Prescription Drugs

Over-the-Counter Birth Control Bill Launched by Senate Republicans

It would fast-track FDA review of applications to free the pill from prescriptions and let people use health savings accounts for non-Rx drugs.

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BSIP/Newscom

A new proposal in the U.S. Senate would help federal regulators fast-track the approval process for converting hormonal contraceptive pills from prescription to over-the-counter drug status. Known as the "Allowing Greater Access to Safe and Effective Contraception Act," it was introduced this week by Republican Sens. Joni Ernst (R–Iowa) and Cory Gardner (R–Colo.).

Only the Food and Drug Administration (FDA) can approve the conversion, upon request from a petitioning drug maker. That's why recent movements to "free the pill" in states such as California and Oregon have only been able to dismantle the requirement for a doctor to write the prescription. Now women in these states can theoretically get a prescription on the spot from pharmacists, but it's still not the over-the-counter sales situation that public health bodies recommend.

Congress can't change the status of birth control pills on its own. But the Ernst-Gardner bill would at least speed up the approval process by directing the secretary of Health and Human Services to "give priority review to any supplemental application" submitted "for a contraceptive drug" with respect to routine use. It would also waive the application fee for anyone submitting the application.

French pharmaceutical company HRA Pharma and research group Ibis Reproductive Health announced in late 2016 they were teaming up to "conduct the research needed" to apply for over-the-counter approval of an oral contraceptive pill. "A typical FDA process from the time a drug company begins an application process until a pill is available over the counter is approximately three to five years," Britt Wahlin, vice president for development and public affairs at Ibis, told me last December.

But with priority review possible, that time could be cut down.

The Ernst-Gardner bill also calls for a "repeal of tax on over-the-counter medications." It would accomplish this by allowing funds from health savings accounts to be used for the purchase of not just prescription drugs but over-the-counter medications, too.

Lastly, it would repeal limitations on contributions to flexible spending accounts.

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  1. > Congress can’t change the status of birth control pills on its own.

    Sure they can! All they need is to get a President to sign it!

    There’s nothing in the US Constitution about prescriptions. Seriously. Go read it. It’s not there.

    1. Actually there is. It’s right there.
      “The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.”

      note: not being snarky AT you, just with you.

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    2. Agreed.

      All legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives.

    3. I have no idea where ENB is coming from with that statement.

        1. Is that where they are building the new light rail?

          1. No, that was the first draft of a Monkees song: Take the right train to Wrongsville..”

    4. I thought exactly the same thing when I read that line. Congress delegated approval authority to the FDA by statute. Congress can revoke, amend or override that approval authority by similar statute anytime they want.

      That said, it’s probably a lot easier to accomplish and more likely to get passed if the Congresscritters pass the buck to the FDA. Much as they talk about it, none of them actually wants accountability.

      1. Just to add.

        Accountability.

        Congress is composed of politicians. None of them are at the level of medical science to have that level of expertise. Some have background. None of them have the ability to design a rocket to the Mars or an iPhone for that matter. These are highly technical. They do have a job.

        That is to provide oversight and have the ability to conduct hearings, have regular reports, hire experts to help them, and change law as needed.

        We all know where accountability runs in any big organization. It runs downhill.

    5. Of course they can. Just amend the FFDCA to make all BCP nonprescription. Congress has made plenty of carveouts in the FFDCA to treat certain products differently from the others.

    6. ENB: Congress can’t change the status of birth control pills on its own.
      “Only the Food and Drug Administration (FDA) can approve the conversion”

      She’s probably correct.

      We’re ruled by the Deep State. Congress has probably previously put the power to schedule drugs in the hands of the FDA.

      They probably could take the power back with legislation, but that’s like where the power currently lies by statue.

      1. Congress could get rid of the FDA tomorrow by passing a law, so of course they can take away the power to schedule drugs from them.

    7. I agree. Congress could get rid of the FDA altogether tomorrow, so of course they can change the status of birth control pills on its own.

