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Tuesday, Jul 9 2019

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Trump Administration Lacks Legal Authority To Force Drugmakers To Include Prices In Ads, Judge Rules

"That policy very well could be an effective tool in halting the rising cost of prescription drugs," U.S. District Judge Amit Mehta wrote. "But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance." The rule was one of the administration's signature proposals to tackle high drug prices, and comes as a blow to President Donald Trump.

A federal judge ruled on Monday that the Trump administration cannot force pharmaceutical companies to disclose the list price of their drugs in television ads, dealing a blow to one of the president鈥檚 most visible efforts to pressure drug companies to lower their prices. Judge Amit P. Mehta, of the United States District Court in the District of Columbia, ruled that the Department of Health and Human Services exceeded its regulatory authority by seeking to require all drugmakers to include in their television commercials the list price of any drug that costs more than $35 a month. The rule was to take effect this week. (Thomas and Rogers, 7/8)

The narrow ruling by U.S. District Judge Amit Mehta in Washington, D.C., struck down a requirement that was set to go into effect within hours, on Tuesday. Drugmakers had argued that requiring them to disclose list prices amounted to coercion that would violate their free speech rights under the Constitution. But in his 27-page ruling Mehta avoided debating the First Amendment, saying simply that the Trump administration had failed to show it had legal authority under the statutes that govern federal programs such as Medicare to require price disclosure. (Alonso-Zaldivar, 7/8)

Mehta in his ruling set aside the entire rule as invalid, saying the HHS lacked authority from the U.S. Congress to compel drug manufacturers to disclose list prices. "It is outrageous that an Obama appointed judge sided with big PhRMA to keep high drug prices secret from the American people, leaving patients and families as the real victims," White House spokesman Judd Deere said in a statement, referring to President Donald Trump's Democratic predecessor, Barack Obama. (Bellon and Raymond, 7/8)

Three drug manufacturers 鈥 Merck, Eli Lilly and Amgen 鈥 sued the administration after the Department of Health and Human Services finalized the rule in May, arguing that HHS overstepped its authority because it did not have permission from Congress to impose the requirement. HHS Secretary Alex Azar, formerly the president for the U.S. division of Eli Lilly, has sought to deliver drug pricing wins that President Trump can tout on the campaign trail. In May, Azar called the rule 鈥渢he single most significant step any administration has taken toward a simple commitment: American patients deserve to know the prices of the health care they receive.鈥 (Abutaleb, 7/8)

It鈥檚 a big loss for the Trump administration. The proposal was the first major drug pricing policy finalized by the administration since releasing its sweeping drug pricing plan in May 2018. Other Trump proposals, like its plan to peg what Medicare pays for drugs to what other countries pay, are likely years away from being enacted. (Florko, 7/8)

The administration said the goal of the rule was to increase transparency, which would put pressure on drugmakers to keep prices low. It argued that list prices matter to patients, especially consumers with high deductibles who must often pay the full amount. The U.S., one of the few countries to allow TV ads for drugs, currently requires them to disclose side effects and other information. 鈥淚f drug companies are ashamed of those prices鈥攍ower them!鈥 Mr. Trump tweeted in May. (Armour, 7/8)

While the new rule does not have an enforcement mechanism, Azar said failing to include the price would be considered a deceptive trade practice and could prompt lawsuits by industry rivals. (Luhby, 7/8)

Many drugmakers, including Lilly and Amgen, have created websites to disclose prices, but argued that including them in ads could result in patients being scared away from seeking treatment. The Trump administration had said that forcing drugmakers to disclose prices for drugs, which have risen sharply in recent years, could push down list prices. (Armstrong, 7/8)

AARP vice president Nancy LeaMond called the ruling a disappointment.聽鈥淭oday鈥檚 ruling is a step backward in the battle against skyrocketing drug prices,鈥 she said in a statement. 鈥淎mericans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.鈥 (Lam, 7/9)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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