Policy & Medicine Compliance Update
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It is hard to believe that it is December already! But since it is, we begin this month with our first two-part series examining the compliance highlights of 2022 and making predictions of what life science compliance professionals will face in 2023.
Next, we focus on the 23rd Annual Pharmaceutical and Medical Device Ethics and Compliance Conference (“PCF Conference”). Although the DOJ’s new policies have generated a lot of questions, the DOJ speakers provided few new insights. However, what they did provide, we covered.
As we saw at the PCF Conference, there is a divergence in views on how best to support CCOs and compliance programs. So next, we explore how talent exchanges might improve understanding between the government and industry.
Switching gears, copay charity cases remain in the news. In this issue, we examine Pfizer’s recent appeal to the U.S. Supreme Court challenging the HHS OIG’s advisory bulletins on paying federal healthcare beneficiary copays.
Finally, we examine the growing criticisms surrounding the FDA’s Accelerated Approval Program.
Articles
FEATURE
Forecasting Winds and Weather (Part 1)
Examining Compliance Outcomes in 2022 & Predictions for 2023
By Dr. Seth B. Whitelaw and Katherine Norris[i]
Summary: As expected, 2022 was a busy year for compliance professionals, and 2023 looks to bring more of the same. In Part 1 of a two-part series examining the year’s top developments, we focus on the government’s enforcement activities in the areas of kickbacks, false claims, and anticompetitive behaviors. As the impact of these developments takes hold throughout the industry, 2023 will likely be another challenging year for life sciences companies.
Tags: HHS, OIG, cooperation, Self-Disclosure, CCO Certifications, False Claims, Kickbacks, Settlements, DOJ, Supreme Court, Speaker programs, whistleblowers, drug pricing, PBM, FTC, Inflation Reduction Act, hospital mergers, industry codes, fca amendments
LITIGATION & Enforcement – PCF Conference
Lots of Questions, But Few Insights
DOJ Officials Speak at PCF Conference About New Policies & Compliance
By Dr. Seth B. Whitelaw and Dr. Saul B. Helman
Summary: The DOJ has increased its efforts to drive individual executive accountability and compliance with a series of new policies. However, while critical questions abound, the DOJ speakers at the recent PCF Conference provided few insights to address the industry’s questions.
TAGS: DOJ, Individual Accountability, CCO Certifications, Resources, Organization, PCF
Governance & Operations – Talent Exchange
Bridging the Great Divide
Making the Case for an Appropriate “Revolving Door” Between Regulators and Industry
By Janetta Brewer and Kirt Kraeuter
Summary: The latest DOJ initiative surrounding CCO certifications illustrates the continuing divergence of opinions on how best to support CCOs and compliance programs. Therefore, there is a critical need to improve understanding between the government and the industry it regulates. Applying the lessons learned from the DoD talent exchange programs, coupled with the self-regulatory approaches in other countries, shows promise to bridge this divide and improve mutual understanding.
TAGS: CCO Certifications, Revolving Door, DoD, Talent Exchange, APBI, Medicines Australia, Self-Regulation, Revolving door
LITIGATION & ENFORCEMENT – CoPAY Charities
“Overcriminalization” of the Anti-Kickback Statute
Pfizer Copay Charity Case Heads to the Supreme Court
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: Pfizer is challenging a decision by the Second Circuit Court of Appeals upholding HHS’s application of the AKS and BIS to its proposed copay assistance programs. The case is now before the U.S. Supreme Court, where Pfizer, PhRMA, and others are contending that the decision amounts to an “overcriminalization” of the AKS.
TAGS: Kickbacks, Beneficiary Inducement Statute, Supreme Court, Copay Charities, HHS, OIG, Advisory Opinions, Intent, Pfizer, PhRMA, Amicus Brief
REgulatory Update – Accelerated Approval Program
A Delicate Balance
FDA’s Accelerated Approvals Come Under Fire
By Gwendolyn A. Ball, Staff Writer
Summary: The FDA’s Accelerated Approval Process is a proven lifesaver for patients suffering from serious, incurable diseases. However, the current program is plagued with flaws that undermine its effectiveness. Therefore, as the FDA and Congress work together to reduce federal healthcare costs, the impetuous for reform is increasing.
TAGS: FDA, AAP, Confirmatory Trials, Surrogate Endpoints, Safety, Efficacy, Post-Marketing, Conditional Approval, Enforcement, Congress, CMS
From all of us here at Policy & Medicine Compliance Update, we wish our readers Happy Holidays and peace and joy in the New Year! And as always, thank you for subscribing and for your continuing support in making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor
[i] Dr. Whitelaw is Senior Fellow and Adjunct Professor, Life Science Compliance at Mitchell Hamline School of Law, President & CEO of Whitelaw Compliance Group, LLC, and the Editor of Policy & Medicine Compliance Update. Ms. Norris, MPA, is a Managing Director with Epsilon Life Sciences and a member of the Policy & Medicine Compliance Update Editorial Board.