Commentators on the American scene going all the way back to Alexis de Tocqueville have noted how Americans are a society of “joiners”—participating in a seemingly endless array of clubs, groups and professional affiliations. In Washington, this becomes a more focused lobbying activity, and while nearly every politician (and voter) bemoans the influence of “special interests,” the reality is that most of us want our special interests tended to—and want the special interests of the others thwarted.
This line of thinking gets interesting when one sees parts of American society—let’s say, the bio/pharma industry—in conflict with itself. Case in point: in late spring and early summer, a large component of the bio/pharma industry, and including wholesaler and retailers, were lending their weight to the effort in Congress to pass a uniform, federal drug security law. A key component is standardized, federal rules for licensure for wholesalers and distributors (another component, not so broadly supported, is unit-level track-and-trace of pharma shipments). The bills proposed (S. 957 and H.R. 1919) are very explicit that their scope is both a floor and a ceiling to state regulations. At the very same time, the Biotechnology Industry Organization (BIO), which shares representation of overall bio/pharma manufacturers with the older Pharmaceutical Research and Manufacturers Assn. (PhRMA), was sending its lobbyists, state by state, to argue for state regulation of bioequivalence and biosimilarity, even while FDA is trying to finalize its policies on the same. In effect, BIO is trying to set the stage for variability in biosimilars substitution, even before FDA has established a national policy.
Imagine the outcome: you could be prescribed one product in one state, but forbidden from getting the biosimilar product in another. Hospital systems that operate across state lines (as more and more of them are doing) will need one set of rules in State A and another in State B. More to the point, state healthcare budgets will have to support generally higher-priced innovator products in one state, while another state will limit what will be prescribed first to the lower-priced products. (It’s not clear under which situation the patient “wins” in all this; if an innovator product is the only choice, the patient could wind up not being able to afford it.) Over a dozen states have had deliberations on this measure; most have either rejected it or put it under further consideration.
The biosimilarity debate is a longstanding and intense one—and we’re all awaiting the outcome of the FDA deliberations (the draft guidance was published in early 2012). I’m not making the case here for one side or the other in biosimilarity, but more about whether healthcare policy belongs at the federal or at the state level. One thing’s for sure: how can industry associations support a federal standard in one context, and then push for state rules in another?
And that question raises another, which is my point: has the time come for all healthcare products (not just pharmaceuticals, but also medical devices and many types of consumer wellness products) to have a unified voice as a trade association? Say, the US Chamber of Healthcare Commerce? I’m encouraged by the development of, for example, Prescriptions for a Healthy America Project, which brings together a truly impressive collection of associations, manufacturers and others to address the knotty issue of medication adherence.
It’s probably only wishful thinking to believe that the diverse range of healthcare product suppliers, let alone healthcare delivery providers, could all sit at the same table. But I wonder what good things could come of a unified approach like that.