Current Issues Affecting FDA-Regulated Companies
Takeaways
Continue Reading EU Bans Whitening Food Additive E171 as of January 1, 2022
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
Many digital health app developers offering health and wellness solutions directly to consumers may find themselves in a space unregulated by the Health Insurance Portability and Accountability Act (“HIPAA”). While potentially outside the scope of HIPAA, developers in this space are reminded of the risks stemming from other federal and state privacy and security laws, including unfair or deceptive abuse acts and practices (UDAAP) laws. A recent Federal Trade Commission (“FTC”) settlement sheds light on the importance of accurately describing how information is collected, used, and shared.
Continue Reading Recent FTC Settlement Serves as Reminder For Digital Health Developers
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak. Manufacturers, including contract manufacturers, anticipating post-approval inspections may welcome the news, given other pressing issues facing ex-US facilities (i.e., facilities located outside the US) in light of COVID-19. Companies with planned pre-approval inspections, however, may find the news distressing.
Continue Reading FDA Postpones Ex-US Facility Inspections
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
The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) within the US Food and drug Administration (FDA) published its annual “Report on the Sate of Pharmaceutical Quality” last week. The yearly report reviews the quality of drug products during the prior year, as measured by recall and product defect information, site inspections of manufacturers, and other post market data. The report provides a few insights that companies may want to consider when working with, or acquiring, contract manufacturers.
Continue Reading Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality
On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that (1) meet the definition of medical devices under section 201(h) of the Federal Food Drug and Cosmetic Act, and (2) could pose a risk to a patient’s safety if the app did not function as intended. The FDA will not exercise authority over apps that are not medical devices under section 201(h), nor will it enforce its rules and regulations against the numerous apps that meet the definition of medical devices but present only minimal risk to consumers or patients.
Continue Reading FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?
On January 20, 2015, the FDA issued draft guidelines[1] designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as medical devices under Section 201(h) of the Food Drug & Cosmetics Act (the “Act”) and are therefore subject to the Act’s regulatory requirements for devices.
Continue Reading FDA Issues Guidance for Low-Risk General Wellness Products
As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information about medical device use and patient health. Whereas once the data that could be obtained from a therapeutic or diagnostic device would be limited to time and error codes, medical devices now have the potential to store personal patient health information. Interoperability between medical devices and electronic health record systems only increases the potential for medical devices to store personal information.
Continue Reading HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers
On July 25, 2013, the Food and Drug Administration (“FDA” or “the Agency”) published a Draft Guidance for Industry entitled “Pre-Launch Activities Importation Requests”, or “PLAIR”. The draft guidance describes FDA policy on requests for importation of unapproved finished dosage form drug products by an applicant preparing for market launch pursuant to a New Drug Application (“NDA”), an Abbreviated New Drug Application (“ANDA”) or a Biologics License Application (“BLA”). The draft guidance describes the procedure for making requests for importation prior to approval, as well as the factors FDA will look to in deciding whether to grant such requests.
Continue Reading FDA’s Draft Guidance For Industry On Pre-Launch Activities Importation Requests: Dead On Arrival?
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