Pink Sheet quotes James C. Shehan in an article reporting pharmaceutical company Sanofi’s settlement with the U.S. Securities and Exchange Commission for violating the Foreign Corrupt Practices Act (FCPA). The article notes that this settlement follows a relatively quiet period for FCPA settlements. Shehan attributes the lack of FCPA enforcement activity to the fact that “there are fewer easy cases out there for prosecutors to go after,” that there can be a long period between the alleged violation and resolution of the case, and that companies have generally become more compliant with the law. (subscription required to access article)

Law360 interviews with James C. Shehan on a broad range of issues, including: critical skills for being a successful FDA lawyer, a move to streamline the FDA’s approval process, patent litigation involving biosimilars, FDA updates to off-label promotion guidance, a push in favor or competition and generics, and understanding why the FDA has reduced the number of warning and untitled letters for promotional issues. (subscription required to access article)

Law360 quotes James C. Shehan in an article discussing the likelihood of an increase in litigation against U.S. Food & Drug Administration (FDA) policies should the Hon. Brett Kavanaugh of the U.S. Court of the Appeals for the District of Columbia Circuit be confirmed to the U.S. Supreme Court. Judge Kavanaugh has criticized the Supreme Court’s Chevron doctrine, which mandates judicial deference to reasonable administrative agency interpretations of ambiguous federal laws, as enabling agencies to “stretch the meaning of statutes.” Shehan predicts that a shift by the Court on Chevron will spark more lawsuits against the FDA. He notes that while Chevron may still inspire judicial deference in cases involving complex scientific matters, any lessening of deference more generally would diminish the FDA’s authority. (subscription required to access article)

4-traders.com and StreetInsider.com note Lowenstein Sandler as legal co-counsel with Gracin & Marlow, LLP to Aravive Biologics, Inc. in connection with its merger with a wholly owned subsidiary of Versartis, Inc. in an all-stock transaction. (Lowenstein deal team: Alan Wovsaniker and Andrew E. Graw.)

Modern Healthcare quotes James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, on how the FDA’s new Medical Device Safety Action Plan will fill gaps in device regulation and may portend further FDA action in other areas.

Steven M. Skolnick and Michael Lerner are highlighted in Law360 regarding their representation of Motus GI Holdings, Inc. and its successful IPO.

James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, is quoted in Modern Healthcare regarding the security of medical devices pertaining to health systems, noting the lack of absolute security in the electronic world.

James C. Shehan comments in Law360 on the FDA’s 2017 enforcement statistics showing a continued drought of drug promotion enforcement.

James C. Shehan is quoted in Modern Healthcare regarding the FDA's final guidance on 3-D printed medical devices and how it will spur innovation.

As New Jersey Attorney General, Christopher Porrino is quoted in Reuters, NJ Spotlight, Observer, and NJ.com (among other outlets) on the state’s suits against drug companies for their role in the opioid epidemic.

As New Jersey Attorney General, Christopher Porrino is quoted on News12 New Jersey and NJ.com (among other outlets) on changes to opioid prescribing rules.

In Law360, James C. Shehan opposes proposal from professors to reduce insurance coverage for accelerated approval drugs and cites good safety and effectiveness record of these products.

Jim Shehan comments in Reuters on Trump administration proposals for FDA deregulation.

Jim Shehan comments in Law360 on the deluge of bold policy statements made by the FDA during the final days of the Obama administration.

In Bloomberg Law, Jim Shehan comments on the importance of maintaining contacts for GCs returning to law firms.

In Bloomberg Law, Jim Shehan comments on the importance of maintaining contacts for GCs returning to law firms.