A U.S. House of Representatives health panel on Wednesday became the first in this Congress to work on , including the Creates Act and a ban on "pay for delay" deals, as lawmakers eye a forthcoming bicameral package to lower pharmaceutical prices.
The packet of bills from the House Energy and Commerce health subcommittee takes oblique aim at brand drugs' patent and exclusivity privileges to push more generic competition, and represents a gentle first step in the growing congressional momentum to scrutinize the entire drug patent system.
Besides the Creates Act, the panel moved the bipartisan "Blocking Act," meant to discourage gaming of the current exclusivity system. It would let the Food and Drug Administration approve a generic drug maker's application to bring a competing drug to market if the first generic manufacturer to apply has not launched its product.
A proposed ban on "pay-for-delay tactics," where brand manufacturers can enter into agreements with generics to keep a competitive product off the market, faced some controversy from the Republicans on the panel although it ultimately passed.
Rep. Morgan Griffith (R-Va.) didn't want the bill to affect existing settlements — a concern supported by Rep. Fred Upton (R-Mich.) who introduced an amendment that would prevent the policy from having a retroactive impact. The amendment failed, but Upton told Project Japan he would bring it up again as work on the measure continues.
Rep. Peter Welch (D-Vt.), in defense of the bill, noted that HHS Secretary Alex Azar supports a "pay-for-delay" ban, as does the White House.
"This abuse is on us if we let it continue," said Welch. "These companies get away with it, but only if we let them do it."
Overall, the prescription drug legislation represented what House Energy and Commerce Chair Frank Pallone (D-N.J.) described as a push to "re-analyze" the drug space. The chairman described the market as increasingly monopolistic in a way that hinders functional competition.
"Something has to be done to make sure a competitive marketplace exists," Pallone said. "It's a progressive thing to do to preserve the marketplace and preserve generic competition as a real factor in lowering drug prices."
The chairman also criticized industry opposition to some of the proposals as attempts "to protect their patents, their exclusivity" and said new generics in 2017 have saved patients and government $265 billion, including more than $82 billion for Medicare.
Less bipartisan were the bills that touched on the Obamacare exchanges and the Trump administration policies that have aimed to reshape that market.
A measure to fund a $10 billion-per-year federal reinsurance program for expensive claims — a key industry ask this Congress — was opposed by Republicans, in a stand-off over the Democratic decision not to include language that would block federal money from funding abortion.
The panel Democrats also moved a bill to block the Trump administration's expansion of so-called short-term, limited duration plans, as well as the recent HHS guidance to give states more leeway through 1332 State Innovation waivers to shift federal subsidies from their individual market exchanges.
Another bill would restore the funds for marketing and navigator outreach for the individual market — funds that the Trump administration have slashed. Republicans on the panel opposed the measure, but wanted to add an amendment to authorize the money for marketing of recently expanded association health plans.
Democrats pushed back, criticizing the idea spending federal money on what Pallone characterized as "deceptive marketing practices" for plans that might not have comprehensive coverage.
One measure previously considered by the panel was not discussed Wednesday: a proposal from Eshoo to add consumer warnings to short-term plans, whose coverage is often barebones. In a February hearing, some Republicans signaled the bill could get bipartisan support.