How Does The FDA Now Justify Rejecting Plan B?

How Does The FDA Now Justify Rejecting Plan B?

December 14th, 2011 // 1:08 pm @

File this under ‘no swapsies allowed.’ Last week, US Department of Health & Human Secretary Kathleen Sebelius took the unprecedented step of overruling the FDA and thwarted a move to ease access to the Plan B pill, which is also known as the morning after pill. The move quickly generated debate that the White House was willing to politicize the FDA in favor of promoting sound science.

The controversial pill was the subject of a fracas when George W. Bush was president, because some believe that Plan B prevents a fertilized egg from implanting in the womb, and some equate this with abortion. Many doctors and pharmacists still refuse to provide the pill. As a result, President Barack Obama has been criticized for the past few days for pandering to conservatives as he faces re-election.

In explaining her decision, Sebelius maintained that the Plan B data provided by Teva Pharmaceuticals was, which included an actual use study and a label comprehension study, were not sufficient to support making Plan B One-Step available to all girls 16 and younger without a prescription or talking to a healthcare professional. At the same time, FDA commish Margaret Hamburg released her own statement saying her agency did not agree with Sebelius but, of course, she had been overruled.

However, The Center for Reproductive Rights still held out hope that the FDA might somehow reverse, because a deadline was coming up today in connection with a court case in which the FDA was accused of contempt. Two years ago, a federal judge ordered the FDA to reconsider its 2006 decision allowing only women ages 18 and older to buy the pill without a prescription. In his March 2009 ruling, Korman chastised the FDA for being “arbitrary and capricious,” making decisions in “bad faith” and being influenced by “impermissble political and ideological considerations” imposed by the Bush White House.

The non-profit had filed a citizen’s petition forcing the issue. “If they are to follow the court’s order, the FDA must follow science,” Nancy Northup, who heads the group, told Bloomberg News. “Which means finally, after 10 years, granting the citizen petition to make the generic two-pill emergency contraceptive available over the counter to women of all ages.”

But no such luck. In a letter to the non-profit, the FDA noted that the application to approve greater access to girls 16 and younger without a prescription was denied because the drugmaker provided data for Plan B One-Step, instead of Plan B. What’s the difference? Plan B One-Step has a different dosing regimen, but with the same active ingredient and indication as Plan B. However, Plan B uses a two-dose regimen with 0.75 mg of levonorgestrel in each tablet to be taken 12 hours apart, while Plan B One-Step is a single-dose tablet that contains 1.5 mg of levonorgestrel.

In other words, the FDA ruled that these two pills just ain’t the same. And that was a problem for Teva, because the drugmaker conducted its studies using Plan B One-Step instead of Plan B. “…And all of the data supporting one application cannot automatically be used for the other,” wrote Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research.

“In particular, because Plan B One-Step consists of a single tablet, the dosing data for Plan B One-Step could not provide support for an OTC switch of Plan B as that data would not adequately address the ability of subjects to correctly follow the directions related to the timing of a second dose that is required for proper use of Plan B.”

For those who may not recall, the FDA two years ago approved Plan B One-Step as an over-the-counter pill for women ages 17 and over, and also as a prescription drug for women under age 17. However, Teva conducted the required studies using Plan B One-Step for gaining approval to sell Plan B to younger girls without a prescription. Why? The drugmaker no longer planned to market Plan B, according to the FDA.

As a result, the “FDA has determined that the actual use and label comprehension studies were necessary for approval of OTC use for younger women for both Plan B and Plan B One-Step. Because these data have not been presented to FDA for Plan B, the drug product that is the subject of this petition, FDA again denies your petition,” Woodcock writes to the non-profit (here is the letter).

“…In contrast to the new data presented in the 2011 SNDA for Plan B One-Step, no new data have been presented to the agency on Plan B,” she continues. “…Despite FDA’s statements regarding the insufficiency of the data and the opportunity to supplement the record, neither you nor any other interested party has submitted any new data or information regarding the approvability of Plan B for nonprescription use by women under the age of 17.”

One might argue the FDA is relying on a tortured explanation to explain its decision. After all, Hamburg was already on record just last week saying that the agency was ready to approve Plan B One-Step. But having been overruled, the FDA had little choice but to divine a reason for rejecting the petition. At the same time, one could also argue that the two pills are not the same and the agency has justification for viewing them differently. However, if Sebelius had not intervened, this rationale may never have emerged, either.

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