Upcoming Legislation

More on legislation, this time more expansive…

The New York Times carried a report yesterday of legislation to be introduced by Senators Kennedy (D-Mass) and Enzi (R-Wyo) that from all appearances is sweeping in the nature of the reforms it would bring to FDA and to industry.  The report indicates that nearly every controversy that has engulfed the industry and the FDA over the past two years is being addressed in this proposal.

Among other things, it appears the bill will propose that companies be required to register all clinical trials and to make public Phase III and IV results public.  Further it would not only require risk management plans, but the annual review of same for a three year period.  Perhaps it was foresight of this that led Dr. Scott Gottlieb to speculate on the role of risk management plans in his recent speech before the American Medical Association this month.  Also included in the plans could be components that curb advertising and marketing practices on a drug by drug basis.  The agency would also have the ability to induce fines for violations. 

This type of proposal is the product of the erosion in confidence of both the public and policy makers in the agency to protect public health and in the industry to self-administer guidelines.  With legislation such as this being introduced prior to the election cycle, it raises the possibility that these issues will be a hearty source of public debate in the coming months.

Given that, it is incumbent on the agency, which has been solely reactive to the unfolding crises, to get ahead of the curve with communications that attempt to achieve one of the aims of the bill – to restore public confidence in the ability of the FDA to protect public health.  And for industry, now more than ever, it is important to steer away from any marketing practices that, while legal, could invite scrutiny.  In other words, if something falls into the "gray zone" – avoid it, or risk becoming a poster-child during the election or following debate concerning this bill.  In addition, as stated here before, companies should review their progress on Phase IV commitments and be prepared to address their track records.  The true benefit that pharmaceutical products bring to so many should not be overshadowed by the debate on these issues.  That is a problem that could impede future developments at a time when public policy should be encouraging innovation, not stifling it. 

Inevitably, the public discussion around these proposals will color the discussion of PDUFA reauthorization.  If enacted and signed into law, the FDA would need a lot more money to institute all of these programs and will carry even greater responsibility than they do now, which raises the question about whether or not public confidence can be boosted by exacting greater fees from the industry that is regulated for the benefit of the agency that is regulating them. 

As stated yesterday, when this legislation is introduced, you can follow it with GovTrack.us and it will also be tracked here. 

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