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I’ve mentioned several times in this blog that sometimes pharma takes a short term approach and takes a position that really paint themselves into a corner. Recently Viropharma seemed to exhibit this same behavior.

Philadelphia Inquirer | 07/03/2006 | ViroPharma wants to stop FDA from easing generics rules

Basically, according to this article, ViroPharma is trying to prevent the FDA from approving a generic version of their antibiotic Vancocin (vancomycin) capsules which is used to treat various infections and particularly infections of Clostridium difficile which has recently been in the news. It is one of the few treatments specifically for this bacteria which lately has become more common. This is the bacteria involved in the recent deaths regarding RU-486 but it has been common in other situations as well including deaths after normal normal child birth.

After reading the article something didn’t seem to be right or was missing, so I decided to look into this in more detail. Here’s what I found.

Here is the first letter from the CEO of Viropharma to the FDA (pdf) and here is the second (pdf). Michel Rosen (CEO of Viropharma) also sent a letter directly to the FDA acting commissioner Andrw von Eschenbach. They claim that since Vancomycin is a drug of last resort and that if it is more widely available then resistance is likely and therefore a generic version should not be approved. They also argue that a simple dissolution test is not sufficient for a variety of reasons.

Here is the Viropharma web page regarding this. For those of you with a scientific background, I highly recommend the scientific evidence pdf.

I fully understand Viropharma’s position that they only have one product (licensed from Eli Lilly) and need to protect it but I think they are going about it in the wrong way (remember my mantra; do the right thing, for the right reason, in the right way). The process for small molecule drugs to become generic is well established. Also one sponsor of a ANDA (Biotechnology Equity research) requested guidance from the Office of Generic Drugs (OGD) and OGD has given specific guidance on what needs to be done to establish bioequivalence, at least in terms of dissolution. Another sponsor (Infinium Capital Corp) also requested guidance from the OGD Division of Bioequivalence and received the same information, basically a dissolution test. Viropharma is arguing (pretty convincingly) that the drug can not be judged based solely on dissolution of capsules. After reading their arguments, I tend to agree that some limited clinical trial testing may be needed.

Another reading of the situation (which is probably closer to the truth) is that FDA was answering a specific question about dissolution (since we don’t get to see the original question it is hard to judge) and are not saying this is all that is required. I really think that the FDA wasn’t saying that if the capsules dissolved in a certain timeframe under certain conditions that was all that was required.

Basically, if the OGD has indeed changed the criteria for bioequivalence of generic drugs without any sort of process or scientific input, it is indeed disturbing. I personally think this is a case of misunderstandings and miscommunication which will hopefully be cleared up soon.

While Viropharma may indeed be in the right, this sort of approach reinforces the view in the public’s mind that pharmaceutical companies are greedy and put profits ahead of everything else, even if in this case they may have very good reasons for doing so. While their scientific argument is persuasive, it wasn’t addressed to the average consumer who views pharma skeptically to say the least. It really boils down to do you let the media handle you or do you handle the media. I think Viropharma should do a better job of managing the information flow. Other than posting the way too technical scientific and legal arguments, I’ve not seen much from the company in terms of getting their message out to the general public.

Other Sources

• ViroPharma Submits Scientific Arguments In Supplement To Vancocin Petition For Stay Of Action
• Viropharma argues to stop copying of Vancocin | Reuters.com

• Prescribing Information for Vancocin from the FDA website (pdf)
• General information about Clostridium Difficile

Technorati Tags: FDA, Vancocin, vancomycin, ViroPharma

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