Fight for Orphan Drug Bill Shows Hard Road for Taking on Pharma

Legislation meant to prevent drugmakers from blocking new opioid addiction treatment medicines from coming to market faces tough prospects in the Senate this year, even though advocates say it’s a layup for lawmakers.

The bill (H.R. 1629) looks to fix an issue in the nation’s orphan drug development rules that was exploited largely by one company, Indivior Plc, for a blockbuster opioid treatment. Supporters say it’s hard to argue against clearing the way for addiction treatment medicines as overdose deaths rise.

The difficulty in getting this legislation to President Joe Biden’s desk showcases how hard it is to pass any bill affecting the pharmaceutical industry.

“This is about tackling a public health crisis made worse in the pandemic by dealing with bad actors,” Rep. Madeleine Dean (D-Pa.), the bill’s House sponsor, said. “There’s no reason we can’t do this.”

Don Emmert/AFP via Getty Images

Pouches of fentanyl are displayed at the Drug Enforcement Administration Northeast Regional Laboratory in New York on Oct. 8, 2019. Abuse of the powerful painkiller has fueled the U.S. opioid crisis.

House Democratic leaders have signaled they want to pass a Medicare drug pricing negotiation bill (H.R. 3) this year over objections from Republicans and some within their own ranks.

Some lawmakers are pushing for less-sweeping measures, such as (H.R. 153) banning brand-name drug companies from paying generic manufacturers to delay bringing their products to market.

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Monopoly Moves

The Fairness in Orphan Drug Exclusivity Act would stop drugmakers from extending their monopoly on “orphan” drugs used to treat rare diseases, including certain opioid use disorder drugs, unless they can prove they aren’t immediately profitable. Orphan medicines can qualify for seven years of exclusivity if they treat medical conditions affecting under 200,000 people in the U.S., or if there is no reasonable expectation that production costs could be recouped via sales.

Two opioid addiction treatments, Subutex and Suboxone, were granted this special exclusivity by the Food and Drug Administration in 2002 despite being largely profitable medicines, said Kao-Ping Chua, health policy researcher at the University of Michigan who studies opioid policy and orphan drug policy.

Suboxone accounted for almost a quarter of Indivior’s $647 million in net revenue in 2020, according to the company’s financial filings. The company didn’t respond to a request for comment.

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These profits came as drug overdose deaths reached an all-time high in the U.S. The Centers for Disease Control and Prevention estimates that about 92,000 people died of drug overdoses between October 2019 and October 2020, putting the country on track to record 100,000 such deaths in 2020.

Indivior’s Sublocade, a buprenorphine extended-release injection, was grandfathered into exclusivity by the FDA in 2017, Chua said. This was done with the understanding that Sublocade wouldn’t be profitable, he said.

The FDA ended Sublocade’s orphan drug designation in 2019 but some worry Indivior will be able to reverse that decision. Dean’s bill aims to prevent that from ever happening, Chua said.

Sublocade alone brought Indivior a net revenue of $43 million in the first three months of 2021, almost 24% of the total revenue the company took in during that quarter, the company’s financial filings show.

Tough Battles

Dean’s bill passed the House May 19 with more than 400 votes, after passing by voice vote last Congress. The Republicans who opposed it did so on procedural grounds: Dean declined to make Rep. Buddy Carter (R-Ga.) a main cosponsor again because he voted against certifying the presidential election earlier in the year.

Carter rallied his Republican colleagues to vote down the bill earlier in May, forcing Democrats to bring it to the floor for a second time in as many weeks.

The path through the Senate could be more fraught, supporters say.

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The Pharmaceutical Research and Manufacturers of America, the drug industry’s main influence group, reported lobbying on the bill this year.

Sen. Bill Cassidy (R-La.), one of the main sponsors of the legislation, said a narrowly tailored bill such as this one can be passed by a voice vote in the Senate, but that requires educating almost every member of the chamber on the topic to ensure no one objects.

“Everyone wants to get something done in this space, so what it comes down to is getting everyone on the same page,” Cassidy said. “Maybe someone has an objection and you work that out. That takes time but it’s something that can be done.”

The bill has support from Sens. Tammy Baldwin (D-Wis.) and Jeanne Shaheen (D-N.H.), but the Senate Health, Education, Labor and Pensions Committee has yet to schedule it for consideration.

Cassidy said taking on such legislation is beneficial because broader legislation often gets bogged down in Senate debate.

“For drug prices there is no silver bullet, but there is silver buckshot,” he said. “If we can take on these individual issues, then we can make progress.”

To contact the reporter on this story: Alex Ruoff in Washington at aruoff@bgov.com

To contact the editors responsible for this story: Robin Meszoly at rmeszoly@bgov.com; Anna Yukhananov at ayukhananov@bloombergindustry.com