Dear Chairman Alexander and Ranking Member Murray:
On behalf of the undersigned organizations, we write to express urgent concern about a proposal in the President’s budget request that would undermine trust in the quality of biologic medicines with healthcare practitioners and patients, including for medicines widely prescribed to treat diabetes, rheumatoid arthritis, cancer, Crohn’s disease and colitis, and other diseases. The proposal, contained in the HELP discussion draft, would exclude biologic medicines from the requirement that all medicines marketed in the United States adhere to quality standards established by the United States Pharmacopeia (USP). We believe that USP standards have been, and should remain, a foundational element in the framework ensuring that the medicine supply in the United States is among the safest in the world.
In the last Congress, a similar proposal was rejected after robust engagement from numerous stakeholders during consideration of the 21st Century Cures Act. We are alarmed that the proposal is being reexamined and could find its way into legislation to be considered by the HELP or Appropriations Committees this year. We respectfully urge that this proposal not be further considered and not be included in any legislation amending the Public Health Service Act (PHSA) or any other provision of law or appropriations legislation.
The proposal set forth in the President’s budget request is framed as one that will lower drug costs by accelerating the development of biologic medicines, including biosimilars, with no data or rationale to support such a statement. We urge Congress to focus on resolving issues that could accelerate the availability of affordable, quality medicines for patients rather than reexamining this proposal, which poses a risk to the quality of medicines and could potentially hinder patient access.