Patient Survey & Comments Regarding Off-Label Drug Promotion

Pharma Marketing: The Year 2015 in Images

submitted to the fda on 17 November 2016

Patient Survey & Comments Regarding Off-Label Drug PromotionSponsored & submitted to the FDA by:

2016. Pharma Marketing News. All rights reserved.inVibe Labs and Pharma Marketing News welcome the opportunity to submit to the FDA the results of a survey of chronic condition patients, patient advocates, and caregivers regarding their opinion of off-label promotion of drugs to consumers by pharmaceutical companies.

inVibe Labs is an all-in-one market research platform that provides healthcare organizations with low cost, high fidelity insights at lightning speeds. inVibe Labs engages research participants (patients, physicians, and payors) on their smartphones and collects responses via automated, voice-response surveys. Learn more at www.invibe.co.

Pharma Marketing News is an independent monthly electronic newsletter focused on issues of importance to pharmaceutical marketing executives. It is a service of the Pharma Marketing Network -- The First Forum for Pharmaceutical Marketing Experts -- which brings together pharmaceutical marketing professionals from manufacturers, communications companies, and marketing service providers for wide ranging discussions and education on a multitude of current topics. Learn more at www.pharmamarketingnews.com. 1Copyright 2015. Pharma Marketing Network.Pharma Maketing News v14 #7: Dec 2015 PMN1407-03

fda notice hints at Off-label DTC communications by pharmaTo what extent is it appropriate for firms to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences? What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers lack of medical training and expertise in critically evaluating this type of information?

2016. Pharma Marketing News. All rights reserved.In the Federal Register notice announcing this public hearing, FDA asked these two questions, which put the the thought in my head that the Agency may be considering issuing guidelines or new regulations regarding the off-label promotion of drugs to patients and consumers.

Considering that the FDA has been in a First-Amendment tussle with drug industry advocates over the issue of off-label promotion, I posited that if drug companies have a constitutional right to promote off-label uses of drugs to healthcare professionals, it also has a right to promote the same directly to consumers. It is not too much of a stretch to believe that the drug industry will eventually do this if given guidance by the FDA.

Recall that no one thought prescription drugs would be advertised on TV until the FDA issued guidance in 1997. That opened the floodgates to the ads we see today. 2Copyright 2015. Pharma Marketing Network.Pharma Maketing News v14 #7: Dec 2015 PMN1407-03

Respondent ProfileN = 5140 Patient Advocates20 Chronic Condition Patients9 Caregivers 100% are U.S. basedA voice-response survey of chronic condition patients, patient advocates, and caregiversConditions:Diabetes (8)Fibromyalgia (7)Arthritis (5)CHF (5)Back Pain (4)Migraine (4)Asthma (3)Crohns Disease (3)Hypertension (3)Rheumatoid Arthritis (3)Sjogrens Syndrome (3)Other (12)

2016. Pharma Marketing News. All rights reserved.The survey asked 51 patients, caregivers, and patient advocates do you think the FDA should allow off-label promotion of drugs to consumers by drug companies as long as the promotions (magazine and TV ads) provide truthful information based on current science? 3Copyright 2015. Pharma Marketing Network.Pharma Maketing News v14 #7: Dec 2015 PMN1407-03

summary of resultsDo you think the FDA should allow off-label promotion of drugs to consumers by drug companies as long as the promotions (magazine and TV ads) provide truthful information based on current science.

2016. Pharma Marketing News. All rights reserved.63% responded Yes, 35% said No, and 2% had no opinion. 4Copyright 2015. Pharma Marketing Network.Pharma Maketing News v14 #7: Dec 2015 PMN1407-03

selected comments from Patients

Comments against:

Comments in favor:Click icons above to hear selected comments or go here: http://bit.ly/OffLabelPatientSurvey

2016. Pharma Marketing News. All rights reserved.The voice-response system also recorded comments from each respondent. 5Copyright 2015. Pharma Marketing Network.Pharma Maketing News v14 #7: Dec 2015 PMN1407-03

