• Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDA AAP-approved products under certain circumstances.) Efforts to enact a so-called "reasonable pricing clause" in NIH licenses and CRADAs
• Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics. Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
• Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products. Efforts to impose "reasonable pricing clauses" on patent licenses from NIH-grantees to commercial partners. The ongoing PTO-FDA collaboration on drug pricing.
• Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
• Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).

Duration: September 3, 2018 to December 31, 2023

General Issues: Health Issues, Trade (Domestic & Foreign), Copyright/Patent/Trademark, Immigration, Taxation/Internal Revenue Code

Spending: about $1,705,000 (But it's complicated. Here's why.)

It can be tricky to figure out how much an organization spent on a particular lobbying engagement. The law only requires lobbyists to report the amount they were paid for federal lobbying each quarter rounded to the nearest $10,000—and if it's less than $3,000 in a given quarter (or less than $13,000 for organizations with in-house lobbyists), they don't have to disclose it at all. Plus, some organizations include spending that doesn’t belong in the report—for instance, money spent lobbying state governments or other legal work.

Agencies lobbied since 2018: U.S. Senate, House of Representatives, Patent & Trademark Office (PTO), Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), Centers For Medicare and Medicaid Services (CMS), Natl Institutes of Health (NIH), Justice - Dept of (DOJ), State - Dept of (DOS), Homeland Security - Dept of (DHS)