LIFE DIGEST: FDA may be ready to OK over-the-counter sale of ‘morning-after’ pill; pill; Baby allowed to die in clinic?
WASHINGTON (BP)--The Food and Drug Administration has signaled it may be prepared to permit an emergency contraceptive with abortion-causing qualities to be sold over the counter.
The federal regulatory agency announced July 31 it is working with Duramed, a subsidiary of Barr Pharmaceuticals, toward possible approval of Plan B on a non-prescription basis for women 18 years of age and older. Barr previously had asked the FDA to approve over-the-counter sale of Plan B, which also is known as a “morning-after” pill, to females 16 and older.
Plan B, as well as another “morning-after” pill known as Preven, is basically a heavier dose of birth control pills. Under the regimen, a woman takes two pills within 72 hours of sexual intercourse and another dose 12 hours later. The “morning-after” pill can act after conception, thereby causing an abortion, pro-lifers point out. The method can block implantation of a tiny embryo in the uterine wall.
Plan B and Preven are now available only with a prescription.
“If the conversations go smoothly and everyone works expeditiously through this, we think this is something that could be wrapped up in a matter of weeks, not months,” a FDA official told Reuters News Service.
Judie Brown, president of the American Life League, said her organization was “aghast that the [FDA] has caved to mounting political pressures.”
“The FDA, as an arm of the federal government, is supposed to protect its citizens –- not put them at risk for death,” Brown said in a written statement. “The FDA should not have authorized any use of this risky drug regimen in the first place and it certainly should not make it readily available over the counter.”
The FDA postponed last August a decision on Barr’s request to sell Plan B over the counter. In May 2004, the agency rejected Barr’s appeal for over-the-counter sales, citing a lack of evidence about the pill's effect on girls 16 and younger. It gave the company an option of reapplying for over-the-counter sales for females 16 and older and prescription sales for girls 15 and younger. Barr resubmitted its request under those guidelines.
BABY ALLOWED TO DIE? –- Hialeah, Fla., police have closed an abortion clinic while investigating a report a baby was born but allowed to die after a failed abortion.
An 18-year-old woman told police she gave birth to a boy July 20 at the A Gynecologists Diagnostic Center, The Miami Herald reported. “Employees cut the umbilical cord, put the baby in a bag and walked away,” Hialeah Lt. Ralph Gracia said, according to Channel 4, the CBS television affiliate in Miami.
An anonymous phone caller told the police a baby had been born at the clinic, but authorities were unable to find a child when they arrived, Channel 4 reported. A call July 21 prompted the police to return to the clinic, where they found the body of a dead baby in a biohazard bag, according to Channel 4.
The baby weighed two to three pounds and was about 12 inches long, according to the report. The woman who gave birth was about 23 weeks pregnant, The Herald reported.
An autopsy was performed on the dead child July 29, but the results may not be available for several days or weeks, according to The Herald.
“In 24 years in law enforcement, I have never seen a case like this," said lead investigator Tony Rodriguez of the Hialeah Police Department.
PAID EGG DONORS -– A British government agency will permit a research institute to recruit and pay women undergoing fertility treatments to donate eggs for cloning and stem cell experiments.
The Human Fertilisation and Embryology Authority (HFEA) said July 27 it had approved an arrangement with Newcastle Fertility Center at Life in which the institute would underwrite some of the treatment expenses for women in exchange for extracting some of their eggs, Reuters reported.
The HFEA approved human embryo cloning in February. Research cloning would enable scientists to have access to more stem cells for experiments in an attempt to develop therapies for debilitating diseases. Embryos in storage at fertility clinics are now used in stem cell research in Great Britain.
Most pro-life advocates oppose such research because the extraction of stem cells requires the destruction of a human embryo. Foes of egg donation say extracting eggs is painful for the donor and can cause medical complications.
Embryonic stem cell research has yet to treat any diseases in human beings and has been plagued by the development of tumors in lab animals.
Unlike research using embryos, extracting stem cells from non-embryonic sources –-such as umbilical cord blood, placentas, fat and bone marrow –- does not harm the donor and has produced treatments for at least 72 ailments, according to Do No Harm, a coalition promoting ethics in research. These include spinal cord injuries, rheumatoid arthritis, lupus, multiple sclerosis and sickle cell anemia.