- A federal judge has brushed off an attempt from pharmaceutical manufacturing trade groups to block a recently passed Nevada bill aimed at increasing transparency around diabetes drug pricing.
- The now denied motion, lobbed by PhRMA and BIO, sought a temporary restraining order (TRO) on Nevada Senate Bill No. 539. Signed into law on June 15, the legislation requires makers and sellers of essential diabetes drugs to hand over pricing information for those those treatments if they have undergone "significant" price increases in the previous two years.
- On Sept. 1, PhRMA and BIO filed a lawsuit against Nevada's governor, Brian Sandoval, and the director of the state's Department for Health and Human Services, Richard Whitley, arguing the law would expose confidential patent and trade secrets and shouldn't be enforced. So far, though, that argument hasn't gained muster with the courts.
Despite bipartisan support for lower drug costs, a bitterly divided Congress has not yet made a serious push to pass any substantial legislation that would regulate the price of medicines. In light of that inaction, state governments have increasingly taken it upon themselves to address the issue.
Maryland, for instance, passed a law in late May empowering the state to gather pricing information from drug manufacturers suspected of price gouging their essential generic products. If officials determine that the prices were raised unreasonably, they can hit the manufacturers with fines and other penalties.
The pharmaceutical industry, however, hasn't taken such jabs lightly. The biggest U.S. trade group for generics, the Association for Accessible Medicines, filed a lawsuit in July looking to block the Maryland bill. Similarly in Nevada, S.B. 539 has been met with a strong pushback from organizations representing branded drugmakers.
PhRMA and BIO claimed “[t]he challenged provisions of SB 539 become effective on October 1, 2017, and officially strip affected manufacturers of trade-secret protection for their confidential data as soon as the department publishes its list of ‘essential’ diabetes drugs," according to an order filed Sept. 14 by Judge James Mahan of the U.S. District Court for the District of Nevada. They also lamented that, because of the bill, their members must "immediately reassess the risks and returns of their investments in diabetes therapies."
The trade groups not only asked for the bill to be blocked, but requested too that the TRO be issued as soon as possible and a hearing for their motion take place earlier than Oct. 1. Mahan, however, wasn't swayed.
"Plaintiffs have not shown that 'immediate and irreparable injury, loss or damage will result ... before the adverse party can be heard in opposition," he wrote in the Sept. 14 order. "The bill became effective for purposes of promulgating regulations on June 15, 2017 (the date it was signed) ... and the department has already published a proposed list of essential diabetes drugs."
"Further, plaintiffs first round of disclosures to [state health agency] are not due until July 1, 2018," he added. "Plaintiffs have not demonstrated that any additional or irreparable harm will accrue on either October 1, 2017, or on October 15, 2017."
In spite of the ruling, the plaintiffs appear ready to keep the battle over S.B. 539 going.
"BIO remains confident in the eventual outcome of the process," George Goodno, BIO’s communications director for state policy, international affairs and intellectual property, told Bloomberg BNA Sept. 15.