4 ms·

The exclusivity period is intended to incentivize developing old drugs for new indications. What would you suggest instead of the exclusivity window?

by notlob 9y ago

otterley 9y ago
What “development” are you referring to, exactly? The alternate indications in many cases are already well known (as they were in the referenced article).
- notlob 9y ago
  The clinical studies needed to support receiving approval to market the old drug for a new indication, as well as whatever lifecycle management and post-marketing surveillance activities (Phase IV) that are required. The alternate indications may be well-known but marketing for an off label indication is not permitted (as in, they actually jail CEOs and executives for that).
toomuchtodo 9y ago
Government manufacturing of generics by the CDC or NSF. It is the only method by which you can guarantee supply as well as ensure transparency in the process.
- notlob 9y ago
  I can't say I understand why you selected those two organizations: the CDC doesn't have pharma manufacturing expertise that I am aware of (interested to hear of what you know on that angle); the NSF is non-medical and it's a grant agency, no labs. I should also note that even if they were chartered for this sort of work and were working on it, they would face the same source material supply problems facing commercial groups that result in some supply interruptions, and the basket of problems associated with manufacturing small amounts of drugs. There are many non-profit and academic institutes that are working on the problem of generic drug costs holistically, including figuring out how to produce APIs (in pharma, API is active pharmaceutical ingredient) from plentiful source materials and how to produce the APIs by flow processes so that small quantities of drugs are more economical to produce. They're doing good work but it's a hard problem, experienced execs and leaders are difficult to come by, and getting funding in biotech is far more difficult than getting funding in IT. They do receive support from NIH, FDA, DARPA (making drugs at a CSH in the middle of Afghanistan is useful), big pharma (being able to make drugs cheaper is generally of interest), and philanthropic groups. Many smart and talented people are "on it!", good progress is being made, but it is a hard problem.

The exclusivity period is intended to incentivize developing old drugs for new indications. What would you suggest instead of the exclusivity window?

by notlob 9y ago

The exclusivity period is intended to incentivize developing old drugs for new indications. What would you suggest instead of the exclusivity window?

otterley 9y ago

What “development” are you referring to, exactly? The alternate indications in many cases are already well known (as they were in the referenced article).

notlob 9y ago
The clinical studies needed to support receiving approval to market the old drug for a new indication, as well as whatever lifecycle management and post-marketing surveillance activities (Phase IV) that are required. The alternate indications may be well-known but marketing for an off label indication is not permitted (as in, they actually jail CEOs and executives for that).

toomuchtodo 9y ago

Government manufacturing of generics by the CDC or NSF. It is the only method by which you can guarantee supply as well as ensure transparency in the process.

notlob 9y ago
I can't say I understand why you selected those two organizations: the CDC doesn't have pharma manufacturing expertise that I am aware of (interested to hear of what you know on that angle); the NSF is non-medical and it's a grant agency, no labs. I should also note that even if they were chartered for this sort of work and were working on it, they would face the same source material supply problems facing commercial groups that result in some supply interruptions, and the basket of problems associated with manufacturing small amounts of drugs. There are many non-profit and academic institutes that are working on the problem of generic drug costs holistically, including figuring out how to produce APIs (in pharma, API is active pharmaceutical ingredient) from plentiful source materials and how to produce the APIs by flow processes so that small quantities of drugs are more economical to produce. They're doing good work but it's a hard problem, experienced execs and leaders are difficult to come by, and getting funding in biotech is far more difficult than getting funding in IT. They do receive support from NIH, FDA, DARPA (making drugs at a CSH in the middle of Afghanistan is useful), big pharma (being able to make drugs cheaper is generally of interest), and philanthropic groups. Many smart and talented people are "on it!", good progress is being made, but it is a hard problem.