FDA Policy/General
Two professors with academic appointments in the schools of public health at Johns Hopkins and George Washington universities say loopholes in FDA regulations on prescription drug promotion “are exposing American consumers to false and misleading claims of drug ads via online businesses promoting potent drugs without accurate information about their
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document describes the agency’s regulatory and enforcement priorities for outsourcing facilities to compound certain ibuprofen oral suspension products for administration
Drugs
Researchers at Harvard, Yale, and Dartmouth say their analysis of the therapeutic value (whether they represent advances over existing treatments) of drugs subject to the most direct-to-consumer advertising from 2015 to 2021 found that fewer than one-third of the most common drugs featured in DTC ads were
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Acacia Pharma’s Byfavo (remimazolam), indicated for inducing and maintaining procedural sedation in adults undergoing procedures lasting 30 minutes or less. The regulatory review period is 4,482 days, of which 3,931 days
FDA Policy/General
Five King & Spalding attorneys say that in 2022 FDA issued nine enforcement letters targeting advertising and promotion violations for prescription drugs and medical devices. Their online post summarizes noteworthy trends and issues seen in the letters. Of the nine letters issued in 2022, four were from CDER’s Office
FDA Policy/General
FDA has issued its long-awaited final guidance entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry.” Changes the agency made since a draft was released 7/2020 include “clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for
FDA Policy/General
The National Advertising Division (NAD) of BBB National Programs says Novartis should discontinue making certain claims in a direct-to-consumer (DTC) ad for breast cancer drug Kisqali. The review was precipitated by a complaint about survival benefit claims lodged by Eli Lilly, the maker of competing drug Verzenio. Lilly
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of Emergency Use Authorizations (EUAs) for medical devices related to the Covid–19 public health emergency. The EUAs were issued from 6/16/2022 through 12/6/20222. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has classified computerized behavioral therapy devices for treating symptoms of gastrointestinal conditions into Class 2 (special controls). The prescription devices are intended to provide a computerized version of condition-specific therapy as an adjunct to standard-of-care treatments for patients with gastrointestinal conditions. To view
FDA Policy/General
Federal Register notice: FDA has classified intense pulsed light devices for managing dry eye into Class 2 (special controls). The prescription devices are intended for use in the application of intense pulsed light therapy to the skin for patients with dry eye disease due to meibomian gland dysfunction, also known
FDA Policy/General
FDA has issued a draft guidance #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The document is intended for sponsors interested in pursuing approval of new heartworm prevention products for dogs. The guidance says that the recommended approach to demonstrate
FDA Policy/General
An HHS Office of the Inpsector General (OIG) report says FDA should improve its management of contracts for acquiring information technology. As part of an audit program examining various HHS contracting operations, the OIG reviewed five FDA orders totaling $23.6 million paid to a contractor during fiscal years 2018-
FDA Policy/General
FDA legislative and policy staff continue to have their sights on urging Congress to take up reforms for medical diagnostics, dietary supplement listing/registration, and supply chain information updates. These are some of the top priorities the agency’s legislative staff are working on this year, FDA deputy commissioner for
FDA Policy/General
[Commentary by Jim Dickinson, Editor] It has been discussed for decades and doubtless comes hard to those who respect heritage, but we agree with the Washington Post’s editorial board: the time has come for FDA to relieve itself of its Center for Food Safety and Applied Nutrition (CFSAN) so
Drugs
A SheppardMullin report on “2023 Top-of-Mind Issues for Life Sciences Companies” looks at several FDA issues as well as other federal agencies. In 2022, the report says, the CDER Office of Prescription Drug Promotion (OPDP) continued its downward trend in enforcement, issuing just one Warning Letter and three
FDA Policy/General
The FDA Office of Digital Transformation (ODT) has launched a technology-focused Leadership Modernization Action Plan (LMAP), the next step in its enterprise transformation efforts. FDA chief information officer Vin Desai and executive officer Jessica Berrellez write in an FDA Voices online post that the LMAP is “the final piece
FDA Policy/General
FDA has approved Anzac Animal Health’s Zycosan (pentosan polysulfate sodium injection) to control clinical signs associated with osteoarthritis in horses. An agency notice says Zycosan is a heparin-like compound and is the first pentosan injectable product to receive agency approval. The notice says that unapproved injectable formulations, including
Drugs
The Federal Trade Commission (FTC) has released its new “FTC Health-Related Advertising Guide” that covers more stringent compliance factors than previously expected that industry should consider before publishing health product marketing (online or offline) advertisements. Attorney Phyllis Marcus (Hunton Andrews Kurth) writes in an online post that the FTC
FDA Policy/General
The recent signing of the year-end omnibus legislation (HR 2617, Consolidated Appropriations Act, 2023) not only provided FDA with a $226 million bump in its spending level (see story), but it also included notable agency reforms that were part of the user fee reauthorization legislation last summer but eventually
Drugs
CDER Office of Prescription Drug Promotion researchers have taken a first look at the tradeoffs for consumer understanding of a drug’s risks and benefits when drugs are promoted in online character space limited (CSL) communications such as Twitter and Google sponsored links. A report says that some stakeholders have
FDA Policy/General
FDA assistant commissioner for criminal investigations Catherine Hermsen, who retired at the end of 2022 after five years as the agency’s “top cop,” says she expects a greater focus in the future on multilateral collaboration to keep up with the ever-evolving transnational criminal groups. “FDA has been strengthening
FDA Policy/General
FDA’s fiscal year 2023 spending bill was signed into law 12/29/2022 as part of the end-year omnibus legislation (HR 2617, Consolidated Appropriations Act, 2023) that gives the agency a 6.5% boost ($226 million) above FY 2022 spending levels. In total, the measure provides FDA’s