Rx Drugs

As biologics companies urge FDA to consider allowing development of authorized biosimilars -- where a reference biologic manufacturer would make a biosimilar version of that product -- experts question whether doing so would undercut the value of biosimilar exclusivity in the same way authorized generics have been accused of undercutting generic drug incentives.

HHS Secretary Alex Azar said his agency is working at the White House’s direction to modify its International Pricing Index plan to ensure the United States pays less for drugs than other developed nations.

Two FDA experts say 2020 presidential hopeful Sen. Elizabeth Warren’s (D-MA) plan to weed out government corruption by restricting how companies share data and information with federal agencies could have a chilling effect on FDA and regulated industries.

White House Domestic Policy Council Director Joe Grogan is not a fan of including drug rebate reform in the Senate’s drug pricing bill, and he would rather spend what little time is left tweaking policies that ensure the bill doesn’t raise premiums and that spread more of the bill’s Part D savings to more seniors.

White House Domestic Policy Advisor Joe Grogan suggested that lawmakers are close to an agreement on surprise billing legislation and believes that something will pass either stand alone or attached to drug pricing measures by the end of the year.

Humira revenues fell 33.5% internationally in the third quarter of this year due to biosimilar competition, according to AbbVie, while revenues increased 9.6% in the United States, where there is no biosimilar competition until 2023.

HHS has sued Gilead for patent infringement after the drug manufacturer repeatedly refused to obtain licenses for HHS patents on an HIV medication. The suit, filed in federal court in Delaware, alleges Gilead willfully infringed on patents given to HHS meant to protect the government’s work in developing pre-exposure prophylaxis (PrEP), and has profited from research funded by taxpayers through the sale of the brand-name drugs Truvada and Descovy, according to HHS.

Senate Finance Committee Chair Chuck Grassley suggested  Tuesday (Nov. 5) that he plans to file an updated drug pricing bill next week, and a White House official said the administration is working with the Iowa Republican and ranking Finance Democrat Ron Wyden (OR) on provisions to limit seniors’ monthly out-of-pocket costs and to help seniors with sharply rising insulin list prices.

The White House Office of Management and Budget is reviewing the controversial price transparency provisions in CMS’ proposed 2020 outpatient pay rule separately from the rest of the rule, according to the OMB website.