Drug Pricing

HHS Secretary Alex Azar on Wednesday (May 16) hit back at the drug industry for criticizing the administration’s proposal to move Medicare Part B drugs into Part D, and he said the announcement on how HHS will execute that policy is coming soon.

A Pharmaceutical Research and Manufacturers of America executive on Tuesday (May 15) criticized several policies that HHS is considering to lower drug costs: moving Medicare Part B drugs to Part D, replacing the Part B doctor-reimbursement system with the Competitive Acquisition Program, encouraging plans to restrict the use of drugs in protected classes, removing the two-drug per-class rule in Part D, basing Medicaid’s average manufacturer price calculation on commercial-market net prices and removing the cap on price-inflation penalty in Medicaid.

Senate health committee ranking Democrat Patty Murray (WA) and Sen. Elizabeth Warren (D-MA) on Tuesday (May 15) criticized President Donald Trump for tying the 340B program to higher drug prices while his administration has repeatedly delayed implementation of a rule on ceiling prices and manufacturer penalties and pulled back guidance to clarify aspects of the program, including the definition of a 340B-eligible patient.

FDA Commissioner Scott Gottlieb said Tuesday (May 15) that the upcoming guidance on waiving the requirement that brands and generics share a safety system will be short and simply put brands on notice that FDA is ready, willing and able to waive the requirement when it is blocking generic competition -- despite an earlier prediction from a policy watcher close to the issue that the guidance would lay out specific steps each party must go through before FDA can waive the requirement.

HHS Secretary Alex Azar said CMS will take a more permissive approach to the performance scores it gives drug plans that use medication management tools for drugs in Part D’s six protected classes.

About 60 patient and consumer advocates told House and Senate leadership to reject proposals to cut back the number of patients and safety net providers that are eligible for the 340B drug discount program, though the groups say they support transparency in the program.

FDA is expected to, as early as Thursday (May 17), unveil a new web page on which it will initially publish 150 letters sent by the agency to brand companies explaining that a potential generic competitor has adequate safety protections in place to receive the brand drug samples for bioequivalence testing, FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar announced Monday (May 14).

Many of the policies in the president’s drug price plan put the onus on patients to get cheaper drugs: such as including prices in drug ads, giving patients information on competing drug prices during office visits, posting drug prices on Medicare’s “dashboard” website and banning gag orders that stop pharmacists from telling customers when it is cheaper to buy drugs without insurance.

Stakeholders are questioning the usefulness and feasibility of the White House’s idea of requiring drug prices be disclosed in direct-to-consumer ads -- with some saying the idea would not survive a First Amendment challenge and others asserting including list prices could mislead consumers.