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Over-the-counter access allowed
By Diedtra Henderson, Globe Staff | August 25, 2006
WASHINGTON -- The Food and Drug Administration yesterday approved nationwide over-the-counter sales of the ``morning-after " pill to adults 18 and older, after a three-year debate that pitted conservatives against liberals and FDA leadership against the agency's own scientists.
Duramed , a subsidiary of Barr Pharmaceuticals Inc. , said the drug, Plan B , will be available over-the-counter by the end of the year.
Plan B, which is taken in a two-pill dose, prevents pregnancy by stopping the ovary from releasing an egg and may also prevent fertilization. It works best when taken within 72 hours of unprotected sex.
The drug currently costs between $25 and $40 a dose; Barr has not set the price for the version that will be sold over the counter. It can be sold only by stores that have a licensed pharmacist on duty and must be kept behind pharmacy counters, not in store aisles. Under the ruling, stores are authorized, but not required, to sell the drug, and pharmacists are not required to dispense it.
Yesterday's decision will not have a significant impact in Massachusetts, where a state law passed last year allows consumers of all ages to purchase the drug without a doctor's prescription.
The FDA ruling also clears the way for Dr. Andrew von Eschenbach to be confirmed as permanent commissioner of the embattled agency as soon as next month . His nomination stalled last year when Democrats -- promised the FDA would soon decide the Plan B question -- instead were told of another delay. They used procedural holds to block a Senate confirmation vote .
Democratic Senators Hillary Rodham Clinton and Patty Murray said they will now allow von Eschenbach's confirmation to proceed. Senator Michael B. Enzi , chairman of the Senate Health, Education, Labor, and Pensions Committee , could schedule a committee vote on von Eschenbach in early September , a spokesman said. Enzi, Republican of Wyoming, said this month that he has enough votes to push von Eschenbach's confirmation out of committee to the full Senate. Murray, Democrat of Washington , and Clinton, Democrat of New York , are committee members.
Conservative Republicans continue to campaign against over-the-counter sales of Plan B, even though FDA scientists have vouched for its effectiveness and safety.
Some opponents of the FDA ruling say they plan to encourage consumers to avoid doing business with drug store chains that sell Plan B. If consumers ``have the slightest doubt over whether a drug store chain or pharmacist is going to have their best interests -- or their child's best interests -- at heart, then it's just so easy to go to a different drug store," said Wendy Wright , head of the conservative group Concerned Women for America.
In Massachusetts, legislators last year voted, over Governor Mitt Romney's veto, to allow consumers of any age to get Plan B without a doctor's prescription, instead allowing pharmacists with special training to write the prescriptions. The training, which can be completed online in an hour, describes how Plan B works and what kinds of screening questions pharmacists should ask customers -- such as whether they recently had unprotected sex.
Some 13 pharmacies currently sell Plan B under those provisions, according to the Planned Parenthood League of Massachusetts .
The CVS drug store chain is developing a training program that will be voluntary for individual pharmacists who decide or decline to participate, said spokesman Michael DeAngelis . More than 300 of the 331 CVS stores in Massachusetts operate pharmacies.
Wal-Mart Stores Inc. in March decided to start selling Plan B, weeks after a state pharmacy board ruled in favor of three women who filed complaints after Wal-Mart had refused to fill their prescriptions. The chain, which operates 41 discount stores and three supercenters in Massachusetts, has not decided whether to sell the emergency contraceptive over the counter.
``It is something we would consider," said Kevin Gardner , a spokesman.
The Plan B controversy began in April 2003 , when Barr sought to sell its emergency contraception to women of all ages without a prescription.
When the FDA balked, Barr revised its application to sell Plan B to consumers 16 and older . Last year, the FDA raised the age restriction, saying those 17 and older could buy the drug without a doctor's prescription.
Earlier this summer, von Eschenbach shifted the age threshold to 18 . This week , President Bush told reporters he endorsed that age restriction. During a Senate hearing, von Eschenbach had testified that he -- not the White House -- triggered the age change.
Dr. Steven Galson , director of the FDA's Center for Drug Evaluation and Research , acknowledged the age cut-off has been controversial ``since the very beginning."
Galson said the agency settled on 18 because it already is the ``age of majority" used for purchases of such products as tobacco and nicotine replacement treatments.
``We have all kinds of age restrictions that click in at that age," Galson said.
According to analysts, over-the-counter status could double Plan B sales in the United States. Barr Labs sold $11.8 million in Plan B prescriptions in the first six months of 2006 , up 41 percent from the year prior, according to IMS Health , a healthcare information company.
Sales of Plan B spiked in Canada after regulators in April 2005 waived the prescription requirement.
In 2004 , the last full year's sales data before the policy change, Canadian drug stores dispensed 447,000 Plan B prescriptions worth $10.3 million in Canadian dollars, IMS Health reported. Sales rose to $17.7 million in 2005 . The robust sales trend continued in 2006 , with 405,000 Plan B doses dispensed in the first six months of the year worth $11.8 million , in Canadian dollars.
Some speculate that sales growth included purchases by American women.