  2. but. but.. republicans HATE women and are secretly trying to bring about a Handmaid’s Tale world!

    1. Obviously the average woman is too stupid to decide whether and when to take birth control. The FDA has been protecting them all these years and now the GOP is executing a cynical ploy to harm these women by letting them make decisions for themselves. It’s really quite shameful. Hopefully the House will protect women by blocking this attempt to burden them with additional liberty.

      1. That’s OBL worthy parody right there.

      2. That’s OBL worthy parody right there.

    2. The hilarious – and plausible – explanation I’ve heard for Democrats always opposing “make the pill OTC and make every woman who uses it have an easier life” is twofold, related:

      1) “Women won’t go get pap smears if they aren’t forced to go to a Dr!”
      2) “It’ll hurt Planned Parenthood because that’s where people go to get The Pill”.

      A river, they can cry me it.

      1. So paternalism and cronyism?

        That sounds about right for Democrats.

      2. No, what they’ll oppose is that making them OTC means that insurance will no longer pay for them.

  3. Gardner tried this a couple years ago, but liberals who had supported the measure before had kittens that a Republican was proposing it, and it never went anywhere.

    1. Much like Bush’s push for immigration reform. While a minority of Republicans in Congress opposes Bush’s plans for immigration reform, in the end it was largely the fault of Democrats who refused to allow a Republican to get a “win”, at the cost of allowing another decade of our fucked up immigration crisis to go on, punishing millions of poor immigrants just to stick it to Bush.

      1. If the Republicans favor motherhood and apple pie, the Democrats will oppose!

        If the Democrats favor motherhood and apple pie, the Republicans will oppose!

        1. Never give your enemy the appearance of a victory.

        2. The latter tine of that fork being purely hypothetical in the real world, of course.

  4. Honestly, this is a good policy. I’ve never understood why Republicans, who claim to want to reduce the number of abortions in this country, have been so slow to offer alternatives, like promoting contraception based solutions to the unwanted / unexpected pregnancy problem. Probably latent religious / traditional angst over sex outside of marriage. That ship sailed long ago; glad they’re finally coming around.

    It’s a market-based solution, it gives individuals a greater number of options to choose among, and it will almost certainly lower the monetary cost and physical cost associated with avoiding having a baby. I only hope that the Democrats don’t block it out of spite.

    1. ” I’ve never understood why Republicans, who claim to want to reduce the number of abortions in this country,”

      Republican *politicians* has no desire to end abortion rights. It’s their most favored war drum. In fact, making birth control difficult so that more women resort to abortion plays right into that game plan.

      1. Sadly, there’s a lot to that.

      2. Which is … why they keep proposing and voting for bills to make birth control easier…?

      3. This assumes a lot of evil intent that I don’t see in the evidence. I think Republicans are dumb and/or stuck in old ways and influenced by outdated religious beliefs.. I think that’s more likely than an evil plot to force people into abortions so they can say “look at all the evil abortions!”

        I highly doubt all the high-profile legislation intended to limit access to abortions were just false republican flags meant to fail so they could fake being anti-abortion just to get elected. Fails Occam’s razor test imo.

      4. This goes both ways, Democrats have no interest in seeing abortion rights secured either, they need that war drum too. Just look at all the handwringing over the Kavanaugh nomination, but then come January when they controlled the House they were quick to introduce a constitutional amendment to eliminate the electoral college, but not one to protect abortion rights (or marriage equality)

    2. “I’ve never understood why Republicans, who claim to want to reduce the number of abortions in this country, have been so slow to offer alternatives, like promoting contraception based solutions to the unwanted / unexpected pregnancy problem. ”

      It’s not complicated.

      Most prolifers consider a fertilized egg a baby, which makes the pill just another way to kill a baby.

      1. I think you are confusing emergency contraception that blocks implantation with hormonal birth control, which prevents ovulation.

