WTF? Ferring Pharmaceuticals Letter

[Anonymous]

I just got a letter yesterday from Ferring Pharmaceuticals that during a routine quality monitoring they recently determined that certain lots of BRAVELLE did not meet potency requirements through the expiration date. They are planning to remove all remaining lots of BRAVELLE from the US market. They are agreeing to reimburse patients who purchased BRAVELLE in the US between March 27, 2014 - October 15, 2015.

I am furious about this! I went through so much during my first IVF procedure in September only to find out that my meds were duds. I don't think that getting reimbursed for the meds is enough. I called today and they asked me a series of questions about my eligibility and said that they would send me a full reimbursement with my receipts as long as it was within that time period. After that, I told them that the reimbursement wasn't enough and the poor customer service rep said that she would give my name to the "escalation" dept. She said that they would be in touch. I'm not a pharmeucutical or class action expert, but this sounds like a class action in the making.

[Anonymous]

the doctor explained this to me as a precautionary measure and the meds were not duds. The problem with bravelle is that its made from LH from urine and there is a significant amount of variance per box. It's just not a good product.

[Anonymous]

Anonymous wrote:I just got a letter yesterday from Ferring Pharmaceuticals that during a routine quality monitoring they recently determined that certain lots of BRAVELLE did not meet potency requirements through the expiration date. They are planning to remove all remaining lots of BRAVELLE from the US market. They are agreeing to reimburse patients who purchased BRAVELLE in the US between March 27, 2014 - October 15, 2015.

I am furious about this! I went through so much during my first IVF procedure in September only to find out that my meds were duds. I don't think that getting reimbursed for the meds is enough. I called today and they asked me a series of questions about my eligibility and said that they would send me a full reimbursement with my receipts as long as it was within that time period. After that, I told them that the reimbursement wasn't enough and the poor customer service rep said that she would give my name to the "escalation" dept. She said that they would be in touch. I'm not a pharmeucutical or class action expert, but this sounds like a class action in the making.

Thank you for posting this - I'm going to call today. I did two rounds, in May and September of this year.

If dud meds were the reason your cycles didn't work, I'd say they owe you a WHOLE LOT MORE than reimbursement.

Would the result of these impotent meds be only a failure to retrieve enough eggs, or could they have some other effect?

[Anonymous]

12:05 - The number on the letter was 1-877-650-3482, Mon - Fri from 8am - 5Pm EST.

[Anonymous]

I used Bravelle and got a decent number of eggs, but most were abnormal. Could that have something to do with the meds or is that just bad eggs?

[Anonymous]

It sounds like it basically won't last until the expiration date. So if the expiration date on the box you used was a long ways off, it likely would not have affected your outcome. If you used it closer to the printed expiration date, it would not have been as potent.

I think.

[Anonymous]

PP again. It looks like there are 4 lots that were affected: 2 expire 10/15, 2 expire 9/16.

[Anonymous]

Anonymous wrote:

Anonymous wrote:I just got a letter yesterday from Ferring Pharmaceuticals that during a routine quality monitoring they recently determined that certain lots of BRAVELLE did not meet potency requirements through the expiration date. They are planning to remove all remaining lots of BRAVELLE from the US market. They are agreeing to reimburse patients who purchased BRAVELLE in the US between March 27, 2014 - October 15, 2015.

I am furious about this! I went through so much during my first IVF procedure in September only to find out that my meds were duds. I don't think that getting reimbursed for the meds is enough. I called today and they asked me a series of questions about my eligibility and said that they would send me a full reimbursement with my receipts as long as it was within that time period. After that, I told them that the reimbursement wasn't enough and the poor customer service rep said that she would give my name to the "escalation" dept. She said that they would be in touch. I'm not a pharmeucutical or class action expert, but this sounds like a class action in the making.

Thank you for posting this - I'm going to call today. I did two rounds, in May and September of this year.

If dud meds were the reason your cycles didn't work, I'd say they owe you a WHOLE LOT MORE than reimbursement.

Would the result of these impotent meds be only a failure to retrieve enough eggs, or could they have some other effect?

Actually, they don't owe anyone anything. It falls within the FDA rules for voluntary recall. You generally cannot sue for lack of effectiveness in these situations, only if the drug turned out to be harmful. The biggest worry is for people currently stimming with it, as you can't switch to the other brands mid-cycle. It's been pulled from shelves.

[Anonymous]

From what I'm reading these four lots failed their potency testing between 12-24 months after manufacturing. This means the doctor would have to up the dosage during stimming in order to get the proper response.

