NJ Spotlight News
FDA panel green-lights OTC birth control pill
Clip: 5/10/2023 | 4m 28sVideo has Closed Captions
The agency isn’t expected to vote on Opill until end of this summer
"I think this is a huge game changer!" Dr. Maria Sophocles cheered a unanimous vote by a Food and Drug Administration advisory panel to make Opill the first birth control pill available in the United States without a prescription. If the FDA agrees, it’d let shoppers pick the medication off a store shelf, without having to consult health care providers.
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NJ Spotlight News is a local public television program presented by THIRTEEN PBS
NJ Spotlight News
FDA panel green-lights OTC birth control pill
Clip: 5/10/2023 | 4m 28sVideo has Closed Captions
"I think this is a huge game changer!" Dr. Maria Sophocles cheered a unanimous vote by a Food and Drug Administration advisory panel to make Opill the first birth control pill available in the United States without a prescription. If the FDA agrees, it’d let shoppers pick the medication off a store shelf, without having to consult health care providers.
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Learn Moreabout PBS online sponsorshipwell the first non-prescription birth control pill could soon be available in the U.S advisors to the Food and Drug Administration today unanimously recommended approval of over-the-counter medication known as Opel saying the benefits outweigh the risks if the FDA gives final approval it'll greatly expand access to contraception in a post-row world has access to legal abortion is no longer a right Nationwide here in New Jersey lawmakers have made it easier for people to access reproductive health care experts say an over-the-counter birth control pill would remove a key barrier senior correspondent Brenda Flanagan reports I think this is a huge game changer Dr Maria Sophocles chaired a unanimous vote by an FDA advisory panel to make opil the first birth control pill available in the U.S without a prescription if the FDA agrees it had let Shoppers pick the medication off a store shelf without having to consult Health Care Providers Dr Sophocles says it would strike down so many barriers I've seen firsthand how hard it is for some women to get to my office and then of course there's the copay and the waiting and this will eliminate all of that I think this represents a landmark in our history of women's health unwanted pregnancies can really derail a woman's life advisors to the FDA emphasize they believed Opel is safe and effective but several expressed reservations about user studies conducted by its maker HRA Pharma which showed 15 percent of women may miss three or more doses at least once a month old pill a progestin only drug should be taken daily within the same three-hour window but it works well advisors said the health risk of pregnancy which is the condition that these products seem to prevent is much greater than the use of any contraceptive product and this is among the safest of the contraceptives again take opportunity to increase access reduce disparities and most importantly increase the reproductive autonomy of the women of our nation I vote yes there was so much testimony from doctors pharmacists young people that all said that there's such a big need that we need this out there the panel discussed the label instructions and decided folks would understand them especially the youngest people of reproductive age even with the limitations was very reassuring that this safe and effective medication can be used by all ages in particular adolescents and those in limited literacy I see no reason to single them out to not have it available even for the youngest adolescent in the wake of the Supreme Court's decision to overturn Roe an over-the-counter pill would open a path for those who have found reproductive restrictions tightening across the U.S HRA Pharma said making birth control over the counter could prevent 37 000 pregnancies a year because of the decisions that are that came out of the court and the decisions that are coming out of state legislatures we need to make sure that women have access to birth control Governor Murphy in January signed a bill that would make all birth control medications and devices not just the old pill available without a prescription but patients would need to see a pharmacist and go through a very simple hopefully uh streamlined patient assessment that checks all the boxes that you would you would do so at a prescriber's office making sure that you know medication is appropriate for the specific individual state agencies are currently approving regulations the FDA meanwhile also complained about HRA pharma's data the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the non-prescription setting but I wanted to again emphasize that FDA does realize how very important women's health is the agency isn't expected to vote on opil until perhaps the end of this summer I'm Brenda Flanagan NJ Spotlight news [Music]
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