Pay-for-delay, evergreening central to GPhA cost-savings report

The Generic Pharmaceutical Association is touting a new report that highlights cost savings associated with generic drugs as additional fodder to fight congressional efforts to limit pharmaceutical manufacturer settlements, while simultaneously calling for the elimination of “evergreening” practices for biologic products — two issues that were central in the healthcare reform debate.

In its report, GPhA contends that generic drugs saved $834 billion during the previous decade, citing drug patent settlements as enabling generic drugs to reach the market months before the brand-name product’s patent expires. These early access settlements have saved billions of dollars, according to GPhA, although opponents to these agreements contend that the practice is abused by instead forcing taxpayers to purchase higher cost brand-name drug products.

Lawmakers have repeatedly attempted to curb pay-for-delay drug patent settlements, where brand-name drug manufacturers pay generic pharmaceutical makers to withhold a cheaper version of the product from the market. A limit on these pay-for-delay settlements was removed from the healthcare reform legislation at the last minute, and both the House and the Senate have attempted to include curbs on these agreements in the war supplemental appropriations bill.

Healthcare reform legislation also created an accelerated approval pathway for biosimilars, with the market for biologics reaching $100 billion by the end of the year, according to GphA. Read more.