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.
Continue reading “(FDA) User Fee Churn”
In the spirit of our blog’s title, this is the first of several posts to tackle the FDA’s controversial revisions to its regulations defining “intended use” and describing the evidence relevant to determining a product’s intended use. This post covers the background—what has happened, and why it is important. Subsequent posts will cover some of the substantive and procedural concerns that have been raised about the agency’s revisions.
Continue reading “The Intended Use Hullabaloo”
(Cross-posted on PatentlyO.)
On May 30, the Supreme Court surprised many of us by ruling that exhaustion of U.S. patent rights occurs even when sale of the item takes place in a foreign country. There is a great deal more to the ruling, and there are now very interesting questions about the characterization of transactions as something other than “sales” and about the use of contractual provisions to prevent resale into the United States following first sale of patented products elsewhere. But for now, let’s stop with the bare bones description: U.S. patent rights are exhausted when an item is sold overseas. This means that shipping an already-sold product into the United States for subsequent-sale to a U.S. consumer will not infringe the patents in question. Depending on how patent owners structure their transactions overseas going forward, this ruling could give U.S. consumers access to products that are intended for foreign markets and that are priced for those markets — lower, for instance.
One of the many topics circulating now: what are the implications for pharmaceutical companies and for U.S. consumers of pharmaceuticals?
Continue reading “Demystifying Drug Importation after Impression v. Lexmark”
We are delighted to introduce Objective Intent, a blog in which we explore legal and policy issues associated with the U.S. Food and Drug Administration (FDA). The FDA is an important and (we think) particularly interesting agency that has broad powers to achieve its public health mission and jurisdiction over roughly 25% of the consumer economy. As some readers will know, the title of our blog, “Objective Intent,” comes from FDA regulations that define “intended use.” This title both pays homage to the critical role that a product’s intended use plays in many FDA controversies and reflects our hope that this blog will serve as a space for objective reflection on FDA issues by legal academics.