"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, Commissioner, Food and Drug Administration
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
- 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.
Share your voice.
Contact your state or federal lawmaker and raise their awareness about this issue:
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 their letters and statements of support below:
National Health Council Letter of Support for CREATES Act (February 2, 2018)
Momenta Pharmaceuticals, Inc. (July 10, 2017)
Pfenex, Inc. (July 10, 2017)
Johnson Matthey (July 11, 2017)
Campaign for Sustainable Rx Pricing (July 19, 2017)
Amneal Pharmaceuticals (July 20, 2017)
CVS Health (July 24, 2017)
Coalition to Reduce Spending (July 25, 2017)
Healthcare Supply Chain Association (July 25, 2017)
FreedomWorks (July 25, 2017)
Mylan, N.V. (July 26, 2017)
BlueCross BlueShield Association (July 26, 2017)
Apotex Corporation (July 27, 2017)
American Society of Health-System Pharmacists (July 27, 2017)
Express Scripts (July 27, 2017)
Academy of Managed Care Pharmacy (July 27, 2017)
America’s Health Insurance Plans (July 27, 2017)
The Pew Charitable Trusts (July 27, 2017)
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).
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)