On November 16, 2017, FDA released a comprehensive policy framework for how the Agency intends to apply existing laws and regulations that govern regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps). The policy framework is set forth in a series …
On November 16, 2017, FDA released four guidance documents that, together, the Agency described as a “comprehensive policy framework” for applying existing laws and regulations governing regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). The policy framework is set forth …
Although the Drug Supply Chain Security Act of 2013 (DSCSA) required publication by 2015 of guidance addressing grandfathering of certain product identifier requirements for packages or homogeneous cases of finished dosage form prescription drugs, “its better late than never,” as the saying goes. On Monday …
Last week FDA formally announced yet another transparency initiative – this time, it’s the inclusion of patent submission dates in the Orange Book! (FDA informally announced the change a couple of weeks ago with a note in the Orange Book stating: “Effective November 21, 2017, …
Last week, FDA did something unprecedented (although not unexpected, at least by this blogger)! And based on the absence of any reporting in the trade press or online chatter, nobody seems to have taken note of FDA’s decision. In a November 6, 2017 response to …
In June, we reported on Nevada S.B 539, a new law that, among other things, requires manufacturers of “essential diabetes drugs” to report certain sensitive financial information concerning these drugs. On October 31, the Nevada Department of Health and Human Services took the first step …
Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2015) – Agreements Filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, …
The Sixth Circuit recently dealt another blow to relators seeking damages under the False Claims Act (FCA) based on allegations of off-label promotion. In a 2-1 decision, the court, in United States ex rel. Ibanez v. Bristol-Myers Squibb Co., affirmed the district court’s dismissal of …
Despite relative inaction on drug pricing at the federal level so far this year, 2017 has been a banner year for state legislation involving pharmaceutical pricing, price reporting, and discounting. Because it is becoming increasingly difficult to keep track of these recent laws, we thought …
On October 31st, FDA made its long anticipated announcement recognizing the first European drug regulatory authorities capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight countries that were announced are: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. The …
On October 2, 2017, the New Jersey Attorney General and Division of Consumer Affairs published Proposed New Rule N.J.A.C. 13:45J, Limitations On and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers. According to the preamble, the proposed rule responds to a concern …
On October 26, 2017, Par Sterile Products, LLC and Endo Par Innovation Company filed a Complaint in the United States District Court for the District of Columbia against the Food and Drug Administration. At the heart of the Complaint is FDA’s Interim Policy addressing compounding …
Earlier this week, the U.S. District Court for the District of Columbia issued a Memorandum Opinion granting summary judgment to FDA in a lawsuit Lannett Company Inc. and Lannett Holdings, Inc. (collectively “Lannett”) filed in June 2016 challenging FDA’s rescission of Lannett’s ANDA 202750 for the …
The Food and Drug Law Institute’s (“FDLI”) Drug Quality and Security Act (“DQSA”) conference is just a few weeks away, and spaces are going fast! The conference will be held on November 15, 2017, in Washington, D.C. Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer …
On October 9, 2017, California Governor Jerry Brown signed into law a bill (SB 17), which imposes new notification and reporting requirements on pharmaceutical companies, health care service plans, and health insurers. Among the many reporting obligations under SB 17, we describe below only those …
