Rx Drugs

HHS Secretary Alex Azar doubled down on the Trump administration’s controversial plan to lower Medicare Part B drug costs by relying on international reference prices in a speech to the Commonwealth Fund International Symposium on Health Care Wednesday.

FDA drug center director Janet Woodcock said rising drug prices are changing the nature of debate surrounding the agency’s drug development requirements.

FDA on Tuesday (Nov. 13) moved toward fulfilling provisions in the 21st Century Cures Act that allow FDA to waive or alter informed consent regulations for minimal risk clinical investigations as long as there are appropriate human subject protections in place.

Michigan has become the second state to gain CMS permission to enter into outcome-based contracts with drug manufacturers under its Medicaid program, CMS Administrator Seema Verma announced at the Prevision Policy Biopharma Congress on Tuesday.

A leading public health advocate official is hopeful the incoming Democratic-led House will investigate FDA’s controversial approval of the sufentanil drug DSUVIA.

Express Scripts is introducing an optional formulary for drugs with alternative drug codes, which starts the move from so-called spread pricing based on rebates to a system that shares those rebates at the pharmacy counter, the pharmacy benefit manager announced Tuesday (Nov. 13).

Democratic governor-elects across the country have lamented high prescription drug prices and proposed aggressive new policies to address the issue, including importing drugs from Canada, starting outcome-based prescription drug payments, and creating anti-price gouging standards.

Health care watchers predict that if OTC monograph reform legislation does not make it to the president before the end of the year, renewed debates around the legislation’s industry incentives could stall the bill in 2019, especially if New Jersey Democrat Frank Pallone, who was critical of the incentives included in the House-passed bill, becomes the new Energy & Commerce chair.

FDA is taking steps to both improve its existing Expanded Access Program and simultaneously implement the recently enacted Right to Try law, which agency commissioner Scott Gottlieb stressed Thursday (Nov. 8) are separate distinct pathways by which certain patients can get experimental drugs.