What needs to be done right away:
NOTA BENEHere are a few developments that haven't received a whole lot of attention, but have the potential to really change the way the industry operates: For example, consider the preemption doctrine. In short, since federal law has constitutional supremacy over state law, FDA regulations—and actions taken in compliance with them—preempt conflicting or contrary state law, regulations, or decisions of a court of law for purposes of product liability litigation." Thus, the preemption doctrine provides a vitally important defense against a potential deluge of state lawsuits. The issue was addressed, sort of, in the PDUFA renewal legislation, but the real battle over preemption is going to take place in the federal court system over the next few years. Manufacturers should be watching this issue closely.
LOSING THE DATA
Another ongoing development to be cognizant of is the move to restrict access to prescriber-identifiable data for commercial purposes. New Hampshire, Vermont, and Maine have all passed laws toward this end. The New Hampshire law was overturned in a federal circuit court but now is being appealed. IMS and the other major data services recently filed suit against Maine and Vermont as well. Outside the United States, Germany has passed a similar law, and Poland is considering doing the same. Most industries can only dream of the depth and breadth of information that IMS and companies like it provide. For pharma this could truly be a case of "you don't know what you've got until it's gone."
Finally, a recent agreement between the Bush Administration and Congress over the country's negotiating position for Free Trade Agreements contains changes in policies on data exclusivity, "linkage" requirements, and patent-term extensions. For a variety of reasons, the administration's new policy is not likely to have a substantial effect on the global drug market. Under the past two presidents, innovative pharma has had no more vocal or powerful supporter than the executive branch of the US government. The FTA stance is one of several signs indicating that this support can no longer be reliably counted on.