Friday, August 25, 2006

FDA Decision on Plan B Irritates, Disappoints Pro-Lifers

Hat tip to Marti

By Jody Brown and Mary Rettig
AgapePress
August 25, 2006

(AgapePress) -- The FDA has taken what pro-life groups consider an ill-advised step by approving Plan B -- also referred to as the "morning-after" pill -- for over-the-counter access for women 18 and older. At least one of those groups contends the federal agency has overstepped its authority in the decision, and that the non-prescription availability of the emergency contraception will have a "detrimental effect" on women and parents.

Plan B, manufactured by Barr Pharmaceuticals, contains the same ingredient used in prescription birth-control pills, only in higher dosage. Today's decision by the U.S. Food and Drug Administration makes the drug available without prescription to women over the age of 18; it remains available as a prescription-only product for women 17 and younger. Those opposed to the change have pointed out that the FDA has no authority to enforce the age restriction, and that Barr has no intention to do so. Perhaps in response to that criticism, Barr has stated it will implement a "rigorous labeling, packaging, education, distribution, and monitoring program" for Plan B.

Tuesday, August 22, 2006

President Bush Approves Over the Counter Early Abortion Pill, Pro-Life Base Decries Move

By John-Henry Westen

WASHINGTON, August 21, 2006 (LifeSiteNews.com) - For his pro-life supporter base, President George W. Bush stepped into one of the biggest political landmines of his Presidential career today with his approval of over the counter status for the abortion-causing morning after pill Plan B.

A press release by Human Life International underscored the seriousness of the move as it was titled, "President Bush Files for Divorce with Catholic Base." Rev. Thomas J. Euteneuer, president of Human Life International commented, "President Bush's implied support for the abortion-causing drug Plan B is completely inconsistent with his recent veto of the embryonic stem cell research (ESCR) funding bill. What the president apparently fails to realize is that Plan B kills the same innocent unborn children that the ESCR process does."

At a White House press conference this morning, the President was asked by Bill Sammon a reporter from the Washington Examiner about Plan B and his new FDA commissioner who supports its over the counter status. "Mr. President, some pro-life groups are worried that your choice of FDA Commissioner will approve over the counter sales of Plan B, a pill that, they say, essentially can cause early-term abortions," said the reporter. "Do you stand by this choice, and how do you feel about Plan B in general?"

The President replied, "I believe that Plan B ought to be -- ought to require a prescription for minors, is what I believe. And I support Andy's decision."

Andy, as the President referred to him, is the new Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach. Pro-life groups last week called for von Eschenbach's resignation over his deal with a drug company to make a high-dose of a drug (Plan B, a morning-after pill) available without a prescription to women 18 year of age and older.

Concerned Women for America (CWA) blasted the decision noting that it is ludicrous to allow Plan B without medical supervision when a low-dose of the same drug (birth control pills) requires medical oversight to protect women from serious health complications.

"It is deplorable that the head of the FDA would put his career ambitions and a drug company's interests above women's health," said Wendy Wright, CWA's President. "CWA provided legal and regulatory evidence that the FDA does not have the authority to do what it is proposing and medical evidence that any dose of the drug requires medical oversight to protect women's health. The drug is known to cause serious complications such as blood clots and stroke."

Rev. Euteneuer added, "The president must demonstrate a consistent respect for the sanctity of all human life or he risks provoking a great divorce with the conservative Catholics that compromise a large part of his support base. Human beings in the embryonic stage of development deserve equal protection under the law and the president's position falls far short of that mark."

To express concerns:
Vice President Richard Cheney: vice_president@whitehouse.gov

See the full text of the press conference online here:
Press Conference

Monday, August 21, 2006

Isle Teens Could Lose Access to ‘Morning After’ Pill

HT to Marti

By Helen Altonn
haltonn@starbulletin.com

Hawaii teens under age 18 would not be able to get "morning after" contraception pills without prescriptions if a proposed federal policy goes into effect and supersedes state law, said Nancy Partika, executive director of the Healthy Mothers, Healthy Babies Coalition.

She said the Food and Drug Administration's guidelines might be less restrictive but would apply only to women 18 and older, while Hawaii's emergency contraception law covers teens age 14 and up.

"We already have better access in Hawaii than the FDA is proposing," Partika said. "Our goal is for all women of childbearing age to have optimal access to EC (emergency contraception)."

She said the FDA is proposing "behind the counter" access that would limit which pharmacies could distribute the pills, along with "some fairly heavy-handed monitoring and enforcement mechanisms," she said.

"So we would potentially roll backwards if ... the FDA moved forward with it."

Her coalition worked with the Pharmacists Association and other organizations to get the 2003 state law allowing nonprescription access to emergency contraception, and it is working well, she said.

Emergency contraception pills are birth control pills in stronger doses. They do not interfere with an established pregnancy, but are intended to prevent an unplanned pregnancy. They must be used within 72 to 120 hours after unprotected sex or a failed contraception method.

In Hawaii, pharmacists who undergo special training and have collaborative agreements with physicians are able to dispense emergency contraception without prescription to women and teens age 14 and up. An intake process includes answering a questionnaire and consultation with the pharmacist.

Partika said 169 isle pharmacists are offering emergency contraception. Hawaii's law is a model for other states, she said. Eight others now have such access: Washington, California, New Mexico, Alaska, Maine, New Hampshire, Massachusetts and Vermont.

Barr Pharmaceuticals Inc., which makes the emergency contraception pill sold as Plan B, has sought permission for over-the-counter sales for three years, changing the age restriction several times to address FDA concerns.

The company said it would raise the age to 18 for nonprescription sales of Plan B, but it could not be accountable for pharmacies that did not follow the restrictions.

The emergency contraception issue has been embroiled in religious and political controversy nationally.

Democratic Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York have said they will block acting FDA Commissioner Andrew von Eschenbach's confirmation as permanent FDA head until the agency announces whether it will approve or reject Plan B nonprescription sales.

Planned Parenthood supports continued nonprescription access to emergency contraception for all females age 14 and up, said Veronica Ryan, director of patient services.

She said the FDA proposal would improve access for women age 18 and older, "but high-risk teens would have to jump through more hoops, even though they're more at risk."

Cost is one of the barriers to access for teens, who might not have cash or insurance, Ryan said.

Pharmacists surveyed in June were charging an average of $50.86 for both the medication and counseling, according to Healthy Mothers, Healthy Babies. The average counseling fee is $25, but 31 percent of pharmacists surveyed are not charging for it. The average medication cost is $34, the coalition said.

Planned Parenthood, one of 38 federally funded family planning clinics, offers the emergency contraception pills over the counter for a fee based on a sliding scale, Ryan said. Most teens get them for free, she added.

Hawaii's program has been "pretty positive," said Cindy Minakami, clinical pharmacist for Longs Drug in Hawaii.

She said more than 35 Longs pharmacists had received training and had issued more than 1,000 emergency contraception pills since they began participating in 2004. Training is continuing for other Longs pharmacists, she said.

They have had clients as young as 14, she said. "Even though doctors have the same guidelines that we do, they (teens) feel they can trust pharmacists more."

The teens and women are all referred to doctors for follow-up, Minakami said. Many are receptive because they have no obstetrician or doctor, she said. If they are referred to a doctor and they do not go, she said, "We call them. We have information on the screening questionnaire."

Access to emergency contraception appears to be improving, but the survey shows significant barriers still exist statewide, reports Healthy Mothers, Healthy Babies. More education is needed, especially targeting teens and women ages 14 to 35, it said.