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The United States Food and Drug Administration Off-Label Promotion

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

I’m Not Dead (Yet): FDA Continues to Enforce Unlawful Product Promotion

by Arnall Golden Gregory LLP on

Many of us remember the classic bit in the epic 1975 Monty Python and the Holy Grail movie, where the Dead Collector asks the pestilence-infested community to bring out its dead, and one hapless individual calls out, “I’m not...more

Arizona Enacts Law Permitting Off-Label Promotion

by Arnall Golden Gregory LLP on

As we have previously covered, the Food and Drug Administration is in the midst of reevaluating its policy on off-label promotion of medical products—that is, promotion of drugs, medical devices, and biologics for uses not...more

What If We Win? Off-Label Promotion & Product Liability

by Reed Smith on

Since the nomination of Dr. Scott Gottlieb to head the FDA, we’ve seen quite a few references to his opposition to the current FDA prohibition against off-label promotion – regardless of the truth of the promotion itself. We...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

AGG Food and Drug Newsletter - February 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

First Circuit affirms Pfizer victory in False Claims Act case

by DLA Piper on

The First Circuit has rejected an appeal in United States ex rel. Booker v. Pfizer, a False Claims Act (FCA) case alleging that Pfizer engaged in off-label promotion of the antipsychotic drug Geodon. In its ruling on...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

by Reed Smith on

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

Guest Post – Midnight Madness - The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion

by Reed Smith on

This guest post is from Liz Minerd, an associate at Reed Smith. She previously wrote the post on the FDA’s off-label promotion meeting last November, so when she indicated that she’d like to write about the FDA’s “Midnight...more

FDA Defends Its First Amendment Position in “Memorandum”

by King & Spalding on

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more

FDA takes a half-step toward acknowledging manufacturers' right to disseminate truthful, non-misleading off-label information

by DLA Piper on

The FDA has issued significant new Draft Guidance on January 17, 2017 that touches on the hot-button issues surrounding manufacturer dissemination of off-label information about approved drugs and medical devices, titled...more

Obama FDA’s Parting Shot On Off-Label Promotion And The First Amendment

by Reed Smith on

We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part...more

Beyond the Eleventh Hour: FDA Prepares to Finalize Intended Use Amendments Despite Midnight Rule Relief Act

On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what...more

The First Amendment Does Not Protect All Off-Label Drug Promotion

by Fish & Richardson on

FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up of FDA regulation, which would allow it to “responsibly” promote new drug...more

Anything Worthwhile For Product Liability Defendants In The 21st Century Cures Act?

by Reed Smith on

We blogged about possibly interesting nuggets in the 21st Century Cures Act (“21CCA”) back in February, 2015 – when it was only 400 pages long. In true congressional fashion, it’s now twice as long and loaded up with enough...more

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

Update on Prosecution for Truthful Off-Label Promotion

by Reed Smith on

We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time. (Like here, here, and here, among many posts.) ...more

Off-Label Promotion And The First Amendment Updates

by Reed Smith on

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist....more

FDA Announces Public Hearing on Off-Label Communications; Registration Deadline October 19, 2016

by McDermott Will & Emery on

The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more

Off-Label Promotion —To Speak or Not To Speak?

by Stinson Leonard Street on

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

FDA Call For Comments on Off-Label Communications

by Goodwin on

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications...more

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