5 ms·
> The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from
by willcipriano 3y ago
> The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an over-the-counter product. For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional
It took 50 years to make packaging that users could understand?
- huthuthike 3y agoMore like no one bothered to apply to make it OTC until a year ago. In the US there is more money to be made from selling prescription medication.
- ghaff 3y agoGenerics at least aren't big moneymakers. With totally pedestrian insurance I pay next to nothing (or nothing) for the variety of meds that I take. Would probably cost more if I could buy them OTC.
- parasense 3y agoGiven the 50 years, I'd say the original investment has paid off many times over, and all the generic brands got their cut. It's more than fair to society to allow the medicine to go over the counter.
- ghaff 3y agoOh I'm not disagreeing in general. There are probably some classes of drugs like antibiotics which probably lend themselves to overuse/misuse and are probably best kept prescription only for the most part (agriculture overuse notwithstanding). But in general, if there's no good reason something shouldn't be OTC, it probably should be. I'm just saying generic prescription drugs don't necessarily have a huge price uplift vs. OTC.
- refurb 3y agoActually, profits are higher for OTC. Check out the cost of a prescription for say esomeprazole versus what Costco sells it for. Price competition across pharmacies is far higher (due to low insurance reimbursement) than cash paying patients.
- huthuthike 3y agoI think you are looking at the cost of generic prescription drugs vs their generic OTC counterpart. When a drug is first invented it is patented, not generic. The drug company has to look at whether to apply for FDA approval as a prescription or OTC. Most often drug companies look to get approval as prescription, because that is more profitable for patented drugs. Once the drugs move out of patent, that doesn't mean it is automatically approved for OTC sale. A drug maker can look at getting FDA approval for making it OTC. But it costs time and money to do so, with no guarantee of success. In the case of Norgestrel it took until now before any drug maker thought it would be worth pursuing.
- refurb 3y agoI think you are looking at the cost of generic prescription drugs vs their generic OTC counterpart. Of course. Drugs that are approved for OTC are almost always generic by that time. Most often drug companies look to get approval as prescription, because that is more profitable for patented drugs. No, it's not approved as prescription because it's more profitable, it's approved as prescription because that's all the FDA allows. The safety requirements for OTC are far stricter than prescription. Most patented drugs could never become OTC, ever. In the case of Norgestrel it took until now before any drug maker thought it would be worth pursuing. Norgestrel is a generic. All birth control pills pretty much are. The hormones can be in different combinations or formulations, but generally they are all generic components. So my point stands, it's often more profitable to be OTC than prescription.
- giantg2 3y agoYep, because it's relying on the cultural knowledge that has been built up over the years through things like health classes and society talking more openly to share knowledge. And people really don't understand all the potential risks for most medications they're on, whether Rx or OTC.
- willcipriano 3y agoCouldn't be that doctors wanted all those easy well visits writing scripts for birth control and the recent supreme court ruling encouraged the FDA to finally be reasonable? It's that this exact moment is the first time in human history that women are capable of understanding "once daily".
- zdragnar 3y agoDoctors (the ones writing the prescriptions) aren't involved in this process at all.
- foooorsyth 3y agoThe AMA is absolutely involved in the medical regulation arena. What are you talking about?
- zdragnar 3y agoAMA != Most prescribing doctors. Best estimates are only ~20% of doctors are even members of the AMA, with some as low as 15: https://www.physiciansweekly.com/is-the-ama-really-the-voice-of-physicians-in-the-us/ https://www.physiciansweekly.com/is-the-ama-really-the-voice...
- giantg2 3y agoThere are many doctors who really hate the AMA. I know a couple.
- giantg2 3y ago
- deleted 3y ago[deleted]
- AndrewKemendo 3y agoYes, because it’s an incredibly important drug that has massive social implications on it. So the design, engineering and implementation of the holistic system around it must prove with extremely high confidence that the default usage of it, with no special education, is in line with the idealized social use of it. Further, it should be shown that non-intended uses or abuses of the drug are rare by chemical function - not simply regulatory. And while it might not be 50 years, required as the mathematical minimum time for this to be true for this particular drug, that is the amount of time this society has decided would be appropriate to allow for individual decision making to be the discriminatory function for acquiring it.
- WesternWind 3y agoThe same people who hate and politicize abortion also usually hate and politicize contraceptives. I don't know if that had an impact in the choice to seek approval or not, but I wouldn't be surprised. If it looks like Trump might win the electoral college and the Dems might lose Congress, it might not be the worst thing to have stocked up on.
- giantg2 3y agoIt expires 1 year from manufacturer, so stockpiling isn't really a viable option.
- hattmall 3y agoThe contingent of people who want abortion restrictions and those who want to ban daily preventative contraception is incredibly minimal. There is no serious mainstream movement whatsoever to ban this type of medicine. This type of hyperbolic proselytizing has no place in reasoned discussion.
- anigbrowl 3y agoYou're assuming a fundamentally democratic decision-making process that doesn't exist in reality. It's entirely conceivable that a 5-4 Supreme Court majority could outlaw or restrict something that enjoys broad acceptance in the population at large, for example.
- supazek 3y agoIn what way would they ban something? I mean, what would that mechanism look like? Honest question. It seems that they would only be able to rule some legislation unconstitutional or to rule on a case to set a precedent. FWIW I think the Supreme Court overall does an amazing job upholding the constitution. The Roe v Wade upset made sense from a legal perspective and they have a strong recent history of supporting citizens rights in the face of overreaching LE agencies.
- crote 3y agoIs the Catholic Church mainstream enough for you? They consider all forms of contraception intrinsically evil. The US is already seeing attempts to pass laws banning Plan B or IUDs, it is not too much of a stretch to think hormonal birth control is at risk too.
- stcroixx 3y agoSure, it’s merely a big coincidence the court made a relevant ruling. FDA was bought a long time ago by pharma and hasn’t prioritized citizens since.
- singlow 3y agoIt could also be that public familiarity with medication procedures and language has changed over time allowing the FDA to believe that this can be used safely now, whereas the same instructions would not have been as effective 20 years ago?