rthstewart (
rthstewart) wrote2016-11-12 09:08 pm
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Contraceptives? What happens next?
Edited below with a good link and some additional thoughts-
After seeing the burgeoning worry regarding continued availability of access to contraceptives in this new climate, I wanted to offer some words that I started here but with the concern, thought I should expand and clarify.
Will I be able to get contraception? I know what Mike Pence did in Indiana. Will the pill be outlawed? Condoms? What do I do?
- Get good information
Information about contraceptives medical abortions here, and here and here,
Planned Parenthood
Here, and here.
Manufacturer websites for particular products are very good for information (and regulated) and may have coupons and patient payment assistance information, for example
http://www.trojanbrands.com/en/condoms
http://www.todaysponge.com/
http://www.mirena-us.com/index.php
http://www.thepill.com/
http://planbonestep.com/
- So what contraception are we worried about?
All these products are regulated by the FDA in the Center for Drugs, and the Center for Devices
- What are we worried will happen? And my short answers
*The products I use now will be made illegal (No, I don't think this will happen)
*I won't be able to buy the products I'm using because I won't be able to find them (This is potentially a concern and there are solutions.)
- What you should do now if you are in danger of loss of health coverage.
- Should I be worried they’ll be gone, like Elaine and the sponge?
Interestingly the sponge wasn’t a problem with BIRTH CONTROL IMMORAL but declining sales and deionized water in the manufacturing process. It came back on the market once a manufacturer was willing to invest in it and solve the manufacturing problems.]
I don’t think you need to stockpile Plan B, condoms, a year’s supply of BC pills, or get an IUD because you are worried the new Pence administration will remove these products from the market. I believe these products will continue to be available. This has to do with a couple of things. TL, DR
- TL,DR about why I think already approved products you can use now will likely stay that way
Some over the counter, non-prescription drugs (like Benadryl or acne medicine) can go onto the market because of some regulations. But every other drug has to be approved by FDA’s Center for Drug Evaluation and Research in a new drug application (NDA) for brand drugs and abbreviated new drug application (ANDA) for generic drugs. To get that NDA or ANDA approval, a pharmaceutical company has to, among conduct a lot of clinical research showing the product is safe and effective for the condition it’s supposed to treat or prevent. This takes many years and millions of dollars usually.
Medical devices are divided into Classes (more about that here) and the more invasive, sophisticated ones, like IUDs, go through a process similar to the NDA, called a PMA. Products like condoms, logically, don’t have as many legal requirements though they need a “clearance” from FDA which isn’t as difficult or expensive; they are cheaper to make and it’s easier for a company to get into the business of selling them, so it can be pretty competitive.
Key takeaway: It’s so difficult and expensive and takes so long to get an NDA, ANDA or PMA approved by FDA, it is really, really hard for FDA to forcibly remove the product from the market if the manufacturer wants to keep selling it. It takes years and hardly ever happens. Like, hardly ever. It may not have ever happened for a PMA medical device and has only happened once for a drug – there are two others ongoing now -- over 40+ more years.
- But, couldn't a BC Pill or IUD manufacturer decide to cave to political pressure?
And even with political pressure, some of them actually really believe in what they are doing, or at any rate, that they'll make money at it. For example, with Plan B the manufacturer fought for years, with both the Bush and Obama administrations, to get its NDA approved and it took a court case before it was finally available to switch and make the product available to women of all ages over the counter. The makers of condoms have been there for generations and I don’t see them stopping even if Mike Pence believes they don’t work.
- But FDA could cave to political pressure.
What all this means is that if Mike Pence or a Congressional committee tries to tell FDA that it should ban birth control pills because drug companies are lying and they are really abortifacients that make tiny dead babies fill women’s wombs, or that condoms don’t work -- and FDA's gotten this crap for YEARS -- the congress critter will eventually get a polite response from an FDA official saying, “With all due respect, sir, the clinical data developed over years of patient use do not support that conclusion” and the pharmaceutical company will quietly pay large sums of money to congressional committee chairmen to make the problem go away.
- What should I worry about?
Things at FDA in the reproductive health area may go slowly. Maybe the office of women’s health will have to disband. FDA may have to respond to lots of stupid congressional requests for information and petitions or even lawsuits by abortion opponents urging them to remove drugs, restrict products, etc. I don’t see FDA moving from its determinations that these products were safe and effective for their intended contraceptive use but it will distract and delay FDA.
- Investigate your pharmacy access now
States may also try to put products like condoms or Plan B behind the counter, making it harder to get these products.
