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Health Care — FDA to review first over-the-counter birth control pill

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July 11, 2022
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Health Care — FDA to review first over-the-counter birth control pill
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We’ll probably reach a global population of 8 billion by the end of this year, at least according to the United Nations. 

In health news, the Food and Drug Administration will review an application for what could be the first over-the-counter birth control pill, amid heightened concerns for contraception access following the overturning of Roev. Wade.  

Welcome to Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. For The Hill, we’re Peter Sullivan, Nathaniel Weixel and Joseph Choi. Someone forward you this newsletter? Subscribe here.

Feds receive application for OTC birth control pill 

The Food and Drug Administration (FDA) on Monday received an application for the first over-the counter birth control pill.   

The move came as the Supreme Court’s ruling overturning Roe v. Wade is heightening attention on contraceptive access.   

The application for a daily birth control pill available without a prescription comes from the drug company HRA Pharma.  

Don’t expect immediate changes: The FDA will likely take months to review the application, but the application itself is an important milestone.    

The company pointed to research showing that 29 percent of women who had tried to get a birth control prescription reported ever having a problem getting one.  

Over-the-counter birth control access has been a long-running push. More than 50 House Democrats wrote to FDA Commissioner Robert Califf on the issue upon in confirmation in March. 

The American Medical Association has also called for over-the-counter birth control access.   

“Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” David Aizuss, an AMA board member, said in a statement last month.  

Read more here. 

Biden: Abortions must be provided in emergencies

The Biden administration on Monday said doctors and hospitals need to follow federal law and provide abortions if there is a medical emergency and the health or life of the patient is at risk, regardless of state law. 

The Department of Health and Human Services (HHS) reaffirmed that the Emergency Medical Treatment and Labor Act (EMTALA)  protects providers when offering legally mandated, life- or health-saving abortion services in emergency situations.  

Administration officials said the federal government can penalize doctors or hospitals that fail to provide care in those circumstances.  

Under the law, if an emergency medical condition is found to exist, the hospital must provide available stabilizing treatment or an appropriate transfer to another hospital that has the capabilities to provide stabilizing treatment.  

Old law: EMTALA has been on the books for over 30 years.  

HHS officials on a call with reporters said the administration is not making any new policy or changes to the existing law. The point of the guidance is to remind providers that the EMTALA law exists, and preempts any state restrictions. 

Read more here.  

ADVOCATES SUBMIT SIGNATURES FOR ABORTION BALLOT MEASURE   

Abortion rights advocates in Michigan are one step closer to securing a ballot measure that would let voters decide whether abortion remains legal. 

A coalition of advocacy groups, including the American Civil Liberties Union (ACLU) of Michigan and Planned Parenthood Advocates of Michigan, said it secured nearly 754,000 signatures to put an abortion rights constitutional amendment on the ballot in November. 

Michigan requires a little more than 425,000 voter signatures for an issue to qualify for the ballot. 

What it would do: The groups said the reproductive freedom ballot measure is the first of its kind nationwide and a blueprint for other states to preserve or restore reproductive freedom post-Roe.  

The amendment would define the right to make and carry out decisions about all matters relating to pregnancy, including birth control, abortion, prenatal care and childbirth, in the Michigan Constitution. 

Read more here. 

END OF ROE MAKES BAD SITUATION WORSE FOR INCARCERATED WOMEN

The Supreme Court’s ruling overturning Roe v. Wade is raising concerns for women of color who are behind bars — a population that could be disproportionately affected by abortion bans in states across the country.   

Women of color are statistically more likely to seek an abortion and to be incarcerated, highlighting why advocates worry they could be hurt by the decision. 

“The criminalization of abortion is going to further drive mass incarceration,” said Chelsea Moore, policy director for the non-profit Dream Corps Justice. “And anytime we see any form of new criminalization, it inevitably disproportionately impacts Black and indigenous people of color.”  

Women in jail already faced severe hurdles to access health care services, including obtaining menstrual products and abortion services.   

Roe’s overturning significantly complicates an already difficult situation, raising questions of how women will be treated in federal facilities, state prisons and county jails that lie under different state laws. 

Read more here. 

After Roe, anti-abortion groups set sights on state level

Anti-abortion groups are focusing their efforts on state legislatures in the wake of the Supreme Court’s decision overturning Roe v. Wade.   

March for Life, a group that organizes a yearly national march in Washington, D.C., against abortion, will start to focus its activism more on the state level, Jeanne Mancini, president of the group, told The Hill.   

In the next year, the group wants to double the number of state marches they have and “over the course of the next five to six years aggressively and quickly grow our state marches program to be in all 50 states,” Mancini said.   

Mallory Carroll, vice president of communications at Susan B. Anthony Pro-Life America, told The Hill the organization plans to focus their efforts in states where they believe they could see progress with anti-abortion legislation.   

“We’ve prioritized plans in states that we believed and are indeed are being most ambitious right away to protect unborn human life and thereby limiting abortion so women are needing more services,” she said. “The status quo is unlikely to change for women in states like California, Illinois, New York and Maryland.” 

The overturning of Roe v. Wade was a huge victory for the anti-abortion movement. The 1973 landmark decision previously hindered activists’ ability to see progress on advocacy for anti-abortion laws at the state level.   

Read more here.  

WHAT WE’RE READING

Moderna is developing two different omicron-targeting booster shots (Wall Street Journal) 
U.S. orders 3.2 million doses of Novavax COVID vaccine (Reuters) 
Hospitals’ challenge: money, staff, training for next crisis (Bloomberg Law) 

STATE BY STATE

Medi-Cal’s reliance on prisoners to make cheaper eyeglasses proves shortsighted (Kaiser Health News) 
Post-Roe, many autoimmune patients lose access to ‘gold standard’ drug (LA Times) 
Pennsylvania is looking at a $250 million investment in long-term care (City & State Pennsylvania) 

OP-EDS IN THE HILL

Don’t forget about our youngest children: Most remain unvaccinated 

That’s it for today, thanks for reading. Check out The Hill’s Health Care page for the latest news and coverage. See you tomorrow.

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