Tag: off-label

off-label

Washington Focus

Executive Order Seeks Better Odds for Competitive Drug Pricing

Executive Order Seeks Better Odds for Competitive Drug Pricing

June 27, 2017 – A draft Executive Order from President Donald J. Trump indicates the administration may seek to “roll back regulations in pursuit of faster drug approvals, promoting drug competition and new payment models for federal health insurance programs,” according to CQ Roll Call. A CQ Roll Call article stated that some of the […]

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Gottlieb Vote Headed to Full Senate

May 1, 2017 – Having cleared the Senate Committee on Health, Education, Labor and Pensions (HELP) with a 14-9 vote on April 27, Dr. Scott Gottlieb’s nomination to be the next FDA commissioner is now headed for a full Senate vote. So far, Gottlieb’s nomination has moved quickly and smoothly through the nomination process. “Gottlieb […]

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CHC News

What Medical Marketers Can Expect from President Trump, Republican-led Congress

What Medical Marketers Can Expect from President Trump, Republican-led Congress

April 24, 2017 – There is no doubt that the Trump administration is likely to change health policy, but the questions that remain to be answered are exactly what those changes will be and how they will affect healthcare communication. If you want predictions and insight from a distinguished panel of FDA and policy experts, […]

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Courts/First Amendment

New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

Jan. 20, 2017 – The FDA effectively delayed any prompt action on new guidance covering the promotion of unapproved or off-label uses yesterday by extending the comment period related to the November 2016 hearing on this topic from Jan. 9 to April 19, and by issuing a 60-plus page memorandum that outlines the agency’s position […]

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Off-label Promotion

Speakers at FDA Off-label Hearing Call for Action that Protects Free Speech

Speakers at FDA Off-label Hearing Call for Action that Protects Free Speech

Nov. 10, 2016 – As FDA Commissioner Robert Califf described the issues surrounding the communication of off-label uses as “numerous and complex” and cautioned that there are many instances where unapproved uses are “unsafe and ineffective,” industry speakers at an FDA hearing held Nov. 9 called on the agency to take immediate action and provide […]

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Regulatory/FDA

OPDP’s Abrams: Enforcement Still a Priority, Despite Decrease in Letters

OPDP’s Abrams: Enforcement Still a Priority, Despite Decrease in Letters

Oct. 3, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued just four enforcement letters in 2016, it remains focused on enforcement through other means, such as issuing guidance documents, and reviewing draft product labeling and launch materials to promote voluntary compliance, according to OPDP Director Tom Abrams. Abrams, who spoke […]

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Courts/First Amendment

Courts’ Support for “Truthful and Non-misleading” Speech Has Not Yet Resulted in FDA Policy Change

Courts’ Support for “Truthful and Non-misleading” Speech Has Not Yet Resulted in FDA Policy Change

May 31, 2016 – Although the U.S. Supreme Court and other courts consistently are deciding cases in favor of First Amendment protections for commercial speech – including speech about off-label uses – the movement toward a “truthful and non-misleading” standard has not moved the needle on this issue at the FDA, according to Alan Bennett, […]

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Commissioner of Food and Drugs Califf Lists Advertising, Labeling Among Priorities

April 25, 2016 — In a speech at the Alliance for a Stronger FDA’s quarterly meeting April 19, new Commissioner of Food and Drugs Dr. Robert M. Califf stated that the agency’s current priorities include determining when advertising is false or misleading and addressing labeling and patient/consumer communication, among others. He also indicated that the […]

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Jury Says “Not Guilty” to Off-label Charges in Medical Device Case

March 3, 2016 – As the FDA fails to update or further clarify its policy regarding off-label promotion, the courts continue to hear cases that are being decided in favor of allowing.S. District Judge Royce Lamberth has entered an order dismissing the case; it is not subject to appeal. companies to share truthful and non-misleading […]

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