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HHS Drug Pricing Disclosure Rule: Chance at a Renewed Life Following District Court Appeal?

Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human Services (HHS) filed a notice of appeal against a federal judge’s decision to block an HHS final rule that would require drugmakers to disclose product list prices within consumer-directed television advertisements for certain prescription drugs. HHS is seeking to compel, through the Social Security Act (SSA), drug price disclosures as a way to increase price transparency and improve the efficiency of the federal government’s Medicare and Medicaid programs. If the rule goes into effect, drug manufacturers would be responsible for including the wholesale acquisition price for drugs in their advertisements if the price exceeds $35 for a one-month supply. The United States District Court for the District of Columbia ruled on the eve of the final rule’s effective date in July that HHS had not been given authority from Congress in the SSA’s statutory scheme to force companies to disclose drug prices. Instead, the court advised HHS to take this matter up with the legislative branch. For a full refresher on the final rule and the district court’s decision, check out our prior blog posts following this issue.

However, HHS is not willing to take this judicial rejection without a fight. Instead, the Trump administration has chosen to appeal the district court ruling, effectively giving HHS another chance to resurrect a key Administration policy that attempts to reduce prescription drug prices.

As the case heads to the United States Court of Appeals for the District of Columbia Circuit, we will continue to keep you posted on new developments.

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About this Author

Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to...

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Elizabeth K. Conti Associate Mintz DC FDA Regulatory Health Care Enforcement & Investigations Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Consumer Product Safety
Associate

Elizabeth focuses her practice on regulatory compliance and enforcement defense matters for companies in the pharmaceuticals, medical device, dietary supplement, cosmetics, and food industries as well as pharmacies and distributors.

She advises clients on FDA regulations related to labeling, advertising, importing and exporting, and manufacturing practices. Her practice also encompasses administrative matters and civil litigation related to DEA requirements. On the enforcement defense side of her practice, Elizabeth counsels clients on fraud and abuse compliance and litigation involving the False Claims Act, the Stark law, and the federal anti-kickback statute.

Prior to joining Mintz, Elizabeth was a health law associate in the Washington office of a Wisconsin-based national law firm, where she assisted clients with a wide range of FDA, DEA, and health care fraud and abuse enforcement matters. Earlier, she was a winter associate at that firm.

While earning her law degree, Elizabeth also completed a clerkship at the White House Council on Environmental Quality and internships with the Environmental Protection Agency’s Office of the General Counsel and Office of Enforcement and Compliance Assurance. At law school, she served as a note & comment editor of the Catholic University Law Review.

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