AG/FDA Blog

Patient – Consumer – Industry Coalition Suggests Reducing Government Barriers to Medication Non-Adherence

In an October 2017 White Paper, Prescriptions for a Healthy America (P4HA), a broad-based group that includes representatives of the pharmaceutical and pharmacy industries, as well as consumer- and patient-based groups, called for a new anti-kickback… Read More
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John Block Reports: The Opioid Crisis – Stop Pointing Fingers

On October 26, 2017, OFW Law founding principal Richard L. Frank filled in for former USDA Secretary John R. Block on his weekly radio broadcast. The opioid epidemic is a national crisis. Drug overdoses are killing 64,000 Americans each year. It… Read More
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2016 – Gone But Not Forgotten

Happy 2017, everyone!  2016 has come and gone.  Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention. As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!),… Read More
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Splitting Headaches for Slack-Fill Plaintiffs

“Take two Advil® and don’t call me in the morning.” That might be the “prescription” that lawyers at a New York plaintiffs’ firm gave to their clients after reviewing an October 18, 2016, decision by Senior District Court Judge Sterling… Read More
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The Zika-Agriculture Connection

By Marshall Matz, as published in Agri-Pulse Q. Is there a connection between the Zika virus and global food security?A. Yes. Genetic engineering has an important role to play in meeting both challenges. The mosquito is the deadliest animal on eart… Read More
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Interstate Structure to Oversee and Regulate Medical Marijuana

There is a need for an interstate structure to provide coordination and regulatory oversight of medical marijuana (cannabis) use in the 23 states that have approved its use by either referendum or legislation.  Five jurisdictions — Colorado, W… Read More
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Medical Privacy Update and 2015 Retrospective

MEDICAL PRIVACY UPDATE: New PHI Disclosures Permitted for Firearm Background Checks Earlier today, HHS published a Final Rule modifying the HIPAA Privacy Rule (45 C.F.R. § 164.512) to allow certain Covered Entities to disclose limited PHI to the FBI… Read More
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EPA Hazardous Waste Pharmaceuticals Rule Begins Circulating: Proposal Applies To Dietary Supplements, 503B Outsourcing Facilities, And Any OTC Retailers

On Tuesday, the Environmental Protection Agency (EPA) announced that its Administrator signed the proposed rule: Management Standards for Hazardous Waste Pharmaceuticals Rule.  The announcement and EPA blog post are here.   The summary of the pre-… Read More
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FDA Drug Promotion Enforcement Update

It has been an interesting week from the perspective of an FDA drug promotion attorney. On the one hand, we have a federal district court expanding how drug companies can promote drugs; on the other, we have FDA’s Office of Prescription Drug Promot… Read More
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FDA Releases Draft Guidance on Compounding Animal Drugs

Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance).  The Federal Register notice accompanying the Draft Guidance can be found here.  The agency also withdrew its previous Com… Read More
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