Category Archives: FDA

FDA Clarifies Trading Partners Under the Drug Supply Chain Security Act

The Federal Food and Drug Administration (FDA) recently published several draft guidelines to aid industry and State and Local governments in understanding how to define entities in the drug-supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). DSCSA — enacted as part of the Drug Quality and Security Act of 2013 — delineates the steps manufacturers, re-packagers, wholesale distributors, dispensers (i.e. pharmacies), and third-party logistics providers need to take to develop an electronic, interoperable system that tracks a drug at a unit…

Continue Reading....

The FTC has its Eyes on Biotech for Antitrust Enforcement

On July 27, 2017, representatives of the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) gave coordinated testimony to Congress that ought to raise alarm bells for pharmaceutical companies. Scott Gottlieb, Commissioner of the FDA, and Markus Meier, Acting Director of the Bureau of Competition at the FTC, both testified before the House Judiciary Committee’s Subcommittee on Regulatory Reform Commercial and Antitrust Law. Their statements announced a renewed coordination between the respective agencies with a goal to increase competition in the pharmaceuticals market…

Continue Reading....

Lobbying is not Conspiracy

Plaintiffs often seek to demonize corporate defendants, and one way they try to do so is by asserting that defendants engaged in a “conspiracy.”  For a plaintiff in one of the many talc/ovarian cancer cases pending in California state court, that tactic was unsuccessful as she failed to convince the court that she could proceed with such a claim. The plaintiff, Eva Echevarria, sought to convince Los Angeles Superior Court Judge Maren E. Nelson that she had sufficient proof that defendants Johnson & Johnson and…

Continue Reading....

Shifting Regulatory Landscape for Off-Label Promotion Continues

On Wednesday, July 12, 2017, the Health Subcommittee of the Energy and Commerce Committee held a hearing to discuss proposed legislation that would impact the regulation of off-label use and promotion for drug products. There were representatives from all facets of the industry discussing the potential impact of decreasing regulation of off-label use of drugs and how it could affect patients, the public, manufacturers, and the economy. The FDA last solicited public comment on the issue of off-label use over six years ago, and the…

Continue Reading....

FDA Issues Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the intent of providing clarity for FDA staff and the medical device industry regarding the benefit and risk factors the FDA may consider when prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. These risk-benefit factors may be considered when device manufacturers evaluate appropriate responses to non-conforming product or regulatory compliance issues, including voluntary recall or market withdrawal, and apply to both diagnostic and therapeutic…

Continue Reading....

New FDA Labeling Changes to Require “Black Box Warning” on Immediate Release Opioid Pain Medications

In an effort to combat what it calls “epidemic levels of opioid addiction and overdose”, the U.S. Food and Drug Administration (FDA) announced that it will require class-wide safety labeling changes for immediate release opioid pain medications, including a new “black box warning” informing patients and prescribers of the serious risks of misuse, abuse, addiction, overdose and death. In addition, the FDA will also require several safety labeling changes across all prescription opioid products to include additional warnings addressing the risks of opioids. Opioid analgesics,…

Continue Reading....

Drug Promotion on Social Media By Consumers: Can It Be Regulated?

Kim Kardashian recently used social media to promote the use of a prescription drug. In her Instagram post, Ms. Kardashian told her followers that a physician recommended use of the drug Diclegis to alleviate her symptoms of morning sickness. Ms. Kardashian is not the only public figure to recently deal with morning sickness as the Duchess of Cambridge also dealt with this issue, reported here. Having experienced positive results following the use of this drug, Ms. Kardashian posted her intent to pair with the

Continue Reading....

Defendants in Mass Tort Pelvic Mesh Lawsuits May Now Succeed With Removal to Federal Court – Non-Diverse Defendant Wins Dismissal

In a significant win for Secant Medical LLC, (Secant), Judge Arnold L. New of the Court of Common Pleas of Philadelphia County granted its motion to dismiss mass tort pelvic mesh personal injury claims in a decision dated August 22, 2014.  The court held that under the Biomedical Access Assurance Act (BAAA), Secant is not a manufacturer or seller of the pelvic mesh. Secant, a Pennsylvania company, was undoubtedly named to defeat diversity jurisdiction in an effort by plaintiffs to stay in state court in…

Continue Reading....

This Week’s Life Science Headlines

        Litigation

Continue Reading....

This Week’s Life Science Headlines

        Litigation

Continue Reading....