1984).I continued to attend grad school for an MA in Political Science from Boston College (1987).Unfortunately, my seizures have continued intractably ever since, preventing me from working, driving, and leaving my parents' home.A variety of treatments have been tried, including brain surgery, without success.Recently, my doctor prescribed Onfi (clobazam) which has been more effective in reducing my seizures recently than most others.Because this had not yet been approved by the FDA, my parents were forced to buy it from a small pharmacy on the Pacific coast of Canada.Fortunately, it has been approved since, and can now be obtained with my other medications. Just think how many other epilepsy patients are unable to gain access to a life-saving medication which would give them freedom from seizures due to such delays in the FDA approval of that medication
- My grandson has epilepsy. He has tried every drug available in his short four years. His chances of having a successful life or even living are diminishing with every seizure. His seizures are severe and often.I know there are many causes, concerns and needs for thousands of people. But, children who have uncontrollable seizures do not have the time to wait for bureaucracy. Please reconsider your polices and quickly!
- As an epilepsy patient, I tried seven different medications before finding one that works for me. I was a member of a clinical trial for five years. Had my epileptologist not been able to help me join the trial, I would have had to wait for five years before having access to this new therapy. I am afraid to think what would have happened to me due to my uncontrollable seizures, considering there were no other new medications available at the time.
- Living with epilepsy after an auto accident since 1985, had partial seizure for about thirteen years and several kinds of medications that did not work. Also stimulation therapy the brain, nothing seemed too work. Went to Boston Massachusetts in 2003 about Brain Surgery? I was a good Candidate after a year of different Testing. Happy to say everything went well. On too Newer medications Lacosamide and Keppra which work very well. Long story short, There should be More options for Doctors and patients.
- Through a personal view, for 21 yrs I had been waiting for new medications etc to help my seizures at least suppress.The threat of this time frame even increasing for someone else to wait this long for a time of seizure freedom is beyond my moralistic thinking.I was lucky to find a new medicine on top of seven others to create a cocktail of medication to finally work.To be seizure free is nice but at the expense of a lot of money, balance, and no sleep.Please do not let this happen as it will hamper chances of survival.
- I have had epilepsy for over 50 years.The nonsense of getting treatment or for medications is not acceptable.
- I have a vns implant that stopped working. I have also had a seizure response dog, Homer, that worked wonderful during his lifetime with me until his passing. But besides having epilepsy, I also have to contend with Psychogenic Non Epileptic Seizures that was diagnosed a few years ago. It been proven that I have both types. I have such a difficult time finding appropriate medical references to help me with my PNES. SO PLEASE DO WHATEVER IT TAKES TO GET HELP WHERE NEEDED
- I am an epilepsy specialist neurologist at a large epilepsy center. I have over 3000 epilepsy patients and at least 1000 have intractable seizures and are awaiting new treatments. About 2 of these otherwise healthy young people die each year from SUDEP (sudden unexplained death in epilepsy) while awaiting new treatments; I have accumulated 56 of them in my career so far. They need new treatments as soon as they can be made safely available. I appreciate the administrative complexity in drug approval. However, antiepileptic drugs do not have any history of abuse and have almost no abuse potential in my opinion based on my experience and the meager data available. Therefore, it would serve Americans best to expeditiously provide DEA scheduling if these drugs are to remain scheduled substances. The two patients with intractable epilepsy in my clinic who will die this year from SUDEP would be very grateful to have new treatments available even a few months sooner.
- I suffered with epilepsy consistently for 21 years. During that time, I was on several anti-epileptic drugs that were not controlling my seizures. However, through my own research, I found out that I had refractory epilepsy, which means that the seizures I was having do not respond to medication. Fortunately, my research also led me to find an epileptologist, who was able to appropriately diagnose and explain my condition to me. He also referred me to a comprehensive epilepsy center, where I underwent brain surgery, by a brilliant neurosurgeon and I've been seizure free for the first time in 21 years. However, everyone's case is different so some may not need to have the surgery because most epilepsy cases can be managed by medication, so please shorten the time for these drugs that can help others suffering with epilepsy control their seizures. Everyone one deserves to live a happy and independent life if possible.
