September 24, 2015 at 5:37 pm ET
Hillary Clinton’s proposal to lower drug costs by increasing competition for some specialty drugs could face an unlikely opponent: Democrats in Congress.
The Democratic presidential front-runner unveiled details on her health platform this week, which includes a proposal to cut down on how long drug makers get exclusive rights to produce complex drugs known as biologics. Right now, pharmaceutical companies have 12 years before competitors are allowed to use their clinical trial data to argue their generic versions of drugs are safe, Clinton’s proposal would reduce that to seven years.
Clinton argues that reducing the so-called “exclusivity period” for biologics would lower drug prices, which have skyrocketed in recent years. President Barack Obama has pushed for similar measures in his annual budget proposals, most recently for fiscal year 2016. Obama’s attempts have garnered opposition from Democrats.
Sen. Chris Murphy (D-Conn.) told Morning Consult Thursday that lawmakers should wait until the Food and Drug Administration releases the final guidelines regulating biosimilars before taking up exclusivity for biologics. At a Senate Health, Education, Labor and Pensions hearing earlier this month, the FDA’s senior drug official Janet Woodcock said the FDA hopes to release draft guidances on biosimilars, “as soon as possible.” But she would not specify an exact date.
“I think it’s probably most important to get the guidance out for the new biosimilars before we start shortening the exclusivity periods,” Murphy said. “I would be willing to look at the period of exclusivity, but our focus right now should just be on getting the framework set up.”
Murphy was one of 50 Democrats and Republicans to sign a letter in 2012 in opposition to changing the exclusivity period to seven years.
The lawmakers wrote that 12 years of exclusivity “struck an important balance between patient access and innovation…because biologics are much more complex and expensive to bring to the market than ordinary drugs.”
Rep. Gene Green (D-Texas), who also signed the letter, said in an interview Thursday that the House Energy and Commerce Committee considered reducing the exclusivity period for biologics when drafting the “Cures” legislation that overhauls parts of the FDA’s drug approval process. Green said he was satisfied with the final exclusivity language in the bill, which did not touch biologics.
“The bill we got out of the House was very compromised,” Green said in an interview. “I’m happy with what we did with the Cures because it was a give and take.”