Winds of Change at FDA

Yesterday the Obama Administration announced a new Task Force at FDA to delve into the issue of transparency.  Later that same day, the FDA opened up a new part of its Web site devoted to FDA transparency and launched a blog, rather unremarkably titled the FDA Transparency Blog.  It's true.  I could barely believe my eyes.  

The first posting is brought to us by none other than Secretary of Health and Human Services Kathleen Sebelius and a note from newly sworn in Commissioner Margaret Hamburg.   The site will have a moderated comment policy though to my friend Brian Reid's point - there is no mention of who will author the blog nor who will be monitoring the comments.  So maybe transparency needs to begin right there.

Is transparency a problem at FDA?  Yes - FDA's embarrassing Plan B fiasco demonstrated that much.  Is it the only problem at FDA?  No.  But it is probably a good place to start.  

In a related development, also occurring yesterday, Congressmen Henry Waxman and Bart Stupak of the House Committee on Energy and Commerce sent Commissioner Hamburg a letter asking that the FDA review its point of view on the role of Bisphenol-A in food containers, particularly baby bottles and sippy cups.  

In an interview with the Associated Press on the same day, FDA stated that the review and decision would take place in a matter of weeks, not months, and would be led by Dr. Jesse Goodman, Acting Chief Medical Officer at FDA.   That was fast work.  But I would not spend much time guessing what the outcome will be....

Nevertheless, yesterday was a busy day.  Not only is there an announcement of a promise for transparency, a Task Force named, a blog launched, but the very first test case for that transparency - the review of Bisphenol-A policy - provides an opportunity for the author of the blog (whoever that may be) to write about the process openly so that we may comment (to be reviewed by whom we know not).  

Comments

[Ken Johnson]

PhRMA and its member companies have a longstanding commitment to the ethical conduct of clinical trials and to increasing transparency by reporting more information about clinical trials. Our newly revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results underscore our members’ efforts to further enhance clinical trial transparency.

Companies following the PhRMA Principles will register all interventional clinical trials involving patients – including some early Phase 1 studies – on a public website, to help patients who need medical care enroll in relevant studies. There are important public health benefits associated with making appropriate clinical trial information widely available to healthcare practitioners, patients and others. The most important clinical trials are those that test a medicine in patients – people who actually require medical care. Results of these trials provide medical evidence regarding the safety and effectiveness of medicines in the precise population the medicine is intended to help.

What’s more, the companies following the revised PhRMA Principles will greatly expand transparency in medical research by committing to provide research results summaries
for all interventional clinical trials involving patients – after the medicines are approved or the particular research programs have been discontinued. By providing results summaries of safety and effectiveness data for clinical trials shortly after a drug’s approval or following discontinuation of development, PhRMA members will significantly expand the universe of publicly available data about clinical trials in patients.

Our commitment to enhanced transparency is balanced by our desire to maintain an environment conducive to ongoing development of life-saving and life-enhancing therapies.

The Food and Drug Administration (FDA) has historically treated information regarding unapproved medicines as confidential commercial information or trade secrets in order to protect the competitive research development process. Any proposal to disclose information about medicines during the FDA review process should be carefully considered to ensure that the competitive development process remains intact to serve patients and the public health.

We welcome a dialogue with regulatory authorities and stakeholders about these important matters.

Ken Johnson

Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President