[Anonymous]

14:27 -- OP here. Thanks for dropping some knowledge about the FDA rules. That answers my question about a possible class action and what a waste of time that would be. I guess these things happen with all sorts of drugs. I definitely think this situation sucks and that the drug company should be held to a higher standard in this situation. But I guess the laws are written so that we should be grateful that we are getting any sort of reimbursement! Ha.

[Anonymous]

Anonymous wrote:14:27 -- OP here. Thanks for dropping some knowledge about the FDA rules. That answers my question about a possible class action and what a waste of time that would be. I guess these things happen with all sorts of drugs. I definitely think this situation sucks and that the drug company should be held to a higher standard in this situation. But I guess the laws are written so that we should be grateful that we are getting any sort of reimbursement! Ha.

I guess it would be nice to know if you used any of the affected lots, just for peace of mind. I found the lot numbers online, but I assume most people no longer have the vials, unless they are currently stimming.

[Anonymous]

There were actually a lot of lot numbers affected, including mine:

http://pharmacy.ca.gov/about/recall_alerts/ferring_10_12_15.pdf

I was mid-stim cycle when I learned and my doctor switched me to Gonal-F immediately.

[Anonymous]

I just threw out my boxes last week. Does the pharmacy keep track of lot numbers?

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I just got a letter yesterday from Ferring Pharmaceuticals that during a routine quality monitoring they recently determined that certain lots of BRAVELLE did not meet potency requirements through the expiration date. They are planning to remove all remaining lots of BRAVELLE from the US market. They are agreeing to reimburse patients who purchased BRAVELLE in the US between March 27, 2014 - October 15, 2015.

I am furious about this! I went through so much during my first IVF procedure in September only to find out that my meds were duds. I don't think that getting reimbursed for the meds is enough. I called today and they asked me a series of questions about my eligibility and said that they would send me a full reimbursement with my receipts as long as it was within that time period. After that, I told them that the reimbursement wasn't enough and the poor customer service rep said that she would give my name to the "escalation" dept. She said that they would be in touch. I'm not a pharmeucutical or class action expert, but this sounds like a class action in the making.

Thank you for posting this - I'm going to call today. I did two rounds, in May and September of this year.

If dud meds were the reason your cycles didn't work, I'd say they owe you a WHOLE LOT MORE than reimbursement.

Would the result of these impotent meds be only a failure to retrieve enough eggs, or could they have some other effect?

Actually, they don't owe anyone anything. It falls within the FDA rules for voluntary recall. You generally cannot sue for lack of effectiveness in these situations, only if the drug turned out to be harmful. The biggest worry is for people currently stimming with it, as you can't switch to the other brands mid-cycle. It's been pulled from shelves.

If they sold thpusands of people salt water for hundreds an ounce and told them it was magical baby-making human hormones, then yeah, they owe someone something.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I just got a letter yesterday from Ferring Pharmaceuticals that during a routine quality monitoring they recently determined that certain lots of BRAVELLE did not meet potency requirements through the expiration date. They are planning to remove all remaining lots of BRAVELLE from the US market. They are agreeing to reimburse patients who purchased BRAVELLE in the US between March 27, 2014 - October 15, 2015.

I am furious about this! I went through so much during my first IVF procedure in September only to find out that my meds were duds. I don't think that getting reimbursed for the meds is enough. I called today and they asked me a series of questions about my eligibility and said that they would send me a full reimbursement with my receipts as long as it was within that time period. After that, I told them that the reimbursement wasn't enough and the poor customer service rep said that she would give my name to the "escalation" dept. She said that they would be in touch. I'm not a pharmeucutical or class action expert, but this sounds like a class action in the making.

Thank you for posting this - I'm going to call today. I did two rounds, in May and September of this year.

If dud meds were the reason your cycles didn't work, I'd say they owe you a WHOLE LOT MORE than reimbursement.

Would the result of these impotent meds be only a failure to retrieve enough eggs, or could they have some other effect?

Actually, they don't owe anyone anything. It falls within the FDA rules for voluntary recall. You generally cannot sue for lack of effectiveness in these situations, only if the drug turned out to be harmful. The biggest worry is for people currently stimming with it, as you can't switch to the other brands mid-cycle. It's been pulled from shelves.

If they sold thpusands of people salt water for hundreds an ounce and told them it was magical baby-making human hormones, then yeah, they owe someone something.

No, that's not what happened here. Their own quality control discovered it, and they recalled it appropriately per US legal standards.