Morn­ing-af­ter pill al­lowed over the counter for adults

The Washington Times Weekly - - National - By Joyce Howard Price

The U.S. Food and Drug Ad­min­is­tra­tion on Aug. 24 an­nounced ap­proval of non­pre­scrip­tion sales of Plan B, the morn­ing-af­ter pill, for menand­wom­en­who­can­provethey are 18 or older.

PlanB will re­mainapre­scrip­tiononly prod­uct for girls 17 and younger,FDA of­fi­cials sai­dat­a­press brief­ing. The over-the-counter sales were ex­tended to men, even though man­u­fac­tur­erBar­rLab­o­ra­to­ries­did not seek ap­proval for male buy­ers.

The de­ci­sion comes af­ter a three­year fight in which fem­i­nist groups, lib­eral law­mak­ers and health or­ga­ni­za­tions have said eas­ier ac­cess to Plan B could cut in half the na­tion’s 3 mil­lion un­planned preg­nan­cies a year. So­cial con­ser­va­tives have said that such sales could in­crease promis­cu­ity and sex­u­ally trans­mit­ted dis­eases, es­pe­cially among­teens and that the pill is an abor­ti­fa­cient.

“This de­ci­sion is long over­due. For nearly three years, pol­i­tics took prece­dence over good science and good health pol­icy,” said Susan F. Wood, re­search pro­fes­sor at the Ge­orge Wash­ing­ton Univer­sity School of Pub­lic Health, who re­signed­her­postas­theFDA’sas­sis­tant com­mis­sioner for women’s health a year ago, when the agency re­fused to al­low over-the-counter (OTC) sales of Plan B.

“The sci­en­tific and med­i­cal ev­i­dence, as well as the con­sen­sus among­ma­jormed­i­cal or­ga­ni­za­tions like the Amer­i­can Med­i­cal As­so­ci­a­tion­sup­port­ingOTCac­cess to Plan B for all women is over­whelm­ing,” she added.

But con­ser­va­tive groups de­cried the rul­ing, say­ing it will let older men buy the drug for young girls.

“This is a dream come true for a statu­to­ryrapist [. . .] it is po­lit­i­cal cor­rect­ness­runamok,”saidJanLaRue, chief coun­sel for Con­cernedWomen for Amer­ica.

Tony Perkins, pres­i­dent of the Fam­ily Re­search Coun­cil, called it “a very le­git­i­mate con­cern that an older male­could­com­mita crim­i­nal sex act with a young girl” and then try to hide it by buy­ing her Plan B.

“This is avery real con­cern since na­tion­al­stud­iesshowthattwo-thirds of ado­les­cent girls have part­ners who are 21 or older,” Mrs. LaRue said. She also cited a 2002 re­port by the Cal­i­for­nia Cen­ter for Health Sta­tis­tics that founda“slight ma­jor­ity” of preg­nan­cies in­volv­ing girls 10 to 14 in that state re­sulted from sex with an adult.

Mean­while on Aug. 24, Demo­cratic Sens. Hil­lary Rod­ham Clin­ton of New York and Patty Murray of Wash­ing­ton lifted their hold on the Se­nate con­fir­ma­tion of Dr. Andrew von Eschen­bach as FDA com­mis­sioner.Thet­wose­n­a­tor­shad­blocked a vote on Dr. von Eschen­bach since March, say­ing they would not lift it un­til the FDA ap­proved Plan B.

But the rul­ing was­note­nough for Mrs. Clin­ton and Mrs. Murray, who said, “We urge the FDA to re­visit plac­ing age re­stric­tions on the sale of Plan B.”

When taken af­ter sex­ual in­ter­course, Plan B re­duces the risk of preg­nancy by 89 per­cent. It works best if taken within 24 hours of sex, and the com­pany says it should be tak­en­with­in72hour­so­fun­pro­tected sex to be ef­fec­tive.

Some pro-life groups say the drug pro­duces an early term abor­tion be­cause it works­bypre­ventingim­plan­ta­tionoftheem­bryoafter­con­cep­tion.

The med­i­ca­tion in Plan B is a higher dose of the main in­gre­di­ent in the tra­di­tional birth-con­trol pill, a pre­scrip­tion-only prod­uct — an­other fact that galls con­ser­va­tive groups.

“How can the FDA jus­tify ap­prov­ing over-the-counter sales of a high­er­po­ten­cyver­siono­fadrugthat re­quires a pre­scrip­tion?” Mrs. LaRue asked.

Dr. Steven Gal­son, di­rec­tor of the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search, said in a tele­brief­ing that the agency hoped to ad­dress many of the con­ser­va­tives’ con­cerns.

While say­ing that “men can buy” Plan B over the counter, Dr. Gal­son said, “We will mon­i­tortheuse of this drug and the pre­scrip­tion pat­terns. If changes are needed, we’ll make them.”

But Carol Cox, a spokes­woman for Barr, said the com­pany did not seek ap­proval for pur­chase by males.

“The prod­uct is not de­signed for men,” she said in an e-mail.

The two-pill post-sex con­tra­cep­tive will besol­don­lyfrombe­hindthe coun­ters of phar­ma­cies, so drug­gistscancheck­photo iden­ti­fi­ca­tions, and not at gas sta­tions, con­ve­nience stores or other places where other non­pre­scrip­tion drugs such as as­pirin are sold.

Dr. Gal­son noted that Barr Lab­o­ra­to­ries plans to send buy­ers of dif­fer­ent ages to phar­ma­cies to de­ter­mine whether drug­gists are fol­low­ing the age re­stric­tions on sales of the drug.

Miss Cox of Barr said the com­pany will be “track­ing how Plan B is sold” and will re­port its find­ings twice yearly to the FDA.

But the con­flict over Plan B may not be over. The Fam­ily Re­search Coun­cil­said it is “pur­su­ing le­gal and leg­isla­tive op­tions” to over­turn the FDA’s de­ci­sion, claim­ingth­eagency ex­ceeded its rule-mak­ing author­ity, which it con­tends be­longs to Congress and state leg­is­la­tures, by grant­ingBarr Lab­o­ra­to­ries’ re­quest to al­low over-the-counter sales of the con­tra­cep­tive.

“I am greatly trou­bled that the FDA has sac­ri­ficed women’s health in the name of pol­i­tics” and that it ap­proved Plan B “just days af­ter Barr Lab­o­ra­to­ries ad­mit­ted its in­abil­ity to en­force dual-sta­tus sale of the drug,” Mr. Perkins said.

Barr says it hopes to be­gin non­pre­scrip­tion sales of Plan B by the end of this year.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.