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FDA Approved 45 Drugs in 2015, Most Since 1996

  • VOA News

The US Food and Drug Administration approved 45 new drugs for use in 2015.

The US Food and Drug Administration approved 45 new drugs for use in 2015.

Forty-five new drugs were approved by the U.S. Food and Drug Administration in 2015, the most since 1996 and four more than 2014.

According to the Associated Press, the increase was spurred largely by drugs for rare and hard-to-treat diseases. Approval for these kinds of drugs is often streamlined.

A high number of drug approvals has been viewed as an indicator of the amount of innovation taking place in the industry. It is also a barometer of the efficiency of the approval process.

However, many of the new, specialty drugs come with very high price tags, adding fuel to the debate in the U.S. about the high price of pharmaceuticals.

For example, Vertex Pharmaceuticals' Orkambi, which is used to treat cystic fibrosis, costs $259,000 per year. Ibrance, made by Pfizer to treat breast cancer costs $118,200 per year.

During the FDA approval process, the price of the drug is not considered.

The high price of drugs in the U.S. is likely to be an issue in the upcoming presidential election with Democratic candidates Bernie Sanders and Hillary Clinton having given proposals for policies to lower the cost.

Some experts think the high number of approved drugs reflects drug makers’ increasing ability to pick winners.

Analyst Tim Anderson of the Bernstein research and brokerage firm told the AP that between 2007 and 2011 only one in 19 drugs reached the market from early-stage research and development testing. Today, it’s one in 13, he said.

"These improvements hopefully reflect the payoff from the industry's conscious, decade-long efforts to 'turn around' R&D," Anderson told investors last year.

In addition to potential political pressure to lower prices, drug companies could face headwinds turning profits on drugs that have high development costs but yield modest sales.

And new drugs have to compete with an increasing number of cheaper generics.

Anderson said the time companies take to come up with new drugs has steadily increased in recent decades, with a 14-year average. On average, it took 11 years to develop a new drug in the 1990s.

The U.S. was not the only place seeing more drugs come to market in 2015. Europe also saw more drugs approved for use, with 93 new products given the green light compared to 82 in 2014