Alex Azar Takes Senate Questions in Bid to Become HHS Secretary

January 15, 2018

Democrats on the Senate Finance Committee grilled President Trump’s nominee for HHS secretary, former Eli Lilly executive Alex Azar, and attempted to tie him to price hikes of several products during his tenure as head of its U.S. business unit. Republicans once again touted his industry experience as a positive. Azar himself agreed that drug costs are too high, and listed one of his major priorities as working to reverse the incentives that drive manufacturers to raise their prices — while still ensuring discovery and innovation through well-funded clinical trials and research. The committee’s ranking member, Sen. Ron Wyden (D-Ore.), described how Lilly more than doubled the list prices for Forteo, Effient and Stratera, as well as its top-selling diabetes blockbuster Humalog, during the five years that Azar was president of Lilly USA. Wyden also cited how, nearly one year ago, Trump described pharmaceutical companies as “getting away with murder” in terms of prescription drug costs.  “I don’t know that there is any drug price of a branded product that has ever gone down, from any company, on any drug in the U.S., because every incentive in this system is toward higher prices,” Azar told the committee Jan. 9. Azar also said the government should look at a more direct negotiation of lower prices under Medicare, but cautioned that a single, national formulary could end up restricting patient access. 

OMB Issues New Notice on Common Rule Delay

January 8, 2018

The OMB Office of Information and Regulatory Affairs (OIRA) posted a notice on its website Jan. 5  noting that OIRA is reviewing a final rule titled “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects.” This notice follows but does not replace an October posting noting the review of a proposed final rule titled “Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year” suggesting a more general delay of unknown length.  The three provisions were not specified in the listing. It’s currently unclear whether either rule will be published as a final rule before the Jan. 19, 2018, implementation date. Read the posting here: