April 2010

Monday, April 12, 2010 to Tuesday, April 13, 2010

With the US government cracking down on Healthcare Reform, and the Sunshine Act about to pass through the house and senate as part of the overall Healthcare bill, there are massive changes laying immediately ahead for Pharmaceutical and medical device commercial compliance departments, including the need to develop a completely overhauled aggregate spend process to comply with the Sunshine Act. This will include putting in place a more sophisticated reporting procedure for speaker programs, as well as collective aggregate spend on smaller marketing expenditures. Training each applicable department on compliance with the new law will only add to the expense - this will be a complete reporting and audit overall for companies. In addition compliance in new marketing mediums is becoming increasingly complex as patients discuss drugs on twitter, face book, and wiki - and companies need to understand their responsibility in clarifying these remarks. The government is also placing the onus on the drug companies to promote health care responsibility through forcing high-level executives to sign affidavits in a move toward individual responsibility, and the FDA's REMS initiative that would hold companies responsible for tracking physician prescribing decisions in attempt to prevent abuse of their products. Attending this conference will provide clarification and interpretation from government officials, and best practices from industry compliance leaders on how to create a profitable and compliant marketing program.