LSIPR 50 2018: Patrick Leahy

Name: Patrick Leahy

Organisation: US Government

Position: Senior Senator

Now in his eighth term, Senator Patrick Leahy is credited with playing a pivotal role in the introduction of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017.

The CREATES Act was designed to target abusive delay tactics being used to block entry of affordable generic drugs, paving the way for generic drug manufacturers to bring their lower-cost products to market.

The Congressional Budget Office has estimated that the bill would lead to a $3.3 billion net decrease in the federal deficit, while the savings for consumers and private insurance companies are likely to be far greater.

CREATES addresses the delay tactic where brand-name drug companies stop generic competitors obtaining samples of the branded product, preventing the generic company performing the necessary testing to show that it is equivalent to the brand-name product.

The second delay tactic addressed by the Act takes place when the brand-name manufacturers, whose products require a distribution safety protocol (a risk management plan), refuse to let generic competitors participate in that protocol. Again, this undermines the generic’s ability to gain Food and Drug Administration approval.

In December 2008, Leahy reached the milestone of becoming the longest-serving senator from Vermont.

As well as serving as the vice chair of the Senate Appropriations Committee, Leahy is the ranking member of the State, Foreign Operations and Related Programs Subcommittee and a leading member of the Agriculture and Judiciary committees.

He is the co-chair of the Senate National Guard Caucus and co-founder and co-chair of the Congressional Internet Caucus. During his extensive career, he has focused on conservation, nutrition and environmental initiatives, work that has seen him help protect Lake Champlain, which straddles the New York, Vermont border.