Are You Prepared For The FDA’s Upcoming Sunshine Act?
The US FDA has measures in the pipeline that aim to ensure clinical trials are carried out ethically and for the right reasons. Under the proposals payments to physicians for participation in trials would become more transparent.
The FDA’s proposed Physician Payment Sunshine Act is due to come into force later this year. This will be important in the future as it affects sponsors giving any money to doctors working on clinical trials. Under the Act, data must be collected from August 1st 2013, with reports being sent to the CMS by March 31st 2014.
DOWNLOAD a list of the information that will need to be reported when the Act comes into force.
The Act will cover payments to physicians (including doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors, who are legally authorized to practice by the State in which they practice) as well as teaching hospitals. It applies regardless of whether the physician is enrolled in Medicare, as long as they have a current license to practice, and does not include medical residents.
Each payment or other transfer of value or ownership or investment interest not reported will attract a penalty of between $1,000 and $10,000. The total amount of penalties will not exceed $150,000. Knowingly failing to submit payment information will result in a penalty of between $10,000 and $100,000 per payment. The penalty will not exceed $1,000,000 with combined penalties not exceeding $1,150,000.
You have three and a half months before you need to start collecting this data and a further eight months to submit it to the CMS. Remember, your company can be fined up to $1,150,000 for failure to comply with the Sunshine Act so it’s vital to get it right.
DOWNLOAD a list of the information that will need to be reported when the Act comes into force.
The information in this article is included in Whitehall Training’s updated online US GCP course – written by Nick Deaney and Dr Laura Brown.
Blog Author: Dr. G.C. Practice
Whitehall Training provides online training courses developed to meet the learning needs of both the clinical and pharmaceutical sectors. Clients range from clinical research doctors and nurses to international Pharma companies and CROs.
Students develop their skills and earn CPD points with industry-recognised compliance training. Trainers and administrators save time by assigning and managing licences with our easy-to-use admin system.
To date we have trained over 21,000 students across 40 plus countries.
The US Good Clinical Practice Course Authors
Nick Deaney
Nick has 30 years’ experience of clinical trials up to Research Director level in MSD UK. He is now a consultant providing on-line and face to face training in GCP and clinical research, and advice to foreign companies on clinical research in the UK.
Laura Brown
Dr Brown is Director of the MSc in Clinical Research at Cardiff University. She runs a training consultancy providing technical, management and soft skills courses for the pharmaceutical industry. Dr Brown has designed and delivered customised training for the pharma industry for more than 11 years.
