Prescription and OTC Drugs

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On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug development — “Regulatory Considerations Guidance”[1] and “Scientific Considerations Guidance,”[2] respectively. These guidance documents replace FDA’s previous draft guidance on the subject,[3] issued in 2005, and clarify requirements and recommendations for brining pediatric drugs to market. FDA will be accepting public comment on the Regulatory Considerations Guidance and Scientific Considerations Guidance through July 17 of this year.[4]Continue Reading FDA Clarifies Approach to Pediatric Drug Development

On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved in 2011 to reduce the risk of preterm birth in certain pregnant women.[1] The final decision followed a hearing and appeal process that took nearly three years, and cited the failure of post-approval studies to prove the drug’s effectiveness as the reason for the withdrawal.[2] Continue Reading Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

As we take a breather during the holiday whirlwind, we wanted to flag for readers a recent development in advertising and promotion regulation that FDA quietly released nearly a month ago. In a Memorandum issued on October 27 (the “Memorandum”), the Food and Drug Administration (“FDA” or the “Agency”) indicated that it will now permit certain COVID-19 drugs that have been granted Emergency Use Authorization (“EUA”) to make claims of safety and efficacy in print, advertising, and promotional materials, pursuant to certain limitations.Continue Reading FDA Lightens Promotional Restrictions for Certain COVID-19 Drugs with Emergency Use Authorization

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting cost-sharing subsidies for life-saving oncology drugs. In October, we discussed the Office of Inspector General’s (“OIG”) Advisory Opinion No. 22-19 (the “Advisory Opinion”), which declared that a charitable organization funded by manufacturers would violate the AKS if it offered certain cost-sharing subsidies under Medicare Part D (“Part D”), even if the organization was independently run and patients had equal access to discounts for 90% of drugs on the market. On November 9, 2022, the Pharmaceutical Coalition for Patient Access (“PCPA”), presumably the organization behind the Advisory Opinion, filed a lawsuit against OIG, seeking declaratory judgment that its cost-sharing program is legal under the AKS and that the Advisory Opinion violates the Administrative Procedure Act (“APA”) and the First Amendment.[1]Continue Reading Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries via 501(c)(3) charities without running afoul of the Federal Anti-Kickback Statute (the “AKS”).Continue Reading OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies

On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a consistent state of inspection operations.  For the near term, FDA reports that it will continue to prioritize critical inspections of both domestic and foreign facilities, including preapproval inspections for priority products and inspections in reaction to recalls or other safety issues.  For the long term, the agency likely will employ the remote monitoring strategies it has implemented during the pandemic and expand its remote data collection capabilities to preserve resources and curb in-person inspections.
Continue Reading FDA Proposes Risk-Based and Remote Inspection Strategies in New Report

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19.  According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered under the bioresearch monitoring (BIMO) program; and (3) outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).  The evaluations do not replace in-person inspections, and FDA Form 483s will not be issued as a result of the inspection, but the results could be used to support regulatory actions, such as approving a pending product application. 
Continue Reading Breaking Down FDA’s New Remote Monitoring Strategy

On Friday, March 26, 2021, FDA published a Federal Register notice,  “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC) monograph drug user program.  This is the first year that FDA has collected user fees from OTC drug manufacturers and submitters of OTC monograph order requests under its new authority under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.  With limited exceptions, all manufacturers of OTC drugs must pay a facility fee, which exceeds $20,000, by May 10, 2021 (45 days after publication of the notice).
Continue Reading FDA Announces Facility Fees for OTC Drug Manufacturers

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations.  In its current form, the regulations have created long-standing confusion as to whether mere knowledge of an unapproved use of an approved product (i.e., off-label) automatically triggers a new “intended use,” for which clearance or approval is required.  The proposed rule clarifies that knowledge alone of off-label use would not create a new intended use, but confirms the Agency’s long-standing position that “any relevant source” of evidence (including knowledge) may be used to determine intended use.  Comments on the proposed rule are due within 30 days unless FDA grants an extension.
Continue Reading FDA’s Proposed Rule on “Intended Use” Confirms Agency Will Rely on “Any Relevant Source” of Evidence

FDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including performing risk assessments to determine whether the virus poses new risks to drug products, or to the manufacturing facilities or processes that produce them.  FDA is not aware of any drugs that have been contaminated with SARS-CoV-2, but the guidance provides the agency’s expectations for limiting potential contamination.  While the FDA has not yet resumed routine facility inspections, and therefore likely will not actively monitor implementation of the risk assessments (or other suggestions in the guidance), manufacturers should consider the recommendations in the guidance to protect the public health and health of their employees.
Continue Reading FDA Issues Guidance on Manufacturing Drugs, APIs during COVID-19