GPhA charges misuse of FDA drug safety programs to prevent generic introductions is costing payers billions

WASHINGTON — The use of Food and Drug Administration drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending, charged the Generic Pharmaceutical Association. That's the amount of money that could be saved if 40 drugs examined in a Matrix Global Advisors report were allowed to come to market, the association noted. 

 

The study, commissioned by GPhA, also found that after biosimilars enter the market, misuse of Risk Evaluation and Mitigation Strategies and other restricted access programs would result in approximately $140 million in lost savings for every $1 billion in biologics sales.

 

“For patients waiting for generic alternatives to expensive brand medicines, every day counts. For lawmakers struggling to balance the budget, every dollar matters,” stated Ralph Neas, GPhA president and CEO. “This study shows that by using safety programs as a smokescreen for anti-competitive practices, some brand companies are delaying generic choices for patients and driving up drug costs," he said. "Further, allowing these kinds of abuses to continue unabated threatens the cost savings potential around the next frontier of innovation: biosimilars. The data reveals that allowing these practices to go unchecked will have exorbitant and spiraling costs. ... This could mean tens of billions more in lost savings in the future.”

 

The study, titled Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry, examines the practice of abusing REMS and “Restricted Access Drug” programs to deny generic drug firms access to samples of brand drug products. Without access to these samples, which traditionally have been purchased by generic drug applicants through wholesalers, manufacturers cannot conduct appropriate testing and secure subsequent approval of generic medicines. 

 

The study was based on 40 products identified in a confidential survey of eight generic manufacturers and conducted from December 2013 to March 2014.