After long battle, FDA OK's Teva Plan B One-Step without Rx, age restrictions
This article was originally published in Scrip
The US FDA on 20 June said it would permit Teva to sell its single-pill emergency contraceptive Plan B One-Step (1.5 mg levonorgestrel tablet) without a prescription or age restrictions – ending a battle that stretched across three administrations, pitting scientists against policymakers.
The agency said its action complies with the 5 April order from Judge Edward Korman of the US District Court for the Eastern District of New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) drug and without any age or point-of-sale restrictions – a ruling the Obama administration notified the court on 10 June it planned to obey after dropping its appeal in the matter (scripintelligence.com, 5 April 2013, 11 June 2013).
Attempts to get emergency contraception available OTC in the US go back to the Clinton administration, when the drug was first approved in 1999, when various advocates had called for the FDA to make the product available to women without a prescription.
Barr Pharmaceuticals, which was later acquired by Teva, initially sought a change in Plan B's marketing status from prescription to nonprescription without an age restriction in April 2003.
But even after the FDA's expert advisory committee voted in favor of making the emergency contraception available as an OTC drug, regulators refused the company's request and issued a rejection on 6 May 2004, declaring the manufacturer’s supplemental new drug application (sNDA) did not contain data demonstrating the product was safe and effective as a nonprescription medicine for women under 16 years.
Barr submitted an amended application in July 2004 asking the FDA to make Plan B available without a prescription to women 16 years or older.
After then-New York Senator Hillary Clinton (Democrat), joined by Washington Senator Patty Murray (Democrat) and other lawmakers, threatened to hold up the confirmation vote for Dr Lester Crawford, who had been serving in an acting capacity as FDA commissioner and had been nominated to lead the agency, the head of Health and Human Services (HHS) at that time, Michael Leavitt, gave his word regulators act on Plan B by September 2005.
The senators let Dr Crawford's confirmation move forward.
But instead of acting on Barr's application, a month after his confirmation, Dr Crawford said the agency was setting the sNDA aside indefinitely, but had determined Plan B could be sold to women as young as 17 years OTC.
But in a matter of weeks of making that declaration, Dr Crawford resigned his post under a financial scandal – leaving the Plan B controversy up to another commissioner to resolve – this time, Dr Andrew von Eschenbach, who President George W Bush had sought to move from leading the National Cancer Institute to the FDA.
The day before his confirmation hearing, Dr von Eschenbach said he thought Plan B could be safely marketed as an OTC product, but only to women 18 years.
Barr amended its sNDA again and the FDA OK'd it in August 2006.
Six months after President Barack Obama took office, he directed the FDA to lower the age by one year, making the drug available to teenage girls as young as 17 years without a prescription.
Meanwhile, a lawsuit had been brewing to get OTC sales status for Plan B – filed in 2005 by the Center for Reproductive Rights, which initially had started out pursuing the Rx-to-OTC switch through a 2001 citizen petition.
After acquiring Barr, Teva submitted an sNDA to the FDA in February 2011 seeking to remove the prescription-only status for girls under 17 and make the drug available OTC to all females of childbearing potential in the US.
But while regulators said the single-pill drug was safe and FDA Commissioner Dr Margaret Hamburg gave her blessing for the move from prescription to nonprescription for Plan B One-Step, her decision was over-ruled in December 2011 by her boss, HHS Secretary Kathleen Sebelius (scripintelligence.com, 8 December 2011).
In his 5 April ruling, Judge Korman had called the HHS chief’s action "politically motivated, scientifically unjustified and contrary to agency precedent."
In a 20 June statement, Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said OTC access to emergency contraceptive products "has the potential to further decrease the rate of unintended pregnancies in the United States."
"After working on this issue for almost two decades, I am so proud to finally see science prevail and this essential part of women’s basic health care become available to women of all ages," Senator Murray said.