Sen. Bernie Sanders (I-VT) has introduced an amendment to the health care reform bill that would prohibit companies from claiming 12 years exclusivity for the clinical trials data that led to approval of their biologic drugs if that claim forced generic firms to conduct duplicative clinical trials.

The situation would arise whenever a patent for an approved biologic had expired, but the data exclusivity period extended for additional years. In theory, other firms wouldn't be prohibited from manufacturing the drug. But they would have to run their own clinical trials to get data to submit to the Food and Drug Administration, since the data contained in the innovator company's filings would be off limits.

Any such trials, Sanders noted, would be a violation of the Declaration of Helsinki and the FDA's own good clinical practice guidelines, which protect human subjects who participate in clinical research. Since the efficacy of the drug is already known, subjecting humans to additional trials would involve all risk (not getting the drug in the control arm of the trial) for no benefit.

"The issue addressed by the amendment has long been of interest to public health groups, on the grounds that regulatory rules providing exclusive rights in clinical trial data violate medical ethics," noted James Love of the Knowledge Ecology International.

It's unlikely Congress will pay attention to the independent socialist from Vermont. But the Helinski Declaration and GCP guidelines are real. The upshot is that failure to pass the Sanders amendment effectively means there will be NO biosimilar drugs brought to market during the data exclusivity period, even when it runs beyond the normal patent life. 

I wonder if biotechnology companies were aware of this ethical roadblock when their representatives claimed that data exclusivity wouldn't prohibit companies from conducting their own trials on patent-expired biologics.