June 24, 2016

Bipartisan Legislation Could Help Reduce Prices of Lifesaving Medications

Sens. McCain and Brown, and Rep. Schakowsky Are Leading Effort

WASHINGTON, D.C. – New legislation could help reduce costs of lifesaving medications, saving taxpayers billions, Public Citizen said today. U.S. Sens. Sherrod Brown (D-Ohio) and John McCain (R-Ariz.) joined U.S. Rep. Jan Schakowsky (D-Ill.) in the Senate and House of Representatives respectively to introduce the Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act.

The Senate-introduced legislation, S. 3094, and its companion bill in the House, H.R. 5573, would amend the Public Health Service Act to reduce the period of exclusivity provided for biologic medicines through the U.S. Food and Drug Administration (FDA) from 12 years to seven years. This would expedite biosimilar competition with originator biotech products, driving down prices for consumers and advancing access to affordable medicines for communities.

For years, the Obama administration’s budget has included a proposal to reduce the number of years of exclusivity for brand-name biologics. Biologics are medical products derived from living organisms and include many groundbreaking treatments for cancer. Under current law, the FDA cannot approve any so-called biosimilar products for a period of 12 years. The PRICED Act would help taxpayers by reducing costs of monopoly-priced prescriptions. The administration’s most recent budget projected that this step alone would save nearly $7 billion in its first decade.  

“Big pharma is holding Americans hostage, with prices for lifesaving medicines running in the tens and hundreds of thousands per person,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines program. “The inevitable result is rationing of treatment by payers, prescriptions left unfilled and pills split in half. This bill responds to consumer demands that our elected officials take real action to rein in monopoly abuses and make medicines affordable.”

Also co-sponsoring the legislation are Reps. Elijah Cummings (D-Md.), Jim McDermott (D-Wash.), Lloyd Doggett (D-Texas) and Peter Welch (D-Vt.).

According to Obama administration officials, the Trans-Pacific Partnership (TPP) trade agreement would require eight years of biologics exclusivity – an interpretation refuted by policymakers in the U.S. and other TPP countries as well as health advocates. But industry lobbyists likely will argue that the TPP precludes steps like those included in the PRICED Act.

Meanwhile, Sen. Orrin Hatch (R-Utah), chairman of the Senate Finance Committee, has refused to support the TPP unless the biologics exclusivity period can be extended beyond eight years.

“This bill shows that the appropriate period for biologic exclusivity, if any, is still being actively debated both in the U.S. and internationally,” said Burcu Kilic, an intellectual property expert with Public Citizen’s Access to Medicines program. “We should not buckle to pharma pressure to accept a long monopoly period under the TPP.”

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