Building the marketplace for generic medicines is a key strategy to containing drug costs in the US, one that USP actively supports through our standards-setting work.
That is why we applaud FDA Commissioner Scott Gottlieb’s leadership and the efforts of FDA staff to encourage generic drug development and enhance its approval process. Increased access to generic medicines will facilitate the availability of life-saving therapies, while helping to ensure affordable and sustainable costs to patients and the healthcare system, and upholding the FDA’s standard for evidence-based, science-based regulation.
The FDA is currently exploring a variety of innovative strategies to help increase the availability of generic medicines, including:
- Expediting review of generic drug applications in therapeutic areas in which there are few generic drugs,
- Providing industry with guidance documents for developing generic versions of complex drugs,
- Exploring how innovative analytical tools can demonstrate drug equivalence for generics and facilitate regulatory review, and
- Publishing information about drugs that are off-patent and off-exclusivity that don’t have approved generics.
These targeted and practical approaches may help increase generic competition in ways that will offer tremendous benefits to patients. In our comments provided to FDA in late September, we noted that USP is evaluating these approaches to consider how we as a standard-setting body can best contribute to support and advance these efforts.
Public quality standards already play an important role in increasing patient access to affordable, quality generic medicines. Generic drug manufacturers use USP standards to establish key quality attributes of their products as part of their FDA approval process. Our standards provide critical information to demonstrate the quality, purity and strength of medicines, as well as guidelines and reference standards for testing, so that drugs can be made consistently. USP standards help generic manufacturers advance their products to market and increase the availability of lower cost, beneficial medicines for patients.
USP’s quality standards are developed through a collaborative and transparent process that brings together the voices and leadership of patients, practitioners, regulators, academics and industry. These standards help create a strong scientific foundation for quality in health and healthcare that help the FDA and drug manufacturers ensure that safe, high-quality medicines make their way to consumers. USP looks forward to collaborating with the FDA and other partners to advance these and other novel approaches that will increase patient access to generic medicines and help build a healthier world.
Jaap Venema, Ph.D., is USP's Executive Vice President and Chief Science Officer.