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PhRMA Sues Arkansas for Meddling in the Federal 340B Drug Discount Program
…actions (see list below). These lawsuits were filed between January and June of 2021. On May 31, 2021, even as the contract pharmacy dispute was playing out in federal courts,…
GAO Issues Report on BTC Drug Category; Update of 1995 Report Could Lead to Legislative Proposal
…issues that need to be addressed before a BTC drug class is established in the U.S. In particular, the GAO report states that: Pharmacist-, infrastructure-, and cost-related issues would have…
NABP and Healthcare Stakeholders Announce Collaborative Efforts Addressing Prescription Drug Abuse and Practitioner Responsibilities
By Larry K. Houck – The National Association of Boards of Pharmacy (“NABP”), along with a coalition of healthcare stakeholders, recently announced collaborative steps to address prescription drug abuse and…
Federal Judge Rejects Effort to Invoke First Amendment to Overcome Misbranding and Fraud Indictment; Holds that Press Release in Case is Labeling
…of pulmonologists to prescribe Actimmune for IPF. Harkonen also collaborated with a specialty pharmacy that sent a fax blast of the press release to more than 2,000 pulmonologists. The pharmacy…
Letter Signed by 65 Members of Congress Urges FDA to Reconsider “Office Stock” Restrictions for Section 503A Compounders
A recent letter from 65 members of Congress to FDA’s Commissioner Gottlieb has caused a bit of a buzz in the pharmacy compounding world. The letter, dated May 23, 2017,…
D.C. Court Strikes Down Copay Accumulator Rule
…insurers and pharmacy benefit managers to use copay accumulators to exclude drug manufacturers’ copay assistance when calculating patients’ out-of-pocket costs and cost-sharing ceilings under the Affordable Care Act (ACA). We…
The Update Continues: FDA’s List of Drugs that May Not Be Compounded Under 503A and 503B
…216.24. FDA is at it again with another proposed rule that would further amend this list. In alignment with the votes of the June 2015 Pharmacy Compounding Advisory Committee (see…
DEA Administrative Decisions Update: DEA’s Questionable Practice of (Un)official Notice
…state authority. We will be blogging on a recently released fourth case, Edge Pharmacy, 81 Fed. Reg. 72092 (Oct. 19, 2016), in the near future. In this post, however, we…
Massachusetts District Court Guts Discount Safe Harbor
…on September 13, 2007, the relators allege that Omnicare, a long-term care pharmacy chain, violated the Federal False Claims Act by soliciting and/or receiving kickbacks from drug manufacturer Organon for…
NIH Again Closes Drug Product Manufacturing Facilities and Halts Clinical Studies
…following the 2015 inspection (those two facilities were the Pharmaceutical Development Section and Clinical Center Pharmacy). We attempted to clarify this with NIH contact listed on the press release, but…
What the Doctor Ordered? What the Pharmacist Understood? FDA Issues Compounding Draft Guidance Addressing Compounding for Office Use under FDC Act § 503A
…Congress and the compounding pharmacy industry disagreed, and sought clarification of the issue. Now – as it exists in draft form – FDA’s opinion (and guidance) is clear. Pharmacies acting…
The U.S. GAO Reports on FDA’s Oversight of Compounded Animal Drugs: FDA Could Improve Oversight with Better Information and Guidance
…and, (3) states regulate pharmacy practice and drug compounding. Notwithstanding these limitations, FDA noted it has sought enforcement action against pharmacies that compound animal drugs on several occasions (including warning…
GAO Reports on DEA’s Interactions with its Registrants: Registrants Generally Want More
…pharmacy calls to verify prescriber prescriptions. The Report noted, though, that stricter distributor thresholds, or limits on the quantity of controlled substance ordering, which were influenced by DEA’s enforcement actions…
HP&M to Speak at Next Week’s FDLI & UMD Conference on Implementation of DQSA
On Wednesday, December 3rd, the Food & Drug Law Institute and the University of Maryland Schools of Law and Pharmacy will hold a conference on “Emerging Issues in FDA Law:…
A Primer for Navigating the Murky, Drug-Infested Waters of Drug Diversion Administrative Revocation and Application Hearings
An article set to be published in the Albany Law Review in Spring 2015, titled “Drug Diversion Administrative Revocation and Application Hearings for Medical and Pharmacy Practitioners: A Primer for…