American consumers will be able to enjoy the benefits of drug competition that results in more choice and lower prices for life-saving drugs via the newly proposed Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, U.S. Sen. Chuck Grassley (R-Iowa) said.
“I constantly hear from constituents about how expensive drugs are and how that’s impacting their bottom line. I believe (this bill) strikes the right balance in ensuring that health, safety and competition goals are appropriately balanced,” Grassley, chairman of the Senate Judiciary Committee, said during this week’s Antitrust Subcommittee hearing on the act.
Specifically, the CREATES Act improves patient access to safe and affordable medicines by taking steps to curb abuses of Risk Evaluation and Mitigation Strategies (REMS) without compromising patient safety, Grassley said. REMS are U.S. Food and Drug Administration (FDA) programs designed to protect patient safety, but he said certain brand drug companies misuse them to block competition from generic medicines.
In fact, recent analysis from Matrix Global Advisors (MGA) found that abuse of programs like REMS costs the U.S. health care system $5.4 billion annually. And if the practice of misusing REMS programs expands to biosimilars as they begin to enter the U.S. health care system, the result could be roughly $140 million in additional lost savings for every $1 billion in biologics sales, according to MGA.
“The bill allows a generic drug manufacturer that is facing a delay tactic to bring an action in federal court for injunctive relief, i.e., to obtain the sample it needs, or to enter court-supervised negotiations for a shared safety protocol,” Taylor Foy, Sen. Grassley’s press secretary told American Pharmacy News.
Delay tactics include those such as when brand-name drug companies refuse to sell samples of their product to potential generic competitors, or when brand-name manufacturers whose products require a distribution safety protocol refuse to allow generic competitors to participate in that safety protocol, Foy explained.
“The bill also authorizes a judge to award damages to deter future delaying conduct,” Foy said.
At the same time, the bill is intended to provide a fast, easy way for generic manufacturers to obtain relief, so they may bring their product to market in a timely fashion without having to rely on the often long process of a traditional antitrust lawsuit.
“By helping to stop delay tactics by some brand name drug companies and getting generic drugs to the marketplace, consumers will have access to lower-cost prescription drugs sooner rather than later,” Foy said.
Such delay tactics frustrate the intent of the Hatch-Waxman Act, a law that streamlines and expedites the approval process for generic drugs, Grassley said.
Brand name drug companies are basically using this FDA regulatory process, which was set up as a safety measure, to instead block generic competition, in turn keeping prescription drug costs high for patients, insurers, and government programs, Grassley said.
“Now, I’m the first one in line when it comes to making sure our drugs are safe and potentially dangerous drugs are restricted and carefully monitored and distributed," Grassley said. "But we also need to make sure that games aren’t being played and laws aren’t being undermined when we’re trying to increase the availability and affordability of prescription drugs.”
The senator added that the bill doesn’t impact the ability of antitrust regulators to go after violations in this area under the antitrust laws, but it does provide for a faster, less complex avenue by which to seek limited relief — primarily injunctive relief – to get lower cost, safe generic drugs on the market as soon as possible.
“Laws currently in place are intended to ensure that drug companies do not undermine the pro-consumer, pro-competition goals of the Hatch-Waxman Act regime," Foy said. "This bill is an effort to make sure lower cost drugs get to consumers as soon as possible and that drug companies don’t engage in anti-competitive activity."
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