Proposed Legislation Seeks to Avoid Duplicative Trials

A new piece of legislation proposed in the US Senate would eliminate some requirements that sponsors conduct clinical testing on subjects, instead allowing some sponsors to enter into agreements with existing sponsors to access their clinical trials data-sometimes on a mandatory basis.

The Ethical Pathway Act of 2012 would specifically allow sponsors of drugs, biologics and medical devices to, "Rely upon existing trials, subject to sharing of the costs of those trials, during the period when regulatory test data is protected."

Under the act, the US Food and Drug Administration (FDA) would be charged with establishing a pathway through which an applicant could request to share the costs of a clinical trial if they would otherwise be required to conduct duplicative testing or would violate Article 20 of the Declaration of Helsinki.

Article 20 states that physicians must avoid conducting research if the risks to patients are not understood or cannot be managed, and should cease any research once the risks are found to exceed the potential benefits or the benefit is proven.

The Cost-Sharing Arrangement

The mechanism set up by FDA would first require applicants to the process to attempt to reach an agreement with the company voluntarily using what the bill refers to as, "Reasonable efforts." If such an attempt is unsuccessful, applicants can petition FDA to act as an arbitrator between the companies and set up a binding agreement.

If one or both of the parties refuse to subject themselves to binding arbitration, FDA would then be able to set a "reasonable and fair fee for the reliance by the applicant on such regulatory test data."

The fee would then be determined by assessing five factors: the out-of-pocket cost of the trial, the risk of the investigation, grants or tax credits that decrease the net cost of the trial, expected sales of the product and the amount of exclusivity obtained by the product.

The bill was introduced by Sen. Bernie Sanders (I-VT) on 2 August, and has been referred to the Senate Health, Education, Labor and Pensions (HELP) Committee for further action.