WASHINGTON — U.S. health regulators are weighing the first-ever demand to make a birth control tablet offered without a prescription.
But in an preliminary evaluation published Friday, the Food and Drug Administration raised many issues about drugmaker Perrigo’s application to sell its decades-old tablet over the counter.
The FDA pointedout issues with the dependability of some of the business’s information on the drug, Opill, and questioned whether females with specific other medical conditions would properly decide out of taking it. The firm likewise keptinmind indications that researchstudy individuals had difficulty understanding the labeling directions.
Advisers to the FDA fulfill next week to evaluation drugmaker Perrigo’s application. The two-day public conference is one of the last actions priorto a last FDA choice.
If the company grants the business’s demand, Opill would endupbeing the veryfirst contraceptive tablet to be moved out from behind the drugstore counter onto shop racks or online.
Friday’s FDA evaluation recommends regulators have major appointments about broad gainaccessto to the drug, consistingof whether moreyouthful teens will be able to properly follow the labeling instructions.
At the end of the conference, the FDA panel will vote on whether the advantages of making the tablet more extensively readilyavailable exceed the prospective threats. The panel vote is not binding and the FDA is anticipated to make its last choice this summerseason.
Perrigo executives state Opill might be an crucial brand-new choice for the approximated 15 million U.S. females — or one-fifth of those who are child-bearing age — who presently usage no birth control or less efficient approaches, such as prophylactics.
“We have no doubt that our information plainly reveals that ladies of all ages can securely usage Opill in the overthecounter setting,” Frederique Welgryn, the business’s worldwide vice president for females’s health, stated this week.
The business’s application has no relation to the continuous suits over the abortion tablet mifepristone, which is not a contraceptive. Research for overthecounter sales of the tablet started almost a years earlier.
Hormone-based tablets, like Opill, have long been the most typical kind of birth control in the U.S., utilized by 10s of millions of females because the 1960s.
Opill was initially authorized in the U.S. 50 years earlier. Perrigo obtained rights to the drug last year with its buyout of Paris-based HRA Pharma, which purchased the tablet from Pfizer in2014 It’s not presently m