Health Law Advisor

“Master Files” are not just for PowerPoints. On April 4, 2024, the Food and Drug Administration (FDA) issued its “New Dietary Ingredient Notification Master Files for Dietary Supplements: Guidance for Industry” (“Draft Guidance”). These latest recommendations build upon the agency’s Final Guidance issued in March—the subject of our prior blog post—regarding procedures and timeframes for industry stakeholders to submit NDINs. The new recommendations also replace and expand upon those portions of a 2016 Revised Draft Guidance, called “Dietary ...

On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). The purpose of the Final Guidance is to assist manufacturers and distributors of new dietary ingredients (“NDIs”) and dietary supplements in preparing and submitting new dietary ingredient notifications (“NDINs”) to the FDA.

The Final Guidance finalizes Section V, “NDI Notification Procedures and Timeframes,” of a 2016 revised Draft Guidance (“Draft ...

On April 11, 2022, the Drug Enforcement Administration (DEA) released a final rule which amends DEA regulations to now require all applications for DEA registrations, and renewal of those registrations, to be submitted online. The final rule is effective May 11, 2022.

On January 7, 2021, DEA published a notice of proposed rulemaking (NPRM) that proposed requiring that all applications for DEA registrations, and renewal of those registrations, be submitted online. DEA is promulgating this rule as proposed in the NPRM with one exception: DEA is clarifying that Automated Clearing House (ACH) fund transfers will be accepted as payment for registrations and renewals.

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans.  Clinical evidence has shown that there are significant differences among the races that impact the safety and effectiveness we can expect from a particular drug or device, and consequently FDA has concluded testing and labeling to identify those racial differences are important.  The question for today is, how are we doing in achieving racial diversity in clinical trials involving drugs?

We recently outlined key provisions of the Environmental Protection Agency’s (EPA’s) Final Rule modifying the standards governing industry management of hazardous waste pharmaceuticals, which become effective August 21, 2019. Client Alert

Impacted industries must immediately comply with the nationwide ban on the sewering of hazardous waste pharmaceuticals as of the August 21^st effective date.  The ban applies to a wide range of stakeholders, including, but not limited to reverse distributors, pharmacies, hospitals, and wholesalers.

Additional regulatory changes ...

In an Advisory Opinion dated October 20, 2017, to Crouse Health Hospital ("Crouse Hospital"), the Federal Trade Commission ("FTC") agreed that the Non-Profit Institutions Act ("NPIA") would protect the sale of discounted drugs from Crouse Hospital to the employees, retirees, and their dependents of an affiliated medical practice (Crouse Medical Practice, PLLC) ("Medical Practice") from antitrust liability under the Robinson-Patman Act.  Significantly, the FTC provided this advice despite the fact that the Medical Practice is a for-profit entity, and is not owned by Crouse ...

One of the most discussed aspects of healthcare has to be how to balance cost, quality and access.  This is especially true when it comes to the pharmaceutical industry, particularly with the rapid growth of and increased focus on highly effective, but highly expensive, specialty drugs.  Discussions about these costs are no longer isolated to negotiations between pharmaceutical companies, PBMs and insurers; instead it appears that price and cost are on FDA's radar. 

For example, the Oncologic Drugs Advisory Committee ("ODAC") hearing, earlier this month, was not only historic ...

When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA's position, Twitter was not going to be a medium that ...

The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.

First, although Centers for Medicare & Medicaid Services (CMS) was required to publish standards for ...