Months after President Donald Trump rolled out his administration’s drug pricing “blueprint,” wheels are in motion in Washington, D.C., as legislators and the federal government work to implement proposals pushing more transparency.
On Thursday, the Senate voted to include legislation from Sen. Chuck Grassley, R-Iowa, and Sen. Dick Durbin, D-Ill., that directs the HHS to form rules about requiring pharmaceutical pricing in DTC advertising. The legislation came in the form of an amendment to a healthcare spending bill; the House of Representatives still needs to approve its own version of the bill.
Speaking on the amendment Thursday, Sen. Chuck Grassley said on the Senate floor that “pharmaceutical companies are already interested in consumer education. We just want them to take it one step further.”
The drug industry opposes the proposal. A PhRMA representative said in a statement that price disclosures 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.” Plus, she said, such a law would “raise significant legal issues, including First Amendment concerns.”
Meanwhile this week, the Office of Management and Budget posted a proposed regulation called “Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency.” Exact details on the proposal remain unclear. An HHS spokesperson said in a statement the agency can’t comment on pending regulations, but that the administration’s “blueprint to lower prescription drug prices and reduce out-of pocket costs clearly states that HHS is looking at options to require drug-pricing transparency.
“It should not come as a surprise that this would require rulemaking,” she added.
The moves come after Trump and HHS secretary Alex Azar presented their drug pricing blueprint in May. The plan calls for more negotiation, more transparency, incentives to lower list prices and lower out-of-pocket costs for patients. After the announcement, numerous industry watchers said they felt the proposals came short of the measures needed to lower prices. Wells Fargo analyst David Maris, however, wrote that the administration is “actually trying to address some of the root causes of price inflation and lack of affordability.”
Already since the press conference, the FDA has started highlighting complaints by generics companies against their branded counterparts for regulatory abuses that stifle generic competition. Additionally, CMS has allowed Medicare Advantage plans to implement step therapy for new patients and negotiate prices in an effort to control pharmaceutical costs.
By Eric Sagonowsky
Source: Fierce Pharma
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