USP's Plan Promotes Competition

Over the past year, the FDA has expanded efforts to promote generic drug competition, increasing the overall number of generics approved in 2018 compared with 2017.

The United States Pharmacopeia (USP) is getting on board with the FDA’s efforts with its own plan to promote generic drug access. The organization recently announced its Generic Access Plan, to facilitate competition in the generic drug market and promote access to necessary medication, according to a USP statement. The plan will encourage competition in an effort to increase access through new and revised standards and offer collaboration withothers in the industry, education, and training.

The scientific nonprofit organization ensures high-quality care by developing public quality standards for drugs sold in the United States. Global generic drug manufacturers receive publicly available requirements, trial methods, and expectations from the USP to improve the process of generic development. In the past, the USP has helped manufacturers provide generic alternatives to necessary drugs for chronic health conditions such as high blood pressure and cholesterol, mental illnesses, and seizure disorders. Although generic access has risen with USP standards, officials highlight the need for broad access to these drugs.

“Millions of Americans have benefited from generic medicines, and in just the last 10 years, $1.5 trillion [has] been saved, yet there are still many off-patent medications that have few or no generic alternatives,” said USP CEO Ronald T. Piervincenzi, PhD, said in a statement about the plan.

The plan will work to develop and update quality standards to support the FDA’s Drug Competition Action Plan, with a focus on the agency’s list of off-patent drugs that have no generic version. The nonprofit will prioritize necessary, lifesaving drugs with no competing generic on the market, including therapies for cancer, HIV, hypertension, and seizure disorders, according to the USP.

The USP will also provide education and training to global manufacturing companies on best practices for following the organization’s standards. It will offer support to manufacturers, regulators, and stakeholders worldwide in producing quality generic drugs. Examples of its work to promote education are the USP Education Programs, the USP Hyderabad Training Institute, and the USP/APEC Center of Excellence.

The Generic Access Plan also highlights the USP’s commitment to working directly with the FDA to create and revise quality standards for the generic drug application and approval process.

The nonprofit will also communicate with health care professionals, industry representatives, patient groups, payers, and regulators to determine other ways to support the development of generic drugs through education and standards, according to the statement.

USP officials have recognized the advances in the generic drug arena in the past year made possible by the FDA’s efforts to improve the generic drug application process and promote competition, but they highlight the need for further improvement.

“[Although] there has been much progress, there are still many off-patent drugs that have limited or no generic options. We must close this gap, which is why USP is committed to doing our part by developing new public standards and processes, working with the FDA and others to facilitate greater access to important drug therapies,” Piervincenzi said.

Reference

USP announces generic access plan [news release]. Rockville, MD: United States Pharmacopeia; January 31, 2019. www.usp.org/news/generics-access-plan. Accessed

February 6, 2019.