pills in bottle made of dollarsA slate of options to reform drug patents is working itsway through the Senate Judiciary Committee, which had a hearingTuesday featuring academics, patient advocates and a representativefrom the pharmaceutical industry. (Photo: Shutterstock)

|

Congress isn't making much headway in finding a solution to theproblem of soaring prescription drug prices, but lawmakers fromboth parties are tinkering on the edges with legislation that aimsto increase competition among drugmakers.

|

A comprehensive piece of drug-pricing legislation is a highpriority for Senate Finance Committee Chairman Chuck Grassley(R-Iowa) and Sen. Ron Wyden (D-Ore.). And it could be introduced bymid-June, according to congressional staff.

|

Related: Lowering drug prices: Can California make ithappen?

|

But while that is hashed out, a slate of options to reform drugpatents is working its way through the Senate Judiciary Committee,which had a hearing Tuesday featuring academics, patient advocates and arepresentative from the pharmaceutical industry. Their mission: toincrease competition without decreasing innovation in theindustry.

|

“I think we're dangerously close to building a bipartisanshipconsensus around change,” Sen. Dick Durbin (D-Ill.) said during thehearing.

|

The four proposed bills share a common goal: avoiding some ofthe thorny issues around drug pricing, like whether the governmentwill set drug prices or negotiate with manufacturers on whatfederal programs will pay. Instead, the patent reform proposals getat the ways branded drug manufacturers use patents, and the legalmonopolies that are granted with patents, to keep lower-pricedgeneric competitors from reaching patients.

|

“A package of patent reforms are important because they fixsystemic problems that allow prices to go up and keep them high,”testified David Mitchell, the president of Patients for AffordableDrugs, a Washington, D.C.-based advocacy group focused on loweringprescription drug prices.

|

Sen. John Cornyn (R-Texas) offered specific examples of drugsthat have benefited from system issues, including Humira, anexpensive drug forarthritis and psoriasis that is protected by 136 patents.

|

That's called a “patent thicket,” because it prevents a genericalternative from entering the market for more years — in this case,until 2023 for a drug first approved for use in the United Statesin 2002. “Is there anyone on the panel who'd like to defend thestatus quo?” he asked.

|

“There is no way a biosimilar can deal with a hundred patents,”testified Michael Carrier, a professor at Rutgers Law School. “Thisis an abuse of the system.”

|

Among the proposed bills, the Stop STALLING (“Stop Significant and Time-wasting Abuse LimitingLegitimate Innovation of New Generics”) Act — the bipartisanbrainchild of Sen. Amy Klobuchar (D-Minn.) and Grassley — issupposed to put a stop to “sham” citizen petitions to the FDA.Critics say these petitions are often introduced by drugmakers under the guise of patient advocacy to slow FDAapproval of new generic medicines. “Nearly every one of thesecitizen petitions is brought by a brand company. None are filed byindividuals. I love the legislation. I would go even stronger,”Carrier said.

|

Grassley is also the lead sponsor on the bipartisan Prescription Pricing for the People Act of 2019. It directs theFederal Trade Commission to investigate mergers of pharmacy benefitmanagers, the middlemen that negotiate between drugmakers andhealth plans.

|

Klobuchar and Grassley teamed up again on another measure, thePreserve Access to Affordable Generics and Biosimilars Act,which they say would end “anti-competitive behavior” —specifically, deals struck between branded companies and genericcompanies to keep a generic, or a biosimilar, off the market.Klobuchar, a Democratic presidential candidate, has frequentlydiscussed her opposition to this practice on the campaigntrail.

|

James Stansel — the executive vice president and general counselof the Pharmaceutical Research and Manufacturers of America, a drugindustry trade group, and the lone voice of the pharmaceuticalindustry on the panel — cautioned against moving too aggressivelyon this point. “We want to make sure we don't do something that'santi-competitive in the hopes it would be pro-competitive,” hesaid.

|

There's also the CREATES (“Creating and Restoring Equal Access to EquivalentSamples”) Act, introduced by Sen. Patrick Leahy (D-Vt.) with 31bipartisan co-sponsors and endorsed by nearly every witness onTuesday's panel. It's supposed to crack down on branded companiesthat refuse to sell samples of their drugs to generic companies, anecessary step to increasing the number of generics on themarket.

|

Versions of all four of those bills have also been introduced in theHouse and advanced out of the House Judiciary Committee.

|

“The American people are being played for chumps,” said Sen.John Kennedy (R-La.). “Just chumps. And it's got to stop.”

|

Kaiser HealthNews (KHN) is a national health policy news service. It is aneditorially independent program of the Henry J. Kaiser Family Foundation whichis not affiliated with Kaiser Permanente.

|

Read more: 

Complete your profile to continue reading and get FREE access to BenefitsPRO, part of your ALM digital membership.

  • Critical BenefitsPRO information including cutting edge post-reform success strategies, access to educational webcasts and videos, resources from industry leaders, and informative Newsletters.
  • Exclusive discounts on ALM, BenefitsPRO magazine and BenefitsPRO.com events
  • Access to other award-winning ALM websites including ThinkAdvisor.com and Law.com
NOT FOR REPRINT

© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.