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, Jeffrey 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; the Patient Protection and Affordable Care Act; and the Inflation Reduction 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 federal pricing laws and the federal and state Anti-Kickback laws.
Jeffrey represents clients in litigation matters, internal investigations, and government audits and investigations, Congressional investigations, and matters before 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. He also has successfully represented the pharmaceutical industry in Administrative Procedure Act litigation challenging HRSA’s interpretation of the orphan drug exclusion from 340B pricing obligations, the Trump Administration’s “most favored nation” rule, and CMS’s 2020 regulation relating to treatment of co-pay accumulator adjustment systems in Medicaid rebate calculations.
Experience
- Representing major biopharmaceutical company in multiple Congressional inquiries related to drug pricing.
- 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 U.S. Court of Appeals for the Second Circuit, and the U.S. 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).
- PhRMA as lead counsel in Administrative Procedure Act challenge to orphan drug regulations promulgated by HRSA in connection with the 340B drug pricing program.
- PhRMA as lead counsel in Administrative Procedure Act challenge to CMS’s 2020 regulation requiring manufacturers to “ensure” that co-pay assistance exclusively benefits patients and is not subject to an “accumulator adjustment system.” Pharmaceutical Research and Manufacturers of America v. Becerra et al., case number 1:21-cv-01395, in the U.S. District Court for the District of Columbia.
- AstraZeneca in successful challenge to HRSA’s contract pharmacy guidance. Astrazeneca Pharmaceuticals LP v. U.S. Department of Health and Human Services et al., C.A. No. 22-1676, 58 F.4th 696 (3d Cir. 2022); AstraZeneca Pharmaceuticals LP v. Becerra et al., C.A. No. 21-27-LPS, 543 F. Supp. 3d 47, (D. Del. 2022).
- 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 U.S. Department of Veterans Affairs (VA) healthcare programs.
- Several pharmaceutical companies 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).
- Requestors in connection with several positive advisory opinions issued by HHS-OIG, including Advisory Opinion Numbers 13-10 (establishment of a subsidiary that provides hospital services to reduce readmissions), 14-05 (direct to patient cash program), 17-07 (collaboration agreement relating to information provided in hospital discharge process), 20-02 (transportation and lodging program in support of cell therapy patients), 21-01 (free drug program for hospital administered product), 21-19 (free eyedrops to manage side effects from therapy), and 22-06 (sponsored genetic test/counseling).”
- Several pharmaceutical companies on structuring contracts and programs in compliance with federal and state anti-kickback statutes.
- Several major pharmaceutical manufacturers on implementation of the Inflation Reduction Act of 2022.
Perspectives
Recognition
"Life Science Star" FDA: Medical Device (2017-2022, 2024)
"Life Science Star" Hall of Fame (2021)
"Life Science Star" Regulatory (2012-2016)
Life Sciences: Regulatory/Compliance — Nationwide (2022-2024)
Credentials
Education
- J.D., The George Washington University Law School, 1995, with high honors
- B.A., Rutgers College, 1992
Admissions
- District of Columbia
- Maryland