Complete Transcript of CommentsPage 1Respondent TypeCondition(s)ResponseCommentsPatient AdvocateAsthma, DiabetesYesI personally think that a lot of times we put too many drugs and too many different products on the market and have to go through too many testings and styles in which things don't get all the way through or it takes so long for the FDA to actually approve it. There are so many FDA drugs that have been approved and get retaken off the market. I feel that if it is something that shows, and data proves, that it's going to help people feel better, stay healthy, why not put it on after it is already said to be effective. If it needs to be pulled just like the FDA often removes things, do it at that time. For me, I'm a huge advocate for if the data shows it and there's been testing, things are working, give it to the people and let's see what happens. CaregiverDiabetes, ArthritisYesI think this should be allowed because I think a lot of the drugs out there could also be helpful for other conditions and many people could benefit from this. Sometimes there's just too many regulations that prohibit people from using drugs for other conditions that would really benefit them. I do think that all people should be able to use drugs for ... We should be able to be aware of what they also might help with and we should be able to try them. Thank you.PatientCHF, Afib, Neuropathy, Gout, GlaucomaYesYes. The reason I voted yes on this question was is in all probability those particular drugs will be cheaper and I'm a senior citizen on a fixed income and I really need to watch how much I spend on prescriptions. My only question about this entire thing is a good portion of the time these companies spend way too much money on television advertising. I wish that there was someway that we could knock that off. It would certainly reduce the costs of the prescriptions. It certainly wouldn't cost them anywhere near as much to put this information on their website. It's just a thought. I guess that's pretty much my opinion on that subject.


Complete Transcript of CommentsPage 2Respondent TypeCondition(s)ResponseCommentsPatientNerve painYesBecause they can be useful in treating some conditions.Patient Advocate, PatientType 1 diabetesYesI believe that prescription drug companies should be allowed to promote off-label usage as long as what they're presenting in their advertisements are truthful because many medications have beneficial uses that are outside of what was originally studied or what the original purpose of the medication was. That can help people who experience other symptoms. I think that if there is a way to treat people, especially those living with chronic medical conditions, with an off-label drug, that that should be able to be advertised. Because they are controlled substances, a patient would still have to discuss with their doctor whether or not it would be the right route of treatment for them. Many doctors are still prescribing something for off-label use or considering them, so making it easier for a patient to be informed even if it is just through advertisements is always a step in the right direction in patient care. PatientKidney diseaseYesI answered 'yes' to question one. I feel that the FDA should allow the off-label conversion because I feel that some of these drugs may be very beneficial to the consumer. It may lower their drug cost, and it also may give them access to drugs that they never had access to. I feel that the off-label drugs might be an advantage to people with chronic illness. I really do support this, and I really hope the FDA passes this, and takes it into account that it will help a lot of chronic diseased patients in the end. Thank you.PatientChronic pain, DiabetesYesMany medications have other benefits besides the one for which they were originally manufactured. Therefore, how can you know what other benefits there can be if you don't allow them to used for off label benefits if the patient and the doctor both think they may be beneficial, and then therefore, get FDA approval for off label benefits.


Complete Transcript of CommentsPage 3Respondent TypeCondition(s)ResponseCommentsPatientNerve painYesBecause they can be useful in treating some conditions.PatientBack painNoWell, I am kind of on the fence about this, but my opinion is I do not think that it should be allowed. People could take it and it could be abused, being that it has no label and we don't really know how it's going to affect each and every individual. Everyone acts and responds differently. I don't think that it is okay. Someone could get really, deadly sick and you have to go to the emergency room and they're going to ask you, What are you taking? Well, I'm taking an off-label drug and it hasn't been approved by the FDA. Then again, the FDA has a little bit too much control over what we take, because I'm for certain things that are not approved by the FDA, as well. It's all in trial and error, so as I said, I'm on the fence about it. If a person wants to, they have the right, but overuse is going to come regardless of whether you have a prescription or you don't have a prescription, if it's approved, if it's not approved. If you can get a hold of it, it doesn't really matter if it's approved or not. People are going to do what they want to do. As a parent, I think my answer leans more toward no because if it's not been approved, then I wouldn't want my children to get a hold of it. As an adult, I feel as though you have your choices. I hope that that answers your question.Patient AdvocateCOPD, Asthma, Heart Murmur, AllergiesNoI do not think that advertising to consumers for any sort of drugs, is the healthiest way for people to be informed. I think that unfortunately the advertising dollars spent make people ask for things that they aren't even sure. They haven't had the education to learn that the need, and I feel that that is a general statement, but especially in addition to off label uses for those items.


