FDA FDAMA 114 Guidance Due in 7 Weeks

NEW YORK - Nov. 17, 2014 - PRLog -- In June 2014, the FDA responded to a citizens petition filed by the Medical Information Working Group for clarification of FDAMA 114 and stated that the Agency

“… plans to issue, by the end of the calendar year, additional guidance that addresses manufacturer responses to unsolicited requests, distributing scientific and medical information on unapproved new uses, manufacturer discussions regarding scientific information more generally, and distribution of health care economic information to formulary committees and similar entities."

It is anyone’s guess, if FDA will truly issue this guidance in the coming weeks.  Despite this uncertainty, the industry still remains abuzz as to what this guidance might say.

In response to the anticipated release of this guidance, American Conference Institute (ACI) has designed its inaugural conference on Health Outcomes Data Communications, Market Access and Contracting to provide a critical guide on what information can be shared in relation to such matters as:

-Formulary determinations

-Risk sharing agreements with payors and integrated health care entities such as ACOs

-Manufacturer - Payor collaborations for outcomes data procurement

See complete list of speakers and agenda at www.AmericanConference.com/HealthOutcomes

Lisa J. Piccolo, Senior Industry Manager, Life Sciences and Health Care with ACI stated “ACI is honored to have the opportunity to provide our delegates with a conference on a cutting edge topic which in essence is the cornerstone of the modern healthcare market place as well as healthcare reform in the U.S.”  Piccolo went on to say that “ communicating findings from health outcomes data and related comparative effectiveness and pharmacoeconomic research to demonstrate value for market access determinations is a critical competency fraught with numerous challenges due to conflicts between FDAMA 114 and Obamacare. This conference will try to provide a forum to discuss these issues and find solutions to these challenges.”

American Conference Institute
A unique organization, American Conference Institute is devoted to providing the business intelligence that senior decision-makers need to respond to challenges both here in the US, and around the world.

Staffed by industry specialists, lawyers and other professionals, American Conference Institute operates as a think tank, monitoring trends and developments in all major industry sectors, the law, and public policy, with a view to providing information on the leading edge.

Headquartered in New York and led by  Leigh Gilmore, Senior Vice President, and  Seth Kerker, Managing Director, American Conference Institute has grown to produce more than 220 events each year, attended by thousands of senior delegates from across the country.

Full information on the forum can be found at www.AmericanConference.com/HealthOutcomes