House report questions FDA’s approval of Alzheimer’s drug
WASHINGTON — A joint investigation released Thursday by House Democrats identified unusual collaboration between Food and Drug Administration officials and drugmaker Biogen, highlighting potential problems in the agency’s approval of the controversial Alzheimer’s drug Aduhelm.
The House Energy and Commerce and Oversight and Reform committees concluded their findings “raise serious concerns” about the drug’s approval process.
“The number of patients and families impacted by Alzheimer’s disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust,” Oversight and Reform Chair Carolyn B. Maloney, D-N.Y., said in a statement, calling the report a “wake-up call” for the FDA.
The FDA previously determined in an internal review that officials acted appropriately, but said it has already begun implementing the report’s recommendations. “It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making,” the agency said in a statement. “We will continue to do so, as it is in the best interest of patients.”
—CQ-Roll Call
Republicans move beyond repeal-and-replace to other health care priorities
WASHINGTON — The Republican health care agenda was dominated for years by the all-consuming goal of repealing former President Barack Obama’s Affordable Care Act but that singular focus seems to have faded.
“For once, repeal-and-replace isn’t the defining backbone of Republican health policy in Congress,” said Jennifer Young, a co-founder and partner at Tarplin, Downs and Young, a strategic consulting and policy development firm. “It took us years, but I think we have learned that repeal-and-replace was not a winning issue.”
Young, who worked in senior Health and Human Services positions during the George W. Bush administration, spoke during a post-election webinar hosted by the Kaiser Family Foundation focused on the direction of health care policy in the new Congress.
Young pointed to a House Republican task force working on health care that includes Rep. Beth Van Duyne, R-Texas. Van Duyne is among members of that task force focused on doctor-patient relationships. In an op-ed over the summer, Van Duyne joined her colleagues in writing they plan to prioritize eliminating federal mandates that restrict how much time doctors spend with patients.
—The Dallas Morning News
Where is Scientology’s David Miscavige? Opposing lawyers want to know
TAMPA, Fla. — The process servers showed up to 10 Church of Scientology properties in Clearwater, Florida, and California with legal documents in hand.
They tried 27 times over four months to serve Scientology leader David Miscavige with a federal trafficking lawsuit that names him as a defendant, according to records filed in the case.
Security guards, the court filings state, refused to accept documents from the process servers, declined to answer questions and said they did not know where Miscavige lived or worked despite him being the ecclesiastical leader of the organization.
The case revolves around allegations from three former Scientologists who say they were trafficked into the church as children and forced to work through adulthood for little or no pay. Valeska Paris and husband and wife Gawain and Laura Baxter, who filed the complaint in April, left the church’s military-style workforce called the Sea Org in 2009 and 2012, respectively.
—Tampa Bay Times
Benjamin Netanyahu sworn in as Israel’s premier once more
Benjamin Netanyahu was sworn in as Israel’s new prime minister on Thursday, following a vote approving his cabinet that cements his political return after just 18 months in opposition.
Sixty-three members of parliament voted in favor of the new government that brings together Netanyahu’s Likud with ultra-orthodox and religious nationalist parties, while 54 voted against it.
This will be the 73-year-old’s sixth term as head of government. By bringing on board right-wing allies Israel’s longest-serving premier has placed himself in the unusual role of moderate.
Addressing parliament earlier in the day, Netanyahu listed three important tasks for his cabinet: preventing Iran from obtaining nuclear weapons, developing the country’s infrastructure, including a bullet train, and expanding diplomatic accords to more Arab countries.
—Bloomberg News
