Bill aims to increase access, competition for generic drug makers

WASHINGTON D.C. — A bill has been introduced that lawmakers say would “close federal loopholes” and increase consumer access to generic drugs while boosting market competition.



Rep. Steve Stivers, R-Ohio, joined Rep. Peter Welch, D-Vermont, to introduce the Fair Access for Safe and Timely (FAST) Generics Act.



“We cannot afford to promote practices that hinder consumers’ abilities to obtain generic alternatives to expensive brand medicines. Our bill closes federal loopholes to ensure consumers have increased access to less costly generic drugs by increasing market competition and eliminating bureaucratic red tape.  This problem must be addressed to save the government and consumers billions of dollars while increasing pharmaceutical options for patients,” Stivers said.



According to Stivers and Welch, there are companies that abuse Food and Drug Administration drug safety programs by withholding access to drug samples for generic manufacturers, resulting in anticompetitive practices and increased pharmaceutical costs.



“Too many Americans, particularly seniors, cannot afford their prescription drugs,” Welch said. “This legislation will ensure that manufacturers of generic medicines can bring more affordable medicines to the market as quickly as possible.”  



The legislation was quick to draw praise from GPhA.



"This important bill introduced today by Congressmen Steve Stivers (R-OH) and Peter Welch (D-VT) promises to prevent unnecessary delays for patients waiting for generic choices and save billions for taxpayers, patients, and the federal government," said Ralph G. Neas, president and CEO, GPhA, in a statement. "These programs should be established for what Congress intended: keeping patients safe. Instead, some companies have adopted business strategies that deter competition under the guise of safety. This bill would put an end to that regrettable practice.”  



GPhA pointed to the findings of a study from Matrix Global Advisors, which indicate that the ongoing abuse of Risk Evaluation and Mitigation Strategies (REMS) and REMS-like programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending that could be saved if the 40 drugs examined in the study were allowed to come to market as generics. GPhA noted that these efforts are particularly critical as the U.S. market prepares for the entry of biosimilars. In fact, the study identifies approximately $140 million in lost savings for every $1 billion in biologics sales.



The FAST Generics bill aims to counter these abuses by setting forth more explicit legal requirements and processes regarding the acquisition of product samples by generic and biosimilar developers, while putting safeguards in place to protect public health, GPhA stated.