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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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« Merck in China | Main | The Loss of the Middle (Drugs and the People Who Find Them) »

December 7, 2011

Plan B and the FDA: Unprecedented

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Posted by Derek

I haven't been blogging about the Plan B contraceptive issue, and I'm certainly staying out of the politics of the whole thing. But today's news that the FDA was planning to make it available over-the-counter, but was overruled by Health and Human Services. . .well, that brings up a question.

Can anyone else recall a case like this, where the FDA was not, in fact, the final word on drug regulation? Having HHS overrule appears to be completely legal under the provisions of the Food, Drug, and Cosmetic Act, but when's the last time it happened? And if this is the first time, how much of a precedent does it set for extra-FDA lobbying and politicking?

Comments (35) + TrackBacks (0) | Category: Regulatory Affairs


COMMENTS

1. Vader on December 7, 2011 2:48 PM writes...

The vast majority of drug regulation decisions turn on the science (even when it's bad) rather than the social implications. So I don't find it terribly surprising that this is the first case anyone's heard of where HHS overrode FDA.

Permalink to Comment

2. John Spevacek on December 7, 2011 2:52 PM writes...

I think that the "politics of the whole thing" is why the overruling was taken. If that is the only precedent set here, then there will be minimal changes. But if this sets up a slippery slope, oh boy, do we have a problem. (There is no slope that lawyers can slip up a little more.)

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3. Aspirin on December 7, 2011 3:01 PM writes...

I don't want to get into the politics of the whole thing either but I do have a simple question; if the HHS thinks that the contraceptive may be misused by very young girls, why not have an age limit for sale, say 16?

Permalink to Comment

4. johnnyboy on December 7, 2011 3:26 PM writes...

Amazing. And this from a putatively "progressive" administration, no less. Seems the Obama white house is so afraid of being obstructed by the republicans that it is starting to obstruct itself pre-emptively.

Permalink to Comment

5. Nick on December 7, 2011 3:55 PM writes...

Importantly, does this suggest that a future HHS secretary could go the other direction and overrule a rejection?

Permalink to Comment

6. Lu on December 7, 2011 4:27 PM writes...

3. Aspirin on December 7, 2011 3:01 PM writes...
if the HHS thinks that the contraceptive may be misused by very young girls, why not have an age limit for sale, say 16?

Actually Plan B can be bought over-the-counter by people age 17 and older

Permalink to Comment

7. Curious Wavefunction on December 7, 2011 4:36 PM writes...

I don't know of any such decisions but I would guess that if any exist they would probably be found in the areas of reproductive or mental health or agricultural products.

Permalink to Comment

8. Sili on December 7, 2011 5:24 PM writes...

And yet, they can't be bothered do anything about homoeopathy.

Permalink to Comment

9. Anonymous on December 7, 2011 5:31 PM writes...

FDA is specifically restricted by law from doing anything about homeopathy. It's Congres and the President who can't be bothered to do anything about homeopathy.

Permalink to Comment

10. Will on December 7, 2011 5:36 PM writes...

@6 - it's true that its over the counter, but you still have to ask a pharmacist for it like you would for pseudophed (at least in my state). I think it has been a constant strategy of the anti-choice group that if they can't outright ban, they make erect as many barriers as possible, which has a deterring effect. In small, heavily religious communities, this deterrent might be quite effective indeed

Permalink to Comment

11. fenichel on December 7, 2011 6:41 PM writes...

When the FDA Commissioner's office overruled the original approval of OTC Plan B by FDA scientists, there was inconclusive evidence that the impetus for that decision had come from the Department level, and ultimately from the (GW Bush) White House. I wrote an invited editorial about the decision then (http://www.fenichel.net/papers/BMJ-OTC.pdf). My mistaken belief at the time -- not explicit in the editorial -- was that only a Republican could so recklessly imperil the scientific credibility of FDA and, more important, the lives of young women.

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12. leftscienceawhileago on December 7, 2011 7:39 PM writes...

Stevia?

Permalink to Comment

13. Fred on December 7, 2011 8:04 PM writes...

HHS has the authority to overrule the FDA?

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14. Matthew Herper on December 7, 2011 9:57 PM writes...