Complete Transcript of CommentsPage 4Respondent TypeCondition(s)ResponseCommentsPatient AdvocateAlzheimer's diseaseYesI think consumers should have options. They should know the facts and then let them decide on how they want to proceed. Some people can not afford name brand medications and this may be their only option. As long as they have the facts, then they should be able to decide for themselves.Patient Advocate, Caregiver, PatientType 2 diabetes, Chronic idiopathic axonal polyneuropathy, Depression, Generalized anxiety disorder, Glioblastoma multiformeNoI believe any direct to consumer advertising of pharmaceuticals is immoral. It is unconscionable. Key driver of healthcare costs. What else? It's essentially a public health crisis. Any expansion of that would exacerbate both the public health costs, the private health costs, a public health crisis as well as being even more unconscionable.Caregiver, PatientHigh cholesterol, Crohn's Disease, Parkinson's disease, Diabetes, ArthritisYesYes, I think the drugs should be allowed off-label uses. There are many drugs currently out there where they were approved for one purpose and they were actually a breakthrough for others areas that weren't the original intent. For example, botox was a migraine medication. People use it cosmetically for the removal of wrinkles. I think there are many examples of that where it was originally approved for one purpose and then it was very effective for a secondary use. I think it's something that the FDA should definitely consider, assuming there's some comfort in the disclosure of the information and they're reasonably confident it's safe. I am a strong proponent of that. PatientDepression, Back pain, NeuropathyNo opinionI selected that response because I'm torn. I think that the research has been done for a drug that should only be used for that particular ailment. I know someone that had a problem with their eye, an elder man, and he was given the option to have this shot put in his eye that was like 1,200 or 1,800 dollars. The doctor, the optomologist or whatever, the eye doctor, offered him another shot that was the exact same thing, and it was like 380 dollars. He chose the 380 dollars, but it was also a risk because even though it was the same thing, it wasn't made for that reason or something. I don't know. So, I'm torn. I don't know what to say.


Complete Transcript of CommentsPage 5Respondent TypeCondition(s)ResponseCommentsPatient Advocate, PatientCrohn's Disease, OsteoporosisYesI think that the use of certain medications that are FDA approved for one condition, using to promote for off-label use is ... I agree with that because as long as it's based on science and the FDA approval process can take a long time. I know that there are compassion laws out there that allow specific drugs to be used for patients in specific situations where it's not completely approved by the FDA but it has been shown to work scientifically. I think that this would open a lot more options up for patients as long as they discuss it with their doctor. I know there are hundreds of medications out there that are FDA approved for one condition and later we found out that hey they're actually working really well for this other condition, but some patients can't have access to it because it's not FDA approved or won't use it because it's not FDA approved. I think as long as it's scientifically backed up and it is shown to work and be safe the specific way, I think it's ... I totally agree.CaregiverCancerNoI actually do support off-label use of drugs, but I don't think that they need to advertise it because there's a lot of gray area there that patients don't always understand. People don't take the time to read the fine print in those magazine adds and tend to disregard the fine-print-sounding stuff on TV commercials. I think that those conversations are best had with the doctors who are recommending the drug for whatever off-label use they're recommending it for, but to have broad-range advertising out there I think would be ultimately kind of confusing to the consumer. PatientFibromyalgia, ArthritisYesWhen my daughter, who is almost 31 now, was about 7 years old, she started demonstrating a very rapid heart rate. We took her to the emergency room a couple of times and her heart rate would be like in the 2 to 300s. We finally got her an appointment with a pediatric cardiologistContinues...

