The Right-to-Try Bill and the Law of Unintended Consequence

Blog

March 2018

The Right-to-Try Bill and the Law of Unintended Consequences

Jim Nolan

On paper, the Right-to-Try bill represented the best in medicine: an effort to do good for those in need.

The bill would have permitted patients with terminal illnesses to petition biopharma companies for access to experimental drugs. Any drug that had progressed beyond Phase I of the clinical trial process could have been requested by a terminally ill patient.

But the bill, which was defeated in the House this week, also serves as a reminder that good intentions without scientific and rational forethought can have unintended consequences, ultimately hurting those they were trying to help.

Had it been enacted, Right-to-Try would have placed a disproportionate burden on smaller biopharma companies, which account for nearly two-thirds of drugs approved in recent years. Young biopharma companies emerging from Phase I trials are often seeking funding. They lack the resources to manage requests for their experimental drugs.

The bill’s reporting requirements would have placed pressure on companies to justify why some patients were given experimental drugs and others were not. To impose these requirements so early in the clinical trial process risked saddling young biopharma companies with negative information.

Moving a drug from the lab to the marketplace, where it can save or improve lives, is a herculean effort. Biopharma companies that are driving innovation deserve support without burdensome distractions like managing patient requests for experimental drugs, justifying decisions on treatment, and fulfilling reporting demands.

Yes, our industry needs to strive to do an even better job of safely accelerating the discovery and delivery of breakthrough drugs.

But good intentions must be married with solid scientific thought and reason. Otherwise, those we most hope to help will suffer further.