FDA Again Delays Decision
On 'Morning After' Pill
Regulators Express Concern
About Teenagers' Access to Plan B
By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
August 26, 2005 6:56 p.m.
WASHINGTON -- The Food and Drug Administration again delayed a decision Friday on whether to allow a "morning after" contraceptive pill to be sold without a prescription, saying it still hadn't figured out how to keep younger women from improperly obtaining the product.
Barr Pharmaceuticals Inc. is seeking FDA permission to sell its morning-after pill, called Plan B, to women ages 16 and older on an over-the-counter basis.
FDA Commissioner Lester M. Crawford said the agency needs to decide whether the same drug can exist as both a prescription and over-the-counter product and wanted to open up that discussion to the public for the next 60 days.
During a rare press conference at the FDA's headquarters in Rockville, Md., Mr. Crawford said FDA staff has concluded that the drug could safely be sold to women 17 and older without a prescription. Barr's application asked for permission to sell to women ages 16 and older.
Mr. Crawford said, however, the FDA won't make a decision until after it deals with the broader regulatory issue of whether the same drug can be sold both over the counter and as a prescription. He wouldn't set a timeline for making a final decision on Barr's application. It also is unclear if Barr will need to submit another application to suggest the drug be sold to those ages 17 and older, rather than its current proposal of age 16.
Mr. Crawford said the FDA has never allowed the same drug to be sold both over the counter and by prescription with the same indication. He said the agency was uncertain how to keep the pill away from younger women and needed to set up some type of enforcement mechanism with pharmacies.
"We cannot have this slippage between age groups," he said.
Barr Disappointed
Barr Pharmaceuticals said it was disappointed in the FDA's decision not to approve the application to sell Plan B on an over-the-counter basis to women ages 16 and older. The company had proposed having pharmacists "card" women and require them to show a photo ID such as a driver's license.
"In our submission to the FDA, we provided a detailed legal analysis supporting approval of a dual-label product and continue to believe that a dual-label status can and should be approved for Plan B," said Bruce L. Downey, Barr's chief executive. "While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an OTC/Rx Product."
Plan B was approved as a prescription "emergency" contraceptive in 1999. It is made of the hormone progestin, and is designed to prevent pregnancy if taken within 72 hours of unprotected sexual intercourse. Women take two pills 12 hours apart. The pills are similar to birth-control pills but contain higher doses of progestin which blocks a fertilized egg from becoming implanted in a woman's uterus. A handful of states currently allow Plan B to be sold over the counter.
Barr said Plan B will continue to remain on the market as a prescription drug product while the FDA continues to debate whether and how to allow the drug to be sold over the counter.
Closely Watched Approval Process
In 2004, the FDA denied a similar application by Barr to sell Plan B over the counter. At the time, the FDA went against the recommendation of its outside panel of medical advisors -- which voted to recommend Plan B be sold over the counter -- and ignited a debate about whether the Bush administration stepped in and asked the FDA to block the application by Barr.
Barr amended its application and gave the FDA additional information. The agency was supposed to rule on the new application in January, but again announced a delay. The delay temporarily set back the Senate confirmation of Crawford to head the FDA this spring and summer.
However, Mr. Crawford told lawmakers then he would rule on Plan B by Sept. 1 and a "hold" that had been placed on his nomination by some Democratic Senators was lifted; he was confirmed to head the FDA in July.
Opponents of making the pill more readily available argue that such access could lead some young teens to have sex, leaving them more vulnerable to sexually transmitted diseases. Supporters of making Plan B available over the counter said the drug would help women prevent unintended pregnancies and reduce the need for abortions, but to make a real difference, women need to be able to get it quickly.
--The Associated Press contributed to this article.
How Plan B Works
Plan B, commonly called the morning-after pill, is a high dose of birth-control pills taken after having unprotected sex. Scientists think the resulting surge of the hormone progestin may interfere with ovulation, or prevent implantation of the embryo in the uterus if ovulation has already taken place.
Two doses of the Plan B pill must be taken 12 hours apart. If taken within 72 hours of having unprotected sex, the treatment reduces the risk of pregnancy by 89%. The pills don't work if a woman already is pregnant and won't induce abortion, unlike the controversial RU-486 pill.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com
On 'Morning After' Pill
Regulators Express Concern
About Teenagers' Access to Plan B
By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
August 26, 2005 6:56 p.m.
