Jeffrey Handwerker focuses his practice on pharmaceutical pricing and investigations, government contracts, and commercial litigation involving the pharmaceutical, medical products, and biotechnology industries. In the pharmaceutical pricing area, Mr. Handwerker regularly advises pharmaceutical and medical technology companies on pricing and contracting matters arising under, among other things, the Veterans Health Care Act; the Medicaid Rebate Act; the Deficit Reduction Act of 2005; the Medicare Prescription Drug, Improvement, and Modernization Act; and the Patient Protection and Affordable Care Act. He also has advised pharmaceutical companies on some of the most important and cutting-edge issues confronting the industry, including healthcare reform implementation, application of the First Amendment to pharmaceutical communications with healthcare professionals, and novel issues under the federal and state Anti-Kickback laws.

Mr. Handwerker represents clients in litigation matters, internal investigations, and government audits and investigations, including investigations initiated by the United States Attorney's Offices in Philadelphia and Boston, among others. He also has extensive experience litigating cases on behalf of pharmaceutical companies under both state and federal false claims acts.

Experience

  • AstraZeneca Pharmaceuticals LP in litigation involving the Public Health Service drug pricing program (known as the 340B Program) filed in federal district court in Alabama and California (see County of Santa Clara v. Astra USA, et al., 2006 WL 2193343 (N.D. CA July 28, 2006); 2006 WL 1344572 (N.D. CA May 17, 2006); 428 F.Supp2d 1029 (N.D. CA 2006); on September 28, 2010, the United States Supreme Court granted the petition for certiorari that Arnold & Porter prepared on behalf of all defendants in this litigation and, on March 29, 2011, the Supreme Court adopted our position and held that the pricing lawsuits could not proceed, see Astra USA, Inc., et al. v. Santa Clara County, 131 S. Ct. 1342 (2011).
  • Pharmaceutical Research and Manufacturers of America (PhRMA) at the district level, the US Court of Appeals for the Second Circuit, and the US Supreme Court in a First Amendment challenge to a Vermont law restricting the rights of drug manufacturers to promote their products using prescriber-identifiable data (records of doctor prescribing histories). See Sorrell, et al. v. IMS Health Inc., et al., 2011 WL 2472796 (June 23, 2011); IMS Health Inc., et al. v. Sorrell, et al., 630 F.3d 263 (2d Cir. 2010); IMS Health Inc., et al., v. Sorrell, et al., 631 F. Supp2d. 434 (D. VT 2009).
  • Lead counsel to amici in support of the defendant in United States ex. rel. Kammerer and Lisitza v. Johnson & Johnson, et. al., a qui tam suit currently pending in the US District Court for the District of Massachusetts.
  • PhRMA as lead counsel in Administrative Procedure Act challenge to orphan drug regulations promulgated by HRSA in connection with the 340B drug pricing program.
  • Several drug manufacturers in connection with government investigations regarding allegations of violations of the Anti-Kickback Act, the Food Drug and Cosmetic Act, and the False Claims Act.
  • Several major pharmaceutical companies on drug price reporting issues under Medicare Part B, Medicaid and the US Department of Veterans Affairs (VA) healthcare programs.
  • Several pharmaceutical companies as lead counsel in connection with internal audits of their price reporting systems, including systems for reporting drug prices under Medicare Part B (average sales price), VA (non-Federal Average Manufacturer's price), and Medicaid (average manufacturer's price and best price).
  • Several pharmaceutical companies on compliance with federal laws relating to healthcare fraud and abuse, including the Anti-Kickback Act and the False Claims Act.
  • Several major pharmaceutical manufacturers on implementation of health care reform legislation.

Recognition

LMG Life Sciences Guide
"Life Science Star" – FDA: Medical Device, Pharmaceutical Healthcare Pricing & Reimbursement (2017)
"Life Science Star" – Regulatory (2012-2016)
Best Lawyers
FDA Law (2015-2018)
The Legal 500 US
"Leading Lawyer" – Healthcare: Life Sciences (2016-2017)
More

Credentials

Education
  • JD, The George Washington University Law School, 1995, with high honors
  • BA, Rutgers College, 1992
Admissions
  • District of Columbia
  • Maryland
Overview

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