If you think Plan B or condoms are something you’re worried you won’t be able to get in a hurry when you need them, by all means get a package or two and keep it on hand, paying attention to expiration dates. But you don't need to stockpile IMO.
- If I can’t buy drugs or medical devices from my pharmacy, I can just buy it on the internet, right? And I heard I can get the medical abortion pill on the internet.
Stop. Many major pharmacy chains and retailers have reputable, US-based online pharmacies. The ONLY safe online pharmacies are in the VIPPS program HERE.
DO NOT BUY DRUGS ON THE INTERNET UNLESS THEY ARE FROM A VIPPS PHARMACY.
Do not assume that because it comes from Canada, it’s the same. It probably isn’t.
If it doesn’t come from a VIPPS pharmacy, there’s a high chance that the product is counterfeit. Certain internet drugs are almost certainly counterfeit. Unlike other parts of the world, we have very little counterfeit product in the US and when we do it comes from 2 places mostly -- people buy it from online fake foreign pharmacies or a hospital or pharmacy buys from a shady supplier because they can make money on the amount they purchased it for and the amount they get reimbursed by the health plan or government payor.
If you do buy something and it doesn’t look right or seem right, contact the manufacturer or FDA. They won't try to throw you in jail. FDA and the manufacturer are worried about you and unsafe product hurting people, not looking to report you.
I know this is all really scary. I’m scared too. I’ll be glad to answer questions. And if I got anything wrong, do correct me.
Edit
First, there's a great comment below by a pharmacist about expiration dating of drugs. The plan B my helpful pharmacy tech at the grocery store got from behind the counter for me to examine (it's for theft deterrent, unfortunately) showed a nice long expiration date of 01/2020. I'm very confident that pressure to make FDA restrict or withdraw approval of these already approved products is not likely to succeed. But, what about the blunt approach, Congress or a State legislature outright bans methods of birth control, like Plan B or BC pills. Could that happen? I'm thinking about it and will post after I do some research. I'm not aware of any instance where a product, lawfully approved by a Federal agency, was banned by a State or by Congress. Even tobacco and liquor remain available for sale, and those are known to have health effects and have never been approved by a US public health agency. Marijuana is a bad example because it remains illegal under federal law and international treaty. There are a number of issues here and I'll think about it.
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(Anonymous) 2016-11-13 06:21 am (UTC)(link)For implants and IUDs, the expiry date is more important because those products have to be sterile to use, and I wouldn't want anyone to put something in their body that you couldn't guarantee was still sterile.
Here's a report on a study done by the FDA at the request of the military: Drug Expiration Dates: Do They Mean Anything? (http://www.health.harvard.edu/staying-healthy/drug-expiration-dates-do-they-mean-anything)
They found that 90% of the active ingredient is still present up to fifteen years past the expiration date. Whether 90% of the active ingredient is enough to give you contraceptive protection is harder to predict, but I think, in dire circumstances, it could definitely be an option.
My totally illicit suggestions for maximising your chances of keeping the medication in a good state for the longest time: From a practical point of view, you'd probably want the kind of pack that has a foil blister, not the plastic discs where all the tablets are exposed to air. You'd want the glossy, sugar-coated tablets rather than the rough-textured chalky lookig tablets, because they've got an extra layer protecting them from air and moisture. (I'm sorry - I'm not from the US, so I can't suggest brands) You'd want to keep the medication in its original box, in the dark, in a cool place. Not the fridge - that way lies condensation and moisture. Just in a cool, dark cupboard.
Disclaimers: I'm a pharmacist. A community one, so not someone who has done stability studies or any research. I'm just working with information I have from training and experience.
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(Anonymous) 2016-11-14 09:35 am (UTC)(link)I try to be as open and unchallenging as possible when someone asks for it - I have a private counselling area where I ask them to take a seat if there's anyone in the store at the time. I've never refused a sale, not even to teenagers under the age of consent, which is 16 here, and nor have I challenged any obviously under age women from buying it. (Still anon because that's technically illegal in my country.)
The thing that breaks my heart is the ones that have all the pro-life misinformation - does it affect my fertility, is this basically an abortion - and are so terrified and desperate that they'd be willing to take it anyway. I'm always glad to be able to dispel those myths.
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When there were all these stupid debates about whether to remove the last age restrictions for an already over the counter product, it was pointed out that many over the counter drugs with no restrictions were far less safe than Plan B. Dextromethorphan, aspirin, acetaminophen, alcohol-containing homeopathics, diphenhydramine. None had age restrictions. Thank you again.
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Also thank you to the lovely anon below!