Trump Vows to Speed Up FDA Approval, Cut Regs for Pharma

January 31, 2017

President Donald Trump told pharmaceutical industry leaders gathered in the White House today that his administration would reduce taxes, regulations, and the time it takes for product approval, but that they must lower drug prices and bring manufacturing jobs back to the United States.

The president laid out the terms of this deal in introductory remarks covered by journalists before he and the drug company executives met behind closed doors. Trump's tone was considerably more genial than when he said in a press conference earlier this month that the pharmaceutical industry was "getting away with murder" by charging prices that patients can't afford.

"You folks have done a terrific job over the years, but we have to get the prices down," Trump said. "We have no choice."

Drug companies represented in the room included Eli Lilly, Novartis, Amgen, and Merck.

Trump repeatedly stressed the need to speed up the review process for new drugs and devices by the US Food and Drug Administration (FDA), also a goal of the Republican-controlled Congress. His nominee for FDA commissioner, yet to be announced, would help reach that goal, Trump said.

"We have a fantastic person that I think I'll be naming fairly soon who's going to streamline the FDA," Trump said. "You're going to get your products approved or not approved, but it's going to be a quick process. It's not going to take 15 years…. Surprised you can't get them to move faster."

According to the website, it takes 12 years on average to bring a new drug from the laboratory to market. Once a pharmaceutical company wraps up clinical trials for a new drug and submits its application to the FDA, the agency's approval process can last as long as 2 and a half years.

The FDA states on its website that, under the Prescription Drug User Fee Act, it aims to complete its "standard review" of drugs that represent only minor improvements over existing treatments in 10 months. With "priority reviews" for drugs that "offer major advances in treatment or provide a treatment where none exist," the goal is 6 months. In 2015, standard reviews were completed in a median 12 months, according to a FDA presentation last month. The median length of priority reviews in 2015 was 8 months.

Up to 80% of Regulations May Be Unnecessary, President Says

Trump blamed a balky FDA approval process on excessive government regulations, which in his opinion also motivates drug manufacturers to make their products in other countries. He estimated that 75% to 80% of government regulations may be unnecessary.

"So we're going to get that taken care of," he said. "We're going to be cutting regulations at a level that nobody's ever seen before and we're going to have tremendous protection for the people, maybe more."

The president already has set the stage for reducing regulations in an executive order that he signed January 30. It requires that for every new regulation the federal government adopts, two existing ones must be eliminated.

Another presidential promise today was tax relief. "We're going to be lowering taxes big league," Trump said. Several drug company leaders voiced their approval. "One of the things that can help us is a lower tax rate," said Novartis CEO Joseph Jimenez. "When we look globally, that's a massive help."

Trump said that increased competition among drug makers will help lower drug prices. "I'll oppose anything that makes it harder for smaller, younger competitors to take the risk of bringing a product to a vibrantly competitive market. That includes price-fixing by the biggest dog in the market, Medicare."

The president has long advocated allowing Medicare to negotiate drug prices with pharmaceutical companies as a means to lowering them. He appeared to allude to that stance when he said the nation can increase "bidding wars big-time."

The leader of PhRMA, the trade association for the pharmaceutical industry, said in a news release that the meeting with Trump was positive and productive. "Our industry takes seriously the concerns raised about the affordability and accessibility of prescription medicines," said PhRMA CEO Stephen Ubl, who also sat in, "and we have expressed our commitment to working with the administrative to advance market-based reforms."

A less sanguine take on the meeting came from the consumer watchdog group Public Citizen. The director of its health research division, Michael Carome, MD, said that Trump's "preposterous promise" to reduce FDA regulations by 75% to 80% would destroy the agency's ability to protect the public, resulting in "countless preventable deaths, injuries, and illness across the US."

"Trump's horrifying proposal reflects utter ignorance about the FDA's essential role in protecting public health and once again demonstrates his commitment to placing corporate profits above protecting the safety of the American people," Dr Carome said in a news release.

Follow Robert Lowes on Twitter @LowesRobert


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