Stop REMS Abuse, Pass the Creates Act

The CREATES Act Passed!

AAM applauds passage of the CREATES Act, which will lower drug prices for patients through increased competition and by stopping the abuse of FDA’s safety programs and non-FDA mandated closed distribution systems.

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Patients will now score greater savings and increased access to generic and biosimilar medicines. Share this video and join us in thanking all who have advocated for its passage.

The Issue

Certain brand pharmaceutical companies prevent competition by blocking the ability of manufacturers to make more affordable generic and biosimilar alternatives. Generic companies need access to samples to conduct drug product development and bioequivalence studies necessary for FDA approval. Access delays to affordable medicines cost patients and taxpayers more than $5 billion each year.

This conduct undermines the careful balance created by the Hatch-Waxman Act to encourage generic entry, and may violate the antitrust laws.
Edith Ramirez, Chairwoman, FTC Testimony, Subcommittee Hearing, March 9, 2016

Key Points

Certain brand pharmaceutical companies prevent competition by blocking the ability of manufacturers to make more affordable, generic alternatives.
This anti-competitive practice (“REMS and restricted access abuse”) costs patients, like Michelle of Stroudsburg, PA, more than $5 billion each year and puts medication out of reach for millions.
Independent agencies (the FDA and FTC) call this abuse “a problem” that “delays the availability of generics.
It’s time for Congress to end this abusive practice and increase prescription drug competition.

Restricted Access Impedes Competition

Bipartisan legislation in the House and Senate, called the CREATES Act (S. 340/ H.R. 965) and the FAST Generics Act (H.R. 985), prohibits companies from using restricted access programs as a way to avoid generic competition.

"I see cases where that vigorous competition isn’t happening because branded companies are gaming the system to prevent generic competitors from entering the market. This isn’t an anecdotal problem. We see too many situations where the generic companies can’t even get access to the doses of the branded company’s drug in order to compare their [generic] drug to the brand company’s drug."

— Dr. Scott Gottlieb, Former Commissioner, Food and Drug Administration

Share your voice.

Contact your state or federal lawmaker and raise their awareness about this issue:

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Watch Michelle's Story

Letters and Statements Supporting Congressional Action

View AAM letter to President Donald Trump asking him to support the CREATES Act.

Letter from Rep. David McKinley (D-WV) to President Trump urging him to support passage of the FAST Generics Act (House of Representative legislation to curb REMS abuses).

Interested parties—generic drug manufactures and a diversity of industry stakeholders and allies—are all urging Congress to pass legislation to stop the anti-competitive practices of some brand companies.

View List of Supporters

Thank You to Congressional Supporters

Find a lawmaker in your state and call or send an email to thank them for supporting the CREATES Act (S. 340/ H.R. 965) and the FAST Generics Act (H.R. 985).

SENATE

Leahy, Patrick (VT)
Grassley, Chuck (IA)
Klobuchar, Amy (MN)
Lee, Mike (UT)
Feinstein, Dianne (CA)
Collins, Susan (ME)
Blumenthal, Richard (CT)
Whitehouse, Sheldon (RI)
Cotton, Tom (AR)
Durbin, Richard (IL)
Cruz, Ted (TX)
Paul, Rand (KY)
Hassan, Margaret Wood (NH)
Kennedy, John (LA)
Smith, Tina (MN)
Murkowski, Lisa (AK)
Baldwin, Tammy (WI)
Daines, Steve (MT)
King, Angus S. Jr. (ME)
Brown, Sherrod (OH)
Stabenow, Debbie (MI)
Young, Todd (IN)
Rounds, Mike (R-SD)
Tester, Jon (D-MT)
Menendez, Bob (D-NJ)
Ernst, Joni (R-IA)
Fischer, Deb (R-NE)
Booker, Cory (D-NJ)
Braun, Mike (R-IN)
Shaheen, Jeanne (D-NH)
Cramer, Kevin (R-ND)
Carper, Tom (D-DE)
Capito, Shelley Moore (WV)
Van Hollen, Chris (MD)
McSally, Martha (AZ)
Hirono, Mazie (HI)
Hoeven, John (ND)
Gillibrand, Kirsten (NY)