1) They did something about homeopathic HCG just this week.

2) FDA and several people in regulation have all told me nobody can remember a precedent.

Permalink to Comment

15. pete on December 8, 2011 12:23 AM writes...

Face it, as far as the W.H. is concerned, some issues will remain radioactive until mid November of 2012. They include:
- Plan B (sex & pregnancy)
- gun control
- abortion (sex & pregnancy)
As for lack of precedence, OK -- although (FWIW) HHS does outrank FDA by being cabinet level, right?

Permalink to Comment

16. fenichel on December 8, 2011 2:43 AM writes...

@pete (#15)
There is lack of precedent, but no lack of precedence. FDA is a part of the Public Health Service, and the PHS is a part of HHS, so Sibelius has, unfortunately, all the authority she needs.

Permalink to Comment

17. Morten G on December 8, 2011 7:09 AM writes...

What does plan B have to be safer than?

Abortion
OTC contraceptives
Prescription contraceptives
Childbirth

(I'm getting political now, aren't I? Sorry)

And if plan B can be bought OTC by 17 and older does that mean that it can be bought online? (preemptively of course since even with overnight delivery you would be cutting it close)

Permalink to Comment

18. simpl on December 8, 2011 7:35 AM writes...

It is preferable for the FDA to be overruled politically than to be forced to find a scientific reason for rejecting the plan-B pill.

Permalink to Comment

19. emjeff on December 8, 2011 9:34 AM writes...

Frankly, I am astounded that educated people reading this board think that it is OK for a 13-year old girl to treat herself for a medical condition as serious as this? Jesus, I don't even let my kids take ibuprofen without permission.

Permalink to Comment

20. SP on December 8, 2011 9:50 AM writes...

@10- The second part of the strategy is "conscience clauses" that let pharmacists not do their job if they have a religious or moral objection. Behind the counter + panty-sniffing pharmacist = no plan B, even for women over 17.

Permalink to Comment

21. Anonymous Academic on December 8, 2011 10:01 AM writes...

@19: Frankly, I am astounded that educated people reading this board think that it is OK for a 13-year old girl to treat herself for a medical condition as serious as this

I don't think anyone was arguing for that (I certainly am not) - alcohol and cigarettes are sold "over the counter" (well, in most states) but 13-year-old girls aren't allowed to purchase those either. The problem here is that the current rules essentially force customers to get permission from a pharmacist, which raises privacy questions and also (as SP points out) may constitute an effective barrier to access. Why not make Plan B available OTC, but require proof of age? It's not rocket science. Count me among those who believe that the real reason for this ruling was to deny access to adults.

Permalink to Comment

22. Biotechtranslated on December 8, 2011 10:32 AM writes...

I have to agree with #19.

Regardless of your opinion on birth control, abortion, and pre-teens having sex, I can completely understand why the HHS made this decision.

Teva would have been smarter to ask for a reduction in the current age limit of 17.

I can picture some 12-year that is 2 months into her pregnancy taking 5 times the dose in order to induce an abortion (which it won't do).

Mike

Permalink to Comment

23. Alig on December 8, 2011 10:55 AM writes...

I believe pseudophederine was also moved to a different mode of distribution (showing ID to buy), not by the FDA but by another agency.

Permalink to Comment

24. Sili on December 8, 2011 11:14 AM writes...

FDA is specifically restricted by law from doing anything about homeopathy. It's Congres and the President who can't be bothered to do anything about homeopathy.
I know. And it's the FDA who's been overruled in this case. Permalink to Comment

25. pete on December 8, 2011 12:28 PM writes...

@16 fenichel
Good point - I guess I'd focused on the fact that the President directly appoints both the heads of FDA and HHS -- even though, as you point out, the FDA commish ultimately reports to Kathleen Sibelius.

Permalink to Comment

26. Lance Stewart on December 8, 2011 1:03 PM writes...

I recall the HHS stepping in over the FDA in relation to the import of FDA approved drugs from Canada at low prices. HHS claimed they couldn't be sure of the quality of the imports. Even though the same exact Products(packaging etc.) is sold in the US. To many, it seemed HHS was being used as a trump card tool of big pharma over FDA. At least that's how I seem to remember this situation.

http://www.hhs.gov/asl/testify/t010905.html

Permalink to Comment

27. johnnyboy on December 8, 2011 1:36 PM writes...

