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...

[Cory255]

I called and got the answering machine.

[Trinity4]

Magnum

I'm a little confused. Has the FDA advisory board determined that the Protease Inhibitor drugs qualifiy for an accelerated approval process?

[orphanedhawk]

Yes, push them into quicker action. If they get enough people bugging them, it does have an affect.
I wrote a letter to the FDA months ago, and sent an email to all my friends asking them to do the same.
What have we got to lose?
What we have to gain, is better treatment and health.

[Magnum]

The income cap quoted is for an individual. The income cap increases as a family. So you may very well qualify. Give them a call and best of luck...

Magnum

[child24angel]

Consider it done....all my best to you
Hugs
Elaine

[spectda]

It does not matter which insurance you have. I believe the program is for low income, uninsured or underinsured people whose insurance won't cover it. I believe that most of the drug companies including the makers of procrit and neupogen offer the same assistance.
- I hope you get the good stuff as soon as possible
- Dave

[susan400]

I thought that Vertex and Medco were separate companies??  My insurance doesn't use Merck for their prescription drug plan, does that matter?  I believe that with my husband's income (although not alot) and my Social Security Disability that we will probably be just over the limit of the cutoff.  Last year we made about $60,000 together before taxes.  However, with bills, the economy, house payment (for his house), car payments, etc., we are actually broker than broke.  So, I'm not sure if we'll qualify.  About the most co-pay that I'm ever going to be able to afford w/ all 3 meds and any incidental rescue drugs is about $200.00 a month and any more than that and it will be out of my reach.  This is why I've been so much wanting a clinical trial, which since I'm a Telaprevir failure patient has been all but impossible to obtain.  VERY FRUSTRATING!!  I think that Vertex should offer all of us Group C patients, the meds for free since we were their guinea pigs in this process!  Susan400

[Magnum]

Okay Susan, I found the post regarding free meds from Merck...

There is a program that will allow you to get free medicine. The yearly income dollar cap amount for individuals is $43,320. There are other caps for family income amounts.

You may qualify. Hopefully this will help some of you that are strapped for cash. The number I have is 800-727-5400. this is the Merck Patient Services...

Magnum

[Magnum]

I believe that within a week or so I posted that Vertex has a plan to help those below a certain yearly income to get free meds. It's worth a try. I can't remember the exact post. I will try to find it. It also had the contact number to call...

Magnum

[pcds]

I called and spoke with this guy at FDA.  Got nowhere.  Big gov't little people.  

[susan400]

I, personally, would much rather have the Boceprevir over the Telaprevir, but at this point, I'll take either one of them.  My biggest hurdle will be how to pay for either one of them, should they ever be approved by the FDA.  I am not so sure that the insurance companies are going to be lining up to want to pay for these new drugs.  They already balk at paying for interferon and Riba.  I have a Medicare Advantage Plan (HMO) and quite frankly it's a really crappy prescription drug plan.  From what I've heard on the news tonight, the plan is to further cut the funding to Medicare and Medicaid and to begin rationing...  doesn't sound real promising for coverage of a new drug.., in my mind.  I don't mean to sound so negative, but it is necessary for me to be realistic in order to keep from being constantly depressed over the situation.  If I say to myself, "Oh yes this is definitely going to happen and I'm going to have a way to pay for triple drug therapy and everything will work out" and then, it really doesn't happen that way, then, I feel hugely discouraged and feel like, "what's the point?".  But, if I say, "this could be a long way off for me due to cost" and then, it happens, then, I am pleasantly surprised.  Anyhow...   Susan400

[spectda]

I called and got her machine and left her a message about how badly we need these drugs.
- Dave

[JennyPenny2009]

It is my understanding that once a drug is submitted for FDA approval, even the "higher" ups in the pharma company have no idea when that approval will come. They are just as surprised as we, as patients are, when it is announced. As for letting Vertex know that we would love to have compassionate use, like Magnum, I think it is always a good idea to let the pharmas know that is what you want. However, Vertex seems pretty set against it according to what little bit I have learned.

[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

[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

[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

[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.

[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."

[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

[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

[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.

[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

[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

[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.