        In fact, even most emergency contraception still just prevents ovulation, not implantation, and for those that do its a secondary effect (with the primary being to block ovulation)

  5. Can we also have a push to simplify the process of buying pseudophedrine? Meth continues to exist, and my ability to help my allergies is limited. Just help me out here.

    1. Also don’t forget lung flutes!

      To find precise details on what NOT to do, to avoid the flute police, please see http://www.churchofsqrls.com/DONT_DO_THIS/ ? This has been a pubic service, courtesy of the Church of SQRLS!

    2. Just end all regulations on all substances. If only…

      1. Medical mafia gotta get their cut.

        If the bill is squashed, it will be by obgyns and Planned Parenthood.

    3. And albuterol inhalers. You can’t even make meth with it but you still have to go to a dr. and pay an outrageous amount to get a script for it even though it has been used safely for years.

      1. Inhalers are even worse, because they outlawed cfc propellants. So now they are “new formulations” that have patent protection. So where generic versions were under twenty bucks before the ban, now…. Ouch. No generic, super expensive.

        Same goes for the epi-pen automatic syringe.

      2. Albuterol problem is due to a change in propellant. (See Cyto’s post)

      3. Is that ever the truth. I’ve devloped a dust allergy, and the occasional puff off an inhaler helps avoid a lot of misery and greatly accelerates my recovery from the inflamed lung tissue. Thanks to Obama I no longer have an internist or insurance. A friend of mine gave me an old inhaler she doesn’t need anymore, so I wouldn’t have to go begging to the gatekeepers of this stuff.

        Goddamn Obama, and goddamn the democrats.

    4. Can we also have a push to simplify the process of buying pseudophedrine?

      Costco. Less than $2.00 for 20 or 25 pills. The real thing, not that ersatz formulation.

      Anyone — subscriber or not — can purchase from a Costco pharmacy in most or all states. Similar rules apply to vision care and alcohol beverages. I have heard that the snack bars do not discriminate, but that seems unrelated to regulatory requirements.

      Ending the drug war will help, too.

      1. I think he’s referring to regulations that require you to show ID, sign a book, and limit how much you can purchase (sucks if you have a whole family down with the flu)


        Required a retrievable record of all purchases, identifying the name and address of each party, to be kept for two years
        Required verification of proof of identity of all purchasers
        Required protection and disclosure methods in the collection of personal information
        Required reports to the Attorney General of any suspicious payments or disappearances of the regulated products
        Required training of employees with regard to the requirements of the CMEA. Retailers must self-certify as to training and compliance.
        The non-liquid dose form of regulated products may only be sold in unit dose blister packs
        Regulated products must be stored behind the counter or in a locked cabinet in such a way as to restrict public access
        Sales limits (per customer):
        Daily sales limit?must not exceed 3.6 grams of pseudoephedrine base without regard to the number of transactions
        30-day (not monthly) sales limit?must not exceed 7.5 grams of pseudoephedrine base if sold by mail order or “mobile retail vendor”
        30-day purchase limit?must not exceed 9 grams of pseudoephedrine base. (A misdemeanor possession offense under 21 U.S.C. ? 844a for the person who buys it.)

        https://en.wikipedia.org/wiki/ Combat_Methamphetamine_Epidemic_Act_of_2005

        1. Absolutely. It is just stupid. The Cascade of awful that is prohibition means that you can only get super cheap medicine when the pharmacist is in. So your 2 am run for a decogestant that works just got longer and more complicated.

  6. While there at it, can they lift rollover caps on FSAs for health care? Honestly, that would be the first step towards helping average Americans have a predictable way of managing costs. Just put a set amount in to the FSA every pay check and if you use it, great, if you don’t, you have it for next year when you get that unexpected ER visit.

    1. I never quite understood why we needed both FSAs AND HSAs, when the HSAs appear to be superior in every way. (But you’re only allowed to have one if you have a high deductible plan.)

      It does kind of tick my off that I can’t use my HSA to pay for OTC products my doctor specifically recommends I take.

