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The following article appeared recently in the Washington Post.

Petitions to FDA Sometimes Delay Generic Drugs

The article talks about the use of what is called a citizen’s petition to delay entry of generics into the market so that a brand name drug can continue to have it’s exclusivity. The FDA has information about providing feedback to on it’s website.

The process involves filing a petition with the FDA and then it can take anywhere from months to a year or more before there is action on the FDA’s part. This in essence gives the brand name drug an extension on it’s exclusivity.

One of my basic tenants of living is to do the right thing for the right reason in the right way (and this includes at the right time). If one of these is out of balance, there will be problems. In this case, we are talking about intent (the right reason). However, determining why someone does something especially in a technical context, can be quite difficult.

In this particular case, it may well be that the brand name company has the most information about the drug over the years of development and is most likely in a good position to determine if there is a potential problem. However, the FDA should also be an expert with even more experience since they see all drugs at various stages of development and have access to knowledge that is not publicly available. However, I’ve also been around the industry long enough to recognize that sometimes companies use this sort of loop hole to their advantage. I personally think this has to do with the legalistic interpretation instead of the moralistic one. While I realize companies are in business to make money, I also realize they have to keep the confidence of consumers. Practices such as this and the misuse of filings in the FDA orange book show to me that companies emphasize the short term gains without realizing the longer term negative effects of the bad publicity. This may be because consumer confidence does not show up in any accounting statements.

One of the things I think might help is to improve the FDA’s response time to these petitions. According to the article the FDA is taking steps internally to shorten the time for rulings on these petitions. There were no details given as to what these changes may be so we will be a wait and see if there really is a quicker response. I think this is an issue that will not disappear anytime soon and probably won’t change until Congress gets involved. And with the current political situation, I think that it highly unlikely.

Technorati Tags: drug safety, FDA

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