Tag Archives: rick ball

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’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 The guidance is intended to replace a withdrawn draft guidance concerning the compounding of animal drugs initially released in May 2015.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.

Federal Agencies Issue Draft Guidance for Drug Master Files for First Time in 30 Years

For the first time since September 1989, federal agencies have issued draft guidance concerning drug master files (DMFs), submissions to the FDA that may be used to provide confidential, detailed information concerning the manufacturing, processing, packaging and storing of human drug products. Notably, the release of this draft guidance comes on the heels of a recent executive order by President Trump aiming to curb the use of agency guidance documents to avoid the formal rule-making process.

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.

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.

DEA Announcement on Improving Access to Marijuana Research

On August 26, 2019, the Drug Enforcement Agency (DEA) issued a press release announcing “it is moving forward to facilitate and expand scientific and medical research for marijuana in the United States.” This announcement comes in the midst of a growing demand for marijuana for medical and scientific research. Several years ago, in an August 11, 2016, press release, DEA first announced its intention to “expand… the number of DEA-registered marijuana manufacturers” because “only one entity was authorized to produce marijuana to supply researchers in the United States: the University of Mississippi.” Since that announcement, 33 entities have applied to DEA for a marijuana manufacturer registration. However, the approval process was stalled during Attorney General Jeff Sessions’ term in office, and to date no new applications have been approved. Meanwhile, the number of entities registered by DEA to conduct research on marijuana, marijuana extracts or marijuana derivatives has jumped from 384 in January 2017 to 542 in January 2019. Thus, while demand for marijuana for research purposes has increased sharply, the number of suppliers has remained stagnant.

View the full Alert on the Duane Morris LLP website.

OTC Personal Products Manufacturer Cited by FDA for Various Regulatory Violations

On August 20, 2019, the U.S. Food and Drug Administration announced that it had sent and posted a warning letter to an over-the-counter drug manufacturer citing “significant” violations of current good manufacturing practice (CGMP) and also issued a news release in connection with this letter. The letter was sent to NingBo Huize Commodity Co., Ltd., a China-based manufacturer of health and beauty products such as sunscreen lotion, shampoo, hand sanitizer and lip balm, following FDA’s inspection of the facility in March 2019. In particular, the warning letter, and concurrent press release and import alert, show that FDA continues to have significant concerns related to data integrity and will harshly sanction companies that falsify data.

View the full Alert on the Duane Morris LLP website.

CMS Issues Proposed Regulations to Expand Open Payments System Reporting

In the Federal Register posted on August 14, 2019, the Centers for Medicare and Medicaid Services (CMS) published proposed regulations that, if finalized, would expand the Open Payments reporting requirements initially introduced under the Physician Payments Sunshine Act. The Open Payments program sheds light on some of the payments (and other transfers of value) made from certain drug, device, biologicals and medical supply manufacturers to covered recipient physicians and teaching hospitals. Under the Physician Payments Sunshine Act, the applicable manufacturers must report certain payments made to the covered recipients through the Open Payments program on an annual basis. Such disclosures are available to the public. The categories of payments or transfers of value that must be disclosed include: research, honoraria, gifts, grants, travel expenses, and marketing, education or research for a specific covered drug or device.

View the full Alert on the Duane Morris LLP website.

FDA Releases Guidance on REMS Modifications and Revisions

On July 9, 2019, the U.S. Food and Drug Administration (FDA) released a final guidance on changes to approved Risk Evaluation and Mitigation Strategies (REMS). For certain drugs, the FDA may require a REMS as an additional risk management plan to ensure that the benefits of the drug outweigh the risks. The final guidance describes the three different types of changes to an approved REMS, how application holders should submit changes to REMS, and how the FDA will process submissions from application holders for changes to REMS.

View the full Alert on the Duane Morris LLP website.