With more than half of U.S. adults regularly taking at least one prescription medication, and a large number taking several,
Addressing Rising Drug Prices: Streamlining the Generic Approvals Process
The U.S. Food and Drug Administration (FDA) has worked to improve competition in the marketplace for generic drugs by reducing the backlog of applications awaiting review at FDA, and most recently, releasing a set of statements as part of its Drug Competition Action Plan in support of increased generics in the marketplace. This three-step plan to boost the rate at which generic drug applications are reviewed, processed and approved includes to:
- Reduce gaming from branded companies;
- Resolve scientific and regulatory checks on drugs; and
- Streamline the generic review process.
These strategies will work in tandem to curtail the multiple cycles of review that typical drug applications are subject to and in the process ease the backlog of thousands of generics pending approval. These efforts will build off of already strong progress last year. In November, for example, FDA saw the highest number of generics approved in a single month, and 2017, as a whole, brought significant decreases in the amount of time it takes to review and approve generics.
Increasing Accessibility of Biosimilar Products
Generics have helped save billions of dollars in drug costs, and biosimilars have similar potential – estimates say the U.S. could save up to $250 billion over ten years.
Helping Consumers Access Lower-Cost Alternatives
We are encouraged by FDA’s progress and commitment, and will continue to work toward ensuring all Americans have access to affordable medicines. For instance, our pharmacy benefit management strategies work to create multiple avenues that connect our members to lower-cost, clinically equivalent options, including encouraging the use of generic medicines through our formulary strategy. Additionally, our strategic partnership with Epic increases the visibility of patients’ drug benefits at the point of prescribing, including information about clinically effective options at the lowest out-of-pocket cost for the patient, to facilitate better prescription-related decision-making for patients and their care teams.
For more information on how CVS Health is working to ensure consumers have access to affordable medicines, check out our Rising Drug Prices information center. And to stay informed about the most talked-about topics in health care, register for content alerts and our bi-weekly health care newsletter.
