More FDA Important Contacts

[Magnum]

I'm relentless in trying to get the Protease Inhibitor drugs on a fast-track licensing. This is the written and verbally spoken letter I prepared for when the main players in the FDA regarding this issue answer the phone. We have to keep bombarding them in order to achieve our goal to save our lives. The name at the bottom is the main person in charge of the Cedar division of the FDA that answers and explores any issues regarding drugs and the public. Please keep calling if you want to save your lives. Desperate situations require desperate measures...

Magnum

"Hello

My name is Magnum. I contracted Hepatitis C from a blood transfusion. The new Protease Inhibitor drugs by Vertrex and Schering-Plough pharmaceutical companies are drugs that should be on a fast-track for licensing as the AIDS drugs were. I don’t know why the FDA isn’t working to get these life saving drugs out faster. People are dying while waiting and most because they’ve advanced to a liver transplant protocol with not enough livers available.

The clinical trials are pretty much over and it’s been years since they’ve been going on. People are dying. The cost to Medicare for a liver transplant is nearly a half a million dollars. Please help the pharmaceutical companies fast-track their license applications so the public can get these Protease Inhibitor drugs ASAP.

Thousands like myself are willing to sign any sort of waiver to indemnify the FDA and the pharmaceutical companies of any liability. These two Protease Inhibitor drugs Telaprevir and Boceprevir have proven very successful in eradicating the Hepatitis C virus in naive and non-responders like myself and have killed no one during the years of clinical trials. Now we’re hearing they may be released at the end of 2011 or the beginning of 2012. People are dying while waiting...


FDA Main Phone Number: 301-796-8460   Office Of compliance: 888-463-6332

Scientific Investigations Office: 301-796-3150

The main person in charge of these issues is: Virginia Behr (ombudsman), handles any issues of concern to the public regarding drugs: Her direct number: 301-796-3436".

Keep bugging her...

[can-do-man]

I might be wrong about this but its my understanding the ball is in the drug companys hands and the FDA can do nothing until they decide to start the clock running.

So shouldn't we be putting the pressure on them for the time being?

cando

[Diamando6]

Hi Magnum,

congretulations, for this very important and active step in achieving our corporate goal. I dont know if a can-do-man is wright, but probably is. If the ball is in the Company's yard, then we will have to refer to them. Anyway  , we better keep doing on both sides. It's our battle , and we have to fight for it !

[JennyPenny2009]

I thought Telaprevir had been granted fast track status by the FDA in 2009. Am I wrong?

[Diamando6]

I dont think so Jenny Penny, otherwise, the medication would have been by now on the market!

[Magnum]

I have to disagree. It was the rep from Vertex who said it certainly couldn't hurt to pressure the FDA. Keep in mind that Vertex and Schering are anxious to get these drugs to market. If for no other reason, for the stock investors. The FDA is the deciding factor as to the granting of the license, not Vertex or Schering.

Once the pharmaceutical companies present their findings, it's totally up to the FDA, not the pharmaceutical companies. For example, Vertex is going to present a rolling NDA application this month. The pressuring of the FDA will mean that they should put this on the front burner. Keep in mind they are processing other drug evaluations constantly. We have to make them aware that these are more important drugs for them to evaluate right now as opposed to new drugs to prevent gas or joint pain. God knows there are enough of those.

Just watch the evening news. Every day there’s a new drug out for things not as important as saving lives, but rather for easing joint pain, male dysfunction, sleep and such.
I’m living with joint pain, no male dysfunction yet and pot for sleeping. Now I need something more important like...... SAVING MY LIFE....

I'm going to keep applying the pressure. Otherwise, it's up to you...

Magnum

[can-do-man]

I'm just going by vertex response to you less then 2 months ago, have things changed?

http://www.medhelp.org/posts/Hepatitis-C/Vertexs-Response-To-Compassionate-Use/show/1238850?personal_page_id=388#post_5669515

[Trinity4]

Mag,

Can you actually get through to Virginia Behr and will she speak with me directly?

Trin

[can-do-man]

Should of added the FDA response to you about getting access to the drug. Really magnum i am hoping you and everyone else could get these new PI's as i was cured by them and think they are great...... But i still see it as the drug company's move here....... Wishing you only the best and you should be commended for staying on this.

http://www.medhelp.org/posts/Hepatitis-C/FDA-Response-To-Compassionate-Use/show/1235432?personal_page_id=388#post_5663377

[Magnum]

Not sure what you're saying. This last coversation with Alan True was about two weeks ago. He at that time said "it couldn' hurt to voice my concern with the FDA". My concern is that they should speed up the evaluation of the drug as soon as the trials are over, which is just about now, while people are dying to get the drug (no pun intended)...

Magnum

[Magnum]

I called her and left a message. Apparently, from what the person who did speak with me said, is that she is the "big cheese" in these matters of public interest and concerns with new and existing drugs. The next target for me will be Secretary Of Health and Human Services Kathleen Sibelius. I don't think you can get much higher than that, unless Obama will show an interest...

Magnum

[dointime]

I've found from my own experiences in life that when you really want something done you go straight to the top, ie. the top political representatives that there are.  It is a waste of time *arting about with the lackeys.  It has always worked for me and I sincerely wish that it works for you too.  I don't see any problem with writing a letter directly to Obama either, as well as those guys I see on tv sitting in congress and the house of reps.  (Excuse my ignorance of US political structure).      

dointime.    

[evangelin]

I have reached two different people at FDA and both were very nice, promising to call me back with information...neither one came through. I'm certainly willing to keep trying.
I admire your determination.  I'm normally a timid person, except on this issue .  I have found on my mission to keep my husband , I can be downright pushy!  After spending so many years of seeking information on forums, my concern extends far beyond my own husband.  There are so many people I wish could be saved from the ravages of this disease.
Thanks for all your effort,
Ev

[Trinity4]

Left a message and will do so on a weekly basis.

