Manuela Tobias
By Manuela Tobias May 15, 2018

Trump administration moves ahead on drug prices

President Donald Trump rolled out a new drug plan May 11 aimed at lowering pharmaceutical list prices and out-of-pocket costs.

The plan hinges on lowering drug prices by getting more generic drugs to market.

Generic medicines 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.

The Trump administration set a record number of generic drug approvals in 2017.

Trump's May blueprint rehashes efforts already underway and proposes loftier goals to get more generics on the market faster.

Food and Drug Administration Commissioner Scott Gottlieb has taken many steps to pull competition into the generic drug market since taking office last year, according to Rena Conti, health policy and economics professor at the University of Chicago.

For example, the administration put out a list of drugs for which there is no generic equivalent to encourage drugmakers to come into that market.

An important root of high drug prices are tactics that extend the life of patents, blocking drugs from getting on the generics market. One way drug companies do that is by refusing to give samples to generic drug makers that would allow them to reverse engineer a generic copy. The Trump administration is now working to reverse that.

Pharmaceutical companies can also pay generic drugmakers not to produce a drug that has come off of patent protection ("pay for delay") or make a small change in the original drug and call it a new drug worthy of more patent protection ("evergreening").

Trump's FDA plans to pair with the Federal Trade Commission and the Justice Department to block those practices.

"I would say they're making progress," said David Mitchell, president of Patients for Affordable Drugs, "but I don't think they're doing enough yet."

Trump's plan addresses many obstacles to cheaper drugs. But those plans must still be put into action. We continue to rate this promise In the Works.

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.

 

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