Health

After Lobbying Push, Drugmaker Resubmits Women’s Sex Pill

Published

11 years ago

February 17, 2015

In this Friday, Sept. 27, 2013, file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company’s Raleigh, N.C., headquarters. The pill has been twice rejected, but Sprout Pharmaceuticals said Tuesday, Feb. 17, 2015, it is refiling its application for flibanserin, adding new information requested by the Food and Drug Administration about how the pill affects driving ability. (AP Photo/Allen G. Breed, File)

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — The makers of a twice-rejected pill designed to boost sexual desire in women are hoping a yearlong lobbying push by politicians, women’s groups and consumer advocates will move their much-debated drug onto the market.

The ongoing saga of Sprout Pharmaceutical’s female libido drug illustrates the complicated politics and unresolved science surrounding women’s sexuality.

For decades, drugmakers have tried unsuccessfully to develop a female equivalent to Viagra, the blockbuster drug that treats men’s erectile dysfunction drug by increasing blood flow. But disorders of women’s sexual desire have proven resistant to drugs that act on blood flow, hormones and other simple biological functions.

Supporters of Sprout’s drug say women’s sexual disorders have been overlooked for too long by regulators at the Food and Drug Administration. But critics argue that women’s sexuality is too complex to be addressed by a single pill.

Sprout’s drug flibanserin is the first attempt to increase libido by acting on brain chemicals linked to appetite and mood. But the Food and Drug Administration has already twice rejected the drug because of lackluster effectiveness and side effects including fatigue, dizziness and nausea.

In an effort to break the regulatory logjam, groups sponsored by Sprout and other drugmakers have begun publicizing the lack of a “female Viagra” as a women’s rights issue.

“Women deserve equal treatment when it comes to sex,” states an online petition to the FDA organized by one such group, Even the Score, which garnered almost 25,000 supporters. The group’s corporate backers include Sprout Pharmaceuticals, Palatin Technologies and Trimel Pharmaceuticals — all companies developing drugs to treat female sexual disorders. A spokeswoman for Blue Engine Media, the public relations group for Even the Score, declined to disclose how much of the group’s funding comes from companies. The group’s nonprofit supporters include the Women’s Health Foundation, the Institute for Sexual Medicine and other organizations.

Drugmakers frequently cite a 1999 survey in the Journal of the American Medical Association that found 43 percent of U.S. women had some type of sexual dysfunction.

Sprout said Tuesday it is refiling its application for flibanserin, adding new information requested by the FDA about how the pill affects driving ability. FDA scientists requested that data after their most recent rejection of the drug, in part, due to results showing nearly 10 percent of women in company trials reported sleepiness as a side effect.

The FDA first rejected flibanserin in 2010 after a panel of expert advisers unanimously voted against the drug, saying its benefits did not outweigh its risks. The drug’s initial developer, Boehringer Ingelheim, abandoned work on the drug in 2011 and sold it to Sprout, a startup headed by a husband-and-wife team from Raleigh, North Carolina.

Sprout resubmitted the drug with additional effectiveness and safety data, but the FDA again rejected the drug in October 2013. After Sprout filed a formal dispute over the decision, FDA regulators requested the driving study and other details on the drug’s interactions with other medications.

As Sprout gathered that data, the company also enlisted support from influential allies in Washington and beyond. Last January four members of Congress, including Rep. Debbie Wasserman Schultz, D-Florida, sent a letter to the FDA, urging a careful reassessment of the drug and lamenting the lack of drug options for low female libido.

“There are 24 approved medical treatments for male sexual dysfunction and not one single treatment yet approved for the most common form of female sexual dysfunction,” states the letter, which was also signed by Rep. Louise Slaughter, D-New York, and two other Democratic congresswomen.

The talking point about the imbalance of drugs for men versus women was picked up by a coalition of seven women’s and consumer health groups who met with the FDA early last year.

“We see this not only as an important unmet women’s health issue, but an inflection point for the agency to ensure that similar standards are applied for drug approvals in conditions uniquely affecting women,” states a follow-up letter to the agency from leaders of the National Organization for Women, the National Consumers League and four other groups.

Then last October the FDA held a two-day meeting at its headquarters to get public input on the problem of female sexual dysfunction and the challenge of developing treatments.

If approved, flibanserin would be labeled for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress. Because so many factors affect female sexual appetite, there are a number of other possible causes doctors must rule out before diagnosing the condition, including relationship problems, hormone disorders, depression and mood issues caused by other drugs like sleeping aids and pain medications.

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Rep. Kamlager-Dove Introduces Bill to Protect Women in Custody After Reports Detailing Miscarriages and Neglect

The Pregnant Women in Custody Act would expand safeguards beyond the federal prison system to include women detained by U.S. Immigration and Customs Enforcement, U.S. Customs and Border Protection and the Office of Refugee Resettlement. The proposal follows reports of pregnant women being shackled, denied medical care and suffering miscarriages while in immigration detention.

Published

1 week ago

May 17, 2026

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By Bo Tefu, California Black Media

Congresswoman Sydney Kamlager-Dove (D-CA-37) on May 7, reintroduced updated legislation aimed at strengthening protections and healthcare standards for pregnant and postpartum women held in federal custody, including in immigration detention facilities.

The Pregnant Women in Custody Act would expand safeguards beyond the federal prison system to include women detained by U.S. Immigration and Customs Enforcement, U.S. Customs and Border Protection and the Office of Refugee Resettlement. The proposal follows reports of pregnant women being shackled, denied medical care and suffering miscarriages while in immigration detention.

The legislation builds on a bipartisan version previously passed by the House during the 117th Congress. The updated bill includes new standards for healthcare access, mental health and substance use treatment, high-risk pregnancy care, family unity protections and increased federal oversight.

