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What Happened, What You Missed: September 12-16

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Biden to Nominate Renee Wegrzyn as First ARPA-H Director

The White House announced on Monday that President Joe Biden intends to nominate Dr. Renee Wegrzyn to be the inaugural director of the Advanced Research Projects Agency for Health (ARPA-H).  Currently the vice president of business development at biotechnology company Ginkgo Bioworks, Wegrzyn was previously employed with the Defense Advanced Research Projects Agency’s (DARPA) Biological Technologies Office, where she studied synthetic biology and gene editing to support the agency’s efforts to enhance biosecurity and promote public health. However, many other details about the new biomedical research agency remain uncertain, including the location of the agency and how ARPA-H will fit into the organizational structure of the Department of Health and Human Services.

Biden Announces Ambitious Goals to Lower Cancer Deaths

While commemorating the 60th anniversary of President John F. Kennedy’s moonshot speech, President Biden announced a new moonshot of his own – to erase cancer “as we know it.”  To achieve this goal, Biden signed an executive order (EO) to launch a National Biotechnology and Biomanufacturing Initiative, in order to help ensure that the technology that will help end cancer is manufactured domestically.  According to the president, the EO will spur the creation of new technologies for cancer treatments and make the US less reliant on other countries for the advancement of cancer treatment.  Biden also noted that the EO would help achieve a goal of halving cancer deaths in the next 25 years.

House Passes Bill to Streamline Prior Authorization in MA

On Wednesday, the House unanimously approved H.R.3173, the Improving Seniors’ Timely Access to Care Act of 2021, which streamlines the prior authorization process in Medicare Advantage by establishing an electronic prior authorization process and a process for real-time approvals for routinely approved services. The popular bill attracted 320 cosponsors and won the endorsement of over 500 organizations prior to the vote.  Forty senators have expressed support for the bill, and some have speculated that the bill could be included in a year-end spending package.

Policy Riders Stall Progress on FDA User Fee Reauthorization 

Extra policy riders are dragging out negotiations on legislation to reauthorize the Food and Drug Administration’s (FDA) user fee programs ahead of a September 30 deadline.  Some of the riders still in play pertain to reforms to the FDA’s accelerated approval pathway and efforts to increase diversity in clinical trials.  If lawmakers don’t reach a deal by the end of the month, the FDA would be forced to send furlough notices to thousands of employees, which industry experts warn could damage morale at the agency.

ICYMI: Lawmakers Win Congressional Softball Game

Members of Congress defeated members of the press at Wednesday’s Congressional Softball Game for the first time in five years.  This year’s game also raised a record total of $540,000 for the Young Survival Coalition, which supports breast cancer patients under the age of 40. Retiring Rep. Ed Perlmutter (D-CO), the coach of the lawmakers’ team, said minimizing mistakes and getting hits were the keys to victory.

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