Policy & Medicine

MEDX Primary Care Conferences Help Clinicians Fight the Teenage Vaping Crisis

Thomas Sullivan Oct 19, 2019 0

Starting Saturday October 26th primary care physicians across the country will engage in education on the emerging health crisis of teenage vaping at the Medical Education Exchange (MEDX) Primary Care 2019 Conferences. MEDX keynote sessions will address the emerging threat of teen vaping with a keynote session by J. Michael Collaco, MD, MPH,…

When Money and Doritos Don’t Suffice – The…

Thomas Sullivan Oct 12, 2019 0

The Chaos Over Drug Compounding Continues As Judge Throws…

Thomas Sullivan Sep 17, 2019 0

MEDX Primary Care Conferences Help Clinicians Fight the Teenage…

Starting Saturday October 26th primary care physicians across the country will engage in education on the emerging health crisis of teenage vaping at the Medical Education Exchange (MEDX) Primary…

FDA Says More Orphan Drug Labels Need Pediatrics Info

The US Food and Drug Administration (“FDA”) provided a report to Congress, entitled Pediatric Labeling of Orphan Drugs, detailing the results of a study that examined drugs that have been approved for…

FTC Warns Law Firms About Potentially Deceptive Claims in TV Ads

The Federal Trade Commission (“FTC”) sent letters to several law firms and marketing companies, warning them that advertisements soliciting clients for personal injury lawsuits against pharmaceutical…

OIG Report Concludes that DEA was Slow to Respond to Opioid…

Recently, the Justice Department Office of Inspector General (“OIG”) released a report criticizing the regulatory activities and enforcement efforts of the Drug Enforcement Administration (“DEA”) for…

FDA OPDP Issues Warning Letter to Galt Pharmaceuticals Regarding…

The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) sent a Warning Letter to Galt Pharmaceuticals LLC regarding its marketing practices for Doral, a drug used to…

“Pay for Delay” Legislation Signed in California

California Governor Gavin Newsom recently signed three legislative bills into law, all aimed at lowering the cost of prescription drugs and fostering greater access to healthcare. One of those bills,…

When Money and Doritos Don’t Suffice – The Crucial…

The current U.S. opioid epidemic has been branded as “the worst drug crisis in America’s history” and a “man-made plague.” According to the Centers for Disease Control and Prevention (“CDC”), the…

FDA ANDA Review and Approval Metrics Improving, But Much Work…

The US Food and Drug Administration (“FDA”) released quarterly data on two programs intended to increase generic competition and to speed approval of priority generic drugs. The programs, which were…

FDA OPDP Issues Warning Letter to Metuchen Pharma About ED Drug…

Recently, the US Food and Drug Administration Office of Prescription Drug Promotion (“OPDP”) sent a warning letter to Metuchen Pharmaceuticals for several false or misleading advertisements in…

How Are Insurers Treating the $2M Drug, Zolgensma?

It has been several months since the United States Food and Drug Administration (FDA) approved Novartis’ gene therapy drug Zolgensma. Zolgensma is meant to be a one-time curative treatment for spinal…

Nevada Fines Drug Manufacturers for Failure to Comply with Drug…

In early October 2019, the Nevada Department of Health and Human Services sent letters to and levied more than $17 million in fines on twenty-one diabetes drug manufacturers regarding non-compliance…

Avanir Settles One Kickback Suit, Agrees to Cooperate in Another

Avanir Pharmaceuticals has been in the news lately for its payment of kickbacks to physicians for its drug Nuedexta. On September 26, 2019, the Department of Justice announced a settlement with the…