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house Bill H.R. 5138

Speeding Up FDA Reviews for Over-the-Counter Contraceptives

Argument in favor

The FDA should prioritize these applications so that more safe, affordable contraception can be available to consumers over-the-counter without the need for a prescription.

Rrrockelle's Opinion
···
10/14/2016
I'm assuming that those not in favor of regular OTC contraception also condemn the use of the Plan B pill? That's OTC also, and I haven't heard tales of tragic abuse and unintended consequences yet. We're adult women; kindly let us live.
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anmaberry's Opinion
···
10/13/2016
It is proven that when birth control is accessible to women and the choice to procreate is our own, birth rates go down and the standard of living rises. For this reason, I believe the process should be sped up, along with the fact that these prescriptions are already known to be safe and effective and do not need clinical trials to prove, unlike cancer treatments and such. Birth control should be easily accessible without a prescription. I've had the experience of not realizing a year down the road that I needed to have my prescription re-subscribed and then had to go a month without birth control. That is not a comforting feeling, when I usually have control over regulating my period. And yes, the portion of ACA should be repealed to allow health accounts to cover necessary over the counter prescriptions, such as this.
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Kelli's Opinion
···
11/09/2016
Stop avoiding women's rights. We deserve easier access to birth control.
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Argument opposed

The FDA shouldn’t prioritize applications for contraceptives that would be available over-the-counter over more critical medications that have fewer alternatives.

Matthew's Opinion
···
10/14/2016
Making contraceptives more widely available is a moral imperative that absolutely needs to happen. However, increasing access to contraceptives, whether they be for birth-control or for other health issues, could better be achieved by addressing a few other rate-limiting steps rather than modifying the FDA approval process (which is increasingly poorly equipped to deal with recent advances in healthcare). I believe this bill is ill-equipped to significantly improve contraceptive approval for the projected cost. There are numerous other bills that could be passed or repealed at both the state and federal level to increase access to contraceptives.
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Loraki's Opinion
···
10/14/2016
Why are we pushing drugs, instead of ABSTINENCE?! It's the ONLY birth control that's guaranteed 100% effective AND best of all, it's earned God's "seal of approval"! I know firsthand about "raging hormones" and that people often don't THINK when the "urge" strikes them. But we are making it TOO EASY TO BE PROMISCUOUS, and then, to make matters worse, the taxpayers often have to foot the bill for ABORTIONS, something which most (?) Christians find abhorrent! Moreover, by pushing birth control pills, guys are less likely to use a condom. INCREASED INCIDENTS OF STDs doesn't appeal to me! I know schools have taken over the parents' job of teaching sex education. More's the pity! What kind of society allows their government to take God out of the schools and substitute things they have no business teaching, things that only serve to lower the moral standards of this nation. And don't give me that "separation of church and state" nonsense! The Constitution has been misinterpreted on that score. All you have to do is read the early (unrevised) history of the United States to know that the founding fathers NEVER intended for religion to be taken out of schools OR government! They did, however, want to prevent any particular church to impose their doctrines on other churches that might object. I recognize that this bill is right up Big Pharma's alley. On the other hand, Planned Parenthood might have mixed feelings about it. As for government, perhaps this is one of their preferred methods of population control. Let the people distract themselves with sex, TV, video games, drugs, and sports, and by all means, make it easier to prevent the birth of more "useless eaters"! Remember, Hillary Clinton is not the ONLY one who wants an "unaware and compliant citizenry"!
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John's Opinion
···
10/13/2016
Over the counter hormonal therapy should not be taken lightly. These are powerful chemicals with potentially severe side effects if not used properly. Not the least of these can be an increased risk of some cancers. Who will be held responsible for misuse, and the adverse events? Liability lawyers are probably already lining up.
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bill Progress


  • Not enacted
    The President has not signed this bill
  • The senate has not voted
  • The house has not voted
      house Committees
      Committee on Energy and Commerce
      Health
      Committee on Ways and Means
      Health
    IntroducedApril 29th, 2016

What is House Bill H.R. 5138?