2016. Pharma Marketing News. All rights reserved.The voice-response system also recorded comments from each respondent.10Copyright 2015. Pharma Marketing Network.Pharma Maketing News v14 #7: Dec 2015 PMN1407-03

Complete Transcript of CommentsPage 6Respondent TypeCondition(s)ResponseCommentsPatientFibromyalgia, ArthritisYesContinued...and they did a study on her and she had a reentry tachycardia SVT. It wasn't life threatening, per se, but it did limit her ability to participate in sports. It was hard on her to be at school and try to ... If it started, to tell her teachers and them really not understanding what was going on, even though I had talked to them.The doctors put her on a beta blocker, which is for blood pressure, but one of the off-benefits or side effects, however you want to say it, was a slow heart rate. This allowed her to really have a younger life, like other kids, for quite a few years before we had to do an invasive procedure, the radiofrequency catheter ablation procedure to locate that extra nodal fiber and ablate it so that it would take care of the problem immediately. A lot of those symptoms are found when a child is much, much younger than my daughter had demonstrated them. We wanted to give her a few years, and that medication allowed her to do that. Without going into a lot of information, as a registered nurse, I saw a lot of times where side effects of medications could have helped people had their body, if their body could tolerate what it was for initially. I often wondered why it wasn't promoted more then. I'm a strong advocate for that. Thank you.PatientCushing's diseaseNoFirst off, I don't think that the drug companies should be allowed to promote their pharmaceuticals in any kind of advertising. I think that it encourages hypochondria. I think that it encourages people to take drugs they don't need and doctors to prescribe drugs they don't need. I am very concerned about drug side effects. I think people are so anxious to have unrealistic results from drugs that they ignore side effects, and then they end up with more problems later on, because the side effects of the drugs are often worse than the problem the drug was supposedly going to fix in the first place. I just don't believe in any advertising, whatsoever, for drugs.


Complete Transcript of CommentsPage 7Respondent TypeCondition(s)ResponseCommentsPatient Advocate, Caregiver, PatientRheumatoid arthritis, CHFYesI answered yes to this question because I think that the public should be aware of everything regarding the drug; whether it's positive, negative or other uses of the drug. Patient AdvocateADHDNoAs a former social worker and a current psychotherapist, I have witnessed many people's lives upended in drastic ways through misunderstandings of the information that is currently presented by drug makers in promotions. I feel like there is some guidance required in the distribution of medications and substances that could be harmful to people regardless of the information that has been provided to them in promotions. I believe that the information is frequently over the heads of the average consumer and they may jump at the opportunity to hopefully remedy a situation almost in spite of or regardless of the possible consequences. It is hard for the average person who has not studied research to understand things like probability and possibility in regards to the consequences of the use of medications. Patient Advocate, PatientBack painNoI don't think it's a good idea, because a lot of people just seem to add to the medicine, in regards what it might help or cure, and that's not good. Not everybody reads the small print. My son takes Risperdal, or risperidone, for autism, which was used as an off-label. Now he has side effects of weight gain and other problems, which we discontinued the use. I don't think it's a good idea, because just like I said, people will see it and read a couple lines and think, Oh my gosh, this is great, and it's not great. It's proven that people just read the first couple of paragraphs, and that's all they do. I don't think it's a good idea, and they shouldn't. Thank you.PatientFibromyalgia, Sjgren's syndromeNoI think this information should come from a doctor, not from advertisers. People ask for medications that they don't need that's not appropriate for them. Everyone responds to drugs differently. It should be between a person and their doctor, not from a drug company.


Complete Transcript of CommentsPage 8Respondent TypeCondition(s)ResponseCommentsPatient Advocate, CaregiverCHFNoIt would concern me that there would be media coverage of off-label drug use because I don't believe consumers are aware of the fact that that drug was not properly tested: the dosages, the age group, the comorbidity factors that go on, drug-drug interactions that might be potentially there and have not been tested. We do have an FDA who oversees our drug approvals. Even though that may be a flawed system, it is a system that we have. I think consumers aren't aware enough about what things actually mean when they see it advertised. They're going to go right to the doctor and ask for it. We could advertise directly to the doctors, inform the doctors of off-label use, and let them prescribe those medications. But when we put it in the hands of consumers it concerns me that there might not be some issues and even some safety concerns, especially with older adults who aren't potentially educated about the differences in different medications and may just be looking for a fast fix on whatever ails them at the time.CaregiverMultiple myelomaYesI totally agree with them having the ability to promote these drugs even if they're not FDA approved for that because, personally, I have used a medication that was not FDA approved for the purpose behind it and it worked. I feel the FDA is a great organization but they're not the all knowing and all encompassing. As long as these drugs are FDA approved, meaning they've been found to be as safe as possible with the potential side effects. I think that if it is found that they are useful for other symptoms, other problems, let people know that. Give them the opportunity to better themselves and better their lives using these sorts of drugs for maybe not the purpose that it was intended. Otherwise, I feel you lose a lot of the potential benefits of these medications. If they were to go through FDA approval again for that particular condition or disorder, who knows how long that might take in order for it to be officially approved to help others and how many people will suffer in the meantime.


