Drug Pricing

FDA soon will make public information about how it could improve its Expanded Access program, based on an assessment by an outside company, FDA Commissioner Scott Gottlieb said at a House Energy & Commerce health subcommittee hearing Wednesday (July 25).

Stakeholders are set to debate Sept. 4 whether FDA's so-called umbrella exclusivity policy will apply to biologics and biosimilars.

The Senate health committee unanimously advanced Wednesday (July 25) a bipartisan bill to ban so-called gag clauses in exchange and private insurance plans. A last-minute addition to the bill also would give the Federal Trade Commission more visibility into potential pay-for-delay agreements between biologic and biosimilar makers.

The House Energy & Commerce Committee unveiled a number of draft 340B reform bills it will take up along with seven pending 340B bills at a health subcommittee hearing Wednesday (July 11), and while some of the draft legislation was expected, such as discussion drafts to change the definition of a patient and give the Health Resources and Services Administration more authority, one attorney said others appear to be messaging bills or focused on very narrow concerns.

The brand drug lobbies dropped Thursday (June 28) their lawsuit against Nevada’s insulin-price transparency law.

HHS is rewriting safe harbor guidelines for anti-kickback restrictions to let drug makers base the price of drugs on how well they work, HHS Secretary Alex Azar said Tuesday (June 26), though he also suggested doing away with rebates in Medicare Part D, and some brand lobbyists say those policies are inconsistent with each other.

FDA announced Thursday (June 21) that the agency is withdrawing a draft guidance outlining the statistical approaches a biosimilar sponsor should use to demonstrate biosimilarity to a reference product.

The American Medical Association is pushing for 340B reforms that would increase transparency in the drug pricing program, expand the Health Resources and Services Administration's authority over 340B and extend program eligibility to all practices that show a commitment to serving low-income patients.

Lawyers representing outsourcing compounders are signaling they may sue FDA should it finalize guidance outlining its plans to evaluate whether there is a clinical need to compound a drug using bulk active pharmaceutical ingredients.