An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer
FDA Law Blog
by Kurt R. Karst
13h ago
By Douglas B. Farquhar & Aisha T. Evans* — A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification.  This means that if your drug manufacturing facility is inspected, it is nearly twice as likely as before that FDA will follow up with regulatory or enforcement action, which can include Warning Letters, freezes on drug approval applications ..read more
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A (Not So) New Avenue to Challenge Misleading Rx Promotion – NAD
FDA Law Blog
by Kurt R. Karst
6d ago
By Dara Katcher Levy — (Caution: Links in the first paragraph are a wild musical ride.  Click at your own risk) For those of you that review Rx ad/promo materials, it’s a familiar scenario:  Marketing has come to the Legal Department with significant concerns about competitor activities – consumers are being misled.  Legal has already drafted a cease and desist letter on the matter (to which the competitor has essentially said “pound sand”), and Legal has also drafted and submitted a trade complaint to FDA that has not produced any action to speak of.  Despite Marketing’s i ..read more
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Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans
FDA Law Blog
by Kurt R. Karst
1w ago
By Faraz Siddiqui & Deborah L. Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).  This requirement, enacted under section 3601 of Food and Drug Omnibus Reform Act (FDORA), will apply to clinical trials that commence enrollment 180 days after FDA finalizes guidance on the topic. FDA’s Past Efforts on Clinical Trial Diversity In 2013, at Congress’ behest under the Food an ..read more
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FDORA Enacted; HP&M Issues Detailed Summary and Analysis
FDA Law Blog
by Hyman Phelps McNamara
1w ago
On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (2022).  FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.  The law enacts significant changes that will have considerable short- and long- term effects on the regulated industry and the FDA. FDORA includes six subtitles, Subtitle A- Reauthorizations, Subtitle B- Drugs and Biologics, Subtitle C- Medical Devices, Subtitle D- Infant Formula, Subtitle E- Cosmet ..read more
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CMS Rolls up its Sleeves on Price Negotiations, Sets Agenda for 2026 Negotiated Prices
FDA Law Blog
by Kurt R. Karst
1w ago
By Faraz Siddiqui — Last week, the Centers for Medicare & Medicaid Services (CMS) released a memorandum on how it intends to implement the Medicare Drug Price Negotiation Program, passed under the Inflation Reduction Act (IRA) (see our blog post and slide deck on IRA).  The memorandum also introduced the Program’s spanking new logo. The memorandum outlines CMS’s priorities and timeline for the Initial Price Applicability Year 2026. Recall that CMS is required to negotiate and publish the 2016 maximum fair price for 10 high expenditure, single source Part D drugs by September 1, 2024 ..read more
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FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests
FDA Law Blog
by Kurt R. Karst
2w ago
By Véronique Li, Senior Medical Device Regulation Expert — A joint eSTAR pilot (which we previewed in November) between FDA and Health Canada has now been launched. This pilot program will test the use of a single eSTAR application submitted to both regulatory bodies. For those unfamiliar or needing a refresher, eSTAR is an interactive PDF template that: allows for form construction and autofill, complements internal review templates used at CDRH, harmonizes with the Non-In Vitro Diagnostic Device Market Authorization Table of Contents used by the International Medical Devices Regulators Foru ..read more
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A Holiday Surprise; FTC Published Its Health Products Compliance Guidance
FDA Law Blog
by Kurt R. Karst
2w ago
By Riëtte van Laack & Ricardo Carvajal — On Dec. 20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). FTC staff  prepared the new Guidance to update and replace Dietary Supplements:  An Advertising Guide for Industry, issued in 1998 (“1998 Guidance”).  The new Guidance provides the first update in 25 years on FTC’s thinking regarding substantiation and disclosures for health-related claims. An accompanying blog post touts the new Guidance as potentially “one of the most important documents you’ll read in 2022.” We are inclined ..read more
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Cannabis Advocates High On Recent Medical Marijuana Research Legislation
FDA Law Blog
by Kurt R. Karst
3w ago
By Larry K. Houck — In October, when pardoning those federally convicted of cannabis possession, President Joe Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General “to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.”  See President Biden Gives the Green Light for Significant Marijuana Reform, October 10, 2022.  The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction.  The legislation ..read more
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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement
FDA Law Blog
by Kurt R. Karst
3w ago
By John W.M. Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. In 2022, the chief regulating entities—FDA, FTC, and DOJ—all continued to forge policies to help bridge the rapidly moving waters between traditional regulatory concerns about safety and effectiveness on one side and cybersecurity, data privacy, and identity integrity on the other. To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat t ..read more
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The PIE Act – A Win for Patients, Payors, and Sponsors
FDA Law Blog
by Kurt R. Karst
3w ago
By Dara Katcher Levy — A win for patient access!   Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. The PIE Act, otherwise known as section 3630, “Facilitating Exchange of Product Information Prior to Approval” of H.R. 2617, the “Consolidated Appropriations Act, 2023,” was signed into law by President Biden on December 29.   The provision amends the Fe ..read more
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