FDA Reaches Deal With Morning After Pill Maker for Over the Counter Sales

National   |   Steven Ertelt   |   Aug 9, 2006   |   9:00AM   |   WASHINGTON, DC

FDA Reaches Deal With Morning After Pill Maker for Over the Counter Sales Email this article
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by Steven Ertelt
LifeNews.com Editor
August 9, 2006

Washington, DC (LifeNews.com) — The Food and Drug Administration has reached a deal with the maker of the morning after pill to sell it over the counter to women over the age of 18. The deal calls for Barr Pharmaceuticals to resubmit its application to the FDA within two weeks to be able to sell the Plan B drug directly to women without a doctor’s visit.

Once Barr reapplies to sell the drugs directly, FDA representative Susan Bro indicated the agency would quickly approve it.

The new application would keep the morning after pill as a prescription-only drug for teenage girls.

Barr chairman Bruce Downey told the New York Times that the morning after pills would also be sold in licensed clinics in addition to pharmacies, meaning that agencies such as Planned Parenthood abortion businesses could likely sell the pills.

Downey indicated that acting FDA commissioner Andrew Von Eschenbach assured him in a telephone call that the FDA was committed to solving the stalemate that has had the agency hold up the approve process for three years.

Though Downey indicated Barr wanted to sell the morning after pill to teenagers as well, he told the Times, "I don’t have the ability to get all that I want.”

The DA may require Barr to package the morning after pill differently for over the counter sales than prescription ones. Downey said he worried some pharmacies wouldn’t stock the prescription version since most demand would be for the non-prescription version and demand for the morning after pill is low in many areas already.

The FDA’s initial announcement at the end of last month came just one day before Eschenbach was to appear before a Senate committee for a hearing on whether to confirm his nomination.

Pro-abortion lawmakers, led by New York Sen. Hillary Clinton and Washington Sen. Patty Murray, put a hold on his nomination until the FDA moved forward on Barr’s request for over the counter status for the morning after pill.

The two released a statement then saying they still plan to prevent von Eschenbach’s nomination until the agency makes a final decision.

Some pro-life groups oppose the morning after pill because it may work as an abortion agent in some situations if taken between conception and implantation — in which case it would kill the unborn child at her earliest stage of life. Others are concerned that it will lead to more and riskier sex among teenagers who mistakenly think it prevents STDs.

“We find it absolutely unacceptable that the FDA is going to turnover the health of American women to pharmacists and clerks in drugstores,” Dr. Janice Shaw Crouse, of Concerned Women for America, said

Crouse worries that men who sexually violate teenagers could use the drug to cover up their actions.

She also said that the morning after pill doesn’t reduce the number of abortions and pointed to its use in Scotland, where it was made available over the counter in 1999. Officials recently announced that abortions there are at their highest points on record.

Deirdre McQuade, pro-life spokeswoman for the U.S. Conference of Catholic Bishops, also expressed dismay with the FDA.

She pointed out a study showing that the morning after pill does not reduce pregnancy rates.

“As surprising as it may seem to proponents of Plan B, a 2005 study co-authored by a Planned Parenthood doctor in the Journal of the American Medical Association showed that having Plan B on hand did nothing to reduce pregnancy rates compared to those who obtained the drug from a pharmacy,” McQuade noted.

“It would also place additional pressure on pharmacists who conscientiously object to dispensing drugs that can kill humans at their earliest stages of development,” McQuade added.

Barr initially filed an application to sell the drug over the counter to all women and came back with a revised proposal to sell it only to girls over the age of 16 after the FDA said it did not submit enough research showing its effect on teenagers.

An FDA committee advised approving the request in December 2003 but, in August 2005, the agency indefinitely postponed any decision on the drug while it investigated enforcement issues.

The FDA also said Monday it had reviewed 47,000 public comments on the morning after pill and that the majority of them supported the drug.