How Does The FDA Now Justify Rejecting Plan B?
9 CommentsBy Ed Silverman // December 13th, 2011 // 9:33 am
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 data provided by Teva Pharmaceuticals was, which included an actual use study and a label comprehension study, were not sufficient to support making the pill 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 health groups relied on older data for Plan B, not the newer Plan B One-Step for which Teva Pharmaceuticals was seeking approval. 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 the health groups, because Teva Pharmaceuticals 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.
Salient point
FDA had to rule this way. The two products are not the same. It may seem like the agency is doing the wrong thing for the right reason, but it’s doubtful they would consider such a proposal for another product.
FDA Matters
Thank you for a detailed, insightful follow-up story. Certainly more twists and turns than anyone would have imagined.
Your readers might be interested in my blog column on this topic: “Beyond Plan B: Scientific Integrity and a Possible Third Class of Drugs.” It can be found at http://www.fdamatters.com/?p=1599.
Here Comes Da Judge
Judging by the farcical nature of these legal twists and turns I wouldn’t be surprised if the judge in this case turned out to be none other than Harvey Korman.
Justice in MI
I’m adding here a comment from recent thread that didn’t get response there. Still wondering about the potential power of HHS re: _all_ FDA decisions….
“What I’m wondering is whether it is always within the powers of the HHS secretary to overrule FDA Are there any limits? Drug approval? Drug withdrawal? for example.
Of course, I would not expect an HHS Secretary to “make a habit” of reversing FDA decisions. Still, I wonder what the the relevant powers actually are.
Condor
JiM asks a great question. I’m afraid a complete answer is beyond the time I have available tonight, but here are a few general principles:
HHS is the agency with oversight authority, as to FDA matters. FDA’s CDER is a part of HHS, as is all of FDA.
The OIG of the HHS has a charter to “keep FDA honest” — and does so quite regularly, on (for example) conflicts of interest processes (January 2009), and financial transparency initiatives, more generally, at NIH and FDA (also 2009).
More directly, while the science should likely be the primary purview of FDA, nothing prohibits HHS from weighing in on any matter affecting public healht, and it is clear that Plan B is within that purview.
To be clear, whether I agree with Secretary Sebelius’s decision — or not — it is plain the power is hers to wield. It may appear to some to be poor politics and bad policy, but it is well within her charter.
On that score, from about 2005 through 2007, it was fairly common to see HSS operatives, or the (Bush 43) White House itself, throwing obstacles in front of the Plan B approval paths at FDA. My sense is an outright reversal of an FDA science decision is pretty rare.
Didn’t the stem cells controversy play out in something like this way (at NIH, also an agency HHS has supervisory responsibility for)?
It would seem so — but no direct HSS intervention ever occured — as the White House (at least) thrice trumped NIH initiatives:
“. . .1999 to 2000: NIH Guidelines and Bush Disapproval
■ The NIH develops guidelines for funding human embryonic stem cell research, but presidential candidate George W. Bush declares his opposition to the research in a campaign speech, so the NIH remains cautious about entertaining funding proposals until after the presidential election. . . .”
Namaste
Justice in MI
thanks, Condor. Of course, I understand that FDA/CDER is under HHS. At the same time, it is governed by the FDCA and, to that extent, is a “creature of Congress.”
While it is possible to imagine lurid scenarios (like snakes on a plane) that would almost certainly never happen, I hadn’t realized the potential for them!
STL
JiM: I posted a reply to the earlier thread, but that thread is probably lost to history now (i.e., is on page 2 of the site). The FD&C act names the Secretary of HHS as the holder of all regulatory authority, and allows the Secretary to transfer that authority to a designee (i.e. the FDA Commissioner). So, in principle, I think the Secretary could overrule any FDA decision, or elect simply to bypass the agency entirely for any given decision.
Flash
It is not certain that the Secretary had the legal authority to overrule FDA. The Secretary is subject to a binding delegation of her power to the FDA on drug approvals, without reservation. So she would have had to first revoke the delegation of power then make the decision. It isn’t clear she did that. Also, the Food and Drug Act specifies what may be taken into account when making approval decisions; the Secretary’s concerns fall outside of the criteria specified by Congress. So it’s too soon to say what the Secretary did was legal.
Justice in MI
Flash, interesting. Where is the “binding delegation” specified? In FDCA? And I assume it applies equally to withdrawals, yes?
Of course, the Plan B decision was neither. But it would be interesting to have this clarified. Will we have a SCOTUS case on HHS preemption?