Tag Archives: justin stern

FDA Clarifies Evidence Used to Determine “Intended Use” of Medical Products

On September 23, 2020, the U.S. Food and Drug Administration (FDA) published a proposed rule amending the agency’s regulations concerning “intended uses.” While the proposed rule does not signal a fundamental change in FDA’s position that all relevant sources of evidence may be considered, it attempts to make clear what sort of evidence is not on its own sufficient to demonstrate a product’s intended use.

To read the full text of this Duane Morris Alert, please visit the firm website.

FDA’s New MAPP Shows the Route to Changing Ownership of Generic Drug Applications

The U.S. Food & Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP), in which it explains the Office of Generic Drugs’ (OGD) policy on facilitating changes to generic drug applications and updating the Orange Book to reflect those changes.

MAPP 5242.1 makes clear that the policies, processes and procedures for changing ownership of an application differ based on whether the change is effected by a simple transfer of ownership or whether it results from a corporate merger or acquisition.

To read the full text of this Duane Morris Alert, please visit the firm website.

COVID-19 Treatment Approvals Accelerated by New FDA CTAP Program

On March 31, 2020, the U.S. Food & Drug Administration (FDA) introduced a specially designed “emergency program”—dubbed the Coronavirus Treatment Acceleration Program (CTAP)—to provide patients with faster access to new COVID-19 treatments. The CTAP allows FDA to “move new therapies to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”

Given the rapidly increasing rate of COVID-19 confirmed cases and fatalities in the United States, efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.

To read the full text of this Duane Morris Alert, please visit the firm website.

A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD

By Justin M.L. Stern and Frederick R. Ball

For consumers, the widespread availability of products containing cannabidiol (CBD) is old news. But for those in the cannabis industry—and in particular, those monitoring applicable regulatory developments—the state of CBD remains largely in flux and continues to be marred by uncertainty.

Under the 2018 Farm Bill, the U.S. Food and Drug Administration (FDA) retained its regulatory authority over products derived from hemp, including CBD incorporated into products it traditionally regulates, such as food, dietary supplements, and cosmetics. Unfortunately for the industry, FDA has yet to propose or issue formal regulations concerning the manufacture, distribution, or sale of such products. At the same time, FDA has issued numerous warning letters to producers and retailers incorporating CBD into products operating in the complex gray area between state and federal law. Nevertheless, recent events occurring across all three federal branches of government may reflect an impetus for change in FDA’s approach to CBD products.

To read the full article, please visit the FDLI website.

FDA’s Report on CBD Reaffirms Status Quo

Consumers want answers from FDA on how it plans to regulate the multibillion dollar market for CBD-related products—and they’re not alone. Under the Further Consolidated Appropriations Act, 2020 (P.L. 116-94), Congress directed FDA to provide a report concerning the agency’s progress in receiving and evaluating data to help inform a policy of enforcement discretion and a process by which FDA will evaluate cannabidiol (meeting the definition of hemp) in FDA-regulated products.

On March 5, 2020, FDA submitted the requested report, painting a more detailed view of its CBD-related activities than the public has seen to date. From a high level, FDA noted that it remains concerned about the potential safety risks posed by mislabeled or contaminated CBD-infused products. At the same time, FDA stated that it “is actively working to evaluate potential lawful pathways for the marketing of CBD.”

View the full Alert on the Duane Morris LLP website.

FDA Postpones Foreign Inspections Through April in Response to COVID-19

FDA announced on March 10, 2020, that the agency is postponing most foreign inspections through April, effective immediately. FDA will consider whether to conduct inspections outside the U.S. deemed mission-critical on a case-by-case basis.

Postponing foreign inspection will likely delay product application reviews that require facility inspections. FDA has committed to trying to mitigate any potential impact that the COVID-19 outbreak and suspension of foreign inspections may have regarding FDA action on product applications. The extent of that impact will likely depend on how soon foreign inspections can resume and the resources, including personnel, available to FDA once they resume.

View the full Alert on the Duane Morris LLP website.

FDA Revises Policies and Procedures for Prioritization of ANDAs in New MAPP

On January 30, 2020, the U.S. Food & Drug Administration (FDA) issued a new Manual of Policies & Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements.

Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it “may grant an ANDA submission either a shorter review goal date or an expedited review” if the submission satisfies a public health priority (or prioritization factor) described in the MAPP.

View the full Alert on the Duane Morris LLP website.

With a Flurry of Warning Letters and a Consumer Update, FDA Signals Commitment to CBD Enforcement Policy

On November 25, 2019, the U.S. Food & Drug Administration (FDA) announced that it had issued warning letters to 15 U.S. businesses engaged in the sale of products containing cannabidiol (CBD); that it had published a revised Consumer Update detailing safety concerns about CBD products; and that it “cannot conclude that CBD is generally recognized as safe (GRAS)” for use in human or animal food. These actions and statements by FDA cut against industrywide hopes that FDA might soon realign its enforcement policy in light of market realities.

View the full Alert on the Duane Morris LLP website.

FDA’s Bark May Be Worse Than Its Bite: Revised Guidance Permits Certain Compounding of Animal Drugs from Bulk Drug Substances

On November 19, 2019, the U.S. Food and Drug Administration (FDA) released revised guidance concerning the compounding of animal drugs from bulk drug substances—in particular, the circumstances under which the FDA would not plan to take enforcement action for certain violations of the Federal Food, Drug, and Cosmetic Act (FDCA) when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances. The guidance is intended to replace a withdrawn draft guidance concerning the compounding of animal drugs initially released in May 2015.

View the full Alert on the Duane Morris LLP website.

In a Regulatory “One-Two,” FDA Modifies Terms of Oversight Concerning Homeopathic Drugs

Late last week, the FDA—in denying a citizen petition and issuing two Federal Register notices—modified published guidance on the manufacture and distribution of homeopathic drugs and declined to convert a current policy guide (CPG) provision into an official regulation. Importantly, the FDA cautioned industry participants and consumers alike that its CPG withdrawal “does not represent a change in the legal obligations that apply to homeopathic drugs”; rather, the CPG—issued in 1988—merely no longer reflects the “current thinking” of the FDA, as it is inconsistent with the agency’s “risk-based approach to enforcement generally.”

View the full Alert on the Duane Morris LLP website.