Diagnostic laboratory tests play a central role in the implementation of precision medicine. It is essential that FDA regulation strike the right balance between protection of patient safety, and encouragement of advancement and innovation in testing. Read an original approach to FDA regulation that Professor David Hyman and I published in Investor’s Business Daily.
Under federal law, pharmaceutical companies can be charged with a crime simply for telling a doctor about a legal, alternative use for an approved treatment. Sadly, government routinely censors the communication of valuable and truthful information that could help improve – and even save – people’s lives.
This changed in Arizona last week when Governor Doug Ducey signed HB 2382, a new state law that safeguards the free speech rights of those in the medical field to share truthful research and information about alternative uses for FDA-approved medicines. [Read More]
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. [Read More]
It’s a shame that in a nation that prizes free speech, the government routinely censors the communication of valuable and truthful information that could help save people’s lives. But it’s a fact. Federal law strictly limits how pharmaceutical companies – those with the most knowledge about drugs and their possible uses and side effects – can share information about the legal "off-label" use of their products.
Last week, the FDA once again thwarted efforts to establish clear guidelines by entering into a settlement agreement in the Amarin case involving free speech and off-label advertisement. [Read More]
In a huge 15 part series currently running at the Huffington Post, author Steven Brill accuses Johnson & Johnson of "crimes" and "illegal" conduct for its efforts to market the anti-psychotic drug Risperdal to FDA-unapproved populations. Brill appears completely unaware of the First Amendment to the Constitution, and that the Second Circuit Court of Appeals and Southern District of New York have held that the Food, Drug and Cosmetic Act must be interpreted in light of the Constitution as not criminalizing truthful statements by a company about its products, even if the FDA would like to prohibit those statements. It is the FDA that is behaving lawlessly. ... [Read More]