Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines. We are thinking of all of you in these difficult times, and hope that you and your loved ones are healthy and safe.
In This Issue
- AGG Food & Drug Podcast Episode 4: FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment
- Not a Very Happy Thanksgiving for One Pharmaceutical Company: OPDP Issues an Untitled Letter For Unlawful Promotion
- CMS Issues Interim Final Rule Implementing the Most-Favored-Nation Model for Medicare Part B Drugs
- What's Old is Not New Again . . . HHS Rescinds FDA's Unapproved Drug Initiative Program
- HHS Proposes Major Changes to the HIPAA Privacy Rule
- DEA Proposes Rule to Govern Partial Fills of Schedule II Drugs
- Industry Activities and Recognition
In this episode, AGG partner Kevin M. Bell and of counsel Robert Durkin discuss some of the more interesting issues and challenges they have encountered when working with clients to ensure they maximized opportunities to monetize the greatest value from their natural products and how a well thought out and executed regulatory strategy can help. To listen to the episode, please click here.
Not a Very Happy Thanksgiving for One Pharmaceutical Company: OPDP Issues an Untitled Letter For Unlawful Promotion
By: Alan G. Minsk and Seth S. Ray
Instead of sending a turkey and cranberry sauce, in the spirit of 2020 where nothing is normal, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) made a different delivery this year for Thanksgiving. It sent an Untitled Letter to a pharmaceutical company for sending a misleading email to healthcare professionals about the prescription drug’s risks and efficacy. More >
CMS Issues Interim Final Rule Implementing the Most-Favored-Nation Model for Medicare Part B Drugs
By: Neil W. Hoffman and Genevieve M. Razick
The Centers for Medicare & Medicaid Services (CMS) published an interim final rule implementing the Most-Favored-Nation (MFN) Model for Medicare Part B drugs and biologics in the November 27, 2020, Federal Register (the “Interim Final Rule”). This follows an Executive Order issued in September 2020 titled, “Lowering Drug Prices by Putting America First,” which directed the Secretary of the Department of Health and Human Services to implement new payment models under the Medicare Part B and Part D programs to curb “unfair” and high drug prices in the United States. More >
What's Old is Not New Again . . . HHS Rescinds FDA's Unapproved Drug Initiative Program
By: Alan G. Minsk and Seth S. Ray
On November 20, 2020, the United States Department of Health and Human Services (HHS) issued a Federal Register notice to: (1) withdraw the Food and Drug Administration’s (FDA) Compliance Policy Guide (CPG) Sec. 440.100 (“Marketed New Drugs Without Approved NDAs [New Drug Applications] or ANDAs [Abbreviated New Drug Applications]); and (2) request information about drugs that may be grandfathered or generally recognized as safe and effective (GRASE), i.e., not “new drugs,” requiring FDA prior approval. The withdrawal notice is effective 30 days from publication. In addition, HHS published a Frequently Asked Questions document. More >
By: Kevin Coy, Madison M. Pool and Erin E. Doyle
On December 10, 2020, the Office for Civil Rights at the U.S. Department of Health and Human Services (HHS) announced significant proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. If finalized, the proposed rule would make numerous changes to the HIPAA Privacy Rule, including requiring a variety of operational changes from covered entities, as well as impact HIPAA policies, forms, processes, business associate agreements, and training. Stakeholders should carefully review the proposed rule and consider submitting comments to HHS before the deadline. More >
DEA Proposes Rule to Govern Partial Fills of Schedule II Drugs
By: Jennifer L. Hilliard
More than four years after enactment of the Comprehensive Addiction and Recovery Act of 2016 (CARA), the Drug Enforcement Administration, on December 4, 2020, issued a proposed rule (the “Proposed Rule”) to address partial fills of prescriptions for Schedule II drugs. Section 702 of CARA amended the Controlled Substances Act (CSA) to permit partial fills requested by either the practitioner that wrote the prescription for the medication or the patient for whom it was written. More >
Alan Minsk Interviewed by NTD News
AGG Food & Drug team leader Alan G. Minsk was interviewed by NTD News on November 20, 2020. Minsk discussed the likelihood of Pfizer filing for emergency use authorization for the COVID-19 vaccine. To listen to the full interview, please click here.
Robert Durkin a Guest Speaker on NutraIngredients’ Podcast
Former acting Director and Deputy Director of the Office of Dietary Supplement Programs (ODSP) and current AGG Nutritional Supplements industry team member Robert Durkin was a guest speaker on NutraIngredients’ podcast “NutraCast.” Durkin spoke to Danielle Masterson in a NutraIngredients’ podcast, titled “Race to Market,” about the prospects of studying an ingredient for use in both food and drugs under the Food, Drug and Cosmetics Act. To listen to the full podcast, please click here.
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