Computerized FDA Licensing

    Overview

    "Not too long ago, filing a new drug application with the US Food and Drug Administration could mean sending four 48-foot trucks stuffed with 100,000 pages of documentation off to the agency's headquarters in Rockville, Md."1

    It may seem far fetched, and most likely is a bit exagerated, but really, thats how it was. Drug companies had literaly thousands of pages of tests, experiments, documentaion, and other notes to submit ever time they submit information for a new drug to be put on the market. Now though, with computerized technology, its easier for drug companies to send that information to the FDA. Instead of thousands of pages, its only thousands of bytes of information to submit, which is still a heck of a lot, but at least its not all tangible right?

    Switching Over

    Gradually, computerized submission, also known as E-File, has become the prefered way to send new drug information from the company to the FDA for approval. Not long ago, companies had to ship not only the pages of documentation, but all other relevent information, causing a large shipping bill. Now with computer technology, a company can easily send just a stack of CDs to the FDA, saving large sums of money on shipping. The image below show a comparison of 2 different drugs, and how much computer technology saved the company in costs.2

    One can see, that saving over three thousand dollars is worth while. Companies can take easily found off-the-shelf software to use for their documentation as well. Many companies have switched to this new way of filing, mainly because of how easy it is. Documents no longer need to be proofread for errors, or notes rewritten due to sloppy handwriting. All the information is collected on neat little CDs, ready for reading. Some larger submissions could also be placed on DVDs, saving space for shipment. The days of truck loads of papers is over, and the FDA is striving to help companies make the change.

    Fully Electronic

    Even if the information is all compiled onto CDs, its still material. The CDs need to be sent to the FDA to be reviewed. However, even this can be changed. The IDEC Pharmaceuticals Corporation, a San Diego company, was the first to file a completely electronic biologics license application (BLA).2 This occured in 1997, and marked a revelusionary way to file for drug licenses from the FDA. Now the information need not even be on disc, all information for electronically sent to the FDA for approval. Since then, this same company has filed for other drugs completely electronically, not having to worry about lost packages, or misplaced files. This shows the usefulness of such a system, and why a totally electronic submission system is the next step in making it easier for companies to file documents to the FDA.

    Current Use

    Currently, drug companies are still using the CDs way to send information to the FDA rather then electronically. its not sure when, but many analysts think that eventually this will all change over the the fully electronic information. A quick hop to the FDA website will show pages of information on what types of data the FDA requires for these submissions. Recent applications for drug licenses have mostly, if not all, been through an electronic medium instead of written pages of information.

    References:

    1 http://www.the-scientist.com/article/display/15718/
    2 http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=140820
    3 http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm