Of­fer the Pill over the counter

Los Angeles Times - - OP-ED - By Daniel Grossman Daniel Grossman is an ob­ste­tri­cian and gy­ne­col­o­gist, a clin­i­cal pro­fes­sor at UC San Fran­cisco, and vice pres­i­dent for re­search at Ibis Re­pro­duc­tive Health, a non­profit re­search or­ga­ni­za­tion. www.OCsOTC.org and www.freethep­ill.org

In a sur­pris­ing mo­ment of bi­par­ti­san unity, Repub­li­cans and Democrats seem to be in agree­ment that it’s time to re­move the pre­scrip­tion re­quire­ment for oral con­tra­cep­tives. Right be­fore Me­mo­rial Day, Sen. Kelly Ay­otte (R-N.H.) and Sen. Cory Gard­ner (R-Colo.) in­tro­duced leg­is­la­tion aimed at mak­ing birth con­trol pills avail­able over the counter, and now Sen. Patty Mur­ray (D-Wash.) has in­tro­duced a Demo­cratic bill that also would add in­sur­ance cov­er­age for a fu­ture OTC pill. Though the pol­i­tics of these moves tend to get the dis­pro­por­tion­ate share of at­ten­tion, it’s worth ex­plor­ing what the im­pact of ei­ther bill would be for women. Since 2004 I’ve led a coali­tion of re­searchers, doc­tors and women’s health ad­vo­cates ex­plor­ing the fea­si­bil­ity of mak­ing birth con­trol pills avail­able with­out a pre­scrip­tion. The science on this is clear: The pill is one of the best-stud­ied medicines on the mar­ket to­day, and it’s cer­tainly safe enough to be avail­able with­out a pre­scrip­tion. Some women have con­di­tions that might make it more risky to take the pill, but stud­ies show that women can use sim­ple check­lists on their own to fig­ure out whether the pill is right for them. Other re­search shows that women get­ting the pill over the counter stay on it longer than women get­ting it by pre­scrip­tion. Ma­jor med­i­cal so­ci­eties, in­clud­ing the Amer­i­can Col­lege of Ob­ste­tri­cians and Gyne­col­o­gists and the Amer­i­can Academy of Fam­ily Physi­cians, sup­port OTC ac­cess to the pill. So do women. Stud­ies show they are very in­ter­ested in get­ting over-the-counter ac­cess to birth con­trol pills, in­clud­ing about a third of women who cur­rently don’t use any birth con­trol but are sex­u­ally ac­tive and don’t want to get preg­nant. This sug­gests that the OTC pill could lead to more women us­ing ef­fec­tive con­tra­cep­tion, with fewer gaps in use, which could help re­duce un­in­tended preg­nan­cies. But chang­ing the pill from pre­scrip­tion-only to over-the-counter is no small feat, and it will re­quire an in­ter­ested phar­ma­ceu­ti­cal com­pany with deep pock­ets. The re­search re­quired by the Food and Drug Ad­min­is­tra­tion to con­sider such a change in sta­tus is costly. The Repub­li­can bill aims to mo­ti­vate phar­ma­ceu­ti­cal com­pa­nies by ex­pe­dit­ing the re­view process and waiv­ing the FDA fil­ing fee, which is at least $1 mil­lion. There’s another rea­son com­pa­nies may hes­i­tate to go for­ward with over-the-counter birth con­trol pills: fear of po­lit­i­cal in­ter­fer­ence — and the costs and un­cer­tainty it in­tro­duces — in the FDA ap­proval process. When Plan B emer­gency con­tra­cep­tion was be­ing con­sid­ered for over-the-counter sale, politi­cians of both par­ties in­ter­vened in the process, slow­ing it down and im­pos­ing an un­rea­son­able age re­stric­tion, one that was lifted only af­ter a 10-year le­gal bat­tle. Un­for­tu­nately, the bill in­tro­duced by Ay­otte and Gard­ner would also in­ter­fere with the FDA process. It would give pri­or­ity FDA re­view and waive the fil­ing fee only for an OTC pill to be sold to those older than 17. From a med­i­cal point of view, there is no more rea­son to pro­hibit ado­les­cents from get­ting birth con­trol pills with­out a pre­scrip­tion than to bar them from buy­ing over-the­counter cough syrup. Re­search shows that al­low­ing teens ac­cess to emer­gency con­tra­cep­tion with­out a pre­scrip­tion has not led them to en­gage in riskier sex­ual ac­tiv­ity. Ado­les­cents of­ten have their first sex­ual en­counter be­fore see­ing a doc­tor or nurse to dis­cuss con­tra­cep­tion, and over-the­counter birth con­trol pills could help re­duce the high teen preg­nancy rate in the U.S. There are other is­sues with the age re­stric­tion in the Repub­li­can bill. Any­one try­ing to buy the pill over the counter would need to show proof of age. Many peo­ple with the most to gain from the non-pre­scrip­tion pill — in­clud­ing un­doc­u­mented im­mi­grants in­el­i­gi­ble for many pro­grams that sup­port fam­ily plan­ning ser­vices — may not have a gov­ern­ment-is­sued ID. The age re­stric­tion also cre­ates ex­tra work for phar­ma­cists, who have to keep the prod­uct be­hind the counter so they can screen buy­ers. This, in turn, in­creases the cost of the pill and lim­its ac­cess to it. Con­cerns about the cost of a fu­ture OTC pill are real, since in­sur­ance gen­er­ally cov­ers OTC con­tra­cep­tives only if a woman has a pre­scrip­tion. The two bills di­verge sig­nif­i­cantly when it comes to help­ing peo­ple pay for the pill. The Repub­li­can pro­posal of­fers a half-hearted so­lu­tion: Peo­ple can use pre­tax dol­lars in f lex­i­ble spend­ing ac­counts or health sav­ings ac­counts to buy over-the counter med­i­ca­tions with­out a pre­scrip­tion (the pre­scrip­tion re­quire­ment was im­posed un­der the Af­ford­able Care Act). But this move is un­likely to help women who strug­gle to pay for birth con­trol. Mur­ray’s bill is bet­ter; it would ex­tend the con­tra­cep­tive cov­er­age guar­an­tee un­der the Af­ford­able Care Act to in­clude the FDA-ap­proved over­the-counter pill. (Sev­eral state Med­i­caid pro­grams al­ready do this, pro­vid­ing a model for mak­ing sure ev­ery woman has af­ford­able ac­cess.) Over-the-counter ac­cess to the pill could be a game-changer for public health, elim­i­nat­ing an un­nec­es­sary bar­rier to a highly ef­fec­tive form of birth con­trol. The sup­port of politi­cians from both sides of the aisle to help make this a re­al­ity is welcome. But politi­cians must stay out of the drug reg­u­la­tory process and let the FDA do its job.

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