3 ms·

I can't say you are wrong. But also remember the industry is lobbing against many things right now which have come around in the past few years, including the

I can't say you are wrong. But also remember the industry is lobbing against many things right now which have come around in the past few years, including the perception of opiate prescriptions where they are trying to moderate the discussion. Hence spending has gone up considerably. My personal logic is they typically have lobbied to keep most drugs regulated (or split) so to keep their reimbursements as high as possible. Most drugs once they go into the OTC market drop in margin, and volume does pick up but only to a point plus it comes with increased competition now. The last few allergy medications like Zertec, Allegra, Claritin etc that were once prescription only went OTC and margins dropped for the OTC versions. However, you will find at least in the case of a couple of them the companies were pushing for them to be OTC from the beginning because they had developed the drug with the intent to be OTC. However, even if you look at OTC allergy meds, most can still be prescribed and hence paid for by medical insurance and the per pill price is drastically higher, but the out of pocket expense for the consumer is lower (which is just screwed up IMO). Last point on this, once it goes OTC the competition on manufacturing skyrockets, again driving down margins for everyone, similar to when a prescription med comes off patent initially. I could see an argument though where the AMA and other physician lobbying groups here may diverge from the pharmaceutical lobbying but in general from my knowledge they work pretty close together.

jrochkind1 8y ago
It reads to me like these medications are _not_ going to be classified as "over the counter." Even though they will not require a prescription, that's the whole point. I wonder if the regulations are written in some way to allow them to keep charging prescription prices without a prescription. The article definitely suggests it's a new "status", not merely making more things OTC. From the OP: > Finding a way to expand access to widely used prescription drugs has been a goal of regulators in recent years. > The FDA explored the idea of a “behind-the-counter” designation in 2007 that would have required interaction with a pharmacist. The Government Accountability Office in a 2009 report on the proposal asked whether consumers would end up paying more for their drugs since nonprescription medications typically aren’t covered by insurance." Note, since they aren't typically _covered by insurance_. A new designation that would be covered by insurance, fit into insurance schedules under "prescription", but not actually require a prescription -- hey, "everyone" wins! From: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u... "Currently, nonprescription drugs can be marketed under either of two regulatory pathways: the Over-the-Counter (OTC) Drug Review (OTC Monograph Process) or the New Drug Application (NDA) process, and there are different requirements under each system. Today’s new FDA draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the NDA process and is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription." The (very brief) draft guidance itself: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM613666.pdf https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula...

jrochkind1 8y ago

It reads to me like these medications are _not_ going to be classified as "over the counter." Even though they will not require a prescription, that's the whole point. I wonder if the regulations are written in some way to allow them to keep charging prescription prices without a prescription. The article definitely suggests it's a new "status", not merely making more things OTC. From the OP: > Finding a way to expand access to widely used prescription drugs has been a goal of regulators in recent years. > The FDA explored the idea of a “behind-the-counter” designation in 2007 that would have required interaction with a pharmacist. The Government Accountability Office in a 2009 report on the proposal asked whether consumers would end up paying more for their drugs since nonprescription medications typically aren’t covered by insurance." Note, since they aren't typically _covered by insurance_. A new designation that would be covered by insurance, fit into insurance schedules under "prescription", but not actually require a prescription -- hey, "everyone" wins! From: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u... "Currently, nonprescription drugs can be marketed under either of two regulatory pathways: the Over-the-Counter (OTC) Drug Review (OTC Monograph Process) or the New Drug Application (NDA) process, and there are different requirements under each system. Today’s new FDA draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the NDA process and is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription." The (very brief) draft guidance itself: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM613666.pdf https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula...