Susi Antoniuk Director, Regulatory Affairs Acorda Therapeutics, Inc. 15 Skyline Drive Hawthorne, NY 10532 RE: NDA: 022250 Ampyra® (dalfampridine) Extended Release Tablets MA #97 Dear Ms. Antoniuk: The Office of Prescription Drug Promotion (OPDP), Division of Consumer Drug Promotion (DCDP) of the U.S. Food and Drug Administration (FDA) has reviewed an Ampyra Video Segment (AMP567) (video)1 for Ampyra® (dalfampridine) Extended Release Tablets (Ampyra), submitted by Acorda Therapeutics, Inc. (Acorda) under cover of Form FDA-2253. The video is false or misleading because it overstates the efficacy of the drug product and minimizes important risk information associated with Ampyra. Thus, this video misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(a). Cf. 21 CFR 202.1 (e)(3)(i); (e)(5)(i); (e)(6)(i); & (e)(7)(viii).
If we don't educate each other and we support these kind of companies don't expect a reasonable cure
Grass roots advocacy fertilized by Big Pharma-DICHOTOMY at it's best
Yes, i know it is bob and i apologize for going off the point but when i read the report i picked up on the use of drugs for treating ADHD and it reminded me of my thoughts in the past of the overuse of this drug.
But yes to go back to the point of the thread it is indeed a game of manipulation and control by accounts relayed in the report
I don't mind really, I just thought I was bullied by stemcellsnadambombs about backing up my thoughts and I did, yet today you went out of your way to give Grammy time to offer any information on what she claims remarkable function in humans
Did I bully you Bob? How many SCI forums have you been banned off of now? You should know about bullying and understand that asking someone to back up their outrageous claims isn't bullying.
Dennis Tesolat
www.StemCellsandAtomBombs.org ______________
"Change does not roll in on the wheels of inevitability, but comes through continuous struggle. And so we must straighten our backs and work for our freedom."
Martin Luther King
I understand that you are passionate about the things you talk of. Its a very emotive subject but in discussion you would benefit by learning that an antagonistic approach will never win anyone over or get your point heard fairly.
If you have information to share because you feel members will benefit to be informed then start a thread, provide an introduction, source it correctly and then add your opinion .
Then....leave it for members or guests who visit the site to make their own minds up and if questions arise in relation to the topic then reply in pleasant manner without insult to anyone and certainly not another member.
Once you present information thats all you can do, your job is done.
Remember also that this is a support community forum for members dealing with SCI in their everyday lives. It would be great if the currently new members including yourself, shared personal experiences and/or offered support to members here..especially with the same passion or energy.
I don't mind really, I just thought I was bullied by stemcellsnadambombs about backing up my thoughts and I did, yet today you went out of your way to give Grammy time to offer any information on what she claims remarkable function in humans
Did I bully you Bob? How many SCI forums have you been banned off of now? You should know about bullying and understand that asking someone to back up their outrageous claims isn't bullying.
It is a battle of who's who if you can get away with calling my questions claims and saying they are outrageous without explaining why or backing up your allegation.
Grass roots advocacy fertilized by Big Pharma-DICHOTOMY at it's best
Stemcell dennis It is true I don't get along with Dr Young, that shouldn't in anyway be taken that there is something wrong with me, is that your point, cause if it is it's pretty weak. I rather you talk about the topic here which is advocacy groups becoming pawns of the system because they take donations from them and then can't criticize that outfit.
Grass roots advocacy fertilized by Big Pharma-DICHOTOMY at it's best
And here is a warning letter to Ron Cohen of Acorda from the FDA
We must educate each other, and refuse sponsorship from companies like acorda
Here's an education of facts that make your proposed conspiracy theories of corruption total nonsense and without merit.
The dalfampridine drug called Ampyra was developed by this biotech company called Acorda. It's a Multiple Sclerosis drug approved by the FDA. It is still being tested in clinical trials on paralysis at this point in time. It's being tested in many labs as reported here and explained on video at a Motion Lab. There is no published data available yet on the results of this ongoing dalfampridine trial that is currently recruiting patients and is listed HERE. There are 23 open clinical trials for various health indications such as optic neuropathy, optic neuritis, Parkinson's disease, Cerebral palsy, Renal Impairments, Spinal Muscular Atrophy, Spinocerebellar Ataxias, Ischemic Stroke and probably other patient groups with this dalfampridine drug.
Dr. Wise Young was one of the original founders of the company in 1995 but is no longer with the company, however Ron Cohen is the CEO.Acorda markets both Zanaflex and Qutenza. They continue working at bringing many other drugs in their pipeline for various neurological diseases to market. The SCI research and development pipeline is listed here. AC105, rHlgM22 , Chondroitinase, and GGF2. (None of these are yet FDA approved for SCI including dalfampridine).
