Considerations for a New Regulatory Environment

February 15, 2006 – This is a time for a lot of soul searching on the part of industry as well as the FDA. Events of the past two years are shaping an entirely new landscape in drug development and regulation. This new era is one which contains a great number of uncertainties for the future of all drugs in the pipeline.

What exactly do the past two years mean?

When we consider the impact, we have to know that the industry is being scrutinized as a whole, but individual companies are also going to face examination.

First, it should be clear that there is going to be greater scrutiny of the post-marketing commitments made by companies and how well goals have been reached. Second, questions have arisen as to whether or not the current system of adverse event reporting is adequate. Third, the nature of clinical trials is probably going to change – what can be done about that for the future, and for the drugs currently in the pipeline?

What Industry Should Think About.

Analysis by companies may not be easy, particularly in those pharmaceutical companies where public affairs, regulatory and marketing divisions often operate in such separate silos. Communications-wise, each member in industry needs to stop and conduct an internal audit to see whether it is up to the task of considering a more holistic approach to analyzing and reacting to the emerging issues that each company faces in the coming two years.

Those issues are apparent. In the coming two years, Congress will consider legislation to remove the Office of Drug Safety from the FDA, motivated in part to determine whether or not the current system of post-marketing safety surveillance and adverse event reporting is adequate. As a consequence, companies need to be able to characterize their own track records with respect to how well they have kept post-marketing commitments and develop a response that is not merely premised on a case-by-case basis, but which collectively spells out a company point of view and perspective. Without the benefit of understanding its own experience, a company will leave it up to media and inquiring policy-makers to fill the vacuum. Companies need to consider how the events of 2004 and 2005 are going to affect their future commitments in this regard. If they do not, legislation may do it for them.

Secondly, companies need to understand and be able to communicate their systems of adverse event reporting. As with the issue of post-marketing commitments, industry will be scrutinized as a whole and member by member and this too will require a company to assess and enunciate a point of view in order to reassure those who would change current policy that the system as it works now does in fact protect the health of the public.

Next, the size and scope of clinical trials is going to change, especially for drugs treating non-life-threatening conditions. Any signal of risk in either pre-clinical or clinical studies is going to have to be further examined in larger Phase III clinical trials that also are balanced to reflect the actual population – which means going beyond mere advertising as a recruitment tactic. It means developing a specific plan for recruitment that helps people understand the nature and need for a clinical trial that is more in-depth than advertising can offer. Without such an effort, it might be possible to achieve size, but scope as signified by minority representation, will simply not meet with success.

Lastly, the way in which the safety of new drugs coming to market is scrutinized has changed. The bar is going to be set higher for all drugs and the risk/benefit ratio more defined. Now, more than ever, companies will find that an FDA Advisory Committee meeting is where branding for the product will be taking its first breath. In the drug approval process of yesterday, advisory committees were an exchange of scientific information – in the meeting of tomorrow, they are likely to be more akin to adversarial proceedings. They will be widely reported, with an emphasis on risk rather than benefit, and this will form the public’s first understanding of a new drug. Companies that do not prepare their presentation accordingly are more likely to find themselves on the receiving side of an approvable letter, rather than approval letter, especially during this time when drugs are being considered today with clinical trial designs of yesterday.

Perhaps most important is the fact that, despite the shifts in outlook on the regulation of pharmaceutical drugs, there is no certainty as to how the dust will finally settle. The legislative proposals before Congress could alter completely the scrutiny, sales and marketing of prescription drugs. Beyond the increase in MedWatch alerts and warning letters, the FDA has not publicly indicated how it is going to work with industry in this new environment so that the conduct of clinical trials is not so burdened by large increases in size and scope that bringing new products to market becomes either too expensive or increases the cost of the eventual approved product. And for drugs coming up for approval in the next year with clinical trials designed in a pre-Vioxx era but being brought before advisory committees in a post-Vioxx era, the agency needs to step forward with some leadership initiatives to work closely with companies during this time. However, in this environment that is highly charged with issues of safety, the agency has been without an appointed leader more often than not. Without such leadership, accomplishing the kinds of initiatives that are necessary are, by definition, difficult and many candidate drugs that could bring benefits to patients may never see the light of market.

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