The FDA treats innovators like outlaws - and it's taking a toll
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In March, I posted about the pharmaceutical company Amarin’s legal battle with the federal Food and Drug Administration over the company’s right to share truthful information about the so-called “off-label use” of its products. Although that case eventually settled in Amarin’s favor, it represented another missed opportunity for the Agency to establish clear guidelines for speech.
Today, Reason TV has posted a new video about yet another FDA attempt to punish a company for sharing information about its products’ off-label use. Although Vascular Solutions, a company that develops life-saving medical devices, was finally vindicated, the 5-year, $25-million legal battle took a toll.
Vascular Solutions CEO Howard Root writes of what he calls his “unjust prosecution” here:
I took the entrepreneurial plunge in 1997 when I started Vascular Solutions. Over the last 20 years, I’ve led the company in developing over 100 new medical devices that are used worldwide to improve the lives of patients suffering from vascular disease. In the process, we’ve created more than 500 well-paying American jobs and never received so much as a warning letter from the Food and Drug Administration (FDA).
But over the past five years, the Department of Justice has tried to convict me of a felony that could have put me in prison for years. My “crime”? The prosecutors thought it was “off-label” for our salespeople to talk with physicians about using just one version of just one of our more than 100 medical devices to treat perforator varicose veins rather than saphenous varicose veins.
They believed this was a felony even though our device was FDA-cleared for treating all varicose veins, over two-thirds of our salespeople never sold even one unit of it, sales constituted only 0.1 percent of our total sales and not a single patient was harmed.
It’s time for the FDA to stop treating innovators like outlaws and instead respect the constitutionally protected right to share truthful information about legal activities.
Partner, Orrick, Herrington & Sutcliffe LLP
Andy excels at solving complex problems for his clients using a variety of effective strategies. As former Chief Deputy Attorney General for the State of Wisconsin, Andy Cook has extensive experience representing businesses before state Attorneys General involving investigations and lawsuits. His strong relationships with Attorneys General and their senior staff frequently facilitate the successful resolution of client issues through diplomacy and negotiations. When litigation becomes necessary, Andy effectively advocates for clients throughout the litigation process.
Andy combines his legal expertise in numerous areas of law covered by state Attorneys General, an understanding of how state AG offices operate, and vast knowledge of legal and regulatory issues facing his clients. This substantive and comprehensive legal approach is crucial to effectively representing clients before state Attorneys General. Andy also has substantial experience drafting and enacting complex civil liability reforms before state legislatures to successfully address client goals.
Andy’s main practice focuses on advising Fortune 500 companies before state Attorneys General in the areas of antitrust, consumer protection, False Claims Act, environmental law, and cybersecurity and data privacy. Andy, in collaboration with a team of attorneys, successfully navigated a client through antitrust regulatory review by state Attorneys General in one of the nation’s largest mergers of two major telecommunication companies. Andy also worked with a team of lawyers representing a large corporation involving the multistate opioids litigation brought by state Attorneys General.
Andy gained valuable experience serving as Deputy Attorney General for the State of Wisconsin where he was the second in command of the 700-plus state agency. In his role as Chief Deputy Attorney General, Andy oversaw the day-to-day operations at the Wisconsin Department of Justice (DOJ); directed the State’s litigation strategy; negotiated, reviewed, and approved all settlements; drafted and reviewed attorney general opinions; managed the agency’s budget; oversaw civil and criminal investigations handled by DOJ; and managed DOJ’s legislative agenda.
Andy played college hockey and remains active by running, cross country skiing, and playing golf. On the weekends, Andy and his wife enjoy watching their kids’ sporting events, including soccer, baseball, gymnastics, and track. In his rare spare time, Andy reads history books.
Executive Vice President, Goldwater Institute
Christina Sandefur is the Executive Vice President at the Goldwater Institute. She develops policies and litigates cases advancing healthcare freedom, free enterprise, private property rights, free speech, and taxpayer rights.
Christina is a co-drafter of the Right to Try initiative, now federal law, which protects terminally ill patients' right to try safe investigational treatments that have been prescribed by their physician but are not yet FDA-approved. She has won important victories for property rights in Arizona and works nationally to promote the Institute's Private Property Rights Protection Act, a state-level reform that requires government to pay owners when regulations destroy property rights and reduce property values.
Christina is the co-author of the book Cornerstone of Liberty: Private Property Rights in 21st Century America (2016). She is a frequent guest on national television and radio programs, has provided expert legal testimony to various legislative committees, and is a frequent speaker at conferences. She is the recipient of the 2018 Buckley Award in recognition of her leadership in the freedom movement, and she is an Advisory Board Member of the Network of enlightened Women. Christina serves on the board of the Phoenix Lawyers Chapter of the Federalist Society and is a member of the executive committee for the Federalist Society's Regulatory Transparency Project: FDA & Health.
Christina is a graduate of Michigan State University College of Law and Hillsdale College.