USP Rivalry With US FDA Over Compendial Standards Provision Busts Into Open Legislative Fight

In a letter to Senate HELP Committee chairman Sen. Lamar Alexander and ranking member Sen. Patty Murray, USP and other stakeholders are calling for the removal of language that would exclude biological products from requirements to follow USP quality standards.

The rivalry between USP and FDA has been renewed.

A little over a year after seemingly settling a conflict over monographs for biological products, the US Food and Drug Administration and the United States Pharmacopeia (USP) appear to be renewing their rivalry in an emerging fight over language in a Senate bill.

USP is specifically taking aim at a provision in draft drug pricing legislation from the Senate Committee on Health, Education, Labor and Pensions that excludes all biologics from requirements to follow USP quality standards. (See sidebar for related story.) In a letter dated 28 May to committee chairman Sen. Lamar Alexander, R-TN, and ranking member Sen. Patty Murray, D-WA, USP and a series of stakeholders contend that the proposal "would have broad negative consequences to public health."

"Product developers would no longer be able to rely upon USP standards for product development, public health authorities would not have access to a publicly available standard to utilize in crisis situations, the pharmacy community would not have access to information that is important to the practice of pharmacy, and patients’ trust in the quality of their medicines would be undermined," the letter states.

In total, 11 groups representing a variety of stakeholders signed the letter, including the Academy of Managed Care Pharmacy, the American Cancer Society, the Association for Accessible Medicines, and the National Community Pharmacists Association.

It's not the first time the USP and the FDA have clashed over the issue of monographs for biological products. In an interview with the Pink Sheet, Tony Lakavage, senior vice president for global external affairs at USP, explained that a similar provision was included in draft legislation of the 21^st Century Cures Act, although it did not make it into the final bill.

"Then after stakeholders became more aware of the impact, there was pretty robust debate around the topic and it was not included in the final bill," Lakavage said.

The issue once again gained prominence last year when USP proposed aligning the monographs with the FDA's suffix-based naming system. The FDA, however, argued that that the move may dissuade sponsors from developing biosimilars. (Also see "US FDA Vs. USP: Regulator Sees Biologic Product Monographs As Barrier To Biosimilars" - Pink Sheet, 2 Apr, 2018.)

USP ultimately backed down from its proposal following the objections from the FDA and other stakeholders and pledged to work collaboratively on the subject moving forward. (Also see "USP Backs Down From Biologic Monograph Naming Plan Amid US FDA Objections" - Pink Sheet, 30 Apr, 2018.)

But now, it appears the FDA may be looking to have its authority on the subject codified. In addition to appearing in the HELP Committee's draft legislation, the proposal also appeared in the president's fiscal year 2020 budget request. USP and the other signatories are urging Alexander and Murray to refrain from including draft discussion's provision in any future legislation.

"There is no compelling or credible reason to change the law to remove USP from the framework that has protected Americans for 80 years," the letter states. "To remove USP would handicap future leaders across government who may have a perspective that is different than current Agency leadership, and who may wish to leverage USP standards in the future."

The letter also reiterates that, "USP’s commitment to a collaborative process and its assurances that it will not publish a new biologic product monograph standard as official (and thereby enforceable) without FDA support, is well documented."

Lakavage argued that, "Quality should be required, and not optional," adding that "I don't think we're really sure what FDA's motivations are" in pushing for the inclusion of the provision.

The agency did not respond to a request for comment.