These situations with old drugs are more a matter of FDA certification than IP.
edit, to speak to the complexity. Up until yesterday, if you asked me if the industry should cease direct to consumer marketing, I’d say “hell yes, I’ll push the big red button myself”. Yesterday however, while watching late night TV (which I rarely do), I happened to pay attention to an ad (which I rarely do) for a biologic that could really help out a friend with a miserable chronic condition. Don’t know if it will work or not until they try, but they are exactly the right population for the treatment. None of their physicians suggested it, I didn’t think of it despite being vaguely familiar with this area of medicine, but the DTC ad was an inspiration. I still think on the balance that DTC marketing is bad, but this personal experience makes me question if the possibility of occasional successes overrides. I have no idea, but I spend a lot of time nursing my beer in the corner the pub trying to figure things out.
Tufts numbers are generally regarded as high. Booth at Atlas puts the cost ranging from $300M for a drug that can be developed on a lean process (like Eli’s Chorus) to $1.6B for something developed by large pharma. Regardless of where in the range you are, it’s risky and it isn’t cheap.
Which brings me to my original question: if not assisted by the exclusivity provided by IP, how should drug development costs be paid for? And beyond that, how should lifecycle costs be paid for?
From the discussion section:
>Pharmaceutical innovation is an international enterprise. Although the United States is an important contributor to pharmaceutical innovation, we found that more than 20 countries contributed to the development of the 288 NMEs with patents at the time of approval. More than 171 companies were involved in the development of these NMEs, and the vast majority of companies were multinationals with facilities located in more than 2 countries. We also found that the United Kingdom, Switzerland, Belgium, and a few other countries innovated proportionally more than their contribution to the global GDP or prescription drug spending, whereas Japan, Spain, Australia, and Italy innovated less.
Granted I know that GDP isn't the end-all be-all for determining how drugs can be financed, but I think there is something to learn from the study and how other countries do business while continuing to innovate.
https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.c...
I wonder if they could tie the exclusivity period to net revenues or something.