Senate Sunshine law gets update, Lilly endorsement
The bill, as currently written, would impose significantly lower penalties than the $10,000 to $100,000 per violation in the original legislation. It distinguishes between “knowing failure to report,” for which companies may be fined up to $50,000 per violation, capped at $250,000 per year, and unintended omissions, which can cost companies $1,000-$5,000 or up to $50,000 per year. The bill would pre-empt state reporting requirements, some of which would be more stringent, and information would be posted online, through a publicly accessible HHS website.
By contrast, for a single infraction, whether willful or not, its House counterpart would not only levy fines but bar companies from taking tax deductions on advertising for a year, potentially costing them millions.
The revised Senate bill would also give companies several years to get themselves in compliance. The original version would have been effective immediately.
In a statement, Grassley, who is ranking member of the Senate Committee on Finance, said: “Eli Lilly deserves credit for its endorsement of the Sunshine Act and its leadership role it is taking for greater transparency in the pharmaceutical industry….The company's forward-looking endorsement of legislation to require reporting of financial relationships between drug and device makers and physicians will be valuable in building more support for this important reform.”
Lilly weighed in on behalf of the revised bill yesterday, with president and CEO John Lechleiter saying in a statement: “Lilly welcomes greater transparency in the healthcare system and believes this legislation represents an important step in building public trust and confidence in the relationships between the pharmaceutical and device industries and physicians. Lilly intends to continue to build upon its leadership position in transparency. In addition to our publicly available clinical trial and educational grant registries, we continue to look at other ways to open up our business to the public. This will help provide the assurance that Lilly runs its business consistent not only with our principles, but with the principles that a healthcare provider or patient should expect from a pharmaceutical company.”
Lilly has made clinical trials and clinical trials data public since 2004 and last year began posting information on its med ed grants online.
The bill was also endorsed by the Association of American Medical Colleges.