Duane Morris – Page 8 – Duane Morris Life Sciences Law

December 7, 2020 by Duane Morris

PBMs Must Say Goodbye to Manufacturer Rebates

Pharmacy benefit managers (PBMs) play a significant role in U.S. drug pricing, yet their existence is little known to those outside of the pharmaceutical and insurance arenas. In an effort to modify one of the largest drivers in increasing drug costs―rebates paid to PBMs by drug manufacturers―the U.S. Department of Health and Human Services on November 20, 2020, published three final rules that, most notably, declared that these rebates are no longer protected by the safe harbors to the anti-kickback statute.

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

November 30, 2020 by Duane Morris

HHS OIG’s Special Fraud Alert on Speaker Programs by Pharma and Device Companies

On November 16, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Special Fraud Alert addressing speaker programs presented by pharmaceutical and medical device companies. Such programs, at which companies may pay physicians or other health care professionals (HCPs) for speeches or presentations about drugs and devices in addition to providing remuneration to attendees, are frequently sponsored by pharmaceutical and device companies seeking to provide education regarding their products. Highlighting what it called “inherent fraud and abuse risks,” OIG’s Special Fraud Alert expressed concerns surrounding the offer or payment of remuneration from pharmaceutical and device companies to physicians or other HCPs associated with such programs.

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

November 10, 2020November 10, 2020 by Duane Morris

Could COVID-19 Data Help Medical Device Manufacturers Accelerate the FDA Approval Process?

Medical device shortages and shortcomings during the COVID-19 pandemic have led the Food and Drug Administration (FDA) to grant Emergency Use Authorization (EUA) to many medical devices manufacturers. Were it not for these EUAs, these manufacturers would be unable to market their devices, as their FDA applications would still be pending. Once the present “emergency” ends, these EUAs will expire, and manufacturers will again be unable to market their devices for the indications cleared under the EUA.

Still, the real-world evidence (RWE) gained about these devices while marketed under the EUA need not be lost with the passing of the pandemic. Once the pandemic ends, manufacturers should be able to use the data collected to support their pending applications for market clearance and for new indications for already-cleared devices.

To read the full text of this article by Duane Morris partners Frederick R. Ball and Erin M. Duffy, please visit the Wharton Health Care Management Alumni Association website.

October 20, 2020 by Duane Morris

3D Printing in the Life Sciences: Mitigating the Risks

With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality. Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked. […]

Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing.

To read the full text of this article by Duane Morris partner Sean Burke, please visit the 3DHeals website.

October 6, 2020October 6, 2020 by Duane Morris

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.

September 8, 2020 by Duane Morris

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.

August 27, 2020August 27, 2020 by Duane Morris

New Guidance Reveals FDA’s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements

In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

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

August 6, 2020 by Duane Morris

FDA Clarifies Policy on Scope of Review of Multiple-Function Device Products

On July 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance containing its current thinking, policies and recommendations relating to the manufacturing and marketing of “multiple function” device products—products comprised of at least one FDA-regulated “device” function and at least one “other function”—a function that either does not meet the definition of a “device” under the Federal Food, Drug & Cosmetic Act; that is not subject to premarket approval; or for which the FDA has expressed an intention not to enforce regulatory compliance.

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

July 23, 2020 by Duane Morris

Discussion of Nondrug CBD Products Omitted on New FDA Draft Guidance on Cannabis-Related Clinical Research

On July 21, 2020, the U.S. Food & Drug Administration (FDA) issued draft guidance outlining the agency’s current thinking on the development of drugs containing cannabis or cannabis-derived compounds. The new guidance is disappointing to many in the cannabis industry because it does not provide insight into the FDA’s views on the marketing of nondrug, hemp-derived CBD products.

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

July 9, 2020 by Duane Morris

FDA Issues Guidance on Procedures for Device Establishment Inspections

On June 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance on how it will implement certain inspection procedures with respect to device establishments—facilities where medical devices are manufactured. The FDA’s guidance contains recommendations about (1) preannouncement notice (and communications prior to an establishment inspection); (2) inspection durations and timeframes; and (3) communications between the establishment’s representative and FDA’s inspector(s) during the inspection process.

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