Proposals to lower prescription drug prices have been announced by President Trump. A blueprint was released by the White House on Friday that seeks “to encourage innovation, while also promoting better price competition and addressing foreign freeloading”.
The plan places a strong emphasis on competition, with the Department of Health and Human Services (HHS) highly involved with the implementation. The list of actions drawn up for the department include advancing biosimilars and generics to boost competition as well as streamlining and accelerating the process for over-the-counter drug approvals.
“We will have tougher negotiation, more competition and much lower prices at the pharmacy counter and it will start to take effect very soon,” said Trump.
FDA Commissioner, Scott Gottlieb MD, said, “The FDA shares the goal of ensuring that American patients have access to quality and affordable care that meets their needs.” Gottlieb pointed to a record number of generic drug approvals in 2017 (>1000 full or tentative approvals) and said he expects the agency to exceed that number in 2018. “Although the FDA doesn’t have a direct role in drug pricing, by ensuring that regulatory requirements are efficient, predictable and science-based; we can help reduce the time, uncertainty and cost of generic and biosimilar product development,” said Gottlieb.
Other initiatives taken by the FDA to streamline generic drug development include: prioritizing the review of certain generics; publishing a list of off-patent, off-exclusivity branded drugs; and enhancing the efficiency of certain aspects of the submission process for generic drug applicants.
Also included in Trump’s proposal are reforms to the Medicare Part D program that would see plans share a minimum proportion of drug rebates with patients and allow greater flexibility in benefit design ‘to encourage better price negotiation.’ However, the proposal did not include plans for the federal government to negotiate directly with drug companies on pricing for Medicare – as Trump had claimed he would do during his 2016 campaign.
Additionally, the HHS will evaluate whether drug maker advertisements should include prices. The HHS secretary, Alex M. Azar said, “We’re immediately going to look into having the FDA require this [drug companies disclosing prices in ads].” The FDA commissioner did not address this in his statement.
For more information visit WhiteHouse.gov.