Lisa Dwyer on Pharmaceutical Industry

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

12/20/2022 / Citations , Draft Guidance , FDARA , FDASIA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Inspections , Manufacturers , Medical Devices , OSHA , Pharmaceutical Industry , Prescription Drugs

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

France - A Charter for the Promotion of Medical Devices (Including IVD)

An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more

3/11/2022 / Actors , Beneficiaries , Certifications , Corporate Monitoring , Food and Drug Administration (FDA) , France , Life Sciences , Medical Devices , Pharmaceutical Industry , Quality Control Plan

FDA Finalizes “Intended Use” Regulations

On August 2, 2021, the U.S. Food & Drug Administration (“FDA” or “the Agency”) published a final rule amending its medical product “intended use” regulations in an effort to provide direction and clarity to regulated industry...more

8/9/2021 / Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Intended Use , Off-Label Use , Pharmaceutical Industry , Proposed Rules

Genus Medical Technologies LLC v. FDA: D.C. Circuit Holds FDA Cannot Regulate Devices as Drugs

FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more

5/5/2021 / En Banc Review , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Petition for Writ of Certiorari , Pharmaceutical Industry , Prescription Drugs , SCOTUS

FDA Proposes New Rule Modifying its “Intended Use” Regulations

Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more

9/25/2020 / Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Intended Use , Pharmaceutical Industry , Proposed Rules

2019 Year in Review: FDA Office of Prescription Drug Promotion

In 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more

3/2/2020 / Food and Drug Administration (FDA) , Manufacturers , Off-Label Promotion , OPDP , Pharmaceutical Industry , Prescription Drugs , Warning Letters

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

A Gimmick No More? HHS Moves to Authorize Prescription Drug Importation

Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if...more

8/7/2019 / Department of Health and Human Services (HHS) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Imports , Medicare , Pharmaceutical Industry

CMS Issues Final Rule Requiring the Disclosure of Drug List Prices in Direct-to-Consumer Television Ads

The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements - On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more

5/14/2019 / Administrative Authority , Advertising , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Direct to Consumer Sales , Disclosure Requirements , Drug Pricing , Final Rules , First Amendment , Pharmaceutical Industry , Prescription Drugs , Price Transparency

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more

2/22/2019 / Advisory Committee , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Manufacturer Liability , Manufacturers , Medical Devices , Pharmaceutical Industry

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

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

6/21/2018 / Final Guidance , First Amendment , Food and Drug Administration (FDA) , HCEI , Labeling , Life Sciences , Manufacturers , Medical Devices , Off-Label Use , Pharmaceutical Industry , Prescription Drugs , Required Communications , Safe Harbors

Lisa Dwyer

King & Spalding

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