WASHINGTON -- The Food and Drug Administration again delayed a decision Friday on whether to allow a "morning after" contraceptive pill to be sold without a prescription, saying it still hadn't figured out how to keep younger women from improperly obtaining the product.
Barr Pharmaceuticals Inc. is seeking FDA permission to sell its morning-after pill, called Plan B, to women ages 16 and older on an over-the-counter basis.
FDA Commissioner Lester M. Crawford said the agency needs to decide whether the same drug can exist as both a prescription and over-the-counter product and wanted to open up that discussion to the public for the next 60 days.
During a rare press conference at the FDA's headquarters in Rockville, Md., Mr. Crawford said FDA staff has concluded that the drug could safely be sold to women 17 and older without a prescription. Barr's application asked for permission to sell to women ages 16 and older.
Mr. Crawford said, however, the FDA won't make a decision until after it deals with the broader regulatory issue of whether the same drug can be sold both over the counter and as a prescription. He wouldn't set a timeline for making a final decision on Barr's application. It also is unclear if Barr will need to submit another application to suggest the drug be sold to those ages 17 and older, rather than its current proposal of age 16.
Mr. Crawford said the FDA has never allowed the same drug to be sold both over the counter and by prescription with the same indication. He said the agency was uncertain how to keep the pill away from younger women and needed to set up some type of enforcement mechanism with pharmacies.
"We cannot have this slippage between age groups," he said.
Barr Disappointed
Barr Pharmaceuticals said it was disappointed in the FDA's decision not to approve the application to sell Plan B on an over-the-counter basis to women ages 16 and older. The company had proposed having pharmacists "card" women and require them to show a photo ID such as a driver's license.
"In our submission to the FDA, we provided a detailed legal analysis supporting approval of a dual-label product and continue to believe that a dual-label status can and should be approved for Plan B," said Bruce L. Downey, Barr's chief executive. "While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an OTC/Rx Product."
Plan B was approved as a prescription "emergency" contraceptive in 1999. It is made of the hormone progestin, and is designed to prevent pregnancy if taken within 72 hours of unprotected sexual intercourse. Women take two pills 12 hours apart. The pills are similar to birth-control pills but contain higher doses of progestin which blocks a fertilized egg from becoming implanted in a woman's uterus. A handful of states currently allow Plan B to be sold over the counter.
Barr said Plan B will continue to remain on the market as a prescription drug product while the FDA continues to debate whether and how to allow the drug to be sold over the counter.
Closely Watched Approval Process
In 2004, the FDA denied a similar application by Barr to sell Plan B over the counter. At the time, the FDA went against the recommendation of its outside panel of medical advisors -- which voted to recommend Plan B be sold over the counter -- and ignited a debate about whether the Bush administration stepped in and asked the FDA to block the application by Barr.
Barr amended its application and gave the FDA additional information. The agency was supposed to rule on the new application in January, but again announced a delay. The delay temporarily set back the Senate confirmation of Crawford to head the FDA this spring and summer.
However, Mr. Crawford told lawmakers then he would rule on Plan B by Sept. 1 and a "hold" that had been placed on his nomination by some Democratic Senators was lifted; he was confirmed to head the FDA in July.
Opponents of making the pill more readily available argue that such access could lead some young teens to have sex, leaving them more vulnerable to sexually transmitted diseases. Supporters of making Plan B available over the counter said the drug would help women prevent unintended pregnancies and reduce the need for abortions, but to make a real difference, women need to be able to get it quickly.
--The Associated Press contributed to this article.
How Plan B Works
Plan B, commonly called the morning-after pill, is a high dose of birth-control pills taken after having unprotected sex. Scientists think the resulting surge of the hormone progestin may interfere with ovulation, or prevent implantation of the embryo in the uterus if ovulation has already taken place.
Two doses of the Plan B pill must be taken 12 hours apart. If taken within 72 hours of having unprotected sex, the treatment reduces the risk of pregnancy by 89%. The pills don't work if a woman already is pregnant and won't induce abortion, unlike the controversial RU-486 pill.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com
