Vermont Business Magazine Senate Judiciary Committee members led by Ranking Member Patrick Leahy (D-Vermont) are calling on all senators to support a bipartisan amendment to benefit consumers and deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace. Leahy, joined by other leading members of the panel, filed an updated version of their bipartisan Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act as an amendment to the 21st Century Cures Act, which the Senate is debating this week.
The CREATES Act targets anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block entry of lower-cost generic drugs. The bill was introduced in June by Leahy, Chairman Chuck Grassley (R-Iowa), and Senators Amy Klobuchar (D-Minn.) and Mike Lee (R-Utah), leaders of the Subcommittee on Antitrust, Competition Policy and Consumer Rights. The Judiciary Committee also held a hearing on the issue of prescription drug prices earlier this year.
“Pharmaceutical companies should be compensated for their important work developing life-saving treatments, but predatory practices at the expense of consumers are unacceptable,” Leahy said. “As the Senate considers legislation to support healthcare innovation, we should be prioritizing the millions of consumers who deserve access to affordable drugs. The CREATES Act combats abusive behavior that drives up prescription costs. All senators should support this common sense amendment.”
“The rising price of prescription drugs is having a major impact on families and seniors everywhere. Some brand-name drug companies are engaging in anti-competitive tactics that delay entry of lower cost generic drugs into the market, and this tactic is becoming more common,” Grassley said. “We need to start taking steps to ensure that our laws are not frustrated and consumers have access to less expensive generic drugs in a timely fashion.”
“The costs of prescription drugs are just too high,” Klobuchar said. “More competition would bring the prices down, yet that competition is being blocked. Our bipartisan legislation will help bring costs down by putting an end to these unfair practices.”
“Two of the biggest problems faced by American consumers are high drug prices and burdensome regulation. The CREATES Act tackles both of these by helping put an end to abuse of a regulatory loophole by branded pharmaceutical companies that has prevented the entry of lower-cost generic alternatives to several life-saving drugs,” Lee said. “I hope this amendment is given a vote as the 21st Century Cures Act moves through the Senate.”
The CREATES Act and the amendment filed on Monday encourage name brand drug manufacturers to share product samples with generic companies in order for lower cost drugs to be approved by the Food and Drug Administration (FDA). The amendment further ensures patient safety by allowing the FDA to require additional information before approving a request for samples of high risk drugs. The original bill and the modified amendment also help generic drug companies develop safety protocols to bring their products to market. Finally, the amendment allows the FDA to more easily approve separate safety protocols.
Source: Leahy 12.6.2016. Text of amendment can be found here.