Lawmakers in Maryland are daring to legislate where theirfederal counterparts have not: As of Oct. 1, the state will be ableto say “no” to some pharmaceutical price spikes.

A new law, which focuses on generic and off-patent drugs,empowers the state’s attorney general to step in if a drug’s priceclimbs 50 percent or more in a single year. Thecompany must justify the hike. If the attorney general stillfinds the increase unwarranted, he or she can file suit in statecourt. Manufacturers face a fine of up to $10,000 for pricegouging.

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As Congress stalls on what voters say is a top health concern — high pharmaceutical costs — statesincreasingly are tackling the issue. Despite often-fierce industryopposition, a variety of bills are working their way through stategovernments. California, Nevada and New York are among thosejoining Maryland in passing legislation meant to undercutskyrocketing drug prices.

Maryland, though, is the first to penalize drugmakers for pricehikes. Its law passed May 26 without the governor’s signature.

The state-level momentum raises the possibility that — ashappened with hot-button issues such as gay marriage and smoke-freebuildings — a patchwork of bills across the country could pave theway for more comprehensive national action. States feel the squeezeof these steep price tags in Medicaid and state employee benefitprograms, and that applies pressure to find solutions.

“There is a noticeable uptick among state legislatures and stategovernments in terms of what kind of role states can play inaddressing the cost of prescription drugs and access,” said RichardCauchi, health program director at the National Conference of StateLegislatures.

Many experts frame Maryland’s law as a test case that could helpdefine what powers states have and what limits they face in doingbattle with the pharmaceutical industry.

The generic-drug industry has already filed a lawsuit to block the law, arguing it’sunconstitutionally vague and an overreach of state powers. Adistrict court is expected to rule soon.

The state-level actions focus on a variety of tactics:

“Transparency bills” would require pharmaceutical companies todetail a drug’s production and advertising costs when they raiseprices over certain thresholds. Cost-limit measures would cap drugprices charged by drugmakers to Medicaid or other state-runprograms, or limit what the state will pay for drugs. Supply-chainrestrictions include regulating the roles of pharmacy benefitmanagers or limiting a consumer’s out-of-pocket costs.

A NewYork law on the books since spring allows officials to capwhat its Medicaid program will pay for medications. If companiesdon’t sufficiently discount a drug, a state review will assesswhether the price is out of step with medical value.

Maryland’s measure goes further — treating price gouging as acivil offense and taking alleged violators to court.

“It’s a really innovative approach. States are looking at how toreplicate it, and how to expand on it,” said Ellen Albritton, asenior policy analyst at the left-leaning Families USA, which hasconsulted with states including Maryland on such policies.

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Kaiser Health News, a nonprofit health newsroom whosestories appear in news outlets nationwide, is an editoriallyindependent part of the Kaiser Family Foundation.

Lawmakers have introduced similar legislation in states such asMassachusetts,Rhode Island, Tennessee andMontana. Andin Ohio voters are weighing a ballot initiative in November thatwould limit what the state pays for prescription drugs in itsMedicaid program and other state health plans.

Meanwhile, the California legislature passed a bill earlier inSeptember that would require drugmakers to disclose when they areabout to raise a price more than 16 percent over two years andjustify the hike. It awaits Democratic Gov. Jerry Brown’ssignature.

In June, Nevada lawmakers approved a law similar to California’s but limited to insulinprices. Vermont passed a transparency law in 2016 that would scrutinizeup to 15 drugs for which the state spends “significant health caredollars” and prices had climbed by set amounts in recent years.

But states face a steep uphill climb in passing pricinglegislation given the deep-pocketed pharmaceutical industry, which can finance strong opposition, whether throughlobbying, legal action or advertising campaigns.

Last fall, voters rejected a California initiative that wouldhave capped what the state pays for drugs — much like the Ohiomeasure under consideration. Industry groups spent more than $100 million to defeat it,putting it among California’s all-time most expensive ballotfights. Ohio’s measure is attracting similar heat, with drug companiesoutspending opponents about 5-to-1.

States also face policy challenges and limits to their statutoryauthority, which is why several have focused their efforts onspecific parts of the drug-pricing pipeline.

Critics see these tailored initiatives as falling short oropening other loopholes. Requiring companies to report prices pasta certain threshold, for example, might encourage them toconsistently set prices just below that level.

Maryland’s law is noteworthy because it includes a fine fordrugmakers if price increases are deemed excessive — though in theindustry that $10,000 fine is likely nominal, suggested RachelSachs, an associate law professor at Washington University in St.Louis who researches drug regulations.

This law also doesn’t address the trickier policy question: adrug’s initial price tag, noted Rena Conti, an assistant professorin the University of Chicago who studies pharmaceuticaleconomics.

And its focus on generics means that branded drugs, such asMylan’s Epi-Pen or Kaleo’s overdose-reversing Evzio, wouldn’t be affected.

Yet there’s a good reason for this, noted Jeremy Greene, aprofessor of medicine and the history of medicine at Johns HopkinsUniversity who is in favor of Maryland’s law.

Current interpretation of federal patent law suggests that theissues related to the development and affordability of on-patentdrugs are under federal jurisdiction, outside the purview ofstates, he explained.

In Maryland, “the law was drafted narrowly to addressspecifically a problem we’ve only become aware of in recent years,”he said. That’s the high cost of older, off-patent drugs that facelittle market competition. “Here’s where the state of Maryland istrying to do something,” he said.

Still, a ruling against the state in the pending court casecould have a chilling effect for other states, Sachs said, althoughit would be unlikely to quash their efforts.

“This is continuing to be a topic of discussion, and a problemfor consumers,” said Sachs.

“At some point, some of these laws are going to go into effect —or the federal government is going to do something,” she added.

Kaiser Health News, a nonprofit health newsroom whosestories appear in news outlets nationwide, is an editoriallyindependent part of the Kaiser Family Foundation. KHN’scoverage of prescription drug development, costs and pricing issupported in part by the Laura and John ArnoldFoundation.