A number of consumer groups submitted a letter in support of S. 340, the Creating and Restoring Equal Access to Samples (CREATES) Act. Introduced by Senator Patrick Leahy (D-VT), this bill would stop abusive delaying tactics that brand name companies use to prolong their monopoly profits and keep drug prices high.
The letter was sent on behalf of Consumer Action, Consumer Federation of America, Consumer Reports, Families USA, NETWORK Lobby for Catholic Social Justice, and U.S. PIRG.
Under our current system, brand drug companies engage in a variety of anticompetitve behaviors to delay the development and market entry of more affordable generic and biosimilar drugs. The first tactic they use is to prevent potential biosimilar and generic competitors from purchasing samples of the branded drug. Without these samples, generic companies can't test their generic medicines to make sure they are equivalent to the brand drugs, which is required for approval by the Food and Drug Administration (FDA). The CREATES Act allows biosimilar and generic companies to file actions in federal court for injunctive relief so they can get the samples they need. It also gives courts the power to award damages against brand companies for egregious behavior, which will deter anticompetitive conduct.
The second tactic brand companies use is when they have prescription drugs that requires a distribution safety protocol (usually referred to as a Risk Evaluation Mitigation Strategy, or REMS) and they use this requirement as an excuse to block competition. These corporations refuse to allow generic or biosimilar companies to participate in this safety protocol. The CREATES Act solves this problem too; it gives the FDA increased power to approve alternative safety protocols so that companies can't use this excuse to deny samples.
Rising prescription drug prices are a huge problem, and Americans overwhelmingly support congressional action. According to a poll from Patients for Affordable Drugs NOW, 83% of Americans support passage of the CREATES Act. And the Congressional Budget Office has found passing the bill would save the federal government $3.9 billion over ten years, mostly by lowering Medicare and Medicaid spending on prescription drugs.
Moreover, the FDA has publicly identified a number of brand drug companies that are refusing to provide the samples needed for generic testing and development. The companies doing this include Celgene, Actelion, GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences, and Novartis Pharmaceuticals. This is not a few bad apples but a widespread problem.
Fortunately, Congress is making progress. Last week, the House Judiciary Committee approved the CREATES Act on a bipartisan voice vote. The Senate version of the bill has thirty two cosponsors, and at a Senate hearing on drug prices this morning, every committee member spoke in favor of the CREATES Act. This bill will help alleviate the problem of increasing drug prices and promote more affordable generic competition. We urge Congress to approve it without delay.