Drugmakers that pay physicians to author ghostwritten papers, switch prescriptions or be "shadowed" by drug reps are likely to violate federal anti-kickback laws, according to a new compliance guidance issued April 28 by Janet Rehnquist's HHS Office of the Inspector General.
The 39-page guidance, published in draft form in October, is meant to give drug companies a benchmark for their marketing efforts, though it is not legally binding.
Specifically, the guidance says the following activities by drugmakers are "suspect":
- Paying physicians for giving their names to ghost-written papers or speeches.
- Switching agreements, in which physicians are paid each time a patient's prescription is changed.
- Shadowing arrangements, when drug company reps pay to observe physicians seeing patients.
- Paying doctors to listen to sales representatives market pharmaceutical products.
- Compensating physicians as "consultants" for attending meetings or conferences primarily in a passive capacity.
- Paying physicians for speaking on certain research when it is "connected directly or indirectly to a manufacturer's marketing and sales activities."
- Presentations to physicians involving meals or entertainment "if any one purpose of the arrangement is to generate business for the pharmaceutical company."
- Research contracts that originate through the sales or marketing functions or that are offered to physicians in connection with sales contacts.