"Frankly, I am astounded that educated people reading this board think that it is OK for a 13-year old girl to treat herself for a medical condition as serious as this? Jesus, I don't even let my kids take ibuprofen without permission."

I was not aware that having sex was a serious medical condition. We're talking about something to prevent conception here, taken within 3 days after sex. You may have moral objections to a 13 year old deciding by herself to not get pregnant, but that's not the issue here. The FDA's mandate is to decide what is safe, not what is moral. They decided it was safe. HHS is overriding the FDA, and is specifically stating safety reasons for their decision, not morals.

Of course I know that it's all politics. But I would have expected just a tad less hypocrisy from this administration. If Sebelius thought that it was not "right" to sell plan B to 13 year olds, she should have said "I think it is not right to sell plan B to 13 year olds", not some bogus "I'm not convinced of the safety".

Permalink to Comment

28. JS on December 8, 2011 2:24 PM writes...

The real question isn't why HHS overruled FDA here. Obviously it was political, but FDA has always incorporated politics (or, more broadly, 'values') into decisions and enforcement actions (this isn't a knock on the agency; to expect their decisions to be entirely objective or value-neutral is an extremely naive position).

A better question (but still not the right one) is why HHS has never overruled FDA before. The answer to that is that it's never needed to; on hot button issues the FDA Commissioner has generally either sided with the administration or (in maybe one case) been replaced by someone who would.

Which brings us to the actual question of interest: why did the Secretary have to overrule the Commissioner in this particular case vs. other politicized decisions. Would Hamburg not play ball? Maybe, but my thinking is actually that this was done at the Department level to give the Agency cover.

Permalink to Comment

29. David on December 8, 2011 2:54 PM writes...

@19: you won't let your 13 year old take ibuprofen because you're a good parent. Part of the issue here is how to accomodate the needs of 13 year olds who are raped by their parents, step-parents, or other guardians.


The HHS over-rule was nominally because of concern that FDA hadn't properly evaluated the ability of 10 and 11 year olds to understand the directions. The approval package was based on comprehension testing in 13-16 year olds. That implies that approval is still possible, pending a reading comprehension test in younger ages.

Permalink to Comment

30. metaphysician on December 8, 2011 5:25 PM writes...

29- The correct solution to children being raped by parents and relatives is "better law enforcement", not "morning after pills." Irrespective of one's opinion on the pills ( I don't know enough about their safety level to judge whether they should be OTC ), they won't stop sexual abuse.

Permalink to Comment

31. Joe T. on December 8, 2011 6:09 PM writes...

#30: The correct solution is not either alone, but both together. Yes, there needs to be sanction of evildoers, but the fact that Daddy or Uncle Pete went to jail may be small consolation to a 12-year-old who now has Daddy's/Pete's baby as a result because she wasn't allowed to use Plan B.

Permalink to Comment

32. Joe T. on December 8, 2011 6:32 PM writes...

#30: The correct solution is not either alone, but both together. Yes, there needs to be sanction of evildoers, but the fact that Daddy or Uncle Pete went to jail may be small consolation to a 12-year-old who now has Daddy's/Pete's baby as a result because she wasn't allowed to use Plan B.

Permalink to Comment

33. cliffintokyo on December 9, 2011 1:13 AM writes...

Plainly speaking:
Its FDA's job to make the scientific calls, and Gov's job to make the 'social norms' calls.
Just like reimbursement decisions are not FDA calls; i.e. Benefit vs Risk (FDA), and Effectiveness vs Cost (Ins)

Permalink to Comment

34. Henrikolsen on December 11, 2011 8:01 PM writes...

#33 quite, but they could damn well be honest about it rather than claiming bogus science as a cover for their "social norms" aka "caving to political pressure" call.
It's not so much the decision as the dishonesty in the way it's expressed that's disappointing.

Permalink to Comment

35. Anonymous on December 15, 2011 4:04 AM writes...

@34:
Reluctantly agree with you in view of the scientific fudging that has emerged since the HHS overcall.

Permalink to Comment

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