Drug Development




Where does that blood pressure medicine come from, and why does it cost so much!?  Drug companies must be making a killing, right?  Well, it’s complicated.  Listen up to this week’s podcast to educate yourself on the lengthy and expensive process of new drug development.  Follow along below to see the info in text and pictures.  Enjoy!





  1. Good Guys, great podcast! Keep them coming. I agree with Perik, the Big Fat Idiom was the kind that are really interesting. A couple of items to note from someone who isn’t JUST the “Made in America” guy, but has a PhD in new techniques for making antibiotics and is also a certified regulatory specialist for US medical products:

    A new drug must first go through the computer simulations you mentioned, then go through various pre-clinical testing such as pharmacokinetics, pharmacodynamics, toxicology, etc. in various animal models. All of this information is bundled up and sent to FDA as a “Investigational New Drug” or IND application. The IND application, once approved, allows the company to BEGIN clinical trials.

    FDA monitors the trials for certain drugs but allows lower risk drugs to be only monitored by an investigational review board or IRB. All parties have very strict responsibilities when conducting trials and, in fact, some of those legal responsibilities are mandated at the state-level and vary state-by-state. Talk about complicated regulatory environment!

    Only when Phase 3 clinical trials are completed does the company submit and pay the $1,958,800 fee (2013) for a New Drug Application or NDA to the FDA.
    Interestingly, the company will then have to pay $526,500 (2013) annually to register the facility where the drug is made, if not already registered. Additionally, the company will pay, for each prescription drug they market, an annual fee of $98,380 (2013) on top of the initial NDA fee to allow it to be marketed.
    Some interesting numbers to chew on that don’t even arise until after the best candidate new chemical entity, or NCE, has been chosen!

    Another topic – You can find the official FDA guidance for the Fast Track Program at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm077104.pdf
    Here, interestingly, section 506(a)(1) of the Act states that a drug designated as a fast track product is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address unmet medical needs for the condition. So new research for an EXISTING drug to be used on a different CONDITION can also be “fast-tracked”.

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