This bill would require the Food and Drug Administration (FDA) to prioritize review of over-the-counter contraceptives that would be available to individuals age 18 or older without a prescription. It would apply to supplemental drug applications, which are used to change the approved use of a drug.

The FDA would also waive user fees for related supplemental drug applications, and any drug that’s eligible for priority review must be available as a prescription drug for individuals under age 18.

Provisions in the Affordable Care Act (ACA) would be repealed so that health savings accounts and health flexible spending accounts can be used to pay for medicine without a prescription. Additionally, the limit on salary reduction contributions under a cafeteria plan would be eliminated. Both reforms would be effective as if the provisions had never been enacted in the first place.

Impact

Individuals over age 18 who would like to buy a contraceptive over-the-counter and under age 18 who would get them as prescription drugs; and the FDA.

Cost of House Bill H.R. 5138

A CBO cost estimate is unavailable.

More Information

In-Depth: Sponsoring Rep. Mia Love (R-UT) introduced this bill to “incentivize contraceptive manufacturers to apply to make their routine use contraceptives over-the-counter for women 18 and older by waiving the filing fee they would normally pay.” She says that “we have a “plan B” over-the-counter, but we don’t have a plan A” and her bill would expand access to contraceptives so that plan B emergency contraception isn’t required as often.

This legislation has the support of six cosponsors in the House, all of whom are Republicans.


Media:

Summary by Eric Revell
(Photo Credit: Ceridwen / Creative Commons)

AKA

Over-The-Counter Contraceptives Act of 2016

Official Title

To allow women greater access to safe and effective contraception.