- As an active epilepsy clinical researcher, I have hands-on experience with many novel therapies in the context of clinical trials. However, the stringent enrollment criteria of these trials mean that a majority of my refractory epilepsy patients do not have access to these novel therapies until they are commercially available. I sub-specialize in epilepsy and see most of the toughest and most refractory patients in my state. I am proud of the fact that I continue to see all patients, regardless of insurance or ability to pay, without any restrictions or tiered priority. I literally have dozens of patients who have tried a majority of available therapies, both on and off label, and who eagerly await the release of new products.Their seizures, uncontrolled despite best medical and/or surgical management, result in clinical emergencies, including costly hospitalizations that ultimately drive up the cost of health care in my community. Some of these patients will become injured and some could die, waiting for the DEA to schedule therapies already approved by the FDA.
- These delays are not just an inconvenience, they are an unethical and immoral injustice imposed on the disabled. While I am sure these delays are dictated by lack of resources rather than willful disregard for the disabled, the unfortunate end result and impact on these patients' lives is the same. I personally urge you in the strongest possible terms to provide a more transparent and understandable approach to this process. These delays are unconscionable - lives hang in the balance.
- Please allow epilepsy patients the opportunity to LIVE!! This procrastination in the DEA scheduling takes hope away ... takes precious days away from the lives of those suffering with epilepsy. My brother, Gerard, a retired Baltimore County Policeman (forced-retirement due to the disease), died in his sleep at 53 years old. He had a seizure. He struggled with the medications available that made him so tired. If he had the chance to try new therapies he may have been alive today to hold his two granddaughters that were born since he passed last year. He would be able to see his daughter's beautiful paintings and his youngest daughter graduate from nursing school, and his son raise his beautiful growing family. He may have been here with me now ... instead I wake every morning in tears and spend each day wondering what I should have done to help him in his struggle with this "silent" disease. Please don't be silent about it ... please, I beg you, to help young epileptics see their future, and senior sufferers enjoy their grandchildren and golden years they worked so hard to achieve.
- It is too late to help my brother.. but in saving another life or at least please, in giving hope, I know another sister won't wake up in tears. May God bless you and your families.
- I started to have seizures at age 6 and I have been on seizure medicine since then.I feel that patients with epilepsy should have access to new treatments because they can live more healthy lives and not fear having seizures on the job or in their case lose their drivers license which has happened twice to me.I happened to be off my seizure medicine at the time because my doctor wanted to see if he could take me off.I had to be put back on my seizure medicine immediately and stayed on the same medicine for 20 years and did well till my body had built up an immunity to the medicine and I passed out in a hot stock room and had a seizure on the job.I now have to take 3 seizure medicines(Kepra, Neurontin and Tegretol). Please give access to patients who have trouble with being controlled even on medicine and provide them with better therapies. I have had Epilepsy for over 39 years and have to struggle with the effects of the medicines that I take causing fatigue.I am currently taking my medicines 3 times a day(1 Kepra 500 MG AM, 1 Tegretol 400 AM, 1 Neurontin 800 MG AM, Lunch: 1 Tegrotol 400 MG, 1 Neurontin 800 MG, and PM: 1 Kepra 500 MG, 1 Tegretol 400 MG and 2 Neurontin 800 MG.The combination causes fatigue as well as dizziness.Please take the fact that people that live with Epilepsy often times cannot get the treatment that they need and it is time for them to get that treatment.
- My son began having seizures at 5 months of age. He is currently approaching the age of 3 and still has seizures every day. His epilepsy has hindered him greatly. He is unable to walk, talk, crawl, and other simple things that a child of his age should be doing. This condition has greatly changed our lives any further hindrance to care may greatly affect his life and our family life.
