Local Pro Choice advocate cautiously optomistic on Federal Govt.'s about face on Plan B by Mitch E. Perry

07/31/06

In a surprise development, the government revived efforts today to widen access to the morning-after pill, but only to women 18 and older, issuing an announcement that it was reconsidering over-the-counter sale of the emergency contraceptive almost a year after it was thought doomed.

The Food and Drug Administration notified manufacturer Barr Pharmaceuticals early today that it wanted to meet within seven days to iron out new steps the company must take in its three-year battle to sell the pill, called Plan B, without a prescription to at least some women.

The announcement came just 24 hours before President Bush's nominee to lead the regulatory agency, Dr. Andrew von Eschenbach, was scheduled to appear before a Senate committee, where he was expected to face grilling on why the morning-after pill had apparently gone into bureaucratic limbo.

The move today is an about face, but the FDA said in reversing itself today that it had reviewed about 47,000 comments from the public, with an overwhelming majority supporting the view that the drug could be sold both as a prescription and nonprescription product.

Barbara Zdravecky is the President and CEO of Planned Parenthood of Southwest and Central Florida . She believes that the timing of today’s announcement has everything to do with von Eschenbach’s appearance before the Senate on Tuesday (roll tape#1 o.q.�health issue�)

But having said that, Planned Parenthood’s Zdravecky says that the news is good- though she wishes it would not come with age restrictions (roll tape#2 o.q.�in a very timely way�)

The morning-after pill is a high dose of regular birth control that, taken within days of unprotected sex, can lower the risk of pregnancy by nearly 90 percent. Contraceptive advocates and doctors groups say easier access to a pill now available by prescription could cut by as many as HALF the nation's 3 million annual unintended pregnancies, and FDA's own scientists say the pills are safe. In December 2003, the agency's independent scientific advisers overwhelmingly backed nonprescription sales for all ages.

But FDA rejected that recommendation, citing concern about young teens' use of the pills without a doctor's guidance. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription and setting up a program for pharmacists to enforce the age rule _ just as they now enforce age restrictions on cigarette sales. But last August, FDA's then-chief postponed a decision indefinitely, saying the agency needed to determine how to enforce those age restrictions _ something that it said would require the formality of writing new regulations.

Kirsten Moore is President of the Reproductive Health Technologies Project. She says the Food and Drug Administration will drag its feet on the morning-after pill due to politics.(roll tape#1 o.q.� (roll tape#3 o.q.�18 and older�)

Critics of the Bush Administration says that they played politics with this issue and many other medical policies – like Stem Cell Research since taking office in 2001. The nomination of the proposed new FDA Chief, Dr. Andrew von Eschenbach, has been in doubt since Democratic Senators Hillary Clinton of New York and Patty Murray of Washing said they would block any vote on Dr. von Eschenbach until the agency makes a decision….A spokesman for Senator Murray says they will continue their opposition until the FDA makes a final decision.

Barbara Zdravecky from Planned Parenthood of Southwest and Central Florida says the political realities have changed for the Bush Admnistration since when they previously maintained their opposition to Plan B (roll tape#4 o.q.�moderate�)

Among the changes that the FDA is still requiring of Barr Pharmacutical’s is that it must agree to sell nonprescription to women 18 and older, not 16 as the company had earlier sought.

Both the nonprescription and prescription versions of the pill would be kept behind the pharmacists' counter. But FDA wants Barr to sell the nonprescription version in completely different packaging to help distinguish the two. And Barr must provide details on how the program will enforce the age restriction. If that's not rigorous enough, Plan B will remain prescription for everyone,

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