Congress Makes a New Push for the CREATES Act


This week, Senator Patrick Leahy, D-Vermont, reintroduced The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act.

This week, Senator Patrick Leahy, D-Vermont, reintroduced The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act.

The proposed legislation would allow a biosimilar or generic developer to bring a civil action against an innovator drug company if the latter refuses to make available enough samples of a product for testing. It would also explicitly empower the FDA to approve alternative Risk Evaluation and Mitigation Strategy, or REMS, programs if a generic or biosimilar developer and the innovator company are unable to arrive at a single shared system.

Both objectives are intended to allow biosimilar and generic competition to enter the market sooner, thereby driving down drug prices for US patients.

In a statement, Leahy said that, “When these companies use unfair practices to keep drug prices artificially high, patients suffer. Patients, families and government programs shouldn’t have to cope with increased drug costs to help name brand companies’ bottom lines.” He added, “Our bipartisan bill continues to gain momentum. It is precisely targeted to stop these abuses, and I’m committed to working on behalf of Vermonters in Congress to see that CREATES and other vital efforts to lower prescription drug prices are signed into law.”

The bill was first introduced by Leahy in 2016 and since then has enjoyed broad bipartisan support; senators from both sides of the aisle who have cosponsored the legislation include Rand Paul, R-Kentucky; Ted Cruz, R-Texas; Dianne Feinstein, D-California; and Amy Klobuchar, D-Minnesota, among others. The bill is also endorsed by a range of organizations, including the generics industry group Association for Accessible Medicines (AAM), AARP, the American College of Physicians, the American Hospital Association, and Consumer Reports, among others.

Furthermore, in 2018, the bipartisan Congressional Budget Office estimated that implementing the legislation would reduce spending by $3.3 billion over the 2019-2028 period and increase revenues by $600 million over the same period.

All of these facts notwithstanding, the CREATES Act has languished without a vote since its introduction. The bill has been heavily opposed by the industry group the Pharmaceutical Research and Manufacturers of America, which says that the proposed legislation would expose brand-name drug makers to significant risk and hinder innovation.

It remains to be seen whether the sitting congress will take action on the bill, but in a recent interview with The American Journal of Managed Care®, a sister site of The Center for Biosimilars®, Michael Brzica, vice president of government affairs at AAM, said that he sees a “a more significant appetite” among law makers for addressing the problem of high drug prices.

In part, said Brzica, that renewed interest in drug pricing among law makers may be driven by “a tremendous amount of media attention to the issue, either driving or in response to public concern.” These conditions, he said, amount to a “perfect storm” for legislators from both parties to feel compelled to work together on legislation that, like the CREATES Act, targets the causes of high drug prices.

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