A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes.

Food and Drug Administration policies on real-world data and evidence in regulatory decision making; H.R. 4511, FDA Advancing Collection of Transformative Science (FACTS) Act; S. 1508, A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S. 4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920);Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D noninterference; Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); S.164 - Advancing Education on Biosimilars Act of 2021; Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2387, STOP GAMES Act of 2019; H.R. 4384, Patient Safety and Drug Labeling Improvement; Transparency of EUA Information and FDA-State Information Sharing; Cures 2.0 Act Discussion Draft; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Clinical Trial Diversity; S. 1644, Promising Pathway Act; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); STOP Fentanyl Act of 2021 (S. 1457/H.R. 2366); S. 1508 - A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes; S. 1260, United States Innovation and Competition Act of 2021; H.R. 2731, Endless Frontier Act; draft Fiscal Year 2022 Labor, Health and Human Services, Education, and Related Agencies funding bill; draft legislation to amend provisions of the National Childhood Vaccination Injury Act to establish new criteria and procedures for covering vaccines in the Vaccine Injury Compensation Program; Country of origin labeling; Supply chain issues; Quality Systems; National Institute of Standards and Technologys (NIST) January 4, 2021 Notice of Proposed Rulemaking (NPRM) on 37 CFR Parts 401 and 404, the implementing regulations of the Bayh-Dole Act; Health Advanced Research Projects Agency (HARPA) proposal.

Client expense: Not reported · Firm income: $480,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)