The Obama administration on Friday urged a federal appeals court to clear the way for what could be a lengthy new review over younger girls’ access to “Plan B” emergency birth control pills, even while keeping in place government limits on access for women of all ages to the version of those pills that has become the most widely sought.   A new brief filed in the Second Circuit Court laid out the agenda that the Food and Drug Administration would be pursuing if a federal judge’s order giving all women greater access is put on hold.

Meanwhile, earlier in the week, supporters of the judge’s broad order filed their own new brief, urging the Circuit Court to leave that order intact — a result that could mean unlimited over-the-counter access to the most popular Plan B version, the newer one-pill version that now accounts for eighty-five percent of the sales of emergency contraceptives in the Plan B category.  The older Plan B, using two pills taken separately, is now available only in a generic version that appears to be rapidly losing its popularity with women.

On Tuesday, a panel of the Second Circuit will take up the government’s request to block Senior U.S. District Judge Edward R. Korman’s ruling last month that the FDA must lift all restrictions on access to either the one-pill version of Plan B or the earlier, two-pill version.  That order has not gone into effect, pending action by the Second Circuit on the government’s motion to postpone it while the government challenges it in an appeal.   It is unclear when the Circuit panel will act.   The controversy surrounding access to Plan B, unfolding over the past dozen years, may ultimately be headed to the Supreme Court.

All versions of the Plan B drug have gained in popularity beause they have been found to be quite effective in preventing pregnancy, if taken soon after engaging in unprotected sexual intercourse.  The FDA’s most recently adopted policy would make the drug available without a prescription to any woman who was fifteen years old or older, but all purchasers of any age would have to prove their age to the drugstore, with a government-issued ID.   Judge Korman’s order, if it went into effect or ultimately were upheld, would lift all retail restrictions on the version of Plan B that FDA found to be most effective.

Advocates of unlimited access to Plan B in all its forms argue that proof-of-age or other retail restrictions on sales would mean that many poor women and younger girls would be denied access as a practical matter.  The advocates argue that FDA’s scientists have found all versions to be safe and effective.

The Obama administration, in laying out a scenario that it prefers to follow, is treating issues of access to the two-pill Plan B generics as entirely separate from access to the one-pill “Plan B One-Step.”  The government has argued that Judge Korman had before him only the question of access to the two-pill variety, but reached out to mandate access to One-Step if that is found by FDA to be the more effective for women of any age.

But, even with Judge Korman having authority to rule on access to the two-pill version, the government brief said, he should not have adopted his own access order, but should have sent the two-pill Plan B proceeding back to the FDA for it to consider whether it would lower the age of non-prescription access to that version below its present level — seventeen years old and older.   Although supporters of full access to all versions have argued that the FDA has found all versions to be safe and effective for women and girls of all ages, the new government brief insisted that the agency has never done so for the two-pill Plan B without a prescription.

If the Second Circuit issues a stay of Judge Korman’s order, this would be the situation: women age fifteen and older would be able to obtain Plan B One-Step over the counter at any pharmacy, if they could prove their age with a government ID.  Girls younger than fifteen would have to have a doctor’s prescription to obtain any version of Plan B.   Women who are seventeen or older would be able to obtain the two-pill Plan B over the counter without a prescription, but would have to prove their age to the drugstore clerk.

If the courts ultimately rule that Judge Korman should have sent the question of access to the two-pill Plan B back to the FDA, the issue of access to the generic version of that contraceptive might remain quite uncertain for some time.   The government’s brief outlined a number of issues that the agency might want to explore in such a continuing proceeding, including whether it was worth the FDA’s time to even explore writing new rules for Plan B generics — including access for those younger than seventeen — since that version only makes up about fifteen percent of current sales of the emergency contraceptives.

The brief also discussed a number of potential studies that might have to be done before FDA could make up its mind about what to do further, if anything, on the tw0-pill Plan B   The brief said that, at this stage, FDA could not say what the likely outcome of such a further review would be, but that was no reason, it argued, to allow Judge Korman to short-circuit the process by mandating immediate unlimited access to all versions of Plan B.

In the Plan B advocates’ new brief, filed at the Second Circuit last Monday, they argued that the FDA has engaged for twelve years in frequent delays and, indeed, an “administrative filibuster” of the Plan B issue while carrying on a running battle with Judge Korman.   Delaying Judge Korman’s order or sending the case back to the FDA for further consideration of what it might do, the new filing contended, would only prolong the denial of access to younger females, and would continue a drugstore access regime that would, in practical operation, deny many women — even fully eligible under FDA rules to obtain the drug — any access to the contraceptive.

“For over a decade,” the brief said, “the FDA has had sufficient scientific evidence to support unrestricted over-the-counter approval of levonogestrel-based emergency contraception for all ages without any point-of-sale restrictions.”  Full access would have been provided by now, it added, if it had not been for the fact that the FDA — and, more recently, higher officials overseeing the FDA review — had not yielded to politics and vetoed access for younger women.   Giving FDA another chance to ponder access for younger women, the filing said, would be futile, because supervising officials have not changed their opposition to access to younger girls.

The brief once again leveled a strong attack on the requirement — in all versions of what the FDA has so far allowed — that eligible women must prove their age with a government ID to gain any access at a drug counter.  “This requirement,” the brief said, “has a disproportionate impact on adolescents, women of color and low income women, many of whom lack the necessary identification.”

In addition, the brief said, many women do not live near a store that has an on-premises pharmacy, so they would not have access even if they were technically eligible.

Posted in Cases in the Pipeline, Featured

Recommended Citation: Lyle Denniston, U.S. plan for a Plan B review, SCOTUSblog (May. 26, 2013, 12:03 AM), http://www.scotusblog.com/2013/05/u-s-plan-for-a-plan-b-review/