The Womenshealth.gov website suggests what to log in a headache diary:
The date, time and duration of your migraine.What you were doing and where you were when the migraine began.Anything you drank or ate within 24 hours of the migraine.If you are a woman, the duration of your menstrual period.The labeling will apply to Bayer's Yaz, its predecessor Yasmin and similar drugs containing the manmade hormone called drospirenone, which mimics the naturally occurring female hormone progesterone. The drugs are among the best-selling contraceptives in the U.S., due to marketing emphasizing their ability to clear up acne and other hormone-related issues.
The FDA said the new labeling will detail recent studies suggesting drospirenone-containing pills carry a slightly higher risk of blood clots than other birth control pills. The risk of blood clots with either group of drugs is still very rare.
The move came a month after the White House tried to calm a furor among Roman Catholic bishops and other social conservatives by announcing it would not require church-run hospitals, universities and charities to foot the bill for birth control coverage but instead shift the burden to insurers.
The administration released preliminary regulatory language for an eventual rule that addressed a number of issues, including a yet-to-be-solved problem of religious institutions that provide their own health insurance.
The action's bearing on birth control and religious freedom places it at the center of incendiary issues that have moved to the forefront of the election campaign for control of the White House and Congress.
The U.S. Conference of Catholic Bishops, which has spearheaded opposition to Obama contraceptives policies, said it would examine the administration's new proposed language to see if it met its demands.
But conference spokeswoman Sister Mary Ann Walsh chided the administration for releasing the document late on a Friday as Catholic leaders prepared to observe St. Patrick's Day on Saturday.
The proposal provoked anger from some religious groups.
"This does nothing," said Michael O'Dea, executive director of the Christus Medicus Foundation, which promotes Christian healthcare. "It's bogus."
The Department of Health and Human Services' notice of rulemaking gave special emphasis to protections for self-insured religious institutions that have been a prime concern for Roman Catholic authorities.
"Our principle is that the religious employer who's self-insured will not be paying for this coverage, full stop," an administration official who spoke on condition of anonymity told reporters in a conference call.
The notice calls for third-party administrators including insurers to handle contraceptive coverage for self-insured groups.
Costs would be covered through a range of options unrelated to the employer, including drug rebates, reinsurance credits and multistate insurance plans.
The public will have 90 days to comment on the notice.
SPLIT OPINION
A policy adopted last month requires that most employers provide free coverage for women's birth control under the 2010 Patient Protection and Affordable Care Act, Obama's signature healthcare overhaul.
Churches and other places of worship are exempt. But the rule now on the books applies to religiously affiliated hospitals, universities, charities and other institutions.
Friday's action won praise from women's health advocates and other Obama allies who saw it as reasonable effort to resolve differences with the Catholic clergy.
"The proposal released today make clears that the Obama administration is fulfilling its promise that women will have access to birth control coverage, with no costly co-pays and no additional hurdles, no matter where they work," Planned Parenthood President Cecile Richards said in a statement.
"In my estimation, this definitely moves things forward toward something the American bishops might be more willing to consider," said Stephen Schneck, a political scientist at The Catholic University of America, who advised Obama on how to reach out to the church.
Friday's announcement followed weeks of behind-the-scenes meetings between administration officials and stakeholders including Catholic bishops and insurance industry representatives.
There was no word on when proposed regulations might become final. The administration's current policy does not come into force for religious employers or educators until August 1, 2013.
(Additional reporting by Anna Yukhananov; Editing by Peter Cooney)
