Nearly three years into the pandemic, it is impossible to ignore that the health care policy environment has been forever changed — and that change continues. The pandemic laid bare long-standing inequities in access for people of color, people with low incomes, LGBTQ+ people, women, and people who live at the intersections of these identities. Here at Medicines360, our work is focused on addressing the gaps women face in accessing the medicines they need. While that of course means our work in drug development, manufacturing, and distribution as a nonprofit pharmaceutical company, it also demands that we pay attention to and speak up about policies that could harm or help the women we serve.
As this work continues, we want to take a minute to share some important policy-related updates from 2022 and a forecast of developments on the horizon as the 118th Congress begins. Foremost, the passage of the year-end omnibus spending bill in December, which includes key provisions for the nonprofit pharmaceutical industry, symbolizes federal support for nonprofit pharma and previews important work to come this year.
End of Year Victories
Support for nonprofit pharmaceutical organizations gained robust congressional momentum in 2022 — three pieces of legislation introduced in the 117th Congress include language to support the nonprofit pharmaceutical industry. Two of these pieces – the HHS study on nonprofit pharmaceuticals and the GAO report – were included in the year-end omnibus bill and will lay important bricks in a foundation of federal policy support for nonprofit pharmaceutical organizations.
- In March, the Senate HELP Committee advanced the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act/S.3799) out of Committee, including a critical amendment that would allow the HHS Assistant Secretary for Planning and Evaluation to include nonprofit pharmaceutical companies in a study. This amendment was included in the omnibus spending bill, signed into law by President Biden on December 29.
- In May, Sens. Rosen and Romney (R-UT), announced the introduction of the bipartisan Advancing Affordable Medicines for Families Act (S. 4341), bipartisan legislation which would direct the Government Accountability Office (GAO) to conduct a report on the impact that nonprofit drug companies would have on lowering drug costs, addressing drug shortages, and accelerating the development of new drugs. The report, the language for which is included in the year-end omnibus spending that passed late last year, will also address existing barriers to the success of nonprofit pharmaceutical organizations, and what Congress can do to support them.
- In June, when the Senate HELP Committee advanced the FDASLA Act (S. 4348) to the full Senate floor with broad bipartisan support, it first added two critical amendments spearheaded by Committee Members Sens. Rosen and Romney. One amendment would call for the same GAO report as S. 4341, while the second amendment would instruct the U.S. Food and Drug Administration (FDA) to hold a public meeting on the value of nonprofit drug organizations, how those nonprofits can help address patient access issues, and whether future user fee processes should be altered to better support their work.
More Key Updates from 2022
● In February, bipartisan cosponsors in the House introduced the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (H.R. 6584), which would require a “diversity action plan” to ensure representative trial enrollment. While this standalone legislation did not advance, similar language was included in a larger legislative package that passed the House in June. Having conducted the longest clinical trial of an IUD and expanded its indications by including women with diverse demographics such as nulliparous and overweight women, Medicines360 has been actively advocating for increased clinical trial diversity. It’s incredibly encouraging that lawmakers are paying attention to this critical issue.
● In March, Civica Inc. — a fellow nonprofit pharmaceutical company — announced plans to prioritize patients and advance health equity by providing insulin for no more than $30 a vial. Organizations like Civica and Medicines360 are working to give patients the access to critical care when they need it and showing policymakers a future that is possible with nonprofit pharmaceutical companies incorporated into our healthcare system.
● In April, amid pushes from state lawmakers to restrict access to sex education and comprehensive reproductive health care, Sen. Marco Rubio (R-FL) forced a failing vote on a Congressional Review Act resolution (S.J.Res.41) that would have nullified the Biden Administration’s rule that reopened the Title X program to all qualified health care providers. Title X – the nation’s family planning program – is a critical program that helps build health equity in this country by expanding access to health care for people with lower incomes. Medicines360 is committed to supporting Title X in all our work.
- In June, reproductive rights champions in the House and Senate introduced the Affordability is Access Act (S.4337 /H.R. 7894) — critical legislation that will require insurance companies to cover, and retailers to not interfere with access to or purchase of, birth control approved by the U.S. Food and Drug Administration (FDA) as safe and effective over-the-counter without a prescription. Medicines360 supports this legislation and is working hard in our advocacy to advance equitable access to contraception for all women.
- In late September, Congress passed a five-year user fee agreements (UFAs) reauthorization as part of the Continuing Resolution that funded our government through December 16th, 2022. UFAs are designed to speed up and modernize FDA drug approvals and drug oversight regulations. In a process intended to ensure they are revisited and rethought routinely, UFAs must be reauthorized by Congress every five years.
- On August 16, President Biden signed the Inflation Reduction Act into law. This important law was passed via budget reconciliation – a mechanism that allowed the Democratic majority to pass legislation with just 51 votes. While the name doesn’t make this clear, the Inflation Reduction Act contains a variety of critical health care provisions, including requiring the HHS Secretary to negotiate prices for some top-selling drugs covered in Medicare and requiring drug companies to pay rebates if prices rise faster than inflation for drugs used by Medicare beneficiaries.
What To Watch Moving Forward
- Sen. Jacky Rosen (D-NV) introduced the Expanding Access to Affordable Prescription Drugs and Medical Devices Act (S. 2257) in 2021 — a bill designed to support nonprofit pharmaceutical organizations in their efforts to sustainably increase access to affordable medicines for Americans. As the longest-standing nonprofit pharmaceutical organization serving the U.S. market, Medicines360 has proudly applauded this legislation as a significant first step toward supporting nonprofit pharmaceutical organizations in reducing the cost of medicines for patients. We will continue to support Sen. Rosen in her push to advance reforms that support nonprofit pharma in the 118th Congress.
Expanding access to critical medicines and devices is at the heart of Medicines360’s work, and we are grateful for this congressional support around the incredible value of that mission. Our policy work, like our work to advance health equity for all women, is just getting started – we look forward to sharing more updates soon.