public comments |

policy and regulatory submissions

Reply affidavit on behalf of the petitioner to the statement filed by the senior panel counsel for the 1st respondent. Seba PA vs. Union of India and Others. Oct 22 2024
Comment on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027. Submitted to Centers for Medicare & Medicaid Services, Department of Health and Human Services. Docket No. CMS-1800-NC3. 2 July 2024.
Proposed changes to Bayh-Dole Act: “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions.” Submitted to the National Institute of Standards and Technology, Department of Commerce. Docket No. 201207-0327. 6 Feb 2024.
Statement for the record for hearing “Why Does the United States Pay, by Far, the Highest Prices in the World for Prescription Drugs?”. Submitted to the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP). 5 Feb 2024.

-Clip of Senator Sanders referencing submission and asking pharmaceutical company CEOs about production costs:
Response to Request for Information on drug shortages.. Submitted to the House Energy and Commerce Committee. 7 June 2023.
- See also: Written testimony for House Energy and Commerce Committee hearing “Legislative Proposals to Prevent and Respond to Generic Drug Shortages”
Review of Risdiplam application for spinal muscular atrophy for the 24th WHO Expert Committee on the Selection and Use of Essential Medicines. Submitted to the the WHO Expert Committee on Selection and Use of Essential Medicines. 6 Apr 2023.
Comment on compulsory license for Paxlovid patent P2021-0232, filed by Pfizer on 6 August 2021. Evidence submitted to Oficina Nacional de la Propiedad Industrial (ONAPI), Dominican Republic. Available on request.
Risks posed by a US-UK trade agreement to NHS drug costs.. Submitted to the EU Committee, International Agreements Sub-Committee, UK House of Lords. 23 Sept 2020.
Statement of the Lancet Youth Commission on Essential Medicines Policy (YCEMP). Submission to the WHO 20th Expert Committee on the Selection and Use of Essential Medicines. 18 Apr 2015.