Shortcuts to Receiving Market Approval

13Think waaaaaaaaaaaaay (haha) back…growing up, did you ever try and take shortcuts when doing your homework? Perhaps reading the cliff notes for a book instead of the actual book you were assigned?!? Sound familiar? Eh…hem…we all took shortcuts at some point! The problem was…those shortcuts typically didn’t work…we probably ended up in a situation where our developing minds were missing important information that was needed for question number 1 on a final exam! Sweaty palms for the rest of the exam…

But…we all know, sometimes shortcuts are OK and more importantly, sometimes they make better sense! A perfect example can be shown in the drug/biologic/medical device industry when navigating pathways to obtain market approval for your product! On average, developing a drug from discovery to market takes about 10 years and costs over a billion dollars! Ouch! This poses a great challenge for a lot of small, start-up life science companies trying to obtain the capital needed to fund their programs.

Luckily, there are other options!

121) Have you considered the 505(b)(2) process? Why not decrease the approval failure rate and achieve a faster time to market with the 505(b)(2) pathway!? Basically, this is a shortened New Drug Application (NDA) process (full process is 505(b)(1) NDA) that alters a current, already approved drug! How does this work? You get to use existing information in the literature and submission documents on the approved product to support your product’s development! Ultimately, this will save you time and money for the nonclinical and clinical development of your product! Often times, little to no animal studies are required, and shorter and much less-expensive clinical trial studies are required (usually just simple bridging studies to compare the marketed product with the new development product).

2) …or how about developing a generic drug via the Abbreviated New Drug Application pathway (ANDA)? This is where an approved, new chemical entity (NCE) is copied. The active ingredient is the same and the dosage form, strength, route of administration, quality, performance characteristics and intended use are equivalent to the approved product. Inactive ingredients may vary in a generic form. When developing a generic, the sponsor company is generally “not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bio-equivalent (i.e., performs in the same manner as the innovator drug).” Once again, a much faster and less expensive route to market!

3) Or wait…did ya ever think of going for an Orphan indication? We over here at McCormick LifeScience Consultants have a real passion for helping others suffering from rare diseases (check out our sponsorships down below)!! These are typically disease indications that come with a lot of unknowns and affect less than 200,000 people in the U.S. (orphan disease indications). If your company chooses to develop a product for the treatment of an orphan indication, there are great benefits to this! At the FDA, the Office of Orphan Products Development (OOPD) provides incentives for companies to research and develop treatments for these “forgotten” populations. The Orphan Drug Designation Program and the Humanitarian Use Device (HUD) Program allow for financial incentives (various grant programs), 7 year market exclusivity (versus 5 with a new chemical entity), clinical program incentives, and often times, faster approval processes. Once again, all saving time and money for the Sponsor company! Not to mention…this is a great way to get your company on the map, which will ultimately help with brand awareness and ongoing financial support! YAY!

Shortcuts! We like them! When they are legal and beneficial of course…

Toto's Tips


Be sure to spend a sufficient amount of time on the back-end researching the information that is already available to you in regards to the marketed product. The more time you spend up-front and the more thorough you are in this literature/research effort, the more time and money you will save in the development of your 505(b)(2) product! Perhaps you can get this 505(b)(2) product on the market and increase your capital to fund a new 505(b)(1) program!

Generic drugs-ANDA process:

  • Make sure you do your homework and are equipped with proper intellectual property (IP) and legal support to determine WHEN and HOW you can develop a generic form of a drug. You don’t want to find yourself in a lawsuit in which you’ve tampered with a sponsor’s market exclusivity and end up guilty of patent infringement!
  • Want to know what drugs are approved and good for generic marketing? Check out the Orange Book here! It even lists Patent and Exclusivity info!

Orphan Designation:

  • Before choosing an orphan disease indication to develop a treatment for, be sure to do your homework and be ready to prove (epidemiology literature or data) that this disease or condition affects less than 2000,000 people in the U.S.!
  • Also be sure you know if other companies are working on essentially the same drug for the same indication, so you don’t waste your time/money. The company that proves clinical superiority wins in the end.