APOTEX CORP. for APOTEX CORP.
What was lobbied
One issue area, each in the filer's own words, with who lobbied on it and where.
Pharmacy PHA
S. 340/HR965, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; HR 938, the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics Act, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; Federal policy relating to pharmaceutical market blockages caused by parked Hatch-Waxman 180-day exclusivity periods; HR 1520, the Purple Book Continuity Act of 2019, provisions relating to publication of patents for biological products in the FDA Purple Book; HR 1503, the Orange Book Transparency Act of 2019, provisions relating to ensuring the FDAs Orange Book is accurate and up to date; HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, provisions relating to patent settlements between brand and generic drug companies; Federal policy relating to generic pharmaceutical drug prices; and Implementation of Public Law 115-52, the FDA Reauthorization Act of 2017, Section 808, Incentivizing Generic Drug Developments, provisions relating to exclusivity for competitive generic therapies.
Foreign entity interest: Aposherm Delaware Holdings Corporation, Aposherm Inc., Apotex Holdings Inc., Sherfam Inc., and Shermco Inc., the parent companies of Apotex Corp. identified on LD-1, have direct or indirect interests in companies that develop, manufacture, and/or sell generic drugs and therefore are interested in the issues identified in this report.
| Lobbyist | Covered position, as disclosed |
|---|---|
| STEVEN GIULI | — |
Shown as published by the Senate Office of Public Records and the House Clerk under the Lobbying Disclosure Act. The official filing is the record; open it for the full form.