- The Senate on Thursday passed a measure that would provide the Department of Health and Human Services with $1 million to implement proposed rules requiring drugmakers disclose the price of their prescription drugs in direct-to-consumer advertising.
- Approved as part of a larger spending bill, the bipartisan amendment gives legislative backing for an idea that the Trump administration has pushed as part of its plan to combat rising drug prices. The broader spending legislation will need to be reconciled with a version in the House of Representatives before it goes to the president's desk.
- While the amendment's sponsors, Sens. Chuck Grassley, R-Iowa, and Dick Durbin, D-Ill., touted the measure as a common-sense step toward greater transparency, it's a proposal likely to generate substantial debate. Drug prices are notoriously opaque, and most patients don't pay the so-called "list price" that such a requirement would likely rely on.
Momentum appears to be gathering behind the Trump administration's price disclosure idea, with action on both legislative and executive fronts.
Grassley and Durbin's amendment tracks with a proposed rule submitted to the White House by HHS this week that reports indicate would be used to require drugmakers to include prices in consumer-facing advertisements. Vaguely titled "Regulation to Require Drug Pricing Transparency," the document is now under review by the Office of Management and Budget.
Still unclear is what exactly either measure would require. Patients can pay very different prices for drugs depending on what their insurance covers, and insurers negotiate with drugmakers to secure rebates and discounts that reduce a medicine's list price.
For some types of drugs, like those for cancer, dosing is calculated by patient's weight, adding another layer of complexity to settling on one standard price to disclose.
"All we're trying to do here is have the consumer get the additional information that they need if they want to consider that drug because everybody ought to want to consider the price, just like you consider the price of a car," Grassley said in remarks on the Senate floor on Thursday.
The White House's drug pricing blueprint, released in May, called for the FDA to require inclusion of list prices, or wholesale acquisition cost.
"We have FDA and CMS working to examine how to require drug companies to post their list prices in direct-to-consumer advertising. When patients hear about a wonderful new drug, they should know whether it costs $100 or $50,000," said HHS Secretary Alex Azar in remarks introducing the blueprint in May.
The administration's proposal, unsurprisingly, has been met with resistance from drugmakers.
"Disclosing list prices in DTC ads would not benefit patients as they are often not the prices insurers pay and are generally not a good indicator of what patients will pay at the pharmacy counter," wrote a spokesperson for PhRMA in an emailed statement to BioPharma Dive.
In recent public comment on the plan, the industry lobby group also raised concerns that the idea could conflict with First Amendment restrictions against compelled speech.
DTC marketing is big business for pharmaceutical firms, which spent $6 billion on such ads last year according to Grassley's office. Its role is controversial, however, with critics questioning whether pitching drugs directly to consumers encourages unnecessary treatment or inflates false hopes.
Among developed countries, only the U.S. and New Zealand permit DTC marketing of prescription drugs to consumers.