      Didn’t used to be that way, they changed HSAs for the worse as part of Obamacare.

      1. That’s cause the point of Obamacare was to fuck over as many people as possible and trash the entire system.

      2. You can only get an HSA with a high deductible insurance plan. FSA can be with any insurance plan, but doesn’t roll over.

  7. I don’t trust Republicans at all, especially not on issues related to reproductive health care access. There must be something sinister at work here.

    1. Never trust anyone in a MAGA hat!

      1. There is a rider in the bill where every chick that buys birth control will receive a free MAGA hat.


  8. Congress can’t change the status of birth control pills on its own.

    Wrong, try again.

  9. “Congress can’t change the status of birth control pills on its own. But the Ernst-Gardner bill would at least speed up the approval process by directing the secretary of Health and Human Services to “give priority review to any supplemental application” submitted “for a contraceptive drug” with respect to routine use. It would also waive the application fee for anyone submitting the application.”

    Wait, is ENB saying that only the states can legalize birth control? Or that only federal regulators can do it?

    It sounds like she’s saying the latter.

    That is so wrong that the word “wrong” is simply inadequate to convey the wrongness of the statement.

    1. We’re pretty sure that ENB is actually just an AI at this point.

  10. Great.
    Now the government knows when certain women are having sex.
    What next?
    Government recording devices in people’s bedrooms?

    1. Are we supposed to leave our phones outside the bedroom?

    2. Actually by making birth control OTC it would make them less able to track who is using it

  11. Good policy. People that are both pro-life and anti-access to birth control make no sense to me. I understand people that they don’t want their tax dollars getting spent on poor people’s birth control – okay, but people who want to make birth control harder to access just for the sake of not liking the idea of people having sex for other than reproductive purposes – fuck off.

    1. Who is keeping birth control prescription only? Last I checked it was the Dems. By coincidence, Planned Parenthood prescribes birth control.

      1. I know several people that whole anti-abortion and anti-access to birth control positions simultaneously. Why is it that when people hop on the internet, they suddenly lose the ability to comprehend what they read – or they suddenly insert things into what they read that aren’t there? I never even mentioned Democrats, Republicans or any politician what-so-ever. I said “people”.

        Quote: “People that are both pro-life and anti-access to birth control make no sense to me.”

        1. It only makes sense in the context of a deeply fundamentalist interpretation of original sin, along the lines of Augustine of Hippo, where sexual desire is in itself sinful. Since sex is required for procreation they have to make an exception for that, but sex for any other reason is carnal sin. Since both abortion and birth control (and other forms of contraception) eliminate procreation they are seen as promoting and facilitating sin, so they are opposed

          1. I suppose it could also make sense from a hypothetical, “Discouraging birth is contrary to public policy because we’re not producing enough babies to keep our population from imploding without massive immigration” perspective.

            1. in a pragmatic world, government policy would aim to lower the birth rate among the impoverished and raise it among those with means.

              last i saw, the birthrate at the bottom of the income scale was 50% higher than it is at the top. reversing that would solve some problems.

      2. Who is keeping birth control prescription only? Last I checked it was the Dems.

        That is false. Democratic governors, for example, have arranged over-the-counter birth control. Many, if not most, Republicans oppose over-the-counter birth control. A few Republicans — purple staters, mostly, trying to defuse the ‘war on women’ issue in their campaigns — have supported some over-the-counter proposals, but in most cases Democrats not only support over-the-counter birth control but indeed support less restrictive proposals. Plenty of Republicans are still in the ‘put a pill between your knees’ phase of thinking on this issue.

        1. Your rationalization is cute.

          1. Your ignorance and backwardness is your downfall, and the part of the reason guys like me shape American progress against your wishes and efforts.

            Carry on, clinger. Whine all you want, but you will obey.

            1. “Whine all you want, but you will obey.”

              Witness a man yearning to be a toe on the foot in the boot stamping a human face forever.