Trin

[Rockerforlife]

Seems like they are holding back on releasing the PI drugs for some strange reason,maybe the drug is "too good".Looks like too me a lot of lives swill be saved if its released to the public.

[Magnum]

I just placed another call to her answering system and will do so twice daily until she waves the white flag and calls me back. One man does not become an army until others join him. As an army of many of us calling, we can be victorious. If saving your life or someone else's life is important to you, then you should also bombard with calls until they cave in...

We are American tax payers who pay these people (FDA) their salaries. They work for us, not for the pharmaceutical companies. They have the sole power to grant the license. The FDA is the target. Never lose sight of that...

The main person in charge of these issues is: Virginia Behr (ombudsman), handles any issues of concern to the public regarding drugs: Her direct number: 301-796-3436".

Magnum

[Magnum]

Just got off the phone with the secretary to Kathleen Sibelius, the Secretary Of Health and Human Services. The "comment Line" is where she said we should leave our messages and concerns. She wished us good luck and also said this is the way to voice our opinions and concerns regarding this very important matter to saving our lives.

The direct number(comment line) to leave your message is 202-205-5445. If you want to explore the site, here it is: http://directory.psc.gov/os/885.html. There is also an email there that I’m not allowed to print on this site to which you can email your concerns. But also...Keep calling....

Magnum

[22hamilton]

Well done Magnum, hope you have a breakthrough with them. Would call myself but not sure they would listen to someone from the uk.I really feel there should be some kind of compassionate access by now, Ive been waiting for telaprevir for years now and still feel its a way off.

[evangelin]

I just happened to get my call back today from FDA.  I really liked the lady .  She had dug around for information and said it was the company that wasn't releasing it for compassionate use and she said they could do it if they chose to.  I had specifically asked agout Teleprevir not Bocep.  Well, that is what she said and I felt she had sincerely checked. The PA. at our Gastro's office (St. Louis University) shook her head and said,"They won't be releasing it early"  The FDA's response seems to back up what the P.A. said.
Ev

[Magnum]

Thanks for the info. Irregardless of that field that's no use in plowing again as far as the “compassionate use”, the point now is to get the drugs licensed ASAP after Vertex and other companies present their findings and ask for a rolling NDA (New Drug Application).

Naturally the pharmaceutical companies don't want to release the drug early because of the nightmarish episodes with other drugs in the past that caused deaths. Once the FDA approves the drugs, they will feel much more comfortable in releasing them.

The task now is to pressure the FDA to speed up the licensing of the drugs. At this point we may as well take the pharmaceutical companies out of the picture entirely. I’ve already plowed that field many times with zero results. To capitulate now is to walk into the face of doom.

And remember...

“What counts is not necessarily the size of the dog in the fight – it’s the size of the fight in the dog”

Dwight D. Eisenhower  


Magnum

[JennyPenny2009]

You guys are confusing me. I know that we all know the difference between fast tracking for FDA approval and expanded access. But everything I read states that telaprevir has been fast tracked for a couple of years now. For example:

"Telaprevir (VX-950)


Telaprevir is designed to inhibit the NS3-4A serine protease, an enzyme necessary for HCV replication. The United States Food and Drug Administration (FDA), has granted Fast Track designation to telaprevir. Vertex has completed dosing of all study drugs in the registration program for telaprevir. It has collaboration agreements relating to telaprevir with Janssen Pharmaceutica, N.V., (Janssen), a Johnson & Johnson company, and Mitsubishi Tanabe Pharma Corporation, (Mitsubishi Tanabe). Its clinical development activities related to telaprevir are focused on genotype 1 HCV infection, which is a prevalent form of HCV infection in the United States, the European Union and Japan."

[JennyPenny2009]

I dropped a note to one of the Vertex employees who sits on the patient advisory committee with me. I asked her if I was wrong about telaprevir being fast tracked. Here is her answer:

"telaprevir has fast track status meaning a 6-month review process once NDA is submitted."

Hope this helps ease everyone's concern about that. Now expanded access is a different story, unfortunately.

[evangelin]

I think the lady I spoke to said the NDA was being filed this month.  I'm sorry if I missed the point.  Sometimes if I get a minute at the computer, it isn't long enough to read everything so it is easy to miss pertinent info.  I get it now...I think.  The 6 month review JennyPenny mentioned above is non-negotiable? If I understood her and the rolling NDA is expected this month then that is good right.  I may still not be understanding what we are trying to ask for.
Could someone that gets it try one more time to explain. If I'd read every past post I'm sure I'd get it by now but I guess I was skimming too much.
Ev

[Trinity4]

Magmum,

I got a call from Virginia Behr's office.  I was told the same thing you've run into which was start the process for requesting the drug on a compassionate use basis and tell them I need priority approval from the drug company.  She said it's not up to the FDA, it's up to the drug company to release the drug under those circumstances.  She would not give me any indication what the FDA plans are for releasing the drugs.

Sigh

[Magnum]

I guess I keep relating my concern back to what the director of clinical trials at Phoenix's Mayo Clinic said, and that was the release of the PI's is predicted at the end of 2011 or the start of 2012. That's too long of a wait. I think the FDA, who will be the deciding factor as to when the drugs will be released per licensing, has to be made very aware that a lot of us need these drugs ASAP and they should be put on the front burner. I don't know how else to drive this important point home...That’s why I insist that we should bombard them with this fact. If we sit on the sidelines, we will have to keep waiting and waiting and waiting... while we get sicker and sicker and sicker...

Magnum