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First Amendment › Food and Drug Administration (FDA) › Manufacturers

The First Amendment to the United States Constitution prohibits the government from making laws respecting the establishment of religion, prohibiting the free exercise of religion, abridging the freedom of speech... more +
The First Amendment to the United States Constitution prohibits the government from making laws respecting the establishment of religion, prohibiting the free exercise of religion, abridging the freedom of speech or the press, preventing citizens from peacefully assembling, or interfering with citizens' ability to petition the government for redress of their grievances. The First Amendment is one of the most sacred aspects of the American legal tradition and has spawned a vast body of jurisprudence and commentary. less -
Troutman Pepper

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Dechert LLP

FDA Issues Revised Draft Guidance on “Off-Label” Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain

Dechert LLP on

The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

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On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Foley Hoag LLP

New Intended Use Rule Finalized

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On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more

Mintz - Health Care Viewpoints

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads

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The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more

King & Spalding

FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

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A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

McDermott Will & Emery

FDA Finalizes Guidance on Payor Communications

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On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more

Hogan Lovells

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

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The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

Troutman Pepper

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

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The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Wilson Sonsini Goodrich & Rosati

FDA Holds Hearing on Off-Label Communications

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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

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

McDermott Will & Emery

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

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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

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