More progress for some types of drugs, less for others

While President Donald Trump has had little success in bringing down the cost of prescription drugs overall, this promise centers on the availability of generic drugs. Drug costs can be high when their patents are in effect. When those patents expire, there's an opportunity for competitors to produce much cheaper generic versions that do the same thing for patients.

Under Trump, the U.S. Food and Drug Administration has accelerated approvals for new generic drugs. In 2016, the FDA approved 73 drugs. In 2019, it gave the green light to 107, nearly a 50% increase.

In addition, late in 2019, Congress passed the Creates Act, which makes it easier for generic drug makers to get samples of the patented product to help prove that their generic copy works just like the original.

"While the process is not simple, it is an improvement over the status quo," said Vanderbilt University health policy professor Stacie Dusetzina.

Dusetzina credits the Trump administration for making headway on getting generic drugs to market. But she said the market hasn't always done its part.

A trade group representing makers of generic and biosimilar drugs reported that of the generic drugs the FDA has approved since 2016, fewer than half were commercially available to patients, and only about half were covered by drug plans under the Medicare Part D program.

The Government Accountability Office, the nonpartisan policy auditing arm of Congress, said in 2019 that the FDA could do more to speed generic drug approvals.

David Mitchell, founder of the advocacy group Patients for Affordable Drugs largely financed by the Arnold Foundation, takes a tougher line. 

"The FDA under Trump has delivered on half the promise — and not the most important half," Mitchell said.

Mitchell gives the administration credit for progress on simple generic drugs, but not on the more complex family of compounds known as biosimilar drugs. These drugs represent a sliver of total prescriptions, but 93% of the overall increase in drug spending since 2014.

"The administration has not succeeded in curtailing the anti-competitive legal maneuvers used by brand drug companies and pharmacy benefit managers that stymie biosimilar uptake," he said.

PhRMA, the leading drug industry trade group, said in a statement that there is a "rich pipeline" of drugs in development, and that they expect that "the coming wave of biosimilars will penetrate the market even more quickly than those already available for patients."

Dusetzina said of the administration's efforts, "they have made progress, but there is a lot of work ahead."

Trump's promise was to remove barriers and that happened for some drugs but not others. We rate this a Compromise.