DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices" conference to their offering.
The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration (FDA). How the FDA will deal with such advanced communication technology that can go viral and just as quickly disappear is the question that the industry is eager to have answered.
The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated traditional advertising for decades, published various guidance documents for industry and issued many violation letters. If the FDA determines that drug or medical device promotional material is false or misleading or lacking in fair balance as between benefits and risks, companies could be forced to implement costly corrective actions, such as remedial advertising, suffer damage to their reputations and incur monetary fines. Already, the government has collected billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or off-label, uses.
In the worst case, responsible executives can be criminally prosecuted for such violations under a strict liability standard, meaning that the government is not required to show that the executive had any intent to violate FDA regulations or had any knowledge of such violations. In addition, Social Media is used by healthcare professionals, sales representatives and consumers to discuss the use of prescription products for specific diseases and conditions. The use of Social Media tools and potential concerns will be addressed.
Rx drug promotion is delivered to two distinct audiences: health care professionals (HCPs) and consumers. Although tasked with regulatory oversight, FDA recognizes that promotional efforts can provide HCPs as well as consumers important information about the newest developments in drug therapies. The value of such information depends upon the integrity and completeness of the information being presented.
FDA regulates all Rx drug promotional materials, which includes both labeling and advertisements. Examples of labeling include, but are not limited to, brochures, booklets, detailing pieces, bulletins, calendars, motion pictures and slides. Advertisements include, but are not limited to, materials published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television and telephone communications systems. Rx drug advertising to doctors, known as detailing, occurs in a variety of settings. In addition to medical offices, detailing occurs in hospitals, pharmacies, at medical meetings and symposia, academic settings, conferences and other meeting facilities. The FDA also regulates direct-to-consumer (DTC) Rx drug advertising. While FDA has complete jurisdiction over prescription drug labeling and advertising, as well as all medical device labeling, it has limited jurisdiction over medical device advertising.
For more information about this conference visit http://www.researchandmarkets.com/research/z6jtgx/marketing