FDA and Healthcare
John Gould's practice spans a broad range of compliance counseling and public policy matters, and focuses on drug price reporting obligations, the federal anti-kickback statute, and related state laws. In the pricing area, Mr. Gould advises on Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program requirements, as well as state drug price reporting laws. Mr. Gould has also assisted clients with restatements, investigations, and litigation related to drug price reporting. Recently, Mr. Gould has spent significant time advising clients regarding the comprehensive healthcare reforms enacted in March 2010 and other changes to drug price reporting requirements. Mr. Gould also advises clients regarding compliance with US Food and Drug Administration requirements and state and federal requirements for reporting gifts to healthcare providers. Mr. Gould frequently speaks at industry conferences on these subjects.
Mr. Gould earned both a JD and a Master of Bioethics degree from the University of Pennsylvania. Prior to that, Mr. Gould developed pharmaceutical company sales and marketing strategies at the consulting firm ZS Associates, and performed scientific research in pharmaceutical manufacturer and academic laboratories.
FDA and Healthcare Representative Matters
- Counseling major pharmaceutical and medical device manufacturers on various sales, marketing, and other corporate programs, e.g., bundled sales, samples, patient assistance, product support services, product replacement, coupons, vouchers, and grants.
- Preparing drug price reporting policies and Medicaid rebate and Average Sales Price reasonable assumptions for major pharmaceutical manufacturers.
- Counseling regarding restatements of drug pricing metrics to the government, and disputes with states regarding Medicaid rebates.
- Drafting PBM, managed care, and Medicare Part D agreements for major pharmaceutical companies.
- Counseling drug manufacturers on avoiding "marketing the spread."
- Drafting comments on Centers for Medicare and Medicaid Services proposed rules and guidance regarding drug reimbursement and price reporting issues.
- Seconded to major pharmaceutical company to provide drug pricing counseling.
and Kristin M. Hicks
"Overcoming the Challenges Stemming from the CMS Proposed Medicaid Rebate Rule
" Pharmaceutical Pricing Litigation, October 2012
"Hot Topics for Manufacturers -- Top Compliance Challenges
" Medicaid Drug Rebate Program Summit, September 2011
"Key AMP and Additional Rebate Changes in Healthcare Reform
" CBI Medicaid Rebates, May 2010
"Understanding the Federal Sunshine Provisions Passed with Comprehensive Healthcare Reform
" West Coast Forum on Tracking State Laws and Aggregate Spend, April 2010
"New FULs on Medicaid Payments for Multisource Drugs and the Legalities Surrounding the AMP Debate
" CBI Medicaid Rebates, May 2009
"Manufacturer and Charity Patient Assistance Programs
" Commonwealth of Virginia Pharmacy Assistance Taskforce, September 2006