FDA Takes Decisive Action to Further Delay Taking Action

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The FDA's current tactic for delaying approval of over-the-counter status of the morning-after pill involves regulators asking themselves tangential questions about the drug and subsequently claiming to have no idea what the answers to those questions might be. The most recent justification came by way of a nonsensical August press release:

The question we have been asked to address is whether Plan B should be available without a prescription…for women age 16 and older, and remain prescription-only for those under the age of 16.

The issues that we were asked to resolve, and the proposal that was put forward by Barr Labs, presented us with many difficult and novel policy and regulatory issues.

That "difficult and novel" problem is one of the agency's own making. The FDA's scientific advisory board has recommended over-the-counter Plan B be accessible to all women, not just those 16 and over. It was FDA policy makers who then insisted that Plan B had not been adequately tested for adolescent females. Barr put forward a proposal to make the drug available to adult women, and FDA regulators almost immediately insisted they had no idea how to make a drug easily available to women but not girls.

Yesterday, Rep. Henry Waxman (D-Calif) claimed to have obtained documents demonstrating that the FDA had actually been considering those same regulatory questions for over a year before announcing that they were in fact "novel" and required an indefinite time period to hash out. (The August FDA statement was followed by a 60 day comment period, followed by silence; apparently FDA policy makers are slow readers.) Waxman has asked for an explanation. The FDA has offered no response as yet, but is currently "reviewing the matter."

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  1. “The question we have been asked to address is whether Plan B should be available without a prescription…for women age 16 and older, and remain prescription-only for those under the age of 16.”

    Just another way for the Puritans to control “children.” The infantilization of adolescents in our society is baffling.

  2. And don’t even get me started on how if a youth gets an MIP their insurance rates can go up even if they’re nowhere near their vehicle. I thought one wasn’t supposed to be able to be punished for a crime one didn’t commit in this country.

  3. Andy, agree with your first post, but the correlation between MIP and insurance a statistical evaluation of risk performed by your private insurance company. While I’m not acknowledging that the correlation exists, it is their decision to make. The second punishment is not at the hand of gov’t but at the hand of the private company that is going to pay a potential liability claim.

  4. …and FDA regulators almost immediately insisted they had no idea how to make a drug easily available to women but not girls.

    You mean like alcohol?

  5. “The second punishment is not at the hand of gov’t but at the hand of the private company that is going to pay a potential liability claim.”

    But why would a car insurance company need to know about your non-driving record? Because the government tells them. Please tell me exactly why they feel obliged to do so.

    Also, I think the argument could be made that since the government forces you to have insurance, and all these companies (as far as I know) are indistinguishable in this regard (re: MIPs), the distinction between public and private is not easy to make.

  6. “But why would a car insurance company need to know about your non-driving record? Because the government tells them. Please tell me exactly why they feel obliged to do so.”

    In Texas, at least, private insurance companies access that information voluntarily. Some actuary in a cubicle in a high-rise building decides that teens who get a MIP are statistically a higher risk and therefore pay higher premiums, while teens that good grades get a discount.

    Agreed that there is not much consumer choice in this regard. But I’m not arguing that the statistics are correct or that we should be forced to carry insurance, I’m just saying that ideally, the private market has a right to evaluate their risk and price the premiums accordingly. The presumption here is that there is a correlative relationship between MIP(or grades) and risk.

  7. “But why would a car insurance company need to know about your non-driving record? Because the government tells them. Please tell me exactly why they feel obliged to do so.”

    In Texas, at least, private insurance companies access that information voluntarily. Some actuary in a cubicle in a high-rise building decides that teens who get a MIP are statistically a higher risk and therefore pay higher premiums, while teens that good grades get a discount.

    Agreed that there is not much consumer choice in this regard. But I’m not arguing that the statistics are correct or that we should be forced to carry insurance, I’m just saying that ideally, the private market has a right to evaluate their risk and price the premiums accordingly. The presumption here is that there is a correlative relationship between MIP(or grades) and risk.

  8. Andy,

    If you could cite state insurance regulatory requirements to review criminal records (or within-MIP you-must-notify-your-insurer provisions), that’s a fine place to argue from. Otherwise, why aren’t your pants all equally a-bunched about insurance companies using credit scores, home ownership and car ownership as predictors on driving outcomes?

    If there are statistically significant attributes that are a matter of public record, complaining won’t change it.

  9. Dammit, sorry for the double. Would somebody please feed the gerbils

  10. “I’m just saying that ideally, the private market has a right to evaluate their risk and price the premiums accordingly.”

    Of course, but when the government forces you to buy into what is basically an oligopoly, I would say that’s not the most free market we could have.

  11. “You mean like alcohol? ”

    There’s a certain irony to the idea that the morning-after pill be distributed via liquor stores…

  12. “Otherwise, why aren’t your pants all equally a-bunched about insurance companies using credit scores, home ownership and car ownership as predictors on driving outcomes?”