“Proper pregnancy care is a human right, regardless of your immigration or incarceration status,” Kamlager-Dove said in a statement. “It’s unacceptable that there are virtually no legal safeguards for pregnant women in federal custody.”

The bill would also limit the use of restraints and restrictive housing for pregnant women, improve data collection on maternal health in custody and require additional staff training and enforcement measures.

Supporters of the measure said the legislation is intended to address long-standing concerns about maternal healthcare and safety in detention settings, particularly for Black women and low-income women who are disproportionately impacted by incarceration and health disparities.

“Pregnant women in custody should never be subjected to dangerous and inhumane treatment that threatens their health, dignity, or the well-being of their babies,” said Patrice Willoughby, chief of policy and legislative affairs for the NAACP and a longtime public policy and government affairs strategist, in a statement.

A 2021 report estimated there are about 58,000 admissions of pregnant women into U.S. jails and prisons each year. Kamlager’s statement also cited a recent investigation by NBC News and Bloomberg Law that identified allegations of severe mistreatment or medical neglect involving at least 54 pregnant women or families in county jails between 2017 and 2024.

Federal policy under the Department of Homeland Security restricts the detention of pregnant, postpartum and nursing immigrants except in extreme cases. However, the agency reported that ICE deported 363 pregnant, postpartum or nursing women between January 2025 and February 2026, including 16 recorded miscarriages during that period.

The bill is cosponsored by several House Democrats and backed by organizations including the NAACP and the Vera Institute of Justice.

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How Is AI Affecting California? The State Wants You to Share Your Story

The program marks the first time the state has opened the platform to all Californians. State officials said the effort is designed to give residents a direct role in discussions about how AI should be regulated and used as the technology rapidly expands across industries.

Published

1 week ago

May 17, 2026

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By Bo Tefu, California Black Media

Gov. Gavin Newsom announced May 7 that California is expanding its Engaged California digital democracy initiative statewide, inviting residents to help shape future state policies on artificial intelligence (AI) and its impact on jobs and the economy.

“We’ve got to be clear-eyed about this moment: AI is moving fast, bringing enormous opportunity, but also real risks,” Newsom said in a statement. “Californians deserve a seat at the table as we shape what’s to come.”

The initiative will roll out in two phases. Beginning immediately, Californians can sign up online to share how AI is affecting their work and communities and provide ideas for possible government action. Later this summer, a smaller group reflecting the state’s workforce demographics will participate in live discussions focused on developing policy recommendations.

State officials said the goal is to identify areas of agreement among Californians and provide policymakers with public feedback as the state develops future AI regulations and workforce strategies.

Engaged California is modeled after digital democracy programs used in Taiwan and is intended to encourage structured public discussion rather than social media-style debate. Officials described the effort as a form of “deliberative democracy” aimed at helping residents engage directly in state decision-making.

“The more Californians are engaged in the democratic process, the better able we’ll be to confront the challenges we face together,” said Nick Maduros, California Secretary of Government Operations, in a statement.

The statewide launch builds on two earlier pilot programs. One pilot gathered public input following the Los Angeles firestorms to help guide recovery efforts, while another collected ideas from state employees about improving government operations.

California has positioned itself as a national leader in AI policy and development. Since 2023, the Newsom administration has introduced initiatives focused on responsible AI use in government, cybersecurity protections, workforce training and regulations targeting risks such as deepfakes and AI-generated robocalls.

The state has also partnered with companies in Silicon Valley — including NVIDIA, Google, Adobe, IBM and Microsoft — to expand AI education and workforce training programs across California schools and universities.

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California Launches Free Diaper Program for Newborns Statewide

The initiative, called Golden State Start, will provide 400 free diapers to every newborn delivered at participating California hospitals beginning this summer. The state is partnering with Baby2Baby, a California-based nonprofit that distributes essential items to children in need nationwide.

Published

1 week ago

May 17, 2026

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By Bo Tefu, California Black Media

Gov. Gavin Newsom announced Friday that California will launch a first-in-the-nation program providing free diapers to families with newborns, part of a broader effort to lower costs for parents and improve infant health outcomes.

The initiative, called Golden State Start, will provide 400 free diapers to every newborn delivered at participating California hospitals beginning this summer. The state is partnering with Baby2Baby, a California-based nonprofit that distributes essential items to children in need nationwide.

State officials said hospitals participating in the program will give families the diapers when they are discharged after birth, helping parents leave with an immediate supply of newborn essentials.

“Every baby born in California deserves a healthy start in life,” Newsom said in a statement. He said the program is part of California’s broader affordability efforts, which also include free school meals, universal preschool for four-year-olds and expanded after-school programs.

The announcement comes ahead of Mother’s Day and is tied to the administration’s broader CalRx initiative, which aims to reduce costs for essential products and medications. State officials said California is also exploring ways to lower diaper prices by challenging high costs from major brands.

The first year of the program will prioritize hospitals serving large numbers of Medi-Cal patients, with plans to expand to additional hospitals and birthing centers over time. Officials said the effort is intended to reduce financial pressure on low-income families and improve infant and maternal health by ensuring parents have access to clean diapers.

“California families deserve to feel supported during one of life’s more exciting, yet vulnerable transitions,” First Partner Jennifer Siebel Newsom said in a statement. She said the program would allow parents to focus on caring for their newborns instead of worrying about basic supplies.

According to Baby2Baby, one in two families in the United States struggles to afford diapers. The organization has distributed more than half a billion items to children over the past 15 years through partnerships with shelters, hospitals, foster care programs and schools.

State officials said Baby2Baby will oversee diaper purchasing, warehousing and distribution through its existing hospital and community partnerships across California.