Prescription Drugs and Biologics

As we begin the final quarter of 2022 and the leaves here on the east coast begin to turn and fall, it seems the clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of …

On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls.  Wilson Bryan opened this new forum for direct agency …

On September 26, 2022, Biogen Inc. agreed to pay $900 million to the United States and various states to settle a False Claims Act (FCA) lawsuit.  This lawsuit was brought to the U.S. district court of Massachusetts by former employee and whistleblower Michael Bawduniak in …

On September 29, 2022, FDA approved Amylyx’s NDA for its drug, Relyvrio (sodium phenylbutyrate/taurursodiol), for treatment of patients with amyotrophic lateral sclerosis (ALS) (see FDA announcement here).  This approval decision charts a path for the exercise of appropriate flexibility in regulatory decisions for other rare …

FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice).  By way of background, 21 C.F.R. § 4.3 requires generally that manufacturing of a …

On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics, including sessions on new FDA Medical Queries and standardized presentations of safety data. For a number of years, FDA has been including …

Earlier this week, President Biden signed Executive Order 14081, titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”  The Executive Order was spurred in part by the COVID-19 pandemic, but it points out that biotechnology and biomanufacturing—defined as use of biological …

Hyman, Phelps & McNamara, P.C.’s Deborah Livornese will be a panelist for FDAnews’ September 15, 2022 webinar titled “Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis”.  Aspirational only title notwithstanding, you can find more information about the webinar and registration at FDAnews and …

Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule.  As it stands, the rule allows insurers and pharmacy benefit managers …

Last month FDA published its 4th annual report on the state of pharmaceutical quality and, needless to say, there were some interesting statistics, particularly for us FDA nerds. Number of Manufacturing Sites and Registered Products The report states that for fiscal year 2021, there were 4,451 CDER …

FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance). This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). As the new Federal …

Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID.  That impression was corroborated this week at the GMP by the …

The Inflation Reduction Act of 2022 (“IRA”) has now passed both the Senate (on August 7) and the House (on August 12), and is headed to President Biden for signature.  We have prepared a slide deck that summarizes Subtitle B of the IRA, entitled “Prescription Drug …

For years, FDA has been wrestling with questions about what patents should be listed in the Orange Book, but, as we have reported, FDA has made little to no progress on addressing those questions.  One of those pressing questions that remains unanswered involves the listing …

In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS).  Pfizer, Inc. v. U.S. Department of Health and Human Services …