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Capitol Checkup: Trump's deal motive; mental health champs honored; FDA/FTC team


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Capitol Checkup: Trump's deal motive; mental health champs honored; FDA/FTC team

White House Office of Management and Budget Director Mick Mulvaney said President Donald Trump's new willingness to work with Democrats on healthcare is more about reminding Republicans they have not kept their promise to repeal the Affordable Care Act.

"You promised to repeal and replace. Do it," Mulvaney demanded during an Oct. 8 appearance on NBC's "Meet the Press."

After Senate Republicans failed in July on three attempts and again in September to repeal the ACA, "can you blame the president then to sort of step back and say, 'OK, if my own party can't deliver what I need, can I work with the other side?' That's not an unreasonable position," Mulvaney said.

Trump acknowledged in an Oct. 7 morning tweet he had reached out to Senate Minority Leader Chuck Schumer, D-N.Y., the night before seeking a deal on healthcare reform.

Trump later told reporters he was open to a temporary deal with Democrats.

"If we could do a one-year deal or a two-year deal as a temporary measure, you'll have block granting ultimately to the states, which is what the Republicans want," Trump said, according to a pool report.

If Trump wants to work with Democrats, "a good place to start" might be the negotiations ongoing between Sens. Lamar Alexander, R-Tenn., chairman of the Senate Health, Education, Labor and Pensions Committee, and Patty Murray, D-Wash., the ranking member, aimed at passing some short-term fixes to the ACA, Schumer said in a statement provided to S&P Global Market Intelligence.

Senate leaders had sidelined the Alexander-Murray effort in September in favor of trying one more time to repeal the ACA with a bill sponsored by four Republicans Lindsey Graham of South Carolina, Bill Cassidy of Louisiana, Dean Heller of Nevada and Ron Johnson of Wisconsin.

But Alexander and Murray resumed their negotiations once it was clear the Graham-Cassidy legislation was not going anywhere before a Sept. 30 deadline expired on using the 2017 budget reconciliation process, which would have permitted a 51-vote simple majority rather than the usual 60 votes.

Wisconsin's Johnson insisted Oct. 8 the Republicans' effort to dismantle the law was not dead.

"I think it's still alive and well," Johnson said on CNN's "State of the Union."

Johnson argued the Graham-Cassidy bill has "not collapsed" and the authors just "need more time" to get it adopted.

But with the Graham-Cassidy bill currently dormant, Johnson said he supported continuing the ACA's cost-sharing reduction payments, which help cover prescription drug and doctor visit copayments and deductibles for low- and moderate-income Americans on the government-run exchanges.

"If we don't do that, insurance premiums will increase," Johnson said.

He also said the catastrophic insurance plans should be opened up for all Americans, not just those under 30 years.

Meanwhile, Trump plans to take matters into his own hands by soon issuing an executive order to make it easier for Americans to buy insurance through "association health plans" — an idea House Speaker Paul Ryan, R-Wis., has backed — lift restrictions on short-term medical insurance and expand health reimbursement accounts, according to an Oct. 7 article in the Wall Street Journal.

PhRMA honors mental health champions

The Pharmaceutical Research and Manufacturers of America, or PhRMA, is putting the spotlight on the work being done in the U.S. to advance mental health treatments and services by honoring a handful of researchers, scientists, patients and community champions on Oct. 10 at the group's annual Research & Hope Awards.

Award recipient Husseini Manji, global head of neuroscience at Janssen Research & Development, a unit of Johnson & Johnson, has focused his research on investigating disease- and treatment-induced changes in gene and protein networks that regulate synaptic and neural plasticity in neuropsychiatric disorders.

Manji's work has helped to conceptualize these illnesses as genetically influenced disorders of synaptic and neural plasticity and has led to the investigation of novel therapeutics for refractory patients, according to J&J. He also has been actively involved in the development of biomarkers to help refine these multifactoral diseases into mechanism-based subcategories to develop targeted therapeutics.

Recipient Jeffrey Conn, director of the Vanderbilt University Center for Neuroscience Drug Discovery, said in a September 2013 Future Science interview that his interest in the brain started at an early age, driven by his experience as a teenager of watching a friend deal with a diagnosis of schizophrenia and seeing the dramatic change following that person's first psychotic break.

Conn is a former executive for Merck & Co. Inc., where he directed the drug discovery efforts in multiple central nervous system therapeutic areas as the senior director and head of the company's neuroscience department from 2000 to 2003. At Merck, he oversaw the company's global efforts in discovering new treatments for schizophrenia and movement disorders.

Also being honored is Judge Steven Leifman of the Eleventh Judicial Circuit of Florida, who created the court's Criminal Mental Health Project, a program that takes people with serious mental illnesses and substance-use disorders out of the criminal justice system and places them into community-based treatment and support services.

The other award recipients include local Washington NBC news anchor Doreen Gentzler, the lead reporter for the station's mental health "Changing Minds" project, and schizophrenia with bipolar disorder patient Peggy Symons, a member of the National Alliance on Mental Illness of Greater Orlando in Florida.

U.S. Olympic swimmer Michael Phelps — the most decorated Olympian of all time, with a total of 28 medals — is the featured keynote speaker at the event.

FDA/FTC team to increase drug competition

A Nov. 8 workshop in Washington hosted by the Federal Trade Commission, or FTC, may provide insight into how the agency under the Trump administration will work with the Food and Drug Administration to drive competition in the U.S. biopharmaceutical market.

Under the Obama administration, the FTC had targeted so-called reverse payment patent settlements, also known as pay-for-delay deals, in which innovators paid generic drugmakers to keep their lower-cost products off the market for a period, allowing the branded companies to extend the time of their monopolies.

The FTC during the Obama years estimated the deals were costing the U.S. about $3.5 billion each year, or $35 billion over a decade.

It is unclear whether the Trump administration will continue to try to rein in those activities.

"In light of concerns about rising drug prices, it's critical we identify barriers that may prevent drugs from entering the market, even after applicable patent protections have expired," Acting FTC Chairman Maureen Ohlhausen said in an Oct. 3 statement.

Ohlhausen and FDA Commissioner Scott Gottlieb, who said increasing competition in the U.S. prescription drug market and facilitating entry of lower-cost alternatives is one of his highest priorities, are set to speak at the November workshop.

At the event, panelists are expected to discuss price and non-price factors that may influence generic market entry and evaluating intermediaries in the supply chain, with particular focus on pharmacy benefit managers and group purchasing organizations.

The panelists are also expected to examine how the contractual relationships between intermediaries, manufacturers and health plan sponsors ultimately affect the prices consumers pay for their prescription drugs.