A record number of generic drugs were approved by the Food and Drug Administration last year.
If President Trump has his way, that trend will continue — or even accelerate — in the coming years.
This increase in generics, which are usually cheaper and more widely used than their brand name counterparts, is a boon for consumers, experts say.
But, the experts add, even more can be done to get generics on pharmacy shelves and keep drug prices coming down.
The Food and Drug Administration (FDA) has been working to clear a backlog of applications for generic drugs. In fiscal year 2017, that resulted in 1,027 approvals, the agency recently announced.
Agency officials say the quick approvals will reduce costs in the Medicare and Medicaid programs as well as for other Americans because more generics equates to more competition.
“More generics means lower prices,” said Will Holley, a spokesperson for the Campaign for Sustainable Rx Pricing (CSRxP).
Holley noted that studies have shown some drug prices dropping as much as 80 percent when generics enter the marketplace.
“It’s an undisputed fact that competition from generic drugs lowers prices,” he told Healthline. “So the FDA’s work to clear the backlog is good for all patients and good for affordability.”
The pharmaceutical industry appears to agree.
“We believe patients benefit when they have greater choice,” said Andrew Powaleny, public affairs director of the trade group Pharmaceutical Research and Manufacturers of America (PhRMA).
The record numbers of generic approvals, he said, “are evidence the FDA is focused on increasing efficiency and competition in the marketplace while prioritizing safety.”
In Tuesday’s State of the Union address, Trump applauded the agency’s work.
“To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history,” the president said.
Generics were also being approved more quickly last year.
In October, agency officials said, a record share, nearly 30 percent, of approved generics got through on the first review rather than having to pass through multiple review cycles.
By comparison, more than 90 percent of nongeneric drug applications typically win approval in the first cycle, Dr. Kathleen Uhl the director of the FDA’s Office of Generic Drugs, said last spring.
Those first-cycle approvals have been rising since 2012, she said, and a Drug Competition Action Plan announced in May was supposed to further ramp up approval of generics.
That plan was intended to identify drugs with expiring patents but no approved generics, as well as expedite review of applications for generics for drugs for which there are fewer than three existing generics.
Getting Congress to act
There’s only so much the FDA can do, however.
Holley called on Congress to act and to follow through on FDA commissioner Dr. Scott Gottlieb’s call to “end the shenanigans” by limiting pharmaceutical companies’ efforts to delay the entry of generics into the marketplace.
A bill called the CREATES Act, which has been included in recent negotiations over government funding on Capitol Hill, would target those “shenanigans.”
The bill “could fulfill some of the promises made during the State of the Union on reducing drug prices,” Holley said.
Generics are likely to be an increasingly large portion of the drug market no matter what happens. The issue is how quickly they can be made available to consumers.
“Today, 90 percent of prescriptions filled are generic, and that number is set to grow in the coming years,” Powaleny said.