Gottleib announces 'action plan' for biosimilars
Food and Drug Administration Director Scott Gottlieb, M.D., announced a Biosimilars Action Plan on Wednesday as part of the administrative's broader plan to address costly prescription drug prices. "Our plan is aimed at promoting competition and affordability across the market for biologics and biosimilar products," Gottlieb said.
Biologics represent 70% of the growth in drug spending from 2010 to 2015 and are expected to remain the fastest-growing segment of drug spending over the next several years, he said.
Among the details Gottlieb laid out during a speech at the Brookings Institution in Washington, Gottlieb said the action plan includes planned updates to the FDA's Purple Book, which lists biologics and evaluating how to improve transparency for product developers and updating guidance to provide additional clarity on how biosimilars manufacturers can carve out indications from their labels where a branded drug maker might still maintain some intellectual property.
It would also include addressing anti-competitive behavior among drug makers in coordination with the Federal Trade Commission, he said. (Plan [PDF]) (Speech)
Trump official explains reasoning for proposal to move SNAP from USDA to HHS
A Senate hearing on a proposal from the Trump administration to reorganize multiple agencies of the government was heavy on political fights about lack of transparency and the future of the U.S. Postal Service and light on specific details.
While Republicans on the committee praised the administration for releasing the early draft of the proposal, Democrats heavily criticized the administration for refusing to release additional information or analysis about it.
But in the midst of the discussion, a nugget about the plan—which includes some major changes to the Department of Health and Human Services—was explained. During her testimony, Office of Management and Budget Deputy Director for Management Margaret Weichert addressed why the Supplemental Nutrition Assistance Program, better known as SNAP, was proposed to be moved from the U.S. Department of Agriculture to HHS.
"The idea of moving it came from the notion that how the benefit is delivered today — electronically, not in commodity food form — at the state and local levels it's delivered together with other forms of aid like [Temporary Assistance for Needy Families]."
During the hearing, Sen. Ron Johnson, R-Wis., chairman of the Senate Homeland Security and Governmental Affairs Committee, announced he was co-introducing legislation to expand the authority of the executive branch to reorganize federal agencies.