Rules will require pharma companies to list prices in direct-to-consumer advertising materials.

As concerns about high drug prices continue, lawmakers are attempting to assuage the situation. The Senate recently passed a spending bill that includes an amendment from Sens. Richard Durbin (D-IL) and Chuck Grassley (R-IA) that requires pricing information to be included in advertisements about prescription drugs.

According to Grassely, the pharmaceutical industry spent more than $6 billion in 2017 on direct-to-consumer (DTC) advertisements, and typical people in the US see nine DTC prescription drug advertisements per day.

The amendment requires that pharmaceutical companies list the prices of prescription drugs in all DTC materials they produce. Any prescription drugs that are advertised directly to consumers without providing pricing information will be considered as “misbranded.” It also includes $1 million for the US Department of Health and Human Services (HHS) to implement the rules.

Noted Durbin: “What Senator Grassley and I wanted to do is to give the American people more information about drug costs. More information gives transparency to the transaction, and will help give American consumers a break and start to slow down the skyrocketing cost of prescription drugs.”

Some issues remain unclear, however, such as whether the prices to be included in DTC ads are list prices or rebate-reduced prices, and whether pharma companies will change their advertising tactics based on the prices of different drugs.

Separately, the Centers for Medicare and Medicaid Services (CMS) recently submitted “Regulation Require Drug Pricing Transparency” for review as a proposed rule, and previously announced plans to begin using what’s called step therapy to try to lower spending on Part B drugs by approximately 20% in Medicare Advantage plans. FDA has also stepped up its activity with respect to speeding up generic drug approvals.