FDA and Healthcare

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 promotional activities, 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.  

FDA and Healthcare Representative Matters

• Represented 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,Santa Clara County, 131 S. Ct. 1342 (2011).
• Represented the 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 amiciin 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;
• Lead counsel to amicus in support of the appellees in Biotechnology Industry Org., et al. v. District of Columbia, 2007 WL 2189156 (Fed. Cir. August 1, 2007) (invalidating the DC Prescription Drug Excessive Pricing Act of 2005 on the ground that it was preempted by the federal patent laws);
• Counseling several major pharmaceutical companies on drug price reporting issues under Medicare Part B, Medicaid and the US Department of Veterans Affairs (VA) healthcare programs;
• Lead counsel for three 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); 
• Counseling several pharmaceutical companies on compliance with federal laws relating to healthcare fraud and abuse, including the AntiKickback Act and the False Claims Act;
• Advising major pharmaceutical companies on issues associated with various state pharmaceutical price reporting, price control, and marketing disclosure statutes;
• Advising several major pharmaceutical manufacturers on implementation of health care reform legislation;