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First over-the-counter birth control pill gets FDA approval
Law Firm News |
2023/07/13 10:25
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U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.
The Food and Drug Administration said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales.
Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.
Medical societies and women’s health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.
Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding child care.
“This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”
Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they typically aren’t covered by insurance.
Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government, which women’s advocates are urging the Biden administration to implement.
Many common medications have made the switch to non-prescription status in recent decades, including drugs for pain, heartburn and allergies. Birth control pills are available without a prescription across much of South America, Asia and Africa. |
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Judge allows North Carolina’s revised 12-week abortion law to take effect
Law Firm News |
2023/07/03 14:11
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A federal judge ruled on Friday that nearly all of North Carolina’s revised 12-week abortion law scheduled to begin this weekend can take effect, while temporarily blocking one rule that doctors feared could expose them to criminal penalties.
The decision by U.S. District Judge Catherine Eagles sets aside that rule but allows the law’s remaining provisions to begin on Saturday while litigation continues.
Abortion providers had last week requested a blanket order halting all of the July 1 restrictions pending their court challenge. Planned Parenthood South Atlantic and a physician said several sections in the newly revised law were so vague and seemingly contradictory that doctors could unintentionally break the law, leaving them unable to care for women seeking legal abortions.
But the Republican-controlled General Assembly passed legislation this week revising or repealing nearly all of the challenged provisions, making arguments against most of them moot. Among other things, the lawmakers clarified that medication abortions will be legal in nearly all cases through 12 weeks, and that a lawful abortion remains an exception to North Carolina’s fetal homicide statute.
Eagles, who was nominated by former President Barack Obama, had said in court that it would be overly broad to block enforcement of the entire law. Instead, she directed that for at least the next two weeks, the state cannot enforce a rule saying doctors must document the existence of a pregnancy within the uterus before conducting a medication abortion.
The abortion providers’ lawyers argued that the language raised questions about whether abortion pills can be dispensed when it’s too early in a pregnancy to locate an embryo using an ultrasound — subjecting a provider to potentially violating the law. |
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Supreme Court asked to preserve abortion pill access rules
Law Firm News |
2023/04/14 17:54
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The Biden administration and a drug manufacturer asked the Supreme Court on Friday to preserve access to an abortion drug free from restrictions imposed by lower court rulings, while a legal fight continues.
The Justice Department and Danco Laboratories both warned of “regulatory chaos” and harm to women if the high court doesn’t block an appeals court ruling in a case from Texas that had the effect of tightening Food and Drug Administration rules under which the drug, mifepristone, can be prescribed and dispensed.
The new limits would take effect Saturday unless the court acts before then.
“This application concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” Solicitor General Elizabeth Prelogar, the Biden administration’s top Supreme Court lawyer, wrote Friday, less than two days after the appellate ruling.
A lawyer for the anti-abortion doctors and medical organizations suing over mifepristone said the justices should reject the drugmaker’s and the administration’s pleas and allow the appeals court-ordered changes to take effect.
The fight over mifepristone lands at the Supreme Court less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.
The justices are being asked for a temporary order to keep in place Food and Drug Administration regulations governing mifepristone. Such an order would give them time to more fully consider each side’s arguments without the pressure of a deadline.
The Biden administration and Danco, which is based in New York, also want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues. As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year.
The court rarely acts so quickly to grant full review of cases before at least one appeals court has thoroughly examined the legal issues involved.
A ruling from the 5th U.S. Circuit Court of Appeals late Wednesday would prevent the pill, used in the most common abortion method, from being mailed or prescribed without an in-person visit to a doctor. It also would withdraw the Food and Drug Administration’s approval of mifepristone for use beyond the seventh week of pregnancy. The FDA says it’s safe through 10 weeks. |
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Wisconsin Supreme Court control, abortion access at stake
Law Firm News |
2023/04/04 21:00
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outcome an election Tuesday that has seen record campaign spending.
The winner of the high-stakes contest between Republican-backed Dan Kelly and Democratic-supported Janet Protasiewicz will determine majority control of the court headed into the 2024 presidential election. The court came within one vote of overturning President Joe Biden’s narrow win in 2020, and both sides expect another close race in 2024.
It’s the latest election where abortion rights has been the central issue since the Supreme Court overturned Roe v. Wade last June. It’s also an example of how officially nonpartisan court races have grown into political battles as major legal fights play out at the state level.
All of it has fueled spending that will double, and likely triple or more, the previous high of $15.4 million spent on a state court race in Illinois in 2004. Democrats have spent heavily for Protasiewicz and Republicans for Kelly.
Democrats are trying to flip control of the court, which has had a majority of conservative justices the past 15 years. That has allowed the court to uphold an array of Republican priorities, including banning absentee ballot drop boxes last year and affirming the 2011 law all-but ending collective bargaining for most public workers.
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