Here's a list of the u2fp supporters that are both corporate and individual supporters who through their generous contributions make it possible for U2FP to lead the worldwide effort to find cures for paralysis. Here's the u2fp mission and a list of partners that work for cure. These are the primary things u2fp is involved in with, both research and the annual Working 2 Walk Symposium.u2fp doesn't lobby drugs and trials.This is the U2FP website.
Acorda was granted special privileges in their MS ampyra clinical trial. They were allowed to only have to compare responders thus only needing a small group of participants showing signs of improvement. Not only that, the fda went further and even though the trial results were insignificant as reported by the fda's own trial reviewer still gave it the green light. So, what did Acorda do they still went ahead after the grace from the fda and violated proper guidelines for advertising by overstating the efficacy and not warning about the major risks involved with ampyra. A major thrust for this drug's approval was helped by a big advocacy group the MS Society.
Don't you think when the FDA relaxes it's standards to help get a drug on the market and then are faced with a company that abuses that privilege and they have to issue warnings they may think twice about doing it again.
The other item about Acorda is why they are not going forward with chase. Have you asked them? They certainly should have funds as Ampyra sales should be about a billion by now.
Ron Cohen, M.D. President & Chief Executive Officer Acorda Therapeutics, Inc. 420 Saw Mill River Road Ardsley, NY 10502 RE: NDA 022250 AMPYRA® (dalfampridine) Extended Release Tablets MA #223 WARNING LETTER Dear Dr. Cohen: This letter notifies Acorda Therapeutics, Inc. (Acorda) that the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has become aware of a Consumer Print Ad (print ad) including information about AMPYRA® (dalfampridine) Extended Release Tablets (Ampyra) and inviting interested parties to attend a presentation regarding multiple sclerosis (MS), published in the February 10, 2013, issue of the Des Moines Sunday Register. This print ad is false or misleading because it omits risk information associated with the use of Ampyra. Thus, the print ad misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(n) & 321(n), and FDA implementing regulation 21 CFR 202.1(e)(5). Acorda also did not comply with 21 CFR 314.81(b)(3)(i). These violations are concerning from a public health perspective because they suggest that Ampyra is safer than has been demonstrated........Prior Communication False or misleading promotional materials by Acorda are particularly troubling considering OPDP expressed concerns regarding violative promotional activities as recently as June 21, 2012. On June 21, 2012, OPDP sent Acorda an Untitled Letter regarding an Ampyra Video Segment. The video cited in the Untitled Letter was false or misleading because it overstated the efficacy of the drug product and minimized important risk information associated with Ampyra. OPDP is concerned that Acorda is continuing to promote its prescription drug products in a violative manner. Omission of Risk Information Promotional materials are misleading if they fail to reveal facts that are material in light of representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The print ad is misleading because it presents efficacy claims for Ampyra, but fails to communicate any risk information. For example, the print ad includes the following claims and representations (emphasis in original): • The company logo and name of the drug, with the language “Has Multiple Sclerosis affected you or someone you care for?” • “AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is indicated as a treatment to improve walking in patients with Multiple Sclerosis (MS). This was demonstrated by an increase in walking speed.” The print ad, however, entirely omits any risk information, including contraindications, warnings and precautions, and the most frequently reported adverse events for Ampyra. By omitting the risks associated with the drug, the print ad misleadingly suggests that Ampyra is safer than has been demonstrated. We note that the print ad includes the statement, “This presentation is not medical advice or an attempt to provide medical advice. Talk to your healthcare provider to determine if AMPYRA is right for you.” However, this does not mitigate the misleading omission of risk information from the print ad. Reference ID: • The company logo and name of the drug, with the language “Has Multiple Sclerosis affected you or someone you care for?” • “AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is indicated as a treatment to improve walking in patients with Multiple Sclerosis (MS). This was demonstrated by an increase in walking speed.” The print ad, however, entirely omits any risk information, including contraindications, warnings and precautions, and the most frequently reported adverse events for Ampyra. By omitting the risks associated with the drug, the print ad misleadingly suggests that Ampyra is safer than has been demonstrated.Failure to Submit Under Form FDA 2253 FDA regulations require companies to submit any labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. 21 CFR 314.81(b)(3)(i). Each submission is required to be accompanied by a completed transmittal Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current product labeling. Acorda failed to submit a copy of the print ad referred to in this letter to FDA under cover of Form FDA 2253 at the time of its initial dissemination. Conclusion and Requested Action For the reasons discussed above, the print ad misbrands Ampyra in violation of the FD&C Act, 21 U.S.C. 352(n) & 321(n) and FDA implementing regulation 21 CFR 202.1(e)(5). Furthermore, Acorda did not comply with 21 CFR 314.81(b)(3)(i). OPDP requests that Acorda immediately cease the dissemination of violative promotional materials for Ampyra such as those described above.
I don't think my stand on this issue is nonsense, and on your blog you posted a few articles about Ampyra (your sponsor), did you ever alert your viewers to the FDA warning letters to Acorda?
