A Texas federal court recently denied a pharmaceutical supplier’s motion to dismiss claims brought by a whistleblower under the federal False Claims Act (FCA) alleging violations of the Anti-Kickback Statute (AKS) and...more
Key Takeaways: ▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more
The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more
On Tuesday June 16th, the U.S. Court of Appeals for the District of Columbia Circuit upheld a District Court decision that invalidated a Department of Health and Human Services (“HHS”) rule requiring pharmaceutical companies...more
Drug prices continue to be a hot button issue in American politics. While many of the Trump Administration’s efforts to curb increasing drug prices stalled in 2019, a number of state legislatures have adopted drug price...more
Manufacturers and other drug developers should be cognizant of the fact that proper licensing is required in order to distribute prescription drugs. The process for obtaining a license to distribute often requires an...more
The new law implementing the EU rules on falsified medicines which has been applicable since February 2019 (Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European...more
FDA issued a Compliance Policy delaying enforcement of the DSCSA’s saleable returns verification requirement by one year. So now, instead of wholesale distributors having to comply by November 27, 2019, FDA will exercise...more
Colorado Passes New Law - The Colorado General Assembly recently passed new statute C.R.S. 12-42.5-308, which would require pharmaceutical manufacturer marketing employees or agents to present, at the time of marketing a...more
In follow-up to our previous post, the pharmaceutical industry gained a win on July 8th when a federal judge struck down the Trump administration’s rule that would have required drugmakers to include list prices for drugs in...more
Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule from...more
On April 23, 2019, the US Department of Justice (DOJ) announced it has entered into a deferred prosecution agreement with Rochester Drug Co-Operative, Inc. (RDC), one of the 10 largest wholesale distributors of pharmaceutical...more
For much of the past 18 months, the Trump Administration, and in particular CMS, have talked a good game regarding reducing pharmaceutical prices. On October 16, 2018, a key component of the Administration’s strategy was...more
Why are prescription drug prices so high in the U.S.? While this question can hardly be considered a new topic in American healthcare, the recent clash of words between the Trump Administration and Democratic Senators has...more
The U.S. Court of Appeals for the Fourth Circuit last month handed manufacturers and wholesalers of off-patent drugs a victory by ruling that Maryland’s anti-price gouging act violates the U.S. Constitution’s dormant commerce...more
On September 28, 2016, the Third Circuit issued an opinion in Mylan v. Warner Chilcott, upholding the Eastern District of Pennsylvania’s holding on summary judgement that Defendants’ “product hopping” conduct did not violate...more
A new declaratory statement from Florida regulators clarifies the restrictions on intracompany sales of pharmaceuticals. Previously, if one pharmacy in Florida wanted to send a bottle of prescription medicine to its sister...more
Florida boasts the most stringent pharmaceutical distribution regulations in the United States. When they do business in Florida, some of the most sophisticated drug companies in the world discover the hard way that their...more