As we celebrate the passage of the health care reform legislation, we can’t rest yet. Vigilance is needed  to ensure  the best provisions are fully implemented, and to continue to work for the full public option and rational use of resources. Alas, a biologics pathway was created in the package, but it is the industry-backed plan for 12 years of market exclusivity.

We’d had some hope in the new year that reason would prevail, as the last version of  the President’s healthcare reform package  included the creation of a biologics approval pathway, but did not specify details.  The President’s Proposal on the Whitehouse.gov website said:

Title VII. Improving Access to Innovative Medical Therapies

Promoting Biologics Price Competition and Innovation

The Act creates a new pathway to create generic versions of biological products so that Americans have access to effective, lower-cost alternatives.

This meant that the final version was still to be determined, which opened a new window of opportunity to advocate for a rational, patient-centered alternative.   Anthony So and Samuel Katz, both physicians professors of medicine at Duke, did just that with an eloquent op-ed that ran in the New York Times on March 8.  Biologics Boondoggle explained the issue succinctly , and made the case for limits on  marketing exclusivity for new biologics as a health promotion and cost-saving  measure:

Of course, one reason why the pharmaceutical industry would like 12 years of protection for biologics is that it would set the stage for lengthening the period of monopoly protection for conventional drugs as well. GlaxoSmithKline has already called for 14 years of exclusivity for conventional drugs.

Congress should allow biologics no more than five years of protection. That would provide drug makers plenty of incentive for innovation, and still protect consumers from the high prices that extended monopolies allow. Striking the right balance will ensure that Americans can afford the most effective medicines available.

So far, there has been relatively little commentary on the effects of the new biologics pathway provisions for patients, and  some mentions related to biotech research.   It’s  certainly positive that the doughnut hole in Medicare part D will eventually be eliminated,  but without price controls on medicines nor a reasonable avenue for generic biologics to become available to consumers, the costs of Rx drugs will only continue to skyrocket and seriously compromise access in the US and worldwide.