Increase Competition And Access To Generics And Biosimilars
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 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. 974/H.R. 2212) and the FAST Generics Act (H.R. 2051), prohibits companies from using restricted access programs as a way to avoid generic competition.
Raise awareness and share this page in your social networks with #stopREMSabuse, #generics.
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. 974/H.R. 2212) and the FAST Generics Act (H.R. 2051).
Leahy, Patrick (VT)
Grassley, Chuck (IA)
Klobuchar, Amy (MN)
Lee, Mike (UT)
Feinstein, Dianne (CA)
McCaskill, Claire (MO)
Collins, Susan (ME)
McCain, John (AZ)
Blumenthal, Richard (CT)
Whitehouse, Sheldon (RI)
Cotton, Tom (AR)
Durbin, Richard (IL)
McKinley, David (WV)
Welch, Peter (VT-AL)
Marino, Tom (PA)
Cicilline, David (RI)
Stivers, Steve (OH)
Schrader, Kurt (OR)
DeGette, Diana (CO)
Background on REMS Sample Access (May 2017)
Myths and Facts Regarding REMS and CREATES Act (April 2017)