              “Libertarian” Moment.

              You can never read 1984 Part 3, Chapter 3 enough. O’Brien explains the Modern Left. And the Rev.
              http://www.george-orwell.org/1984/19.html

              The Party seeks power entirely for its own sake. We are not interested in the good of others; we are interested solely in power. Not wealth or luxury or long life or happiness: only power, pure power. What pure power means you will understand presently. We are different from all the oligarchies of the past, in that we know what we are doing. All the others, even those who resembled ourselves, were cowards and hypocrites. The German Nazis and the Russian Communists came very close to us in their methods, but they never had the courage to recognize their own motives. They pretended, perhaps they even believed, that they had seized power unwillingly and for a limited time, and that just round the corner there lay a paradise where human beings would be free and equal. We are not like that. We know that no one ever seizes power with the intention of relinquishing it.
              Power is not a means, it is an end. One does not establish a dictatorship in order to safeguard a revolution; one makes the revolution in order to establish the dictatorship. The object of persecution is persecution. The object of torture is torture. The object of power is power. Now do you begin to understand me?’


              1. But always — do not forget this, Winston — always there will be the intoxication of power, constantly increasing and constantly growing subtler. Always, at every moment, there will be the thrill of victory, the sensation of trampling on an enemy who is helpless. If you want a picture of the future, imagine a boot stamping on a human face — forever.

            2. and the part of the reason guys like me shape American progress against your wishes and efforts.

              The only thing guys like you shape are butt-shaped craters in the over-sized chairs you spend your lives sitting in in your mom’s basement.

            3. Arty, instead of obeying, I figured I would just beat you into submission and have you call me ‘master’.

        2. It says in the article that the FDA needs to approve the pill for over the counter sale. So what are you talking about.

  12. ENB, did you seriously believe the FDA had powers superior to the Congress that created it? Or that the drug licensing approvals drug cos. had could somehow bind pharmacies?

  13. Once the pill goes OTC, it will no longer be convered by insurance and manufacturers can charge whatever the uninformed market will bear. Where is the upside of this?

    1. “Once the pill goes OTC, it will no longer be convered by insurance a”

      That was one of the reasons why the Left didn’t want birth control pills OTC. Then they couldn’t force prolifers to provide it.

      Bake the fucking cake! Buy the fucking pills!

      It’s all just about domination. The thrill of forcing your enemies to bend to your will.

      1. I think that’s exactly it: Make birth control OTC, and you’ve no longer got an excuse for demanding that the Sisters of Mercy pay for it.

    2. Well, OTC drugs are still covered by some insurance if accompanied by a prescription. I take generic Flonase, and get it provided by the pharmacy as a prescription despite having the same product on the OTC shelf.

      The pill is already generic. It won’t get more expensive, just like Allegra and Zyrtec didn’t get more expensive when they became OTC/generic.

  14. Once the pill goes OTC, it will no longer be convered by insurance and manufacturers can charge whatever the uninformed market will bear. Where is the upside of this?

    1. The same could be said for Advil.

      Actually there is no one “pill”. There are multiple formulations of OCPs with significant differences between them. I suspect what will happen is that a few manufacturers will apply for a formulation as an over the counter while others will remain prescription.

      The FDA has said already that they will look at any application but it must be specific with studies showing it is safe as an over the counter drug. All this does is help speed up the process.

      Also OCs have become less popular with many women going to IUDs and other forms of contraception.

      1. Hormonal contraceptives are still popular to regularize periods, though. Something no IUD is any good for.

        1. “Something no IUD is any good for.”

          This is false, as they make IUD’s that are not only superior to OC’s in terms of pregnancy prevention efficacy (taking out the need for remembering to take the pill…most humans mess this up) but also have a hormonal component that improves period regulation and severity as much if not better than OCs

      2. “what will happen is that a few manufacturers will apply for a formulation as an over the counter while others will remain prescription.”

