Pharmaceuticals

  • Read more: Platform Progress, Transparency Gaps in the EU Pharma Package

    Platform Progress, Transparency Gaps in the EU Pharma Package

    The European Union is in the middle of revising its medicines legislation. This reform, often referred to as the “pharma package,” centers on a proposed new Pharmaceutical Regulation and a proposed new Pharmaceutical Directive. Its stated aims are to improve access to medicines, encourage innovation, and strengthen the EU’s competitiveness and security of supply. 

  • Read more: Hazards Ahead for FDA’s Drug Review Process

    Hazards Ahead for FDA’s Drug Review Process

    In June 2025 the U.S. Food and Drug Administration (FDA) launched the Commissioner’s National Priority Voucher Program (CNPV), billing the initiative as “accelerated drug review for companies supporting U.S. national interests.” 

  • Read more: Can Pharma Companies Reverse String of Judicial Defeats at SCOTUS?

    Can Pharma Companies Reverse String of Judicial Defeats at SCOTUS?

    Following the passage of the Inflation Reduction Act’s (IRA) provision granting Medicare the authority to negotiate drug prices, pharmaceutical companies and allied organizations have brought a dozen lawsuits challenging the legality of the negotiation program. 

  • Read more: Small Provision in the One Big Beautiful Bill Reveals the GOP’s Next Health Care Target

    Small Provision in the One Big Beautiful Bill Reveals the GOP’s Next Health Care Target

    Health policy experts, patient advocates, and the news media have understandably focused on the One Big Beautiful Bill’s threat to Medicaid. The budget reconciliation law, passed with slim GOP majorities and exclusive Democratic opposition in July, included numerous reforms to Medicaid eligibility that will likely reduce the number of Medicaid beneficiaries by more than 10 million and decrease federal Medicaid spending by more…

  • Read more: Nonprofits Are Ready to Repurpose Generic Drugs

    Nonprofits Are Ready to Repurpose Generic Drugs

    Drug companies typically seek a formal labeling change from the U.S. Food and Drug Administration (FDA), or a parallel regulatory body outside the U.S., to market a drug for a new use.

  • Read more: The False Promise of Smart Pills in a Loosely Regulated Market

    The False Promise of Smart Pills in a Loosely Regulated Market

    By Spencer Andrews We’ve all had the experience: you receive a targeted ad on your phone or computer which mysteriously seems to read your mind. This happened to me recently when I, a busy law student, began receiving a wave of ads selling supplements which purport to improve brain focus, clarity, and memory. I had…