Sunshine Act Still in the Shade

Apr 01, 2012
By Pharmaceutical Executive Editors

The issue isn't meetings, or companies paying doctors to present at meetings to their colleagues about a drug. After all, who knows more about a new drug than the company that made it? The issue between drug companies and physicians is transparency.

Would you as a physcian receive the information differently if you knew how much the presenter was being paid? And does anyone really believe a very good meal is enough to sway a scientist? Context matters, but so often what are shouted out are sensational cases and the subsequent cover-ups (like all scandals, the cover-up can be more egregious than the event itself). When Pfizer paid $2.3 billion and pleaded guilty to one felony count in 2009 to settle federal criminal and civil charges that it illegally promoted its Bextra painkiller and other drugs, it was the largest healthcare fraud settlement in history.

The amount of money gave pause, and brought home the severity of the crime, but in truth it was a relatively rare incident. Nonetheless, the headlines increased. A tipping point finally was reached when Senator Grassley proposed the Physician Payments Sunshine Act (PPSA), which was passed by the federal government and rolled into the broader healthcare reform package. It was signed on March 23, 2010 and will be fully implemented on March 23, 2013.

By requiring public disclosure regarding the monetary relationship between a doctor and a drug company, the hope is that it will cleanse medicine of the perceived conflicts of interest by shaming doctors. But will it work? After all, there is no data that proves quid pro quo corrupts. Will it be worth the costs of implementing it? And does it go far enough?

Not everyone thinks so (see "Sunshine Act Still in the Shade"). Will it change meeting attendance? Or more seriously, will it dissuade doctors from working on the clinical trials pharma companies need to get their drugs through the Food and Drug Administration approval process?

Tranparency is good, but so is discourse, accuracy, and taking the time to consider all the ramificatuons before it's too late.

Traversing the shifting sands of the Physician's Payment Sunshine Act (PPSA) is difficult at best. First there's the Act itself and its disclosure demands; second there's the confusion of what it entails; and third there's the new deadline.

Rolled into a section of the Patient Protection and Affordable Care Act (PPACA), the so-called Sunshine Act was slated to be implemented Jan. 1, 2012. That deadline evaporated when The Centers for Medicare and Medicaid Services (CMS) published in December 2011 a notice of proposed rulemaking for a provision that stated any gift or payment of more than $10 to physicians from a pharmaceutical or medical device maker must be reported publicly. Now, the new date for implementation is March 2013.

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