- I am a nurse working with patients and families with epilepsy. It is very sad and frustrating when patients are not allowed to try a medication that an expert seizure doctor feels would work because the insurance will not allow it. Some of these patients have daily debilitating seizures and do not have access to certain medications that can possibly help with the control. Even having one seizure every three months is debilitating. It only takes one seizure to result in injury or death. This is not a question of becoming addicted to particular medications, it is about controlling the seizures and having a better quality of life.
- My daughter, Bella, who has suffered from seizures since the age of 9 months old depends on the ability to get new medications that might help control her seizures. In the recent past we have had to go through other countries to get medicine that was not yet available here in the states. Please keep this issue in the for front of your mind when discussing the current delay between FDA approval.Thank you very much for your time.
- My oldest son Jakob had his first seizure at 9 months of age. He was started on medication which over the years has had to be changed due to undesirable side effects.We have been very fortunate in that his seizures have been very well controlled. Jakob recently had 6 grand mal seizures which has been very scary for us since he started back to school and we cannot be with him every second of the day. He also had been approved to have a vagal nerve stimulator placed in two weeks which was already scheduled prior to these recent seizures. As a medical professional, I am fortunate to be able understand the need for regulation but as a mother, seeing your child go through these horrific episodes makes it hard to wait.
- My son has lived with Epilepsy for over 20 years. Medicines have provided him the chance to finish college, work part time and have an active life. The sooner new medications can be marketed it will help the different communities of needed medications.
- I've had epilepsy almost all my life and what concerns me is medications have been approved by the FDA that could possibly benefit people like me and you are delaying them being made available to people like me. Most people with epilepsy are on multiple AED's and if a new drug has been approved that could reduce the amount of medications we have to take, then why isn't the process being hurried up instead of delayed? Most of the time multiple AED's don't control seizures and you're preventing drugs that could possibly give us control from being made available. There is no reason in the world for this to happen.
- My daughter is 18 years old now, and we have been living with epilepsy since she was diagnosed 9 years ago...the medication roller coaster is frustrating and when there is a wait for a new drug to come, it is excruciating to watch your child go thru daily seizures because we are just waiting for a drug to come on the market and think that this new drug could be the one to help her survive each day and try to live a normal life. Please consider this action and help make a change!
- For those of us afflicted with this neurological disorder time can often be of the essence. Epilepsy is not as in the public eye as cancer, heart disease, MS, etc. but for someone who has lived most of her childhood and certainly her whole adult life battling it I can tell you it is important to know that I have access to the best possible treatments and medications, both to me and my family. If there were something that could control my seizures better with fewer side effects I would be heart broken to know that the signing of a simple form and a whole lot of red tape was all that was keeping me from a better quality of life. I would hope that you could see past the mundane drudgery of a 9-5 and understand that you control something far more important than a file full of papers. You carry with you the weight of people's hopes for a more normal tomorrow, a happier today, and often the promise of just a little more time to spend with those you love. I hope that the letters you receive will help you to understand the importance of our cause, and perhaps soften you to it just a bit. Thank you for taking the time to read them,
- I am an Epilepsy specialist caring for patients in an academic setting.
Too many people suffer from this devastating condition, with far too few interventions at our disposal. The FDA process is long enough. Adding additional time to patient access to new therapies such as the current DEA delays is dangerous for this population.
- My two year old daughter has intractable epilepsy and should not have to wait to try new drugs because of bureaucracy. Please find every way to expedite your processes especially for children with life threatening seizures.
- My wife lived for many years without full control of her seizures. To people like this, every day of delay in access to potentially helpful treatment is too much. It is important to ensure that new therapies are safe and effective, but it is critical to ensure that this process is done as quickly as is physically possible. This REALLY does affect the lives and quality of life of many Americans. Politics and bureaucratic delays have no place in this critical process!
- I have a twenty-eight year old daughter.before being diagnosed with epilepsy she graduated with a bachelor of arts from a local school.now due to her epilepsy she is barely able to keep a simple job. She can only take brand drugs generic allow for more seizures.I fear her not being able to get the drugs she needs.
I care for many children with intractable epilepsy who anxiously await the promise of new medical therapy that has already been FDA approved.