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GPhA, Major Health Stakeholders Support New Senate Judiciary Bill to Curb REMS Abuse

Contact: Steve Arnoff 202.249.7113 


CREATES Act Promotes Pharmaceutical Competition, Helps Expand Patient Access to Affordable Medicines

WASHINGTON, DC (June 14, 2016) — The Generic Pharmaceutical Association (GPhA) supports today’s introduction of the Creating and Restoring Equal Access to Equivalent Samples (“CREATES”) Act by Senate Judiciary Committee Chairman Chuck Grassley (R-IA), Ranking Member Patrick Leahy (D-VT), and Antitrust, Competition Policy & Consumer Rights Subcommittee Chairman Mike Lee (R-UT) and Ranking Member Amy Klobuchar (D-MN).

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.

“GPhA is committed to improving access to safe, effective and affordable generic and biosimilar medicines for millions of patients. We continue to advocate for common sense reforms that enhance patient access, increase competition and lower health costs,” said Chip Davis, President and CEO, GPhA. “It is worth noting and recognizing recent efforts by representatives in the branded industry to highlight the valuable role generic medicines play in driving healthcare system savings, including their support for reducing the backlog of pending ANDA applications at the FDA. However, continued use of these anticompetitive practices by certain manufacturers drives the exact opposite outcome; delaying or eliminating alternative treatment options to advance patient outcomes while continuing to increase healthcare costs. It is time to put a stop to these anticompetitive maneuvers.”

REMS are Food and Drug Administration (FDA) programs designed to protect patient safety, but certain brand drug companies misuse them to block competition from generic medicines. Matrix Global Advisors analysis found that abuse of programs like REMS costs the health care system $5.4 billion annually. Further, if the practice of misusing REMS programs expands to biosimilars as they begin to enter the U.S. healthcare system, Matrix notes that it could result in approximately $140 million in additional lost savings for every $1 billion in biologics sales.

A group of 15 major healthcare stakeholders wrote a letter to welcome the bipartisan introduction of the CREATES Act and applauded the leadership of its sponsors:

“Companies that exploit restricted access programs – whether under the pretext of an FDA-mandate or on their own accord - delay generic competition and undermine the intent of Hatch-Waxman at the expense of America’s patients. The CREATES Act is a common sense solution that will prevent such abuses, and further patient access to safe, effective, and affordable medications. We thank you again for your incredible efforts in introducing this bill.”

REMS abuse can occur in two scenarios. First, when a brand drug company refuses to sell samples of its product to potential generic competitors, a ploy that prevents the generic company from conducting bioequivalence tests necessary to gain FDA approval and provide patients and their providers more affordable treatment options. Second, when a brand drug company intentionally prevents generic competitors from joining a “shared REMS,” a distribution protocol applicable to both brand and generic versions of the medicine. This tactic also has the effect of keeping generic competitors off the market, even at times when the brand drug patent is past expiration.

The CREATES Act addresses these scenarios by authorizing a judge to award damages to deter future misconduct. The bill allows a generic drug manufacturer to bring an action in federal court to obtain the sample it needs, authorizes a judge to award damages to deter future misconduct and allows brands and generics to enter court-supervised negotiations for establishing shared safety protocol. The bill also helps deter misuse among brand manufacturers with self-imposed (not required by FDA) REMS-like restrictions on the sale or distribution of products.

“GPhA and the Biosimilars Council strongly support FDA-mandated REMS programs. These critical patient safety programs serve a public health good and should be strengthened so that they are used as intended,” said Davis. “As experts continue to point to unsustainable brand and specialty drug costs, the CREATES Act takes needed steps needed to stop brand drug company REMS abuses.

At a time when everyone is looking for ways to lower health costs, the CREATES Act takes a clear bipartisan stand in favor of pharmaceutical competition, patient access and patient savings from safe, effective and more affordable generic and biosimilar medicines.”

Visit www.StopREMSAbuse.org for more information.

Resources:
The CREATES Act (full) (summary)
CREATES Act group letter
Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry
The Hill: Strengthening REMS for Patient Safety, Faster Access to Generics
AP: Drug Distribution Becomes Weapon to Block Competition

About the GPhA Biosimilars Council
The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.