Grass roots advocacy fertilized by Big Pharma-DICHOTOMY at it's best
Bob, please, you're dramatizing again. This isn't an all points red alert bulletin...
Anytime a company talks about a new product in a media ad for television, radio, newspapers, meetings, pill bottles, etc... it's required they have the small paragraph at the bottom with required information on it. (Most of the time those paragraphs are so tiny or run by the screen so fast I can't read them anyway). If a company misses putting the little label anywhere the product is mentioned, they get a letter.
About my blog posts? Seriously, if a citizen mentions a pharmaceutical on the internet should they be required to print an FDA label? Will the FDA cops be coming after me to throw in jail because I typed the word "a----a" or you think I violated 21 U.S.C. 352(n) & 321(n) 21 CFR 202.1(e)(5) 21 CFR 314.81(b)(3)(i)? I hope they go easy on me, I don't want to be a jailbird. I can't bake cookies for the grandkids if I'm behind bars.
Besides that, I'm not interested in MS drugs nor do I personally know any MS patients in my area. It's a horrible disease. I'm interested in a cure for chronic spinal cord injury and an FDA label isn't on my list of important things that will get paralyzed people a cure. YOU should call someone yourself if you're worried about a label.
That's a bit old isn't it? Dr. Silver feels he could start curing people of being vent dependent bowel and bladder if he had Chase to use have you pressured acorda. And what information do you have on the peptide that Dr. Silver says can be used instead of Chase?
Grass roots advocacy fertilized by Big Pharma-DICHOTOMY at it's best
Bob, you're dramatizing again. This isn't any all points bulletin alert...
Anytime a company talks about a new product in a media ad for television, radio, newspapers, meetings, pill bottles, etc... it's required they have the small paragraph at the bottom with required information on it. (Most of the time those paragraphs are so tiny or run by the screen so fast I can't read them anyway). If a company misses putting the little label anywhere the product is mentioned, they get a letter. Seriously, if a citizen mentions a pharmaceutical on the internet should they be required to print an FDA label? Will the FDA cops be coming after me to throw in jail because I typed the word "A-----" or you think I violated 21 U.S.C. 352(n) & 321(n) 21 CFR 202.1(e)(5) 21 CFR 314.81(b)(3)(i)? I hope they go easy on me, I don't want to be a jailbird. I can't bake cookies for the grandkids if I'm behind bars. Besides that, I'm not interested in MS drugs nor do I personally know any MS patients in my area. It's a horrible disease.
As a spokesperson for people with sci it's unsettling how you brush off the violations of your financial supporter Acorda and make light of what they did. If you would read the warnings, it wasn't just once that Acorda was called on this. They've been called on it many times. If they can't follow those simple rules does it end there or did they try to manipulate other areas?
I am sorry you are not interested in MS drugs, but MS, TM share many similarities with traumatic version of spinal cord injury.
Grass roots advocacy fertilized by Big Pharma-DICHOTOMY at it's best
I went to a conference at "Push to Walk" in riverdale, NJ a place I work out in. It was held by Accorda, talked to a few patients there who had MS, listened to their stories about using Ampyra. I asked the Doc who was speaking if there was any information on its efficacy for TM they had no information for me. The patients with MS had some good results mostly with stamina and endurance while doing exercise. Nothing earth shattering. Emailed the company to see if they had done, are doing, or planned on doing any trials with TM never got a reply. Never followed up with them after that.
Post by stemcellsnatombomb on Jan 23, 2014 19:24:07 GMT -8
Bob, There's no talking with you. I feel that you're just talking at everyone. Repeat. Repeat. Repeat. It's almost like you're trying to win an argument by making the other person give up.
So I ask you. Are you saying: U2FP takes money from Acorda and has therefore been corrupted? This is what it sounds like to me.
Therefore, I'd like to hear what you propose be done. Not by U2FP since you believe they've been corrupted, but what action do you propose to lead. Apparently you know the problem and feel confident that something needs to be done, now it's time to "pooh" or "get off the pot".
Let's hear what you propose to do and lead. It's no good just pointing out problems.
Dennis Tesolat
www.StemCellsandAtomBombs.org ______________
"Change does not roll in on the wheels of inevitability, but comes through continuous struggle. And so we must straighten our backs and work for our freedom."
Martin Luther King
Dennis, I wasn't so thrilled with the answers I got involving Acorda. It does have the feel there was a deliberate effort to minimize the warnings from the FDA. I don't know if it's possible, but funding from McDonalds, Nike, Sara Lee etc. would be more appropriate. It also would get the word out to the general public instead of within the research/pharmaceutical landscape.
I don't think that way when people point out a problem. I feel good they have identified something that needs to be corrected. I also feel our leaders should be happy and interested to hear what's on the minds of people in the community.
Grass roots advocacy fertilized by Big Pharma-DICHOTOMY at it's best