Jun 10 2009, 2:25 PM EST
News source: Business Wire
A new report released today from the Federal Trade Commission (FTC) entitled “Follow-on Biologic Drug Competition” finds 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, the Pharmaceutical Care Management Association (PCMA) said today.
“This new report is good news and confirms that biotech products don’t need additional exclusivity protections before a generic competitor can enter the market,” said PCMA President and CEO Mark Merritt. “The findings support Chairman Waxman’s approach to the issue and undermine other proposals which demand excessively long periods of exclusivity.”
Specifically, the report noted:
“Central to each of these exclusivities is a public policy trade-off: a restriction on competition is provided in return for the development of a new drug product or new use of an existing product. A 12- to 14-year exclusivity period departs sharply from this basic trade-off, because it does not spur the creation of a new biologic drug or indication. The drug has already been incentivized through patent protection and market-based pricing.
“The potential harm posed by such a period is that firms will direct scarce R&D dollars toward developing low-risk clinical and safety data for drug products with proven mechanisms of action rather than toward new inventions to address unmet medical needs. Thus, a new 12- to 14-year exclusivity period imperils the efficiency benefits of a FOB approval process in the first place, and it risks over-investment in well-tilled areas.”
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 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).
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.
“Many underestimated the savings from generics when the original Hatch-Waxman bill was passed into law,” Merritt added. “Now, many underestimate the ability of generic biologics to save money. However, pharmacy benefit managers and others have consistently found new and innovative ways to promote generic utilization and competition.”
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.
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