Complete Transcript of CommentsPage 9Respondent TypeCondition(s)ResponseCommentsPatient Advocate, PatientSickle cell anemiaYesIt's marketing and if anybody has anything to say, oh that's the way to go. I don't care whether it's the FDA or the EPA or whoever else, everybody, whoever's selling a product, the way you sell the product is to market it to the masses. That is, even if it's the FDA and it can effect lives, you have to be honest and if you're not honest with the public, and someone gets hurt, then you need to be accountable.Patient Advocate, PatientCeliac disease, Thyroid diseaseNoI do not think that the FDA should allow off label usage in advertising because it could be misleading. If the FDA is approving a usage, then that is one thing, but if the FDA has not approved that usage it may diminish the authority of the FDA in the eyes of the consumer.PatientDiabetes, Heart conditionYesI think it's time that drug companies take the lid off of all the secrecy going on, and maybe by doing it this way it will force them to post and promote the truth about the drugs and reactions, and side effects and everything else. I think this would be a way to push everything forward to a better, what do you call it, better knowing about the drug itself, better un-secrecy is what I'm trying to say. PatientArthritis, DiabetesYesI believe, we as consumers of these medications, should have the right to be informed of all drugs available to us so that we're able to talk to our doctors about all the choices that we have and the knowledge of what can help us.Patient Advocate, PatientMigraineYesI think it's a good idea to share off-label drugs with consumers because those of us with chronic conditions may not be aware of other drugs that may be able to help us manage our chronic pain or chronic illness, so it's a good idea to advertise those things to us consumers so that we can present that to our physicians when we go in to see them for our appointments.


Complete Transcript of CommentsPage 10Respondent TypeCondition(s)ResponseCommentsPatient Advocate, PatientOccipital & Geniculate Neuralgia, POTS, Post Surgical Chiari Malformation, DDD, Continous Chronic Pain, Alexia, Dysphagia, MigraineNoAs a patient who's taken two different medications off-label in my lifetime, I would have to say one has been a blessing, and one has been a curse. I actually did the research and found out about the one that was a blessing. I have developed serotonin syndrome, so I can't take any anti-depressants. That's really bad because I've had major brain surgery and spine surgery and multiple rare diseases. I'm now taking Adderall XR, and it's helped with my depression and helped, unbeknownst to us, with my chronic pain. In the very beginning when I became sick I took another medication that almost killed me, so, and it's widely prescribed. It's Neurontin, and it's prescribed for every central nervous system illness or symptom, basically that comes along. It's over prescribed for off-label use.I think if there was a set list of illnesses or diagnoses or symptoms that a doctor could prescribe it for, that that would be fine. If the doctors could be policed and trusted to do that, but just to give a doctor a blanket approval to write a drug as off-label use is very bad. Also, I disagree with the fact that, I remember when Nexium came out, there was Nexium commercials everywhere. The purple pill. At the time I worked for Blue Cross and Blue Shield and people just thought in their mind, they had to have the purple pill. That was the only thing that would work for them.I don't think direct marketing of any drug is a good thing. Especially something that's being used off-label because you have more chance for having problems. Those are just my personal opinions. Thank you.Patient Advocate, PatientCrohn's Disease, Grave's disease, Atypical hemolytic uremic syndromeNoI do not think they should allow it because I think that once it's FDA approved that they know all the risk and the side effects and the long-term side effects. This is what the public needs to know. As a person with incurable diseases, we need to know what the drugs can give us. We need to know that the FDA backs us and is approving these things.


