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The changing face of drug marketing regulation

The DIA 2014 50th Annual Meeting: Celebrate the Past – Invent the Future is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development, and life cycle management of medical products all with a common goal to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.

This post is sponsored by DIA.

Could recent major court rulings see substantial changes in the regulation of drug marketing? This key issue will be discussed in-depth at the DIA 2014 50th Annual Meeting.

This year’s Annual Meeting, in San Diego from June 15 to 19, will feature a session titled “FDA Drug Claims Substantiation after IMS and Caronia: Will Court Scrutiny Based on the First Amendment Lead to Change in Current Policy and Practice?” under the Public Policy/Health Care Compliance/Law track.

The session, to be held on June 19 from 9:00-10:30 AM, will focus on the emerging law of claims substantiation in light of major court rulings affecting FDA regulation of marketing. An experienced and high-profile speaker on the ethical, legal, and political issues surrounding drug marketing, John F. Kamp, JD, PhD, Attorney at Law Director for Wiley Rein LLP and Executive Director for the Coalition for Healthcare Communication, will chair the session.

Panelists will highlight the case of IMS v. Sorrell in June 2011, when the Supreme Court decided that Vermont’s Prescription Confidentiality Law violated the First Amendment. This law required that records containing a doctor’s prescribing practices not be sold or used for marketing purposes unless the doctor consented. The Supreme Court ruled that the law placed content and speaker based restrictions on speech and rejected Vermont’s claims that the law was necessary to protect medical privacy and achieve improved public healthcare.

The session will also focus on the US 2nd Circuit Court of Appeals decision in US v. Caronia. In December 2012, the court vacated the conviction of former pharmaceutical company sales rep Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce, in violation of the Federal Drug & Cosmetic Act (FDCA). His appeal successfully contended that he was convicted for his speech – speech that promoted the off-label, but legal, use of an approved prescription drug – which violates his First Amendment right to free speech. In its ruling, the court concluded: “we construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.”

Attendees will also discuss Citizen Petitions before the FDA by PhRMA and the Information Working Group (IWG) of 13 major biopharmaceutical companies seeking clarity and reform of existing policies.

The DIA 2014 50th Annual Meeting: Celebrate the Past – Invent the Future is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development, and life cycle management of medical products all with a common goal to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.

This year’s event celebrates DIA’s 50th Anniversary and will feature 260+ educational offerings over 21 tracks, 450+ exhibiting companies, over 125 representatives from global regulatory agencies, plus much more. The meeting provides participants with a valuable opportunity to network with professionals from around the world, share knowledge, and build new relationships.

Find out more about DIA 2014 50th Annual Meeting at http://www.diahome.org/DIA2014.


DIA

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