New Biogenerics Legislation Will Save Lives, Money 

(Washington, DC)-The Pharmaceutical Care Management Association (PCMA) today launched a new ad campaign-“Waiting Isn’t An Option”-that urges policymakers to reject biogenerics legislation that creates unnecessary delays and instead support follow-on biologics legislation which allows generics to compete with expensive biotech medicines the way they already do with conventional brand-name drugs.

“This bipartisan bill will increase access to life-saving medications, save billions and ensure continued innovation for new groundbreaking biologics. It’s one of those rare ‘win-wins’ supported by consumers, ‘budget hawks,’ business, labor and policymakers on both sides of the aisle,” said PCMA President and CEO Mark Merritt.

Introduced last month in the House of Representatives by Energy and Commerce Committee Chairman Henry Waxman (D-CA), Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO), “The Promoting Innovation and Access to Life-Saving Medicine Act” would create a regulatory pathway for the Food and Drug Administration (FDA) to approve generic versions of biologic products.  

Companion legislation was introduced in the US Senate (S. 726) by Senators Charles Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), David Vitter (R-LA), Debbie Stabenow (D-MI),  Jeanne Shaheen (D-NH), and Mel Martinez (R-FL). 

This bill would give brand-name biologics five years of exclusivity before generic versions could enter the market and would allow for greater savings to fund broader health reforms, in contrast to the competing House bill (H.R. 1548), which would give brand-name biologic manufacturers up to an unprecedented 14 years of exclusivity before generic versions could hit the market.