PCMA: President Obama, MedPAC Call for Follow-On Biologics

WASHINGTON--(BUSINESS WIRE)--Both President Obama and The Medicare Payment Advisory Commission (MedPAC) today called for creating a pathway for the Food and Drug Administration (FDA) to approve follow-on biologics (FOBs), adding to strong momentum to pass meaningful biogenerics legislation this Congress, according to the Pharmaceutical Care Management Association (PCMA).

“We need to introduce generic biologics into the marketplace”

“We need to introduce generic biologics into the marketplace,” said President Obama in a speech to the American Medical Association today on health reform. The President emphasized that creating an FDA pathway for generic biologics “will save us billions of dollars.”

Separately, the independent Congressional agency MedPAC said today that the “establishment of a regulatory approval process for FOBs is necessary to provide more competition among biologics and generate cost savings.” Highlighting the issue’s importance, MedPAC included an entire chapter on follow-on biologics in its June report to Congress, “Improving Incentives in the Medicare Program.”

“Real biogenerics reform will save billions that can be used to finance broader health reform,” said PCMA President and CEO Mark Merritt.

Building on today’s news, a report released last week from the Federal Trade Commission (FTC) found that patents for biologic products already provide enough incentives for innovation and that additional periods of exclusivity would “not spur the creation of a new biologic drug or indication” and “imperils” the benefits of the approval process.

Introduced 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” (HR 1427) would create a regulatory pathway for the 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).

HR 1427/S 726 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 (HR 1548), which would give brand-name biologic manufacturers up to an unprecedented 14 years of exclusivity before generic versions could hit the market.

PCMA represents the nation’s pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use of electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 200-plus million Americans.