Digital Marketing for Pharmaceutical and Medical Devices Expectations from FDA
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.
The Food, Drug, and Cosmetic Act (FDCA) generally provides that a "drug or device shall be deemed to be misbranded...if it's labeling is false or misleading in any particular." The statute defines labeling to include any "written, printed, or graphic matter" (1) upon a drug itself, its immediate or other "containers or wrappers," or (2) "accompanying such article." FDA and courts interpret labeling broadly to encompass a variety of printed or written materials supplied by a manufacturer, packer or distributor, or disseminated on behalf of a manufacturer or distributor. FDA has jurisdiction over all drug and medical device labeling, including "promotional labeling," a term which FDA uses but does not differentiate from "labeling" as defined in the FDCA and related regulations. In determining whether a drug or device is misbranded due to misleading labeling, FDA takes into account not only representations made about the drug or device, "but also the extent to which the labeling . . . fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article . . . under the conditions of use prescribed in the labeling or advertising . . . or under such conditions of use as are customary or usual." Consequently, the authors point out the first distinction between FDA's regulation of drug and device promotion. Specifically, "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."
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He has been involved in many FDA and other regulatory inspections as well as part of multiple FDA remediation activities involving CIA's Consent Decrees, Seizures and other enforcement actions, including responding to Warning Letters. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, addresses all aspects of postmarketing requirements involving advertising, promotional and labelling claims, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.
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Date: September 4th and 5th, 2014
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