The U.S. Food and Drug Administration (FDA) approved on Friday Ulipristal Acetate, which will be marketed under the brand name as “ella,” as an acceptable emergency contractive for the American market. Watson Pharmaceuticals, a specialty drug company located in California and New Jersey, will introduce the drug by the end of the year.

The FDA’s decision came down despite numerous concerns and warnings related to ella‘s deceptive marketing and its detrimental impact on women and the preborn.

DECEPTIVE MARKETING

Even though it is being marketed as a 5-day emergency contraceptive – potentially preventing ovulation or fertilization, or causing an early abortion by preventing implantation – the chemical makeup of the drug is similar to that of RU-486, a controversial abortion drug approved by the FDA that causes abortions up to 7 weeks into a pregnancy.

On Aug. 2, an admonishing letter, signed by 90 pro-life members of Congress, was sent to FDA Commissioner Margaret Hamburg, for not responding to a June 3 request for more research data, as well as the Reproductive Health Drugs Advisory committee’s failure to address the safety concerns in its June 17 meeting.

“We also have significant concerns about the safety of ella. The FDA summary indicates that the clinical study was too limited to draw any meaningful conclusions about risks associated with ectopic pregnancy. Since ella‘s chemical make-up and mode of action are very similar to RU-486, which causes serious adverse health risks, such as severe bleeding, ruptured ectopic pregnancies, serious infections – and even death – further study is necessary to ensure ella is safe for women, particularly if it is used off-label. Limited to no data is available about ella‘s effect on minors or its interaction with other drugs, such as hormonal birth control.

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“We also believe that ella should not be approved unless there is significant evidence that it does not pose a risk to unborn children after implantation. Without such evidence, it certainly should not be categorized as “emergency contraception.”

SCIENCE AND POLITICS

Pro-life groups decried the agency’s swift departure from scientific review –and toward ideological stances –belying their concern for women’s health.
It also defies President Obama’s 2009 pledge of “ensuring that scientific data is never distorted or concealed to serve a political agenda and that we make scientific decisions based on facts, not ideology.”

Wendy Wright, president of Concerned Women for America, said the timing of the FDA’s announcement was purely political.

“The fact that the FDA waited until late on a Friday night in August to release this (decision) when ….nobody was paying attention,” said Wright, “underscores that this is a political decision.”

Carrie Gordon Earll, senior bioethics analyst for CitizenLink, said there’s a big difference between preventing a pregnancy and causing an abortion of an established pregnancy.

“Women deserve to know the truth about ella, so they can make an informed decision,” said Earll. “In addition to posing conscience-related concerns for pharmacists, since the drug will be marketed as ‘emergency contraception,’ it could force taxpayers to subsidize abortion through Medicaid, Title X and the new health care reform law.

“The deliberate mislabeling of an abortion drug by a federal agency should concern every American.”

FOR MORE INFORMATION
July 28 letter sent from pro-life organizations to the FDA objecting the approval of ella.

Letter to FDA from 90 pro-life members of Congress.

Read The Washington Post article, “FDA approves ella as 5-day-after emergency contraceptive.”

Watson Pharmaceutical’s announcement concerning its distribution of ella.

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