Drug and Pharmaceutical Law

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On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs.[1] …
Continue Reading Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the 340B Battlefield

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts patients’ and is being ‘abused’ by hospitals. Its defenders say it’s ‘vital’ to the health of low-income patients and essential to helping safety net hospitals care for their communities.”…
Continue Reading Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

The House and Senate continue to focus on prescription drug pricing though it is unclear whether any of the proposals currently pending in either chamber will become law. On December 6th, Senators Grassley and Wyden introduced an updated version of the bipartisan Prescription Drug Pricing Reduction Act (the “PDPRA”). Senate leadership, however, appears to be in no rush to vote on the bill. On December 12th, the House passed its own version of a prescription drug price reduction bill, H.R. 3, called the Elijah E. Cummings Lower Drug Costs Now Act, which was introduced by Speaker Pelosi. Senate leadership has already indicated the Senate will not take up the measure. While members of Congress on both sides agree that reducing prescription drug prices is a “must do,” they don’t agree on how to do it.
Continue Reading Congress Continues to Focus on Prescription Drug Pricing

U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning Letters”). In just the last week, the USAO for the Eastern District of Wisconsin sent warning letters to over 180 prescribers identified by Drug Enforcement Administration (“DEA”) data as prescribing opioids at relatively high levels. The Food and Drug Administration and the Federal Trade Commission have also been issuing their own warning letters to opioid marketers and distributors over the past several months, evidencing a concerted effort to combat the opioid epidemic on a number of fronts through various federal enforcement and regulatory efforts.
Continue Reading Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers