Thoughts on “Reciprocal Marketing Approval”

On October 26, Senator Cruz introduced the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2017” (S. 2022), which is interesting from an FDA law perspective as well as an administrative law perspective.  We have seen this proposal before — in 2015 (S. 2388, introduced by Senator Cruz) and in 2016 (H.R. 6241, introduced by Congressman DeSantis).  Rachel Sachs wrote about it from a policy perspective in December 2015, and Zach Brennan offered more details in his own piece the same month.  I am going to dig into the details a bit more than they did and explain why I call it the “Send All the FDA Employees Home Act of 2017.”

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FDA’s Reliance on User Fees

Cross-posted on Notice & Comment.

On August 18, the President signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA), which reauthorized FDA to collect user fees in connection with new drugs, biologics, and medical devices for human use.  These user fee programs are colloquially known as PDUFA (innovator drugs and biologics), GDUFA (generic drugs), BsUFA (biosimilars), and MDUFMA (medical devices).

The White House had been urging Congress to change the structure of FDA’s user fee programs so that much of the agency’s programming is funded by user fees rather than appropriations.  Congress has more FDA user fee programs to reauthorize, however, and the Administration’s basic proposal is unlikely to go away.  I explain more of the history and the debate below.

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(FDA) User Fee Churn

Cross-posted on Notice & Comment

This post is one of several this summer that will focus on the pending FDA user fee reauthorization legislation.  It starts with a basic introduction: what is “user fee reauthorization,” and why must it pass?

The short version:  this summer we are talking about FDA’s medical product user fee legislation, which authorizes the agency to collect user fees from drug and device manufacturers.  The first medical product user fee law, in 1992, was the Prescription Drug User Fee Act (PDUFA).  The statutory provisions in question expire every five years, which means Congress must reenact them every five years if FDA is to continue collecting fees.  The process used to be called “PDUFA reauthorization,” but now user fees apply to more than prescription drugs.  This summer’s legislation relates to MDUFA (medical devices) and GDUFA (generic drugs), as well as BsUFA (biosimilars).  All must be renewed on the same five-year cycle, and the process is called “UFA reauthorization.”

Because the agency is now heavily dependent on these user fees, many view the reauthorization legislation as “must pass” — and that makes for an interesting legislative process.

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