Independent Advisors Prove Independent

Reasons for the tougher regulatory environment, according to Baghdadi? “First, the FDA is bringing more drugs in front of advisory panels due to changes in FDA law that require most new drugs to be reviewed by outside experts,” the article notes. “Second, stricter conflict of interest rules implemented by FDA (in the wake of the 2007 reform law) have made it more difficult for the agency to recruit experienced panel members.”

If inexperienced members without conflicts of interest are more prone to voting no, how does that explain 2007, when the current rules weren’t in place and there were still 50 percent “no” votes?

Here’s my analysis: Generally speaking, the FDA calls advisory committees for two reasons: either its staff is internally divided or uncertain of its analysis of the safety and efficacy of a particular new drug application; or, it is looking for the outside panel to ratify what is going to be a controversial decision. In the former case, one would expect votes to go about 50-50. It’s like a well designed clinical trial where the observers truly don’t know what the outcome will be. You’d expect success — or failure — about half the time.

As for “ratification” votes, I’d look to the shifting political environment for an explanation. The FDA serves two constituencies: people and organizations primarily concerned about bringing new drugs to market (industry, many clinicians and patient advocacy groups) and those primarily concerned about drug safety and overutilization. FDA decisions generate controversy whenever they alienate either side.

In the wake of the Vioxx scandal, safety advocates have recouped some ground lost during the 1990s and the first half of the last decade, when the agency became overly industry friendly. These days, I would put their influence at the FDA about on par with industry, i.e., the odds of the FDA making a controversial decision requiring advisory committee ratification are about 50-50.

The 2008 and 2009 high approval numbers marked the end of an era when advisory committees served as rubber stamps for an industry-friendly FDA. Let’s hope this year’s votes mark the beginning of a new, more scientific era.

(Hat tip to FDAWebview – subscription required – for alerting me to TheStreet.com story.)

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10 replies »

  1. I forgot to add that that reference was originally provided by, I believe, Bobby G.; so give credit where it’s due.

  2. Actually, Dr. Jones, I mentioned CMS because an article in some Harvard publication (Business review?) did a nice study of how to regulate EMR’s and concluded the FDA was not suitable, but CMS could be involved in setting up a system. That article was also referenced in past posts (Margalit, thanks and help me out, again!)
    Please read the evidence before you sound off. We all need to be more evidence-based, not just in our clinical activities.

  3. Thanks ya all,
    That email to Bev indicates that the FDA is controlled by the ONCHIT with Blumenthal at the helm. What does CMS have to do with devices that endanger every citizen of this country, and internationally? CMS should have nothing to do with safety and efficacy of devices.
    Giving these devices carte blanche deployments is a directive from the White House (the CEO of Allscripts-Eclypsis advises POTUS)handed to Sebelius, the trial lawyer running HHS, who in turn, has enlisted ONCHIT and CMS to run interference and block thje FDA from doing its job of carrying out the Federal Food Drug and Cosmetic Act.

  4. Dear Bev,
    I am desirous of reading the email. Please be specific about where to find it. Was it on this blog or Margalit’s blog, if she has one? Thank you in advance for posting it again for all to read.

  5. Dr. Jones;
    I corresponded with the FDA this summer about regulating EMR’s; their response was that they and CMS are actively looking at this issue. Unfortunately I deleted their email response,but I believe I printed it in a comment on one of Margalit’s recent posts on EMRs, complete with the email address of the FDA official should you care to write yourself. Of course, this does not mean anything will happen, but I believe they are honestly looking at it.

  6. The FDA is extraordinarily user friendly to the HIT industry. Neither EHRs nor CPOEs have any scrutiny, pre or post market. ZILCH.
    EHRVA in conjuction with HIMSS and its offspring, CCHIT, have created the facade of certification and convinced Congress and HHS that certification equates to safety. The new script for certification written by NIST does not consider safety or usability as necessary to allow these devices to be used subjecting patients to risks of death and injury.
    On severla other health and IT blogs, there are reports that the CCHIT laboratory for certification does not exist, at least the reporters could not find it at the address listed in Chicago.