I recently wrote a preliminary reaction to the Supreme Court’s Sandoz v. Amgen decision on Health Affairs Blog. This was the Court’s first foray into the Biologics Price Competition and Innovation Act (BPCIA), which created a pathway for licensure of biosimilar biologics. As my essay for Health Affairs notes, the issues presented by this litigation are not entirely resolved. There is fodder for a great deal of further discussion.
Today I am starting with the Court’s ruling that Amgen was not entitled to a federal injunction ordering Sandoz to share its marketing application and manufacturing information with Amgen. The topic here is the origin of the argument that Sandoz made to the Court — the omission of manufacturing process patents from the declaratory judgment provision.
Continue reading “Origins of the Theory that the “Patent Dance” Might Not Be Required: Omission of Process Patents” →
Cross-posted on Notice & Comment and Stanford’s Law and the Biosciences Blog.
Industry funding of patient advocacy organizations recently has received attention from media and researchers. For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when FDA was considering approving it. This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.
Continue reading “Advisory Committees and Industry-Funded Patient Advocacy” →
Cross Posted on Notice and Comment.
Budget documents released by the White House and FDA in May suggest the Administration intends to restructure medical product user fees, so that a greater percentage of the agency’s work is fully user fee funded. The Secretary’s May 15 letter, explaining the President’s earlier Budget Blueprint, suggests the goal is for medical product user fee programs to be 100 percent user-fee supported.
Congress structures agency user fee provisions many different ways, and the current approach to medical product user fees is complex and unusual. Among other things, it ensures that annual appropriations play a role in supporting review activities. This means the Administration’s proposal would require revision of the bills currently winding their way through the legislative process.
Continue reading “Supporting FDA Product Reviews with User Fees Alone” →
Cross-posted on Stanford’s Law and Biosciences Blog
A few news stories over the past week or so—one in the Wall Street Journal about “neurotech,” one in Geek Gadget about “neuroscience wearables,” one in the Washington Post about baby monitors for measuring an infant’s vital signs, and one in Gizmodo about “vaginal wellness products” marketed on Etsy—reminded me how much I enjoy questions of intended use. As I wrote last week, intended use is a critical concept in FDA law, in part because a product’s intended use is crucial to determining whether it meets the law’s definition of drug or device within the FDA’s jurisdiction. And, for whatever reason, I have an unabashed and—as far as I can tell—limitless love for thinking through questions about whether, and how, products fall with the definition of a drug or device.
As for the reported neurotech, neuro-wearable, baby monitor, and vaginal wellness products, it seems to me that many of these products may fall within the Federal Food, Drug, and Cosmetic Act’s (FDCA) definitions of drugs or devices. Why is that?
Continue reading “I <3 Intended Use (and why some new technologies may fall within FDA jurisdiction)” →
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.