Why is an efficient, high-functioning U.S Food and Drug Administration (FDA) so important? Because it can encourage competition and innovation needed to make prescription medicines more accessible and affordable for the millions who need them, explained CVS Health Chief Policy and External Affairs Officer and General Counsel Tom Moriarty at today’s POLITICO Pro Health Care Briefing on Drug Safety and the Trump FDA.
The event brought together health care thought leaders to discuss drug safety and the future of the FDA under the new Administration, focusing on changes that could help promote safety, efficacy and affordability.
With FDA Commissioner-appointee Scott Gottlieb scheduled to meet with the Senate HELP committee the same morning, and Congressional hearings on the Prescription Drug User Fee Act taking place earlier in the week, this discussion was especially timely.
Delivering Safe, Affordable Medications to Patients is a Top Priority
"Our ability to continue to deliver value to the millions of patients who rely on us is contingent on the most efficient and effective FDA possible,” Moriarty explained.
To underscore this point, Moriarty highlighted the large and growing impact of chronic disease on America’s health and bottom line. “Because of its influence on the approval pipeline,” he noted, “the FDA can encourage competition and innovation, which has a downstream impact on patient access and cost.”
Competition Improves Affordability
There are significant backlogs in the drug approval pipeline, with more than 4,000 generic drugs pending approval at the start of 2017. Moriarty remarked that these backlogs – particularly for generic medicines and biosimilars – are restraining the type of competition that is proven to help control costs.
In 2016, CVS Health reduced trend, the rate of drug spending growth, from an unmanaged 11 percent rate – largely driven by brand list price increases – to 3.2 percent actual cost growth by using PBM management solutions that include price protection and the negotiation of rebates.
Making the Regulatory Process More Efficient and Increasing Competition
Moriarty highlighted three key areas to help increase market competition, which can drive down costs and improve access:
Speeding approval of generic drug applications
Providing incentives like expedited reviews to attract additional entrants to the market
Increasing the availability of biosimilars
As the debate over the future of the FDA continues, improving the efficiency of the regulatory process will help ensure patients have access to safe, affordable and effective prescription medications.
For more information about CVS Health’s efforts to tackle rising drug costs, visit our Rising Drug Prices information center. And to stay informed about the most current topics in health care, register for content alerts and our bi-weekly health care newsletter.