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340B Drug Pricing Program Compliance
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Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
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Drug Pricing Initiatives During the Trump Presidency
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Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to...more
Did you know that the United States currently has over 2 million Drug Enforcement Administration (DEA) registrants engaging in activities with controlled substances? Whether you’re a student in residency, a healthcare...more
In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to...more
Health workers with legal prescribing privileges have gotten newly revised federal guidelines — once again — making it easier for them to help those addicted to powerful opioid painkillers by prescribing buprenorphine,...more
The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more
The opioid abuse and drug overdose crisis has tarred yet another of the nation’s business titans: McKinsey, a globally renowned consulting firm, has discovered that providing corporate clients sketchy advice about addictive,...more
On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more
In light of the novel coronavirus pandemic, health care practitioners should be aware of relaxed guidelines for prescribing controlled substance. This blog post describes when practitioners can prescribe controlled substances...more
In response to the opioid epidemic, many states, including Texas, created prescription drug monitoring programs to monitor high-risk patients and provider behaviors. The Texas Prescription Drug Monitoring Program (“PMP”) is...more
Last year, the Oklahoma legislature joined a growing number of states in taking direct aim at the opioid crisis by enacting legislation designed to combat the forgery of paper prescriptions. More than a year and a half after...more
In a second criminal case against a pharmaceutical distributor and its executives this year, the Department of Justice has accused Ohio-based Miami-Luken and its former President and Compliance Officer of conspiring to...more
The national opioid epidemic is almost unprecedented in every conceivable way—its catastrophic death toll, its broad effect on a wide swath of this country’s population, its rapid escalation (which is alleged to have been...more
An estimated 400,000 Americans have died due to opioid drug overdoses between 1999 and 2017 — and the fatalities only are increasing. By 2025, according to expert forecasts, there will be 700,000 more opioid deaths....more
In response to the opioid crisis, the Drug Enforcement Administration (DEA) is cracking down on pharmacies, pharmacists, and prescribers by leveraging an old enforcement weapon: revocation of controlled substance...more
In the fifth episode of our series on the national opioid crisis, Hilary Bowman discusses the Drug Enforcement Administration’s (DEA) role in regulating individuals and entities handling controlled substances, including...more
Today, in a move that is widely supported by those in both political parties and across the country, President Trump declared the opioid epidemic a national emergency. Doing so will allow for additional resources to be used...more
On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online...more
In July, New Jersey Governor Chris Christie signed legislation that expands the access, registration, and utilization of the New Jersey Prescription Monitoring Program (NJPMP). The legislation, Senate Bill 1998 (S-1998), is...more
Amid a recent surge in opioid-related deaths in Massachusetts, with over 1,200 accidental deadly overdoses last year, the Senate passed legislation on Thursday, October 1, that is designed to fight the epidemic on various...more