Politics, Pricing

Trump scolds pharma execs, demanding lower prices, more US manufacturing while promising to slash FDA regs

Some of the top CEOs of the pharma industry got together with President Trump Tuesday morning looking for common ground. Instead, they got another lecture on drug pricing, a renewed promise that the FDA will speed up new drug approvals with just a fraction of the old regulations in play, and assurances of an FDA pick waiting in the wings who will help put everything in order.

“We have to get the prices way down,” said Trump, flanked by Celgene CEO Bob Hugin and Merck CEO Ken Frazier. “The pricing has been astronomical for our country.”

But there was a carrot offered along with the stick, as Trump repeatedly hit on his promise to slash drug regulations to help speed new drug approvals.

“We’re also going to be streamlining the process,” he told the execs, “so that from your standpoint when you have a drug that you can actually get it approved instead of waiting many, many years.”

“We’re going to get the approval process much faster,” he said. “We’re going to be cutting regulations at a level people have never seen before,” he added. People can still be protected, he said, “but instead of 9,000 pages it can be 100 pages. And you don’t have to double up and quadruple up. We have companies that have more people working on regulations than they have working at the company.”

To illustrate his point, Trump came up with an anecdote of a dying patient with just weeks to live, unable to get an experimental therapy. Those days, he vowed, are over. And he insisted that the companies would be required to do far more of their drug manufacturing inside the country.

“You have to get your companies back here,” he said, repeating a pledge to reduce the regulatory workload needed to get a new plant approved and in operation.

Trump signed a new executive order Monday ordering that every government agency would be required to eliminate two regulations on the books, for every one they want to add.

Said the president: “I’ll oppose anything that makes it harder for smaller, younger companies 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, which is what’s happening. But we can increase competition and bidding wars big time.”

Trump also leveled a blast at the rest of the world, which have relied on high prices in the US to subsidize their own discounted rates.

“We’re going to end global freeloading,” he pledged. “You’re going to get your products either approved or not approved, but its not going to take 15 years,” he said, citing average cost of drug development at $2.5 billion. Both of those figures are hotly debated in biopharma, where poor R&D returns in Big Pharma have long inflated the cost and time it takes to get a new drug to market.

“We’re going to be changing a lot of the rules,” Trump noted about the FDA, adding that he has an FDA commissioner who’s been picked out and will be named soon. He also seemed to zero in on safety as a key consideration of quick approvals, echoing a suggestion from Jim O’Neill, a Libertarian close to Trump supporter Peter Thiel, who’s advocated approvals based on evidence of safety alone. O’Neill is one of several rumored candidates for the top job at the FDA.

Along with Hugin and Frazier, David Ricks at Eli Lilly, Joe Jimenez at Novartis and others joined the session.


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RAPS Regulatory Convergence 2017