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.
Andrew Van Haute, Esq. is Associate General Counsel of Advanced Medical Technology Association (AdvaMed).
Interactions between health care professionals and medical technology companies fuel the advancement of new technology and improve the quality of medical care through training and education. However, it is important that these relationships never cross the line to impropriety, particularly in today’s age of the Sunshine Act and state and federal anti-kickback regulations. Even the appearance of misconduct in this respect can have serious regulatory, products liability, and even criminal consequences for life sciences companies. The AdvaMed Code of Ethics provides guidance and a set of standards for companies to follow in order to ensure that their interactions with healthcare professionals are appropriate, and thus that the healthcare professionals’ selection of particular products are only reflections of their independent medical judgments and cannot be attributed to the influence of company personnel.
This webinar will address:
What the AdvaMed Code of Ethics is and what it covers
The impact the Code has had on life sciences companies
With an ever-changing political climate and the promulgation of new laws and regulations all the time, it can be difficult for life sciences companies to know what’s going on in Washington and how it affects their businesses and bottom lines. In this month’s webinar, long-time life sciences lobbyist, Jeffrey J. Kimbell, will provide a rundown of current Hill happenings that matter most to drug and device companies, as well as a prediction for what life sciences companies can expect in the upcoming policy cycles.
This webinar will address:
The current political composition of Congress and the new faces of the 113th Congress
Preview of the 2014 and 2016 elections
The future regulatory environment life sciences companies can expect
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.