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Jon Greenberg
By Jon Greenberg July 15, 2020

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.

 

Our Sources

U.S. Food and Drug Administration, First Generic Drug Approvals, May 19, 2020

U.S. Food and Drug Administration, First Generic Drug Approvals - Previous Years, Feb. 14, 2020

U.S. Food and Drug Administration, Access to Product Samples: The CREATES Act, March 13, 2020

Government Accountability Office, Generic drug applications, August 2019

Association for Accessible Medicines, Access Denied: Why New Generics Are Not Reaching America's Seniors, September 2019

Email exchange, Stacie Dusetzina, associate professor, Vanderbilt University Medical Center, June 25, 2020

Email exchange, David Mitchell, founder, Patients for Affordable Drugs, June 26, 2020

Statement, Press Office, PhRMA, July 15, 2020

 
Jon Greenberg
By Jon Greenberg December 19, 2017

Some progress on prescription drug access, but big changes have yet to come

The promise was to make cheaper drugs available. About one in four Americans say they have a difficult time paying for their medicines. Prescription drugs represent about 10 percent of all health care spending, and the share is projected to creep higher.

Here's how Donald Trump spelled out his goal on his campaign website:

"Remove barriers to entry into free markets for drug providers that offer safe, reliable and cheaper products. Congress will need the courage to step away from the special interests and do what is right for America."

In practice, making headway here hinges on getting generic drugs to market. Those are the medicines that no longer have patent protection. A patent gives the original drugmaker monopoly power for 20 years, or longer if the company finds a way to extend it. When a drug goes generic, many producers can make it, and the price plummets.

David Mitchell, head of Patients for Affordable Drugs, an advocacy group that takes no money from drug makers, told us the Trump administration has helped clear the backlog of generic drugs waiting for approval.

"More generics are coming to market faster," Mitchell said.

The Food and Drug Administration numbers show that the average number of generic drugs approved each month went from about 54 in the last year of the Obama administration, to 71 during the Trump administration.

But Mitchell said that doesn't get to root of the problem of high prices -- thebtactics that extend the life of patent protection.

"The administration has done virtually nothing in that regard," Mitchell said.

Drugmakers have several tools at their disposal. They can pay generic drugmakers not to produce a drug that has come off of patent protection, a practice known as "pay for delay." They can make a small change in the original drug and call it a new drug worthy of more patent protection. That's called "evergreening." And they can refuse to give samples to generic drug makers that would allow them to reverse engineer a generic copy.

While some legislation has started in Congress to address some of these issues, nothing has passed.

Trump also promised to make it easier for cheaper drugs to be imported, but Mitchell said there's been no progress on that front either.

We reached out to the White House for an update and did not hear back.

We rate this promise In the Works.

 

Our Sources

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