That would be the result of language inserted into the 2009 version of the Kohl/Grassley Physician Payments Sunshine Act.
New language in the bill proposes to give states authority to require disclosure or the reporting of information not required by the FDA.
Result: 50 state FDAs … and chaos.
Chaos for drug companies, certainly. But even worse -- chaos for patients and physicians. Imagine a doctor in New York getting different information on a medicine than a doctor in Michigan. Imagine a patient in Vermont getting different treatment than a patient in Arizona because their physicians weren’t sure who to listen to or what directions to follow.
Talk about emasculating the drug label.
And who should pharmaceutical companies go to with data and questions? 50 state health commissioners who may or may not have ever even looked at clinical trial data? Are there any state health commissioners who hold a technical candle to even a mid-grade FDA reviewer? Is there a state in the Union that employs a biostatistician? And how would states pay for these new professional employees? Likely source is lucre from lawsuits. And it's even more likely these professional services would be provided by outside “experts" -- the same folks who earn a nice living from being “expert” witnesses.
Speaking of expert witnesses, the Physician Payments Sunshine Act makes no provision for reporting fees earned for such activities.
That ain’t sunshine.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
