A To-Do List for Dr. Hamburg – RX for an Ailing FDA

J0309384 Eight years ago, the FDA was a gold standard agency.  Today that gold is tarnished by eight years lacking in leadership, vision and growth with the times.  High level mis-steps and a lack of momentum has caused a crisis in credibility among policy-makers and the public in the once highly regarded agency.  That is a bad place for an agency that regulates over one-fourth of the U.S. economy.  Dr. Margaret Hamburg, as the new commissioner, will have her hands full.   Last year, the agency received the lowest public opinion rating it had ever gotten and this year, polls showed some improvement, but still with a long way to go.  

The first 100 days of the Obama Administration have passed without her installment to this most important post.  It is past time for her to begin work, and from my corner, here is her to-do list:
1.  Restore Credibility to the Agency – This will be a process, not an event.  It will involve developing a strategic plan through consultation with key stakeholders and then sharing that plan.  But it is more than just the development of the plan that must be accomplished, but rather it must also be strategically communicated.  She needs to lay out where she is going to take the agency and say how she is going to get there, with frequent updates.  She needs to be strongly out on the circuit and she needs to talk, talk, talk.  And more than that, there need to be results – it cannot be like the Critical Path Initiative – a strategic effort that makes little progress and about which people know next to nothing.  

2.   Offer Clear and Consistent Regulation on Product Promotion - DDMAC has made clear it does not understand emerging media nor does it know how to regulate it.  One week the agency puts out the message that "it is the message, not the medium" and the next week they act in exactly the opposite manner.  DDMAC does not know how to communicate its intentions with regard to regulation and instead treats their responsibility like some sort of game of "Gotcha" which has compromised faith in the ability to properly regulate marketing promotion. Consistent regulatory standards need to be clearly decided upon and enunciated.  Actions like these undercut the credibility of the agency.  It is past time for the agency to clarify the rules on digital and to engage in a transparent and inclusive process for doing so.  

3.  Integrate and Build the Computer Infrastructure – It has been well-documented and publicized that the FDA does not have consistent or broad enough computer operations to do its job – with disparate data bases hampering the ability of the agency to conduct inspections and to effectively oversee clinical trials.  In late 2007, the HHS Office of the Inspector General cited several problems on this front that kept the FDA from accomplishing proper oversight.  That cannot go on.  

4.  Develop a More Comprehensive Pathway to Food Safety - In the recent Harris Survey – 40% of people polled expressed a negative attitude about the ability of the agency to protect the public with respect to food safety.  There is a drive among some to divide the agency into two – one for drugs and one for safety.  Make clear early on what is going to happen.  In any case, enunciate better standards for companies to self-inspect and report and promote higher standards of traceability than currently exist.  

5.  Do Not Let Risk Overshadow Benefit in Drug Approvals - The FDA has been reluctant to approve pain relievers for people in extreme pain because the agency has been remiss in developing standards for Risk Evaluation Management Strategies (REMS) for these drugs.  Meanwhile, people in hospice and palliative care facilities are left without the benefit that these drugs would provide in pain relief.  During the AIDS epidemic in the 1990s, withholding the approval of drugs because the agency was not keeping up to speed would have been intolerable.   The standard should be no less today.  Getting drugs approved in a timely manner is a main responsibility of the FDA.  REMS are necessary, but this task should have been attended to long ago.

That is my two cents' worth anyway.
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