The U.S. Department of Health and Human Services, Food and Drug Administration (FDA) recently issued draft guidance entitled “Guidance for Industry-Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media For Prescription Human and Animal Drugs and Biologics.”

The draft guidance is intended to describe the FDA’s current thinking about how manufacturers, packers, and distributors (firms) can fulfill regulatory requirements for post marketing submissions of interactive promotional media (e.g. blogs, microblogs such as Twitter, social networking sites like Facebook, online communities, and online podcasts) for FDA-approved products.

Under FDA regulations, if a firm has any control of, or influence on a site, it must submit promotional material about its product(s) to the FDA under the FDA’s postmarketing submission requirements.

Recognizing the challenges of submitting promotional materials that display real-time information, the FDA provided recommendations for submitting interactive promotional media.  In its examples, the FDA explained:

  • At the time of initial display, a firm should submit in its entirety all sites for which the firm is responsible, including submission in a way that allows the FDA to view and interact with the submission in the same way as the end user;
  • For third-party sites on which the firm’s participation is limited to interactive or real-time communications, a firm should submit the third-party site’s home page, along with the interactive page within the third-party site and the firm’s first communication;
  • Once a month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant;
  • If a site has restricted access, a firm should submit all content related to the discussion to adequately provide context to facilitate the review; and
  • A submitting firm should take formatting factors into consideration to enable the FDA to view the communications as a whole.

When finalized, the guidance will not create or confer any rights, and will not operate to bind the FDA or the public.  Rather, the guidance should be viewed as recommendations, unless specific regulatory or statutory requirements are cited.

Specific industry guidance concerning social media is not a novel idea.  In fact, the financial industry issued its own guidance late last year.  When examining your businesses social media participation, it is imperative you familiarize yourself with any applicable industry specific guidance.

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Photo of Jason C. Gavejian Jason C. Gavejian

Jason C. Gavejian is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. and a Certified Information Privacy Professional (CIPP/US) with the International Association of Privacy Professionals.

As a Certified Information Privacy Professional (CIPP/US), Mr. Gavejian focuses on the matrix…

Jason C. Gavejian is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. and a Certified Information Privacy Professional (CIPP/US) with the International Association of Privacy Professionals.

As a Certified Information Privacy Professional (CIPP/US), Mr. Gavejian focuses on the matrix of laws governing privacy, security, and management of data. Mr. Gavejian is Co-Editor of, and a regular contributor to, the firm’s Workplace Privacy, Data Management & Security Report blog.

Mr. Gavejian’s work in the area of privacy and data security includes counseling international, national, and regional companies on the vast array of privacy and security mandates, preventive measures, policies, procedures, and best practices. This includes, but is not limited to, the privacy and security requirements under state, federal, and international law (e.g., HIPAA/HITECH, GDPR, California Consumer Privacy Act (CCPA), FTC Act, ECPA, SCA, GLBA etc.). Mr. Gavejian helps companies in all industries to assess information risk and security as part of the development and implementation of comprehensive data security safeguards including written information security programs (WISP). Additionally, Mr. Gavejian assists companies in analyzing issues related to: electronic communications, social media, electronic signatures (ESIGN/UETA), monitoring and recording (GPS, video, audio, etc.), biometrics, and bring your own device (BYOD) and company owned personally enabled device (COPE) programs, including policies and procedures to address same. He regularly advises clients on compliance issues under the Telephone Consumer Protection Act (TCPA) and has represented clients in suits, including class actions, brought in various jurisdictions throughout the country under the TCPA.

Mr. Gavejian represents companies with respect to inquiries from the HHS/OCR, state attorneys general, and other agencies alleging wrongful disclosure of personal/protected information. Mr. Gavejian negotiates vendor agreements and other data privacy and security agreements, including business associate agreements. His work in the area of privacy and data security includes counseling and coaching clients through the process of investigating and responding to breaches of the personally identifiable information (PII) or protected health information (PHI) they maintain about consumers, customers, employees, patients, and others, while also assisting clients in implementing policies, practices, and procedures to prevent future data incidents.

Mr. Gavejian represents management exclusively in all aspects of employment litigation, including restrictive covenants, class-actions, harassment, retaliation, discrimination, and wage and hour claims in both federal and state courts. Mr. Gavejian regularly appears before administrative agencies, including the Equal Employment Opportunity Commission (EEOC), the Office for Civil Rights (OCR), the New Jersey Division of Civil Rights, and the New Jersey Department of Labor. Mr. Gavejian’s practice also focuses on advising/counseling employers regarding daily workplace issues.

Mr. Gavejian’s litigation experience, coupled with his privacy practice, provides him with a unique view of many workplace issues and the impact privacy, data security, and social media may play in actual or threatened lawsuits.

Mr. Gavejian regularly provides training to both executives and employees and regularly speaks on current privacy, data security, monitoring, recording, BYOD/COPE, biometrics (BIPA), social media, TCPA, and information management issues. His views on these topics have been discussed in multiple publications, including the Washington Post, Chicago Tribune, San Francisco Chronicle (SFGATE), National Law Review, Bloomberg BNA, Inc.com, @Law Magazine, Risk and Insurance Magazine, LXBN TV, Business Insurance Magazine, and HR.BLR.com.

Mr. Gavejian is the Co-Chair of Jackson Lewis’ Hispanic Attorney Resource Group, a group committed to increasing the firm’s visibility among Hispanic-American and other minority attorneys, as well as mentoring the firm’s attorneys to assist in their training and development. Mr. Gavejian also previously served on the National Leadership Committee of the Hispanic National Bar Association (HNBA) and regularly volunteers his time for pro bono matters.

Prior to joining Jackson Lewis, Mr. Gavejian served as a judicial law clerk for the Honorable Richard J. Donohue on the Superior Court of New Jersey, Bergen County.