New Legislation and BPCIA Uncertainties Dominate the Biosimilars Council Policy Update

On June 7, The Atlantic hosted a Policy Update on Biosimilars sponsored by The Biosimilars Council (Association for Accessible Medicines) as part of the publication’s “The Next Drug” series.
Kelly Davio
June 12, 2017
On June 7, The Atlantic hosted a Policy Update on Biosimilars sponsored by The Biosimilars Council (Association for Accessible Medicines) as part of the publication’s “The Next Drug” series.
 
The discussion began with Steve Clemens, Editor-at-large of The Atlantic, interviewing Peter Welch, (D-Vermont). Clemens called Congressman Welch “one of the great gladiators in the drug industry” for his co-sponsorship of the Fair Access for Safe and Timely Generics Act of 2017 (or the FAST Generics Act). The proposed legislation would amend the Federal Food, Drug, and Cosmetics Act to prohibit license holders of FDA-approved drugs or biologics from restricting availability of their products for testing by competitors who seek to develop generics or biosimilars of their own.
 
Congressman Welch said that his legislation is “about affordability” of biologics. Calling the high prices of drugs “punitive” to taxpayers, employers, and individuals, Welch explained that his legislation seeks to balance the need to foster innovation in pharmaceuticals with the need to keep biologics affordable for patients. Welch, who also favors such cost-saving moves as importing cheaper drugs from Canada, says that biosimilars should be “ready to go on the market the moment that exclusivity ends,” calling efforts to extend patent protection through litigation “sketchy.” Welch also indicated a desire to see a 7-year rather than the current 12-year exclusivity period for drug patents. 
 
Congressman Welch seemed to tap into patient frustration with what many view as unaffordable drug prices, and made reference to “the Martin Shkreli thing” (or Turing Pharmaceuticals’ choice, under then-chief Shkreli, to increase the price of a decades-old drug to $750 per pill, earning the outrage of patients and the media alike) in making his case for lower pricing for taxpayers and patients. 
 
“There’s this pricing system that’s totally opaque,” Congressman Welch went on, saying that government will have to play a role in fostering market competition and bringing down prices, referencing the success of governmental price negotiation in European markets. 
 
When Clemens asked whether President Trump’s administration is friendly to the legislation’s objectives, Congressman Welch responded, “is it friendly to any objectives?” 
 


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