    I'm assuming that those not in favor of regular OTC contraception also condemn the use of the Plan B pill? That's OTC also, and I haven't heard tales of tragic abuse and unintended consequences yet. We're adult women; kindly let us live.
    Like (23)
    Follow
    Share
    Making contraceptives more widely available is a moral imperative that absolutely needs to happen. However, increasing access to contraceptives, whether they be for birth-control or for other health issues, could better be achieved by addressing a few other rate-limiting steps rather than modifying the FDA approval process (which is increasingly poorly equipped to deal with recent advances in healthcare). I believe this bill is ill-equipped to significantly improve contraceptive approval for the projected cost. There are numerous other bills that could be passed or repealed at both the state and federal level to increase access to contraceptives.
    Like (12)
    Follow
    Share
    Why are we pushing drugs, instead of ABSTINENCE?! It's the ONLY birth control that's guaranteed 100% effective AND best of all, it's earned God's "seal of approval"! I know firsthand about "raging hormones" and that people often don't THINK when the "urge" strikes them. But we are making it TOO EASY TO BE PROMISCUOUS, and then, to make matters worse, the taxpayers often have to foot the bill for ABORTIONS, something which most (?) Christians find abhorrent! Moreover, by pushing birth control pills, guys are less likely to use a condom. INCREASED INCIDENTS OF STDs doesn't appeal to me! I know schools have taken over the parents' job of teaching sex education. More's the pity! What kind of society allows their government to take God out of the schools and substitute things they have no business teaching, things that only serve to lower the moral standards of this nation. And don't give me that "separation of church and state" nonsense! The Constitution has been misinterpreted on that score. All you have to do is read the early (unrevised) history of the United States to know that the founding fathers NEVER intended for religion to be taken out of schools OR government! They did, however, want to prevent any particular church to impose their doctrines on other churches that might object. I recognize that this bill is right up Big Pharma's alley. On the other hand, Planned Parenthood might have mixed feelings about it. As for government, perhaps this is one of their preferred methods of population control. Let the people distract themselves with sex, TV, video games, drugs, and sports, and by all means, make it easier to prevent the birth of more "useless eaters"! Remember, Hillary Clinton is not the ONLY one who wants an "unaware and compliant citizenry"!
    Like (10)
    Follow
    Share
    Over the counter hormonal therapy should not be taken lightly. These are powerful chemicals with potentially severe side effects if not used properly. Not the least of these can be an increased risk of some cancers. Who will be held responsible for misuse, and the adverse events? Liability lawyers are probably already lining up.
    Like (9)
    Follow
    Share
    It is proven that when birth control is accessible to women and the choice to procreate is our own, birth rates go down and the standard of living rises. For this reason, I believe the process should be sped up, along with the fact that these prescriptions are already known to be safe and effective and do not need clinical trials to prove, unlike cancer treatments and such. Birth control should be easily accessible without a prescription. I've had the experience of not realizing a year down the road that I needed to have my prescription re-subscribed and then had to go a month without birth control. That is not a comforting feeling, when I usually have control over regulating my period. And yes, the portion of ACA should be repealed to allow health accounts to cover necessary over the counter prescriptions, such as this.
    Like (5)
    Follow
    Share
    Speeding OTC contraceptives, but FDA procedures already have been adjusted to err on the side of caution. We do not need to repeat thalidomide or certain septic shock contraceptives -- prescription or otherwise. We are dealing with human health. If the Congresswoman wants to go quicker, she should advocate for significant increases in the FDA budget.
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    Not that I don't think bureaucrats should work faster, but the FDA is in cahoots with big Pharmaceutical to keep prices high, and keeping competition too regulated to compete.
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    The FDA constantly battles with nutritional supplements that destroy organs when used outside the control of a provider, why would we allow folks hormone therapy from convenience store with zero oversight? Will the drug company be absolved from any side effects or other allegations of harm? If the purpose is to fast track the dissemination of contraceptives, fast track the healthcare system that provides it. I'm for getting it out there to those who need it sooner, but this bill reduces Patient Safety (a national healthcare goal) in the process and is not worth the risk. Other means are available.
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    Hormonal contraceptives have been proven safe. There is no reason to restrict their sale other than misguided desire to control women. We are adults and know how to use birth control. We can take care of our own bodies, thankyouverymuch. Time to trust women and get out of our way.
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    Hormonal therapy available to anyone over the counter. What could possibly go wrong?
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    Stop avoiding women's rights. We deserve easier access to birth control.
    Like (3)
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    No, no, no - just a dumb idea no matter how well meaning. These drugs are very powerful and potentially very harmful. We need to have doctors prescribe them and monitor the women who take them. Just a profoundly bad idea although I do understand why someone might want that - still it's total wishful thinking that will undoubtedly actually "kill" many women.
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    The government shouldn't keep out of the birth control business and stop using our tax dollars. But out.
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    Abstinence is the best drug and should be pushed before drugs!!
    Like (2)
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    From what I've heard on this so far. It would be up to the pharmacy to help pick out the best OTC birth control for the person, which is more stress for a pharmacist, but I think it would cut down on unwanted pregnancy. I think if a minor has a consenting parent with them, it should be ok for them to get OTC BC as well.
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    Legislatively prioritizing contraceptives for review over other drugs is absurd. With untold numbers of contraceptives currently available, both prescription and over the counter, pushing drugs aside which are most likely for treating illness, is reckless and irresponsible. Let new contraceptives be tested in the proper order, if not pushed to the end of the line behind new drugs which might actually address something previously untreatable, something which doesn't already have hundreds if not thousands of drugs and devices already available.
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    No to OTC BCs. And women seeking this avenue of reproductive control should obtain and read a "drug package insert" before using. The Warning list goes on forever and that's in fine print.
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    We have way more important drugs to approve. We don't need more contraceptives or the morning after pills, we need more antibiotics, more advanced in just about every kind of medicine, not more plan B pills.
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    I think that all drug approval is important. Speeding up sometimes means overlooking or missing the details that would be detrimental to the people who rely on the drugs to be safe and effective. It is important that the process is not sacrificed for speed. We need to take whatever time needed to make sure it meets our high standards.
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    The title is a little misleading as they're prioritizing the review of contraceptives. Which I think they should do as women should be able to determine when they want to have children.
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