Question:What risk management precautions should a firm take if significant sales are derived from off-label use of its drug or device?
Sara Dyson, Esq.
Answer:Promoting medical devices and drugs for uses that have not been approved by the Food and Drug Administration (FDA) constitutes off-label promotion, which is forbidden by the Federal Food, Drug and Cosmetic Act (FDCA). Companies that promote off-label face severe criminal and civil penalties. In recent years, off-label promotion has been the subject of countless Warning Letters, cost the industry billions in fines, led to jail time for company executives, resulted in Corporate Integrity Agreements and Deferred Prosecution Agreements, and triggered costly products liability lawsuits. Yet, even so, many medical device and drug companies continue to profit significantly from the off-label uses of their products.
David Colquhoun in his office at UCL: ‘People simply still don’t get that to prove “effect B” is caused by “intervention A” you have to use randomised controlled testing.’ Photograph: Karen Robinson
Professor of pharmacology David Colquhoun is the take-no-prisoners debunker of pseudoscience on his unmissable blog
David Colquhoun, professor of pharmacology at University College London for 30 years, has lately led a double life. In his day job, he has pioneered painstaking research into the binding properties of molecules and contributed extensively to understanding the particular influences on ion channel function in the development of drugs. In his after-hours alter ego, however, he is the take-no-prisoners scourge of quackery and mumbo-jumbo in his unmissable blog, DC’s Improbable Science.
I can’t tell you how many times people complain about “cyclists” who run red lights, blow through stop signs, ride without lights at night or and don’t pay for the roads. If I had a dollar for every time someone told me that cyclists should be taught the rules of the road and given a test like motorists, I could retire and move to Copenhagen where those things actually happen.
A year has passed since President Barack Obama enacted a law intended to spark business growth by encouraging “crowdfunding” of startups. Much of the law remains to be implemented, but that hasn’t stopped crowdfunding sites Poliwogg and Microryza from employing different models toward raising money for biopharmas and researchers, respectively.
This month, Poliwogg is launching its platform, focusing on helping fund small- and mid-sized companies in biopharma and other “healthcare” specialties, as well as in community-based businesses and projects, and portfolios of high-yielding investment-grade assets…