rthstewart: (Default)
rthstewart ([personal profile] rthstewart) wrote2016-11-12 09:08 pm

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
FDA
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?
Drugs (implants, BC pills, Sponge, etc.) and medical devices (IUDs, cervical cap, condoms)
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
                   *Loss of coverage or I won't be able to afford what I use now because I'll lose my coverage (Yes, worry and act now)
                   *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.
There’ve been lots of posts about how women worried about losing healthcare coverage should contact their providers about getting a Long Acting Reversible Contraceptives (LARC) like an IUD or an implant. Yes, absolutely, do this if it’s right for you. If you’re on ACA or you work for an employer that might decide it doesn’t want to cover your pills, and you’re worried about affordability, yeah, get in and do this right now. Get as much as you can before your copays or deductibles go up or if you think your coverage might disappear.
  • 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
First, these products are all regulated by the FDA and once they are approved, it’s really, really hard to get them off the market if the manufacturer wants to keep selling them.

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?
Theoretically, yes, but not likely, again for several reasons. First, drug and device manufacturers make money selling their products and they’ve been in the reproductive space a long time. Moreover, they are represented by a very, very powerful and wealthy lobby that pay millions to congressmen and senators to make life easier for them. An easier time for them means a well-funded FDA to get their products approved quickly and to keep the agency off their backs once they are on the market. They don't pay Congressmen to ban their FDA-approved products that they make money on.

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.
And, a word about FDA. It is a science-based public health agency. And while some people come and go, and yes, some Commissioners and HHS Secretaries (HHS oversees FDA) are wretched, and priorities change, the essential mission of FDA and the people in it don’t. As one woman I know at the agency said this week, “I’ve been there 28 years and I’m not going anywhere.” The current head of the Center for Drugs, Dr. Woodcock, has been there since the 90s -- products like the Pill, the implant, and Plan B all were improved or developed and approved while she's been there. FDA is pharmacists, doctors, and scientists.

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?
Lots of things, of course. In the area of reproductive health, no new products, decreased innovation, no easier access for already approved contraceptives, like making BC pills available without a prescription. While companies will zealously defend their right to make money by selling you as much of their products as they can, I would not expect any to embark upon new contraceptive research for the US market. However, due to the climate, the US has lagged behind the rest of the world for decades, so this will be more of the same. (The medical abortion pill manufacturer has an unlisted phone number and a PO Box).

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
I’m worried about pharmacies who will invoke conscience clauses to stop carrying contraceptives. This won’t be a problem if you are in a city or suburb and have a car and access to a chain pharmacy or big retailer like Walmart or Costco (if you can afford a Costco membership, their prescription drug programs and pricing are terrific). But if your local, independent or rural pharmacy only carries Plan B or contraceptives now because your state law requires it, I think we’ll see more pharmacies refusing in the future and they'll get support they didn't have before. So, get educated about what’s up in your state. This is a start, though dated.

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.
psyche29: A brown eye with rainbow eyeliner all around it (Default)

[personal profile] psyche29 2016-11-14 04:56 am (UTC)(link)
Lots of good info here. I hadn't even gotten to this level of worry yet, so all these answers here help to alleviate even my mostly-vague fears, in that it's generally not an issue for me regardless. Thank you, Rth. 💖