Draft Order on Drug Prices Proposes Easing Regulations

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But the proposed order does little to specifically call out the drug industry and instead focuses on rolling back regulations, a favorite target of the administration across many federal agencies.

“I do believe that the president wants to do something to lower drug prices for people, but this is a far cry from what he said on the campaign trail,” said David Mitchell, the founder of Patients for Affordable Drugs, a nonprofit that does not take money from the industry. “I don’t see anything there that addresses the drug companies getting away with murder, and it appears that is because Pharma has captured the process.”

With a new administration in place, the pharmaceutical and health products industry spent $78 million in lobbying in the first quarter, a 14 percent increase over last year, according to the Center for Responsive Politics.

The draft executive order, obtained from an official with knowledge of the proposals, was prepared before last week’s meeting of cabinet members and other high-level administration officials. John Czwartacki, a spokesman for the Office of Management and Budget, said the session was the “first of many meetings which will be held throughout the summer,” adding that “they will be working to identify both root causes and innovative solutions, leaving no stone unturned.”

Many of the people Mr. Trump has hired to work on drug policy have ties to the industry. Joe Grogan, the associate director of health programs in the budget office, worked as the head of federal affairs for Gilead, whose expensive hepatitis C drugs have helped fuel the debate over rising drug costs. Tom Price, the secretary of health and human services, was a Republican congressman whose policies were seen as industry-friendly and who opposed measures like allowing Medicare to negotiate drug prices. And the new commissioner of the Food and Drug Administration, Scott Gottlieb, was a longtime consultant to the drug industry.

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Several of the proposals appear to reflect that industry influence. For example, the document directs the United States trade representative to conduct a study of price differences between the United States and other countries, and to review trade agreements that may need to be revised “to promote greater intellectual property protection and competition in the global market.”

The pharmaceutical industry has said that Americans pay the highest prices to compensate for low prices in other countries. However, “other countries pay lower prices for drugs in part because their governments control prices,” said Allan Coukell, senior director of health programs at the Pew Charitable Trusts. “It’s unclear what ability the U.S. would have to change that.”

The draft order targets a program, 340B, that requires the drug industry to give discounts to hospitals and clinics that serve large numbers of low-income patients. The industry has complained that the program is being abused, while hospitals say they would have to cut services without it.

“That’s one that sticks out as a bit of a head scratcher,” said Dr. Joshua M. Sharfstein, a professor at Johns Hopkins Bloomberg School of Public Health who was a top F.D.A. official under President Barack Obama. “This is the executive order to lower drug prices — why would you put in a provision that would raise drug prices?”

In recent weeks, the industry has shown signs it believes it is getting a fairer shake.

In May, Joseph Jimenez, the chief executive of Novartis, told investors that he believed the administration would offer a solution that “will preserve the business model of how we innovate and discover and develop and launch in the U.S., as opposed to some of the bigger and more draconian elements that were discussed earlier,” according to Bloomberg.

Dr. Sharfstein and others said they were intrigued by one proposal, known as value-based pricing, that appeals to the industry and policy wonks alike. The idea refers to paying drug companies for the value that a drug brings — refunding money if a drug fails to prevent a costly health condition, for example.

Some proposals appear to address alleviating the rising out-of-pocket costs that patients are being asked to pay. One calls on reducing burdens caused by “regulatory or administrative actions” that cause Medicare beneficiaries to pay the list price for drugs when the companies that run the drug plans — known as pharmacy benefit managers — get a lower price from drugmakers. Another would target regulations “that inappropriately or unfairly contribute to higher prices or cost-sharing for medical products for American patients.”

Dan Mendelson, president of Avalere Health, a health advisory company whose clients include drug companies and insurers, said, “All of our research shows that when a patient faces high cost-sharing for a drug, they’re more likely not to take it.”

Still, it was unclear how much issues could be addressed through administrative or regulatory changes. Indeed, many of Mr. Trump’s most aggressive statements on the issue — including allowing Medicare to directly negotiate the price of drugs — would require legislative action.

Congress has been consumed by negotiation over the replacement of the Affordable Care Act, and while several drug-pricing bills have been introduced, few have gained much traction so far.

For its part, the F.D.A. is taking action that even Mr. Trump’s critics say may well help drive down prices. Mr. Gottlieb is expected this week to announce a new plan to make sure the generic drug approval process isn’t being gamed in ways that hamper competition.

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