Complete Transcript of CommentsPage 11Respondent TypeCondition(s)ResponseCommentsPatient Advocate, PatientRheumatoid arthritis, Ankylosing spondylitis, Sjgren's syndromeNoI don't believe that it's appropriate to be prescribed off-label medications, regardless of any type of scientific proof, because of the fact that the FDA requires fairly stringent regulations in order to prove that it is actually safe and effective. A scientific experiment is a scientific experiment, and it could go either way. There is biased scientific facts, or scientific information all the time. That in itself, if you're going to be prescribed something, you should have the right to have something that was indicated by the FDA to treat your disease. Second of all, health insurance company policies, if that would happen, then insurers would force patients to take these off label drugs prior to things that are actually cited to treat their conditions, which end up hurting the overall healthcare system. Lastly, it's the ethical obligation of the practitioner to treat towards the unique characteristics of their patient. However, the insurance companies will force the doctor to prescribe based on cost, because they justify that decision by saying, Well, the research proves that this is okay to use. You need to try this first, which is understandable, except for when the doctor knows that it's not the best option, which could happen in a case of non-label. In that case, it would cause some major ethical issues for insurance companies, if they're trying to suggest that a patient take something that the doctor believes is not best for treating a condition.Patient AdvocateRheumatoid arthritis, HypertensionNoI don't like drug advertisements anyways, I feel like they market the people when doctors should be handling what medications are best for patients. Off-label use ... A lot of times, off-label medication is not covered by insurance, and there's not enough data to backup prescribing medications that's off-label. That's not what it's developed for, and so forth. That's my reasons.


Complete Transcript of CommentsPage 12Respondent TypeCondition(s)ResponseCommentsPatient Advocate, PatientUlcerative colitisYesMy doctor has prescribed off label medication for me. It's been, I think it's at least two medications and they've worked so I'm a proponent of that. I also trust the research and doctors who have used that, they are the ones that know best and have seen the results themselves with their patients. I think that it's also a great way to inform people, you know, especially if they're going to be doing promotions, ads, whatever, a great way to inform people that there is another method of alleviating symptoms or whatever, by these off label uses so that they can ask their doctor to prescribe that medication or discuss it with their doctor.Patient AdvocateCHFNoMost people are not aware of side effects and may have numerous medical conditions that would not benefit from off-label use. I think that medical degree is needed to really understand intricacies of off-label use.Patient Advocate, PatientFibromyalgia, SarcoidosisYesI think so many patients are not able to find relief with the current treatments that are out there. It is known that a lot of medications are able to be really really helpful for off label use. I think that patients deserve to know about that and know about those options. It doesn't mean that we're saying automatically everybody is going to start taking any drug for any purpose, but it gives them a basis to start a conversation with the doctor and say hey, I heard that this could be helpful for that also. What do you know? What do you think? The more we're able to educate patients, the more patients are able to learn about their options, the better chances are that they can actually get any kind of help. PatientOsteoarthritisYesThe reason I said yes was because as long as the information is truthful and based on current science, I don't seeing any problem with allowing off-label promotion of drugs to continue.


Complete Transcript of CommentsPage 13Respondent TypeCondition(s)ResponseCommentsPatient Advocate, PatientEndometriosis, RSD, HypothyroidismYesI think that the FDA should allow off-label prescribing for medications and several medical equipment, because I am a patient that has found that the medications and treatments that have helped me the most are ones that are prescribed off-label. It's actually got me from wheel chair to walking, it's definitely changed my life and I know that it would change others if they had the options and access to it.PatientDiabetesNoI don't believe they should allow it because the average person does not have the medical training to make proper choices on medicines that are not approved for that specific treatment or illness. I think it's best left to doctors to make that decision. Thanks. Caregiver, PatientBack painYesI answered yes, because I think the process to get a drug approved for off label use is too long, too tedious, too expensive, if it can be used currently for people who need it. Lyrica is a good example. It was approved for one use, I think fibromyalgia, but it also works on nerve pain and during that time before they did all the studies for diabetic or neurogenic nerve pain, I think it could have been used off label for that, so I answered yes.PatientChronic pain, Spinal stenosis, ArthritisYesI trust most of the inaudible 00:00:06. I think that the TV commercial for, everything is mentioned by verbage, on paper or on pamphlets, more on the television. I think that that has to be trusted because I don't think they could do that if it wasn't true. Therefore, they could be sued for fraud or misrepresentation because that would be illegal. Also, the FDA, they approve a lot of things that shouldn't be approved, so my entire trust is not with the FDA, to be honest with you.


