Tag Archives: frederick ball

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.

Discovery Ruling in District of Minnesota May Have Far-Reaching Implications for FCA Defendants

In a concise, six-page discovery order, a federal judge in Minneapolis may have just started the proverbial shifting of tectonic plates undergirding routine defense procedures in False Claims Act (FCA) litigation by requiring a defendant in an FCA lawsuit to produce the information provided to the Department of Justice (DOJ) during the DOJ’s process of determining whether to pursue the matter.

The FCA creates liability for persons or entities found to have knowingly submitted false claims to the government or having caused others to do so. Like some other federal laws, the FCA creates a private right of action; under the act, a private party—a whistleblower or “relator”—may bring a qui tam action on behalf of the government. When initially filed, the court seals the complaint pending the government’s investigation of the case. If the government chooses, it may intervene and pursue the matter. If not, the relator may pursue the case on its own. (In either case, the relator is entitled to a percentage of the government’s recovery.)

View the full Alert on the Duane Morris LLP website.

FDA’s New Medical Device Rules Speed Up Review Process

This was originally published in Law360.

With the advancements in technology and the advent of artificial intelligence, the medical device industry is flourishing. But regardless of the type of technology involved, the U.S. Food and Drug Administration must clear the device for marketing before any commercialization of a medical device.

There are typically three mechanisms for seeking FDA clearance for a medical device: a 510(k) submission, a de novo classification request and a premarket approval application. The FDA will not accept a 510(k) application unless the applicant can demonstrate that the device is at least as safe and effective (i.e., substantially equivalent to) a device that has already obtained FDA clearance (i.e., a predicate device).

For the full article by Frederick R. Ball and Carolyn A. Alenci, visit the Duane Morris LLP website.

BYOD and eCOA: A Match Made in Heaven?

This was originally published in the Food and Drug Law Institute’s Update magazine.

Patient-focused drug development and the selection and development of Clinical Outcome Assessments (COA) continue to be a focus for the U.S. Food and Drug Administration (FDA). At the same time, we continue to see an increase in technology available at our fingertips and on our wrists. As electronic capture of data becomes more robust and systems to ensure its integrity are put into place, FDA has started to embrace electronic clinical outcome assessments (eCOA). This increase opens up a plethora of new data sources that can be used to facilitate and enhance clinical trials, including the use of a study subject’s own devices (a/k/a “bring your own device” (BYOD)). This article discusses eCOA, BYOD, and FDA’s guidance on their use in clinical studies.

For the full article by Frederick R. Ball, Carolyn A. Alenci and Sandra Stoneman, visit the Duane Morris LLP website.