        You are correct. That is exactly what will happen. Mainly because, absent any significant legislative changes to the Food Drug and Cosmetics act, that is what must happen.

        From the FDA perspective what makes a product suitable for OTC classification is that it can be safely used by the average lay person by following the package directions. So it is that package information that matters most. In order to sell a currently approved Rx drug as an OTC any manufacturer will have to re-dress it in new packaging that included directions for use intended for the consumer (while Rx package inserts now include end user information that information is not written to current FDA ‘OTC standards.’)

        So yeah, they would be creating parallel product lines, and if the OTC products did not represent a savings (which could be both time and money) then they would not be successful in the market.

        1. My big concern is that some users would achieve (or enhance) their ‘savings’ by doing things like skipping their annual PAP smear.

          But, that is a risk that liberty says we are free to assume, and wrong to restrict.

    2. You can’t be serious. I refuse to believe it.

    3. theres no such thing as the uninformed market when prices are clearly posted. You should worry more when you have no idea how much things cost and purchase them anyway, like in our current healthcare system.

      1. Indeed. And with the Internet, it’s not hard to eat a price check on much of anything.

    4. Just look at what hospitals charge you for OTC drugs like Tylenol and Advil when they know your insurance will cover it, vs what you pay out of pocket for it at the store. Making birth control OTC will make the price go down, because the consumer is less able to bear high prices than insurance companies

      1. Yes and you know why the hospital ED does that. They are maxing out charges against losses.

        They will still collect pennies on the dollar. Yet if they drop the charge they will get even less.

        The move to make some OC pills over the counter should happen. Might take few years but great idea.

        Trump screwed up with his tweets about obamacare but this is one way to cut costs which can get political support.

  15. There are a lot of drugs that should be over the counter. This is a good place to start though.

    1. A libertarian magazine would say that all drugs should be over the counter. We should not have to get permission to medicate ourselves from the State.

      But Reason only thinks you should be free to get stoned and avoid/end unwanted pregnancies.

      “Libertarian Moment”

  16. There are few more important legal changes than getting doctors out of the drug dispensation process. It is abused and obscene.

    Ending the ” Drug War” of course, is an even higher priority. Stopping rampant crime and corruption in the entire legal process.

    But I’ll not hold my breath!

    1. Holding your breath is not recommended.

      Unless you are under water. Then swimming would be followed by breathing.

      Drug does not mean the same thing to a medical. Not talking about getting high here.

      Oxygen is a miracle drug. So is lidocaine, epinephrine, and vancomycin.

      Just a few simple examples.

    2. “There are few more important legal changes than getting doctors out of the drug dispensation process. ”

      Isn’t it curious that a “Libertarian” magazine never manages to get around to advocating for health care freedom of consumers, and thereby an end to government enabled rent seeking of the corporate medical mafia?

      It’s almost as if they’re really only about corporate profits, and not freedom at all.

      1. What freedom have you been denied?

        Do not show up. Go to the acupuncture naturopath.

        Stay home.

        What you are asking for is more government regulation.

        1. Wrong.

        2. “What freedom have you been denied?”

          1. The freedom to sell a drug product to a knowing and willing consumer absent massive Federal legal and regulatory burden.

          2. The freedom to be that consumer purchasing such a product.

          Right now in the US anything you attempt to sell by making any claims to treat any specific illness requires FDA approval – either as an OTC or Rx product.

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  19. Why in the world wouldn’t Congress be able to make a class of products OTC, unilaterally? How have they possibly given away this much power to a regulatory agency of their own creation?!

    1. They didn’t. It’s a mistake by the author, who actually believed what politicians told her. There is no legal reason that Congress can’t get rid of the FDA tomorrow, much less take away a product from their control.

  20. It will be curious to see if those same republicans seek to block men from purchasing them. (while the dosage is lower, transgendered m2f people will seek to purchase them for DiY hormone replacement)

    1. I doubt any republican lawmaker will give a shit.

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