Complete Transcript of CommentsPage 14Respondent TypeCondition(s)ResponseCommentsPatientCHF, MigraineYesI think it should be allowed because there's a lot of medicines that are used off label that could treat illnesses that people don't even know about so it would give them an opportunity to see and try and even talk to their doctors about the possible medicine. Patient AdvocatePTSD, HypertensionYesThe question actually should be why wouldn't they want to do that. Yes, I do believe that they should share that information even though it is not FDA approved. They should provide information as to what the drugs can do for any type of condition.PatientFibromyalgiaYesI believe that current science, if they do unbiased and several samples to find that a drug is helpful, I definitely believe that it should be used. I'm open to secondary benefits of medication. I know often one would take a medication prescribed for neurological things and it doesn't help so you would go to a secondary one and continue on that way. I think that anything that might be helpful, herbal or otherwise, should be used. I do think that insurance should also cover this.PatientEnd stage renal diseaseNoDrugs inaudible 00:00:00 clear. Then we can find cures for most of these ailments that some people have. Patient AdvocateSarcoidosisNoThe Food and Drug Administration needs to make sure that the drugs are safe for consumer use.


Complete Transcript of CommentsPage 15Respondent TypeCondition(s)ResponseCommentsPatient Advocate, PatientFibromyalgia, MigraineYesI work with people with fibromyalgia as well as having it myself. I find that the three FDA approved medications for fibromyalgia are actually less effective than many of the off label uses of other medications. Also, same goes with my migraines. The things that I take to manage my migraines are blood pressure medication. For my fibromyalgia, I take things, again, completely not fibromyalgia drugs. I work with lots of patients and providers and I find that this is usually the case. Most of the medications that are the most helpful are not the ones that are approved for fibromyalgia. In addition, I think that this will help both providers and patients realize that there are more options out there than the ones being advertised right now. A lot of people have trouble taking the three fibro medications and some other options they might appreciate having will increase awareness of those uses. I think that this would be a great move if they do this. Patient Advocate, PatientMS, Fibromyalgia, Psoriatic arthritis, Hypertension, Asthma, Bipolar disorderYesI think it's fine for them to promote or advertise off-label use of medications even if they haven't been approved by the FDA because lots of times there is already science behind it. That process to be approved by the FDA can take years and years. I can think of a lot of different medications that off-label use has been promoted for years and it's very effective for those purposes. It takes the FDA a while to get caught up. As long as they make it clear in the ad or promotion that it is off-label, it hasn't been approved by the FDA yet, but here's the science then I think it's just fine. CaregiverDementiaYesI think it is important to share this information with consumers because the benefits, to me, outweighs the detriment.


Complete Transcript of CommentsPage 16Respondent TypeCondition(s)ResponseCommentsPatientCOPDYesIt would make it easier for those of us who have chronic diseases to follow up on newer information on our disease and what may help even though it's off label. I have actually a couple medications that I use off label now, but I found that through long fought searches. It would have been good if that information had been more readily available. Thank you. Patient Advocate, PatientLupus, Sjgren's syndrome, FibromyalgiaYesI believe patients have the need and the right to know all possible treatments for their diagnoses. They should be the advocate and take responsibility for their own healthcare these days and knowing all options available is vital. There are so many aspects to allowing off-label promotion of drugs but just to answer the question of whether I believe promoting off-label drug usage should be allowed, I have to say yes.


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2016. Pharma Marketing News. All rights reserved.I will continue to collect more survey responses and submit the final results to the FDA before the docket closes in January. Follow me on Twitter for more information or go to www.pharmamarketingsurveys.com to take the survey. Thank you for listening.22Copyright 2015. Pharma Marketing Network.Pharma Maketing News v14 #7: Dec 2015 PMN1407-03

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Patient Survey & Comments Regarding Off-Label Drug Promotion