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Pamela Mejia

Senior Manager of Government Relations

[email protected]

+1.202.434.7313

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Pamela is a Senior Manager of Government Relations at ML Strategies, and is based in Washington, D.C. Pamela helps manage several relationships with a wide range of clients, and provides creative strategies to help them reach a broad set of policy influencers in Washington.

Prior to joining ML Strategies, Pamela was the Legislative Affairs Manager for the Community Justice Action Fund, a nonprofit organization that mobilizes communities of color to tackle the causes of gun violence. In that role, she oversaw the organization’s engagement with federal lawmakers on legislation, appropriations bills, and budget funding and led a coalition of national, state, and local organizations focused on building support for evidence-based solutions to address gun violence in underserved communities. Previously, as a Staff Assistant to US Representative Katherine Clark (D–MA), she prepared legislative documents related to immigration, health care, and educational issues.

Earlier in her career, Pamela worked for now-retired Congressman José E. Serrano (D–NY) and then US Representative Ben Ray Luján (D–NM), who is now in the US Senate, and the Justice Center for the Protection of People with Special Needs, back in her home state of New York.

Pamela is active in the Congressional Black Associates and Black Women’s Congressional Alliance, an officially House-recognized, bipartisan Congressional Staff Organizations whose mission is to enhance the political, social, and economic capabilities of Black people, and women on Capitol Hill. She also engages with the Congressional Hispanic Staff Association, an official, non-partisan, bicameral Congressional Staff Organization whose mission is to recruit, retain, and advance Hispanic staffers in the Congress.

viewpoints

Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders. An announcement on August 7, 2024 by the Centers for Medicare and Medicaid Services (CMS) of a final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway was therefore a welcome development. However, digging under the surface of the TCET pathway uncovers some less than thrilling details. CMS’s failure to address stakeholder proposals to modify the TCET program has increased interest and advocacy around Congress’s consideration of the Ensuring Patient Access to Critical Breakthrough Products Act. We explore both the shortcomings of the TCET pathway and the possible legislative solutions to its perceived gaps below.

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On June 28, 2024, the Food and Drug Administration (FDA) released draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (the Draft Guidance), for public review and comment. The Draft Guidance was issued pursuant to a directive from Congress in the Food and Drug Omnibus Reform Act (FDORA), signed into law in December 2022, which required FDA to issue or update guidance on diversity action plans that sponsors submit for certain clinical studies of investigational drugs and medical devices. The Draft Guidance also serves to update guidance that FDA previously issued on the topic in April 2022.

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Read about President Biden’s recent withdrawal from the 2024 presidential election and his endorsement of Vice President Kamala Harris as the Democratic nominee, including her stance on technology, climate change, health care, and tax policy.

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On March 18, President Biden signed an executive order (EO) that contributes to the administration’s objective to create solutions to long-lasting women’s health issues that have been historically understudied and under-evaluated.

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Read about Sprint for Women’s Health, a first-of-its-kind initiative to commit $100 million for research and development in women’s health, announced by the Advanced Research Projects Agency for Health.

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On Friday, September 22, 2023, in the Rose Garden, President Biden announced the establishment of a White House Office of Gun Violence Prevention. This initiative builds on several actions President Biden spearheaded to advance gun violence prevention such as working with Congress to enact the Bipartisan Safer Communities Act and issuing executive orders to support communities impacted by gun violence.

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The next three weeks will be full of activity in Washington D.C., as the House of Representatives and Senate are working to push their legislative agendas to garner support from their constituents ahead of an August recess and before political “silly season” officially kicks in ahead of the upcoming mid-term elections in November. Here’s our latest update on what you can expect in Congress during the July work period.
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Pamela Mejia

Senior Manager of Government Relations

Washington, DC