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Attorneys: Cures Combo Product Language Could Give Exclusivity To Previously Approved Drugs

Language in the House-passed 21st Century Cures bill could allow combination products that rely on previously approved drugs to go through the 505(b)(2) pathway, which could grant these drugs new exclusivity, attorney sources tell Inside Health Policy.

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CMS and its actuaries say health care spending in the country increased 5.8 percent in 2015 primarily due to the growth of hospital and physician services, but also because of the growth in retail drug spending.

The AIDS Institute is urging the incoming administration to maintain the country's leadership in the battle against AIDS and to refrain from undermining treatment access for millions of Americans, including patients with the disease as Republicans go about replacing the Affordable Care Act.

House Energy & Commerce Republicans slammed the U.S. Preventive Services Task Force for a lack of transparency while promoting legislation that would amend the entity.

While one former CMS staffer thinks the ACA's medical loss ratio provision will remain if Republicans repeal and replace Obamacare, a health policy analyst says the MLR policy does not have GOP support and would likely vary depending on the state.

Rep. Greg Walden (R-OR), tapped to lead the House Energy & Commerce Committee in the new Congress, says he will work to move the GOP's “Better Way” agenda, which includes Medicare premium support, moving Medicaid to a block grant or per-capita caps system and repealing the Affordable Care Act.

House Speaker Paul Ryan (R-WI) said Democrats are engaging in “Medi-scare politics” as they charge the GOP with waging a war to destroy Medicare -- charges that escalated after the nomination of Rep. Tom Price (R-GA) as HHS secretary -- and said he hasn't discussed Medicare reform plans with President-elect Donald Trump's administration.

Scott Gottlieb, former FDA deputy commissioner and resident fellow at the American Enterprise Institute, who has advocated for relaxation of FDA's limits of off-label uses of drugs and has said FDA policies are partly to blame for high drug prices, was named to President-elect Donald Trump's HHS Agency Landing Team Thursday (Dec. 1).

Rep. Richard Neal (D-MA) is now expected to be tapped ranking Democrat on the House Ways & Means Committee, a positive development for brand drug makers because Neal has defended the industry more aggressively than Rep. Xavier Becerra (D-CA), who was vying for the same position before being named as California attorney general Thursday (Dec. 1).