    Because those things actually are related to liability. Admittedly, youth (or anyone, for that matter) who drink (and get MIPs…) are more likely to drink and drive, but it’s still unfair to assume that a kid who gets caught with a beer at a party is also a drunk driver (drunken driving being a good reason to raise somebody’s rates)

    Also, what you mentioned affects everyone equally, while my example is a clear example of age-bias.

  13. This is not surprising. That’s just par for the course for the FDA. It would be nice if the FDA stuck to resolving issues about the safety of drugs and avoid the moral aspects of allowing people to take safe drugs, but instead its just another politcal entity pushing an agenda.

    It’s the same bullshit with the HPV vaccine. It’s chilling to think that a member of the Centers for Disease Control’s Immunization Committee would believe

    …that mass use of an HPV vaccine or the availability of emergency contraception will encourage adolescents to engage in unacceptable sexual behavior; some have even stated that they would feel similarly about an H.I.V. vaccine, if one became available.

  14. Andy,

    You’re free to self-insure in some states, including my own:

    http://www.dmv.state.pa.us/insurance/self_insurance.shtml

    If one can demonstrate having the assets to cover liability claims against you for the coming year (which appears to mean plunking at least $50K in a conservative and liquid investment or an escrow account) you don’t have to buy insurance.

    I have no problems with requiring a demonstration of liquidity to settle claims on a driver before any accidents may occur, rather than after.

  15. “Admittedly, youth (or anyone, for that matter) who drink (and get MIPs…) are more likely to drink and drive, but it’s still unfair to assume that a kid who gets caught with a beer at a party is also a drunk driver”

    There. Now that you said it, doesn’t it feel better? “More likely” are the operative words here, and that’s all insurance is about. The likelihood of a claim. Of course it doesn’t hold true 100% of the time.

    “Because those things actually are related to liability.”

    And how is my credit score or home ownership related to my liability? There not, because many states exclude these things from potential torts. They are however (according to the insurance actuaries) indicators of my responsibility. And statistically responsible people generally get into fewer accidents.

  16. Homeownership, car ownership and credit score don’t have any skin in the game for liability. Your house and car aren’t on the line for the liability; the insurance policy premium is. If you cause more damage than your policy covers, then your house, title, credit and income come in. But that’s true for everyone.

    These attributes are used by the insurance companies because they are available facts about a person that have a statistically significant proxy relationship with responsibility.

    And a discount for homeownership (or 10 year history of good credit management) is not an age bias against teenagers and young adults?

  17. Here in VA we have it better, we don’t need no stinkin’ insurance. The only catch is you have to give the commonwealth $500 a year. Still, if you’ve got a few DUI’s, speeding tickets, insurance claims, accidents, and somehow still have your license, it may not be a bad deal.

    http://www.dmvnow.com/webdoc/citizen/vehicles/uninsured_fee.asp

  18. Mike –

    If you’re still around – are insurance rates any cheaper in VA because of this?

  19. Put it on the shelf, I’ll have a small supply on the shelf and will administer it personally to my sons lay of the day g/f’s!

    Hey it for sure beats the cost of a fake marriage and subsequent divorce dont it? Or an abortion at gunpoint? (what you never heard of a shotgun wedding)?

    come on, keep it fair.

    If you do not desire a child or are not in a position to care for one, ON YOUR OWN MONEY, then you have no business burderning me with said cost!
    I care not your upbringing, your personal beliefs or such, in fact I care less about YOU right now than about any other living human being on the planet! Take the pill or……?

    This is one father that is very tired of watching fine young people with portntial ruined by their parents morals! Even though they had no hesitation of opening their legs to some dude with a dick! And yes that for sure put the challenge on the women! I’ve been around far too long to be fooled by anything other than forcable and violent rape to be fooled by any other such notion some young and dumb little girl will say.

    She knows from a very early stage who controls the pussy. SHE does.

  20. What’s “MIP”?

  21. “What’s “MIP”?

    Isn’t it something some knights in “The Holy Grail” said?

  22. MIP = Minor in Possession

  23. “The question we have been asked to address is whether Plan B should be available without a prescription…for women age 16 and older, and remain prescription-only for those under the age of 16”

    The FDA should not be attaching an age restriction here. They should only be deciding OTC vs. prescription. They have absolutely no business making the decision of 16=OTC. Are pregnant 14 or 15 year olds different from pregnant 16 year olds?

    Nore importantly, why 16? Nearly every other drug deals with under/over 12. I’ve yet to see an OTC drug that uses any other age as the line between “child” dose and “adult” dose.

    If a 14 year old gives birth and drops the baby in a dumpster, will she be tried as an adult who knows right from wrong, or as a child incapable of buying a drug OTC?

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