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SECTION A- Won’t You Come In, Join the Party? (10 points) Welcome to the midterm exam. But enough about that . Did you ever watch the Dallas Buyers Club (2013) if not, you’re missing out on a great multiple-Oscar-winning film. Matthew McConaughey dropped over 50 pounds for his performance. To summarize from Wikipedia (because I’m kinda lazy): The film tells the story of Ron Woodroof (played by McConaughey), an AIDS patient diagnosed in the mid-1980s when HIV/AIDS treatments were under-researched. while the disease was not understood and highly stigmatized. As part of the experimental AIDS treatment movement he smuggled unapproved pharmaceutical drugs into Texas for treating his symptoms, and distributed them to fellow people with AIDS by establishing the ‘Dallas Buyers Club” while facing opposition from the FDA. For example, check out the following clips available on YouTube (please pardon the one word of bad language presented; it’s in context for the movie character’s personality, but I find it offensive) https://www.youtube.com/watch?v=WpZ4KY3AJWU https://www.youtube.com/watch?vKGudyrV0v4 In general, the movie hit its mark portraying this important turning point in USFDA regulatory history. Several AIDS doctors have chimed in praising the movie, while still noting some of the over-simplifications. Below is one example review: https://www.newswise.com/articles/dallas-buyers-club-an-aids-specialists-take-on-the-oscar-nominated-movie If you listened to the whole thing, and especially if you’ve seen the movie – great! But the relevant bit is from 1:30m – 2:30m under the “Rules” heading. The doctor echoes the story told by the movie, and mentions that “Buyers Clubs” such as this one led to new approval pathways over the next half-decade, including “parallel track reviews (1992) and faster drug approvals. But it also led to something else, directly related to what you hear in the movie clips. Also refer to the hint below to respond to the following questions 1) (2 points) What pathway was introduced to one of the workflow elements in the pre-commercial FDA application process to investigate and market new drugs. You should be able to identify it based on the context of the video clips. What is it? 2) (2 points) If you answered the first question correctly, you’ll recall that there are two other pathways in that part of the FDA review and approval process. Please identify the two other types. 3) (6 points) Compare and contrast all of the available pathways for that part of the workflow (at least three similarities and at least three differences), and provide with an example a product that has used each of the other two pathways. Hint: To avoid you becoming Dazed and Confused (ha, that’s another McConaughey movie), recall the general workflow to bringing a product to market is: a) pre-clinical testing, b) application to clinical investigate, c) clinical testing, di marketing application e) commercial production and distribution & pharmacovigilance
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