Maryland’s House Bill 631, which is scheduled to take effect in October 2017, is facing a lawsuit filed by the Association for Accessible Medicines, which calls the bill unconstitutional.
Maryland’s House Bill (HB) 631, which is scheduled to take effect in October 2017, is facing a lawsuit filed by the Association for Accessible Medicines (AAM), which calls the bill unconstitutional.
AAM filed suit in a US district court in Maryland in July. The industry trade group says that the bill “grants Maryland unprecedented powers to regulate the national pharmaceutical market, violating the United States Constitution and posing harm to vulnerable patient communities.”
The bill, which targets price gouging (which the bill defines as “an unconscionable increase in the price of a prescription drug”) in the sale of off-patent or generic drugs, requires the Maryland Medical Assistance Program to notify the state’s attorney general of increase in the prices of generic or off-patent treatments, and authorizes the attorney general to:
AAM calls into question the bill’s focus on generic drugs as a way to save health costs for Maryland; according to the group, generic medications, which account for the majority of prescriptions written each year, saved Maryland $4.1 billion in 2016. The bill includes no provisions addressing the cost of patent-protected drugs.
When the Maryland legislature passed the bill, Governor Larry Hogan (R) declined to sign it, but allowed the legislation to pass into law. In a letter to the state’s Speaker of the House, Hogan expressed reservations about the bill, saying that it raised “legal and constitutional concerns,” and that he found it “troubling” that the bill did not target patent-protected drugs or medical devices. Hogan’s letter concluded with a statement that, in his view, the problem of drug pricing can only be addressed at a national or global level, and that state legislation such as HB 631 did not present a solution to the problem.
Maryland’s Attorney General Brian Frosh, however, has been a vocal supporter of HB 631, saying that the law will “give Maryland a necessary tool to combat unjustified and extreme price increases for medicines that have long been on the market and that are essential to our health and well-being.”
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Cost Savings and Efficacy of Biosimilars in Psoriasis Treatment for Veterans
October 17th 2024Biosimilars are safe, effective, and well-tolerated for psoriasis treatment, providing significant cost savings for the Veterans Health Administration, which saved over $67 million in 2023, while highlighting ongoing provider concerns regarding their use.