Prescription and OTC Drugs

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

The Federal Circuit Court of Appeals has just rejected the longstanding U.S. government position that the country of origin of pharmaceuticals in the context of U.S. government procurement is determined by where the active pharmaceutical ingredient (API) is made.  Acetris Health, LLC v. United States, 2018-2399, judgment of February 10, 2020.  In the Acetris case the API was made in India.  It was then shipped in bulk to the United States, where it was manufactured into tablets.  The central question in the case was whether the resulting tablets were a “U.S.-made end product” and thus qualified under the Buy American Act (BAA) to be sold to the Department of Veterans Affairs.
Continue Reading Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals