• When you’re in a hole, stop digging

    I’ve said that I’m most upset about the Plan B decision of last week because it seemed to be politics trumping science. I said this because in spite of evidence being offered as to the safety and efficacy of Plan B, Secretary Sebelius declared that none existed. Yesterday she doubled down:

    The decision to block wider access to the morning-after contraceptive known as Plan B was not political, Health and Human Services Secretary Kathleen Sebelius said Monday.

    According to a Bloomberg report, Sebelius said the decision was not “about politics.” She discussed the Plan B controversy with reporters after an event with New York City Mayor Michael Bloomberg — who said he disagreed with Sebelius’s decision.

    She says it’s not about politics. So here’s where it gets peculiar. The head of the FDA, and those on the committee making the decision, were trained and experienced in the science. They heard all the testimony, and evaluated all the evidence. And then they made an expert opinion.

    Let’s be blunt. Secretary Sebelius is trained in none of those things. She’s a political appointee – literally. So when she gets involved, she’s saying that she’s more equipped to evaluate the science than all those who worked on this decision. She’s saying they were wrong.

    How so? What was their error? What did she see that they did not?

    Sebelius reportedly said the drug’s manufacturer, Teva, can apply again for over-the-counter status if it finds new data about Plan B’s safety and effectiveness.

    What data? What’s missing? Again, let’s be clear. Since Plan B is approved with a prescription, it’s already been ruled safe and effective for women of child bearing age. No changes have been made there. No more data will be needed on that front. All that it takes for a drug to become over the counter at this point is evidence that individuals can make decisions about its use without the intervention of a health care professional. That evidence has already been offered and evaluated. Here’s Margaret Hamburg (emphasis mine):

    The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

    It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence.  The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process.  Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs.  CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.

    I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.

    If the decision is political, as it appears to be, then I wish Secretary Sebelius would stop digging. If she truly believes her decision is for scientific reasons, then she needs to detail where the science is lacking, where Dr. Hamburg and the FDA were wrong, and exactly what “new data” she requires that the CDER didn’t. I look forward to someone asking her.
    AEC

    Comments closed