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Trump to 'tout' healthcare agenda; NIH told to do more to protect US research

President Donald Trump will "tout" his healthcare agenda during an Oct. 3 speech at The Villages retirement community in Florida, the White House said, though it is unclear if the address will be used to reveal the plan he has repeatedly promised.

SNL ImagePresident Donald Trump
Source: AP Photo

Trump is also expected to sign an executive order affecting the Medicare program, White House spokesman Judd Deere told S&P Global Market Intelligence.

Deere declined to say if the order also involved drug prices or the "favored nations" action Trump said in July was coming "very shortly."

Trump has been promising since June to unveil his healthcare plan, telling ABC and NBC in separate interviews it would be out in a month or two.

White House Counselor Kellyanne Conway told reporters Aug. 7 Trump would outline the details of his plan in a September speech. Conway said Trump's plan would not be a replacement for the Affordable Care Act, though he has repeatedly vowed to ensure all 330 million Americans are covered.

Another official said Trump's plan, when it comes, would consist of a set of principles he expected Congress to put into legislation.

Trump has been building up to his speech by unveiling a number of proposals this year, including initiatives aimed at ending HIV infection and improving care for kidney patients, his order to improve the flu vaccines and pathways for potentially importing drugs from foreign nations.

NIH told to do more to protect research

Meanwhile, Sen. Chuck Grassley, R-Iowa, chairman of the Senate Finance Committee, told the U.S. National Institutes of Health and U.S. academic research institutions they must do more to ensure the integrity of taxpayer-funded biomedical research is protected after federal investigators found that threats of theft persist.

While the NIH has made some progress in identifying and managing financial conflicts of interest by federally funded researchers, gaps remain in the agency's oversight, the Office of Inspector General for the U.S. Department of Health and Human Services said in three reports published online on Sept. 27.

SNL ImageNIH Director Francis Collins
Source: AP Photo

At an August 2018 Capitol Hill hearing, NIH Director Francis Collins revealed he had personally written letters to senior representatives at more than 10,000 institutions that receive grants from the U.S. agency and asked them to review their records for evidence of any malfeasance.

At a hearing in April, Collins said the NIH had been interacting with the FBI in the ongoing investigations of the research institutions, some of which he said were considered classified.

At a June 5 Senate Finance Committee hearing, an official with the HHS OIG said the NIH had referred 16 allegations of noncompliance with its terms and conditions for receiving a medical research grant.

At least two institutions — MD Anderson Cancer Center and Emory University — have fired researchers as part of the ongoing investigation.

NIH awards nearly $1B to battle opioid crisis

Last week, the NIH awarded nearly $1 billion in congressionally allotted funds to support research aimed at battling the U.S. opioid crisis. The agency awarded 375 grants across 41 states under the NIH's Helping to End Addiction Long-term initiative, launched in 2018.

The number of awards was an "unprecedented investment" for the NIH into research for new ways to treat substance-use disorder and nonaddictive pain therapies and "represents the urgency of addressing this crisis," Collins said.

Former HHS chief eyes Senate following scandal

Tom Price, who resigned as HHS secretary in September 2017 amid a scandal for spending about $1 million in taxpayer funds on private aircraft and other travel, is seeking the U.S. Senate seat being vacated by Sen. Johnny Isakson, R-Ga., who is stepping down because of poor health due to Parkinson's disease.

SNL ImageTom Price
Source: AP Photo

Price, a Republican, submitted his resume to the Georgia governor's office last week to fill the open seat for 10 months until a special election is held in November 2020 for the remainder of the six-year term, which will be open for election again in 2022.

Price previously served in the House from January 2005 to February 2017. He served at HHS for seven months.

In July 2018, the HHS OIG said Price should pay back $341,000 in taxpayer funds for his unauthorized travel.

FDA biologics transition

Also last week, the U.S. Food and Drug Administration revealed its preliminary list of medicines whose applications will transition from the new drug application process to being licensed as biologic therapies — medicines derived from natural sources, such as microorganisms or plant or animal cells.

Starting March 23, 2020, the applications for insulin and other protein products must go through the FDA's biologic licensing process for approvals — a transition Congress mandated under the Biologics Price Competition and Innovation Act.

That 2010 law, which was adopted as part of the Affordable Care Act, granted the FDA the authority to approve lower cost biologics, or biosimilars.

Companies whose products will be affected by the transition include AbbVie Inc., Eli Lilly and Co. and Sanofi.