S. 415 · 117th Congress · enacted
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
Became Public Law No: 117-9.
Latest official action 2021-04-23 · Enacted
The bill, briefly
This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases. Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity. The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.
Congressional Research Service · 2021-04-14
Who reported lobbying on this bill?
Amount spent specifically on this bill: not disclosed
The reports below name this bill and disclose an organization’s overall lobbying expenses or a firm’s client income for the period. They can cover many bills and issues. These amounts are not payments to the bill or its politicians.
No matching lobbying report is imported yet. This is not evidence that no lobbying occurred.
2,409 latest lobbying reports imported. Some source imports are still in progress.
Politicians behind the bill
Sponsors and cosponsors from the official source, limited to members currently in office. Campaign amounts are cycle-wide and are not payments for this bill.
Sponsor
Bill Cassidy
Senate · LA · Republican
$1,221,279PAC receipts · 2025–2026
Cosponsor
Tina Smith
Senate · MN · Democratic
-$35,500PAC receipts · 2025–2026
Cosponsor
Roger Marshall
Senate · KS · Republican
$1,702,385PAC receipts · 2025–2026
2 of 2 source cosponsor records retrieved; only current officials and unwithdrawn sponsorships appear.
PAC donors to the listed sponsors
These are all-cycle contributions to the listed sponsors’ and cosponsors’ campaigns. FEC does not attribute them to this bill. A donation plus sponsorship does not establish why a politician acted.
NORPAC$24,500
Roger Marshall · Cosponsor · $24,500
Official PAC recordCHEVRON EMPLOYEES POLITICAL ACTION COMMITTEE - CHEVRON CORPORATION$20,000
JOBS OPPORTUNITY NOW POLITICAL ACTION COMMITTEE$20,000
THE HAWKEYE PAC$20,000
TOMORROW IS MEANINGFUL PAC$20,000
HEALTHEQUITY, INC. PURPLE POLITICAL ACTION COMMITTEE (HEALTHEQUITY PURPLE POLITICAL ACTION COMMITTEE)$17,000
AMERICAN COLLEGE OF RADIOLOGY ASSOCIATION PAC$16,500
AMERICAN INSTITUTE OF CERTIFIED PUBLIC ACCOUNTANTS POLITICAL ACTION COMMITTEE$15,000
BEST AT BRINGING ENTREPRENEURIAL RESULTS NEVER IMAGINED OR ENVISIONED PAC$15,000
DAVITA INC. POLITICAL ACTION COMMITTEE (DAPAC)$15,000
HONEYWELL INTERNATIONAL INC. TECHNOLOGIES PUBLIC AFFAIRS COUNCIL (HONPAC)$15,000
LUMEXA IMAGING PAC$15,000
Bill Cassidy · Sponsor · $15,000
Official PAC recordMERCK & CO., INC., EMPLOYEES POLITICAL ACTION COMMITTEE (MERCK PAC)$15,000
MORTGAGE BANKERS ASSOCIATION POLITICAL ACTION COMMITTEE (MORPAC)$15,000
NATIONAL ASSN. OF DENTAL PLANS POLITICAL ACTION COMMITTEE$15,000
NATIONAL AUTOMOBILE DEALERS ASSOCIATION POLITICAL ACTION COMMITTEE$15,000
NATIONAL BEER WHOLESALERS ASSOCIATION POLITICAL ACTION COMMITTEE$15,000
NEBRASKA SANDHILLS PAC$15,000
OORAH! POLITICAL ACTION COMMITTEE$15,000
SEND IN THE SEAL PAC$15,000
THE HOME DEPOT INC. POLITICAL ACTION COMMITTEE$15,000
UNITED PARCEL SERVICE, INC. PAC (UPSPAC)$15,000
WALMART INC. PAC FOR RESPONSIBLE GOVERNMENT$14,000
FRESENIUS MEDICAL CARE HOLDINGS, INC. POLITICAL ACTION COMMITTEE$13,500
QUEST DIAGNOSTICS INCORPORATED POLITICAL ACTION COMMITTEE$13,500
AMERICAN SOCIETY OF ANESTHESIOLOGISTS POLITICAL ACTION COMMITTEE (ASA PAC)$13,000
NATIONAL ASSOCIATION OF REAL ESTATE INVESTMENT TRUSTS, INC. POLITICAL ACTION COMMITTEE$13,000
AFLAC POLITICAL ACTION COMMITTEE (AFLAC PAC)$12,500
ALSTON & BIRD PAC$12,500
AMERICAN CRYSTAL SUGAR COMPANY POLITICAL ACTION COMMITTEE$12,500
AMERICAN HEALTH CARE ASSOCIATION POLITICAL ACTION COMMITTEE$12,500
AMERICAN OPTOMETRIC ASSOCIATION POLITICAL ACTION COMMITTEE$12,500
COX ENTERPRISES PAC (COXPAC) INC.$12,500
ENVISION HEALTHCARE OPERATING, INC POLITICAL ACTION COMMITTEE$12,500
EXXON MOBIL CORPORATION POLITICAL ACTION COMMITTEE (EXXONMOBIL PAC)$12,500
MEDICAL DEVICE MANUFACTURERS ASSOCIATION PAC$12,500
NATIONAL ASSOCIATION OF REALTORS POLITICAL ACTION COMMITTEE$12,500
Bill Cassidy · Sponsor · $4,500
Tina Smith · Cosponsor · $3,000
Roger Marshall · Cosponsor · $5,000
Official PAC recordNATIONAL CONFECTIONERS ASSOCIATION OF THE UNITED STATES, INC. POLITICAL ACTION COMMITTEE (CANDY PAC)$12,500
TROUTMAN PEPPER LOCKE LLP POLITICAL ACTION COMMITTEE, INC.$12,500
GARNEY HOLDING CO. PAC$12,000
The largest 40 donor totals appear here. Open each politician for their complete, paginated PAC donor list.
What happened after enactment?
Dated agency-reported implementation and uptake measures are shown with their scope. They do not by themselves establish causal success. If no evidence is listed, the outcome is not established.
Measured outcome: not established
Enactment alone does not show whether a law improved its intended outcome. We need a dated evaluation